Archive for September, 2017

$MOBL Wins CyberSecurity Breakthrough Award, Application Security Solution of the Year

MOUNTAIN VIEW, Calif., Sept. 29, 2017 — MobileIron (NASDAQ:MOBL), the security backbone for the multi-cloud enterprise, today announced that MobileIron Access has been selected as winner of the Mobile Security “Application Security Solution of the Year” award from CyberSecurity Breakthrough, an independent organization that recognizes the top companies, technologies, and products in the global information security market today.

There are a variety of security risks that exist between devices and apps and the services to which they connect. For example:

  • Jailbroken device: An employee uses Office 365 mobile app to access business data from a jailbroken device. Business data is now on a hacked device.
  • Unauthorized Mac or PC: An employee syncs Google Drive files to a personal computer. Business data is now on an unsecured device.
  • Unauthorized cloud app: A salesperson downloads one of the dozens of apps that use APIs to connect to the salesforce.com cloud service. Business data is now in an unsecured mobile app.

The critical link between the mobile app and the cloud service, MobileIron Access solves these security risks by acting as a gate on the authentication path between the user and the cloud data. With MobileIron Access, only trusted users on trusted devices using trusted applications can get to that data. Untrusted users, apps, and devices are blocked.

“We believe we are the first to solve this problem and are proud to see MobileIron Access recognized by CyberSecurity Breakthrough,” said Barry Mainz, President and CEO, MobileIron. “Identity solutions and cloud gateways alone are insufficient because they lack visibility and control over the security posture of mobile devices and apps. MobileIron Access is the next generation of cloud security and lets our customers confidently expand their use of cloud services.”

The mission of the CyberSecurity Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of information security categories, including Cloud Security, Threat Detection, Risk Management, Fraud Prevention, Mobile Security, Email Security and many more. This year’s program attracted more than 2,000 nominations from over 12 different countries throughout the world. All nominations were evaluated by an independent panel of experts within the information security industry.

About MobileIron
MobileIron provides the secure foundation for companies around the world to transform into Mobile First organizations. For more information, please visit www.mobileiron.com.

About CyberSecurity Breakthrough
The CyberSecurity Breakthrough Awards program is devoted to honoring excellence in information security and cybersecurity technology companies, products and people. The CyberSecurity Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough information security companies and products in categories including Cloud Security, Threat Detection, Risk Management, Fraud Prevention, Mobile Security, Web and Email Security, UTM, Firewall and more. For more information visit www.CyberSecurityBreakthrough.com.

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$TNXP Presented at the 2nd Annual Cohen Veterans Care Summit in Washington, D.C.

NEW YORK, Sept. 29, 2017 — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company developing innovative pharmaceutical and biological products to address major public health challenges, announced today that Seth Lederman, M.D., president and chief executive officer of Tonix, presented at the 2nd Annual Cohen Veterans Care Summit that took place September 27-28, 2017, in Washington, D.C. During the Coalition to Heal Invisible Wounds Panel session of the Summit, Dr. Lederman addressed policy approaches for greater incentives to develop new medicines, with a focus on small molecule medicines, for the treatment of mental health disorders. Tonix is in Phase 3 development of Tonmya®*, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy for the treatment of PTSD.

“At Tonix, we believe in the potential for new medicines to address the psychiatric disorders that contribute to a wide range of challenges faced by society, including problems linked to inadequate treatment options for posttraumatic stress disorder,” commented Seth Lederman, president and chief executive officer of Tonix. “We are proud to be an active participant in discussions of public policy approaches in support of broader efforts to develop improved pharmacotherapies in areas of deep need, which is particularly evident for psychiatric conditions.”

*Tonmya has been conditionally accepted by the U.S. Food and Drug Administration (FDA) as the proposed trade name for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for PTSD. TNX-102 SL is an investigational new drug and has not been approved for any indication.

About the Cohen Veterans Care Summit

The Cohen Veterans Care Summit is the pre-eminent convening event for private and public sector leadership to gather and advance the Veterans Brain Health research agenda and clinical care delivery model. The Summit is jointly hosted by Cohen Veterans Bioscience and Cohen Veterans Network to advance the state of PTSD and Traumatic Brain Injury (TBI) care today and tomorrow.

About Tonmya and the Phase 3 HONOR Study

Tonmya is a patented sublingual transmucosal formulation of cyclobenzaprine that is in Phase 3 development. PTSD is a serious condition characterized by chronic disability, inadequate treatment options, especially for military-related PTSD, and an overall high utilization of healthcare services that contributes to significant economic burdens. In a Phase 2 study, Tonmya 5.6 mg (2 x 2.8 mg tablets), was found to be effective in treating military-related PTSD, which formed the basis of the Breakthrough Therapy designation granted by the FDA. Tonix is currently conducting a Phase 3 trial of Tonmya in military-related PTSD in the United States, the HONOR study, which is a multi-site 12-week randomized, double-blind, placebo-controlled trial evaluating the efficacy of Tonmya 5.6 mg in participants with military-related PTSD. This two-arm, adaptive-design trial is targeting enrollment of up to approximately 550 participants. An unblinded interim analysis will be conducted once the study has accumulated efficacy results from approximately 275 randomized participants. In a recent Cross-Disciplinary Breakthrough Therapy meeting, the FDA confirmed that (i) a single-study new drug application (NDA) approval could be possible if the topline data from the HONOR study are statistically very persuasive, and (ii) an additional abuse assessment study is not required for the NDA filing. Additional details of the HONOR study are available at www.thehonorstudy.com or https://clinicaltrials.gov/ct2/show/NCT03062540. The U.S. Patent and Trademark Office has issued a patent (U.S. Patent No. 9,636,408) protecting the composition and manufacture of the unique Tonmya formulation. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary Tonmya composition. This patent is expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034.

About Tonix Pharmaceuticals Holding Corp.

Tonix is developing innovative pharmaceutical and biological products to address major public health challenges. In addition to Tonmya for PTSD, Tonix is developing TNX-601 (tianeptine oxalate), a clinical candidate at pre-IND (Investigational New Drug) application stage, designed as a daytime treatment for PTSD and TNX-801, a live synthetic version of horsepox virus, at the pre-IND application stage, to be developed as a potential smallpox-preventing vaccine.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission (the “SEC”) on April 13, 2017, and future periodic reports filed with the SEC on or after the date hereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Contacts

Jessica Morris (investors)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(212) 980-9159

Russo Partners (media)
Rich Allan
rich.allan@russopartnersllc.com
(646) 942-5588

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$TRXC Reports Progress on Senhance FDA Submission

RESEARCH TRIANGLE PARK, N.C.

– Files additional information response with FDA
– Continues to expect 510(k) clearance in 2017

TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has filed its response to the Food and Drug Administration’s (“FDA”) Additional Information (“AI”) request related to the Company’s Senhance Surgical Robotic System 510(k) submission.

“We are very pleased to have submitted our AI response ahead of schedule, demonstrating our team’s effectiveness and our ongoing collaboration with the FDA,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “The submission of our response is a key step towards achieving 510(k) clearance for the Senhance, which we continue to expect in 2017.”

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The Company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

Forward-Looking Statements

This press release includes statements relating to our second quarter 2017 results, the Senhance™ Surgical Robotic System and our current regulatory and commercialization plans for this product. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including, whether the Senhance 510(k) will achieve clearance in 2017, if at all. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2016, which was filed on March 6, 2017, and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

 

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
or
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com

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$ZGNX Positive Top-line Results Phase 3 Clinical of ZX008 in Dravet Syndrome

Primary Endpoint Achieved – Statistically Significant Convulsive Seizure Reduction for ZX008 versus Placebo for Adjunctive Treatment of Seizures

ZX008 Also Demonstrated Statistical Significance in All Key Secondary Endpoints

Zogenix to Host Conference Call Today at 8:30 AM Eastern Time/5:30 AM Pacific Time

EMERYVILLE, Calif., Sept. 29, 2017 — Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today reported positive top-line results from its first Phase 3 trial (Study 1) for its investigational drug, ZX008 (low-dose fenfluramine hydrochloride), for the treatment of Dravet syndrome. The trial met its primary objective of demonstrating that ZX008, at a dose of 0.8 mg/kg/day, is superior to placebo as adjunctive therapy in the treatment of Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period (p<0.001).  ZX008 0.8 mg/kg/day also demonstrated statistically significant improvements versus placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval. The same analyses comparing a 0.2 mg/kg/day ZX008 dose versus placebo also demonstrated statistically significant improvement compared with placebo.

“Dravet syndrome is a rare, but catastrophic form of epilepsy that can be devastating for patients and their families,” said Joseph Sullivan M.D., director of the Pediatric Epilepsy Center in UCSF Benioff Children’s Hospital San Francisco, and Principal Investigator of Study 1 in the U.S. “These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of low-dose fenfluramine for patients with Dravet syndrome. If approved, ZX008 could play an important role in treating this devastating condition.”

The randomized, double blind, placebo controlled, Phase 3 study enrolled 119 patients across sites in the United States, Canada, Europe, and Australia. The median age of patients was 8 years (range, 2-18 years). Following a six-week baseline observation period, patients were randomized to one of three treatment groups: ZX008 0.8 mg/kg/day (30 mg maximum daily dose; n=40), ZX008 0.2 mg/kg/day (n=39) and placebo (n=40) in which ZX008 or placebo was added to current regimens of antiepileptic drugs. Patients were titrated to their target dose over two weeks and then remained at that fixed dose for 12 weeks. The mean baseline convulsive seizure frequency across the study groups was approximately 40 seizures per month.

The primary efficacy measure was a comparison of the change in mean monthly convulsive seizure frequency between ZX008 0.8 mg/kg/day and placebo during the 14-week treatment period compared with the 6-week baseline observation period. Patients taking ZX008 0.8 mg/kg/day achieved a 63.9% reduction in mean monthly convulsive seizures compared to placebo (p<0.001). The median percent reduction in monthly convulsive seizure frequency was 72.4% among ZX008 0.8 mg/kg/day patients compared to 17.4% in placebo patients.

A key secondary endpoint was the same analysis for a comparison of ZX008 0.2 mg/kg/day and placebo. Patients taking ZX008 0.2 mg/kg/day achieved a reduction in mean monthly convulsive seizures of 33.7% compared to placebo (p=0.019). Collectively, these top-line data suggest a dose-response relationship for ZX008 in the adjunctive treatment of convulsive seizures in Dravet syndrome.

Additional key secondary objectives of the study were to compare 0.8 mg/kg/day and 0.2 mg/kg/day ZX008 (independently) with placebo in terms of (1) the proportion of patients who achieved ≥50% reductions in monthly convulsive seizures and (2) the median of the longest convulsive seizure-free interval. These results are shown in the following table. The proportion of patients who achieved ≥75% seizure reductions, a secondary efficacy measure, is also presented.

ZX008 0.8
mg/kg/day
(N=40)
ZX008 0.2
mg/kg/day
(N=39)
Placebo
(N=40)
Patients with ≥50%
reduction in monthly
convulsive seizures
70.0%
(p<0.001)
41.0%
(p=0.001)
7.5 %
Patients with ≥75%
reduction in monthly
convulsive seizures
45.0%
(p=0.001)
20.5%
(p=0.033)
2.5 %
Longest seizure-free
interval (median)
20.5 days
(p<0.001)
14 days
(p=0.011)
9 days

ZX008 was generally well-tolerated in this study with the adverse events consistent with the known safety profile of fenfluramine. The incidence of treatment emergent adverse events was higher in the treatment groups as compared to the placebo group, with 95% (n=38) of patients in the 0.8mg/kg/day group and 94.9% (n=37) of patients in the 0.2 mg/kg/day group experiencing at least one treatment emergent adverse event compared to 65.0% (n=26) of patients in the placebo group. The incidence of serious adverse events was similar in all three groups with 12.5% (n=5) of patients in the 0.8 mg/kg/day group and 10.3% (n=4) of patients in the 0.2 mg/kg/day group experiencing at least one treatment emergent serious adverse event compared to 10.0% (n=4) of patients in the placebo group. Five patients in the 0.8 mg/kg/day group had an adverse event leading to study discontinuation compared to none in the other treatment groups. Prospective cardiac safety monitoring throughout the study demonstrated no clinical or echocardiographic evidence of cardiac valvulopathy or pulmonary hypertension.

“On behalf of everyone at Zogenix, I would like to extend my sincere appreciation to the patients, families and investigators involved in this study. We are extremely pleased with the top-line efficacy and safety results from Study 1 which reinforce the potential of ZX008 to be an important new treatment for seizure control in children with Dravet syndrome.  We look forward to presenting further data in future publications and at medical conferences,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix.  “We expect top-line results from our second pivotal Phase 3 trial, Study 1504, which is nearing full enrollment, in the first half of 2018. We remain on track to submit applications for regulatory approvals in the U.S. and Europe in the second half of 2018.”

ZX008 is designated as an orphan drug in both the U.S. and Europe, and has received Fast Track designation in the U.S. for the treatment of Dravet syndrome.

Conference Call Details
Friday, September 29 @ 8:30 AM Eastern Time/5:30 AM Pacific Time
Toll Free: 888-455-2265
International: 719-457-2627
Conference ID: 7770264
Webcast: http://public.viavid.com/index.php?id=126480
Audio Replays, available through October 13, 2017:
Domestic: 844-512-2921
International: 412-317-6671
Replay PIN: 7770264

About Zogenix

Zogenix (Nasdaq:ZGNX) is focused on developing therapies for patients with rare central nervous system (CNS) conditions that have limited or no treatment options but face a critical need. For more information, visit www.zogenix.com.

About the ZX008 Dravet Syndrome Global Development Program

Study 1 is a prospective merged analysis of two identical double-blind, placebo-controlled studies, ZX008-1501 (US/Canada) and ZX008-1502 (Europe/Australia), designed to enroll approximately 40 patients per treatment group and includes patients from sites in the United States, Canada, Europe, and Australia.  A total of 119 patients were randomized into one of two dose groups of ZX008, 0.2 and 0.8 milligrams per kilogram per day, or placebo.  After a six-week baseline period, randomized subjects were titrated to their target dose over two weeks, and then held to that fixed dose for 12 weeks of maintenance treatment. The primary objective of the study was to demonstrate that ZX008 at the high dose is superior to placebo in controlling seizures based on the change in the frequency of convulsive seizures between baseline and the combined titration and maintenance periods.  The percent of patients who achieve equal or greater than a 50% reduction in convulsive seizures, and measurement of the longest seizure-free interval, were key secondary endpoints.  Patients who complete Study 1 are eligible to enter a long-term, open-label extension study.

Zogenix is conducting a second double-blind, randomized, two-arm pivotal Phase 3 trial, Study 1504, in which all patients will be taking stiripentol, valproate and clobazam as part of their baseline standard care.  In February 2017, the Company announced the initiation of the safety and efficacy portion of Study 1504, which compares a single dose of ZX008 versus placebo across the titration and 12-week maintenance periods.  Study 1504 will enroll 40 patients per treatment group.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding ZX008’s potential as a treatment for seizures associated with Dravet syndrome; the timing of topline results from Study 1504; and regulatory submission timelines for ZX008. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: the top-line data Zogenix has reported is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA may not agree with Zogenix’s interpretation of such results; the uncertainties associated with the clinical development and regulatory approval of product candidates such as ZX008, including potential delays in the enrollment and completion of clinical trials; the potential that earlier clinical trials and studies may not be predictive of future results; Zogenix’s reliance on third parties to conduct its clinical trials, enroll patients, manufacture its preclinical and clinical drug supplies; unexpected adverse side effects or inadequate therapeutic efficacy of ZX008 that could limit approval and/or commercialization, or that could result in recalls or product liability claims; Zogenix’s ability to fully comply with numerous federal, state and local laws and regulatory requirements, as well as rules and regulations outside the United States, that apply to its product development activities; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

CONTACT:

Investors:
Andrew McDonald
Founding Partner, LifeSci Advisors LLC
646-597-6987 | Andrew@lifesciadvisors.com

Media:
David Polk
Senior Media Relations Strategist, INC Research/inVentivHealth
310-309-1029 | david.polk@inventivhealth.com

University of California, San Francisco:
Suzanne Leigh
Senior Public Information Representative, Strategic Communications & University Relations
415-476-2993   Cell: 415-680-5133   Suzanne.Leigh@ucsf.edu

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$CIIX NetworkNewsWire Publication on Investment Opportunities in the Cannabis Industry

NEW YORK, NY–(Sep 29, 2017) –  NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company, today announces the publication of an editorial featuring ChineseInvestors.com, Inc. (OTCQB: CIIX), a client of NNW recognizing unprecedented opportunities in the U.S. cannabis industry and laying the groundwork to capitalize on growing demand for cannabidiol (CBD)-based nutrition and health products.

The publication is titled, “Cannabis Companies Demonstrate the Diverse Nature of the Global Marijuana Market.” It discusses various public companies across multiple sectors that are getting their share of the profitable marijuana market.

To view the full publication, visit: https://www.networknewswire.com/cannabis-companies-demonstrate-diverse-nature-global-marijuana-market/

ChineseInvestors.com, Inc. (CIIX) is staking its position in the market with several product lines, including hemp-infused skin care products. Cannabis is known to have anti-inflammatory and antioxidant properties. The company noted the benefits in this area in an August 2017 press release (http://nnw.fm/z9WPp). They include improvements to skin complexion, thanks to the omega-3 and omega-6 fatty acids present in hemp seed oil. The fatty acids help keep skin moist and stimulate collagen production, helping skin to become firmer. In fact, the human endocannabinoid system includes cannabinoid receptors in the skin.

“Fully aware of the demand for medical cannabis, CIIX has worked to improve the user experience as well. It has developed an investing process, known as the ChineseInvestors Method, and introduced various web-based tools to disseminate market information to investors. That puts investors on the front lines of China’s $30 billion per year skin care product industry.

“The company also developed and launched a Chinese-language social media app, approved for download via the Apple App Store. It enables users to view, discuss, and write reviews on cannabis strains and marijuana dispensaries. People can use the application’s maps to find retailers, view business summary reports and see product recommendations.”

About ChineseInvestors.com

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 and online sales of hemp-based products and other health related products. For more information visit www.ChineseInvestors.com.

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information please visit https://www.NetworkNewsWire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

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.

NNW Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

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$SPPI Poziotinib Data in Lung Cancer Presented at 18th IASLC World Conference

HENDERSON, Nev.

Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced the release of an abstract from a clinical study evaluating poziotinib in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer (NSCLC) by scientists from The University of Texas MD Anderson Cancer Center, the sponsor of the trial. This abstract contains limited data as of the submission deadline of June 21, 2017. Additional data from their clinical experience and the ongoing Phase 2 study will be released in an oral presentation at the 18th International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in Yokohama, Japan, October 15-18, 2017.

Wednesday, October 18th, 2017:

Abstract # Type Title First Author/Presenting Author Time
10369 Oral The Preclinical and Clinical Activity of Poziotinib, a Potent, Selective Inhibitor of EGFR Exon 20 Mutant NSCLC Elamin, Heymach 11:00 AM-11:10 AM JST

Abstract #10369: The Preclinical and Clinical Activity of Poziotinib, a Potent, Selective Inhibitor of EGFR Exon 20 Mutant NSCLC

Background

Approximately 10% of EGFR mutant NSCLCs have an insertion/mutation in exon 20 of EGFR resulting in primary resistance to currently available tyrosine kinase inhibitors (TKIs). We previously reported that the structural features of poziotinib could potentially enable it to circumvent the steric hindrance induced by exon 20 mutations. Here we further characterize the preclinical activity of poziotinib and report on initial clinical activity of poziotinib in patients EGFR exon 20 mutations from an ongoing phase II study.

Methods

We evaluated poziotinib activity in vitro using human NSCLC cell lines and the BAF3 model as well as several patient-derived xenograft (PDX) models and genetically engineered mouse models (GEMMs) of exon 20 insertion. We launched a phase 2 investigator-initiated trial of poziotinib in patients with metastatic NSCLC with EGFR exon 20 insertions (NCT03066206).

Results: In vitro poziotinib was approximately 100x more potent than osimertinib and 40x more potent than afatinib against a common panel of EGFR exon 20 insertions. Furthermore, it had ~65-fold greater potency against common exon 20 insertions compared with EGFR T790M mutations; 3rd generation inhibitors osimertinib, EGF816, and rociletinib were all significantly less potent for exon 20 mutations/insertions compared with T790M. in vivo poziotinib led to >85% reduction in tumor burden in GEM models of EGFR exon 20 insertion (D770insNPG) NSCLC and the PDX model LU0387 (H773insNPH).

To date, 8 platinum-refractory patients with EGFR exon 20 insertion mutation metastatic NSCLC have been enrolled in the clinical trial and treated with poziotinib at a dose of 16 mg PO daily. Two patients have reached the first interval-imaging time point (at 8 weeks of therapy per protocol). Both patients exhibited dramatic partial response, with one patient reporting improvement in dyspnea and cough at one week of therapy. In this early stage of the study, one case of grade 3 paronchycia was observed. One additional platinum- and erlotinib-refractory patient with EGFR exon 20 insertion was treated with poziotinib on compassionate basis. The patient achieved partial response after three weeks of treatment.

Conclusion: Poziotinib has selective activity against EGFR exon 20 mutations and potent activity in cell lines, PDX, and GEM models. Three platinum-refractory patients with EGFR exon 20 mutations have been treated thus far and are evaluable for response; all three had partial responses at the time of the initial scan. Updated data from the ongoing phase 2 clinical trial of poziotinib will be presented at the meeting.

About Poziotinib

Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license to develop, manufacture and commercialize worldwide excluding Korea and China from Hanmi Pharmaceuticals.

About the WCLC

The World Conference on Lung Cancer (WCLC) is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting over 6,000 researchers, physicians and specialists from more than 100 countries. The goal is to disseminate the latest scientific achievements; increase awareness, collaboration and understanding of lung cancer; and to help participants implement the latest developments across the globe. Organized under the theme of “Synergy to Conquer Lung Cancer,” the conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit http://wclc2017.iaslc.org/.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company. Spectrum’s strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.

Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum’s business and its future, including certain company milestones, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.® is a registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

© 2017 Spectrum Pharmaceuticals, Inc. All Rights Reserved

Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com

Thursday, September 28th, 2017 Uncategorized Comments Off on $SPPI Poziotinib Data in Lung Cancer Presented at 18th IASLC World Conference

$AEHR Receives Follow-on Orders for FOX-XP™ Test and Burn-in Solution

FREMONT, Calif., Sept. 28, 2017 — Aehr Test Systems (NASDAQ:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced that it has received follow-on orders totaling $2.7 million from a subcontractor of its initial lead FOX-XPTM Test and Burn-in System customer. The orders include a partially populated FOX-XP system, multiple DiePak® Carriers for their next generation devices and multiple FOX DiePak Loader/Unloaders to increase their current production capacity.

Gayn Erickson, President and CEO of Aehr Test Systems, commented, “We are excited to receive these additional follow-on orders from this large multinational customer for their production test/burn-in requirements. The new orders build on an existing device test/burn-in implementation at this customer now moving into volume production, which continues to expand our production presence for multiple generations of devices.

“The FOX-XP system’s unique capability to deliver thousands of test resources to each DiePak Carrier loaded in the FOX-XP system makes it appropriate for volume test/burn-in production of high power small footprint devices such as those being produced by this customer. In addition, the system is capable of heating or cooling devices while in test/burn-in using a proprietary design, which can handle up to 2 kW of heat energy per DiePak Carrier to ensure that each device’s desired junction temperature is maintained very accurately. Another advantage of the FOX-XP system design is the integrated autoloader option, which handles device loading/unloading of the DiePak Carrier in high volume production.

“We believe that the FOX-XP system’s capabilities and our cost-effectiveness for high volume singulated device test/burn-in differentiate Aehr Test from the competition and enable us to address our customer’s current and next generation devices requirements.”

The FOX-XP system, available with multiple WaferPakTM Contactors (full wafer test) or multiple DiePak Carriers (singulated die/module test) configurations, is capable of functional test and burn-in/cycling of integrated optical devices, 2D and 3D sensors, magnetic sensors, flash memories, microcontrollers, and other leading-edge ICs in either wafer form, before they are assembled into single or multi-die stacked packages, or in singulated die or module form.

A single FOX-XP test system may be configured with up to 18 Blades of wafer test resources, enabling up to 18 wafers to be tested simultaneously handling 1 kW each, or 9 wafers or DiePak Carriers at up to 2 kW each. Each Blade may be configured with up to eight Channel Modules of test resources. These Channel Modules may be: Universal Channel Channel Modules (UCCMs), High Current Channel Modules (HCCMs), or High Voltage Channel Modules (HVCMs) to supply device stimulus to test/burn-in/cycle die or modules. The footprint of the 18-wafer test system is similar to the footprint of typical semiconductor Automatic Test Equipment (ATE) that can only test one wafer at a time.

The FOX-XP system’s FOX WaferPak Contactor provides a cost-effective solution for making full wafer electrical die contact in a multi-wafer environment and may contain up to tens of thousands of probes to contact all die simultaneously on wafers and substrates up to 300mm. The DiePak® Carrier provides a cost-effective solution for making both thermal and electrical singulated die/module test contact in a multi-DiePak Carrier environment and may contain up to thousands of contacts to test/burn-in 100’s of devices on a single DiePak Carrier. Other key components of a FOX-XP test cell are the FOX WaferPak Aligner, which provides fully automatic alignment of the customer’s wafers to the WaferPak Contactor, and the FOX DiePak Loader/Unloader, which enables fully automatic handling of device exchanges with the DiePak Carriers.

About Aehr Test Systems
Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic, optical and memory integrated circuits and has an installed base of more than 2,500 systems worldwide. Increased quality and reliability needs of the Automotive and Mobility integrated circuit markets are driving additional test requirements, incremental capacity needs, and new opportunities for Aehr Test products in package, wafer level, and singulated die/module level test.  Aehr Test has developed and introduced several innovative products, including the ABTSTM and FOX-PTM families of test and burn-in systems, the FOX WaferPak Aligner, the FOX DiePak Loader/Unloader, the FOX WaferPak Contactor, and the FOX DiePak® Carrier.  The ABTS system is used in production and qualification testing of packaged parts for lower power and higher power logic devices as well as all common types of memory devices. The FOX-XPTM system is a full wafer contact and singulated die/module test and burn-in system used for burn-in and functional test of complex devices, such as leading-edge memories, digital signal processors, microprocessors, microcontrollers, systems-on-a-chip, and integrated optical devices.  The WaferPak Contactor contains a unique full wafer probe card capable of testing wafers up to 300mm that enables IC manufacturers to perform test and burn-in of full wafers on Aehr Test FOX systems.  The DiePak Carrier is a reusable, temporary package that enables IC manufacturers to perform cost-effective final test and burn-in of both bare die and modules. For more information, please visit Aehr Test System’s website at www.aehr.com.

Safe Harbor Statement
This press release contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve risks and uncertainties. These statements are based on information available to Aehr Test as of the date hereof and actual results could differ materially from those stated or implied due to risks and uncertainties. Forward-looking statements include statements regarding Aehr Test’s expectations, beliefs, intentions or strategies regarding the FOX products, including statements regarding future market opportunities and conditions, expected product shipment dates and customer orders or commitments. These risks and uncertainties include, without limitation, acceptance by customers of the FOX and WaferPak Contactor technologies, acceptance by customers of the FOX-XP system, WaferPak Aligners, DiePak Loader/Unloaders, WaferPak Contactors and DiePak Carriers shipped upon receipt of a purchase order and the ability of new products to meet customer needs or perform as described, as well as general market conditions, customer demand and acceptance of Aehr Test’s products and Aehr Test’s ability to execute on its business strategy. See Aehr Test’s recent 10-K, 10-Q and other reports from time to time filed with the Securities and Exchange Commission for a more detailed description of the risks facing Aehr Test’s business. Aehr Test disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

Contacts:

Aehr Test Systems  
Carl Buck
V.P. of Marketing
(510) 623-9400 x381
cbuck@aehr.com

MKR Group Inc.
Todd Kehrli or Jim Byers
Analyst/Investor Contact
(323) 468-2300
aehr@mkr-group.com

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$EXA to be Acquired by Dassault Systèmes

  • Transaction valued at approximately $400 million or $24.25 per share
  • Proven Technology and Industrialized Solutions Will Be Available to Customers in All Industries

BURLINGTON, Mass., Sept. 28, 2017 — Exa® Corporation (NASDAQ:EXA), a global innovator in simulation software for product engineering, today announced that its Board of Directors has unanimously agreed to be acquired by Dassault Systèmes in a transaction valued at approximately $400 million or $24.25 per share.

Headquartered in Paris, France and Boston, Massachusetts, Dassault Systèmes (www.3ds.com) provides business and people with virtual universes to imagine sustainable innovations.  Its world-leading solutions transform the way products are designed, produced, and supported.  Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world.  The group brings value to over 220,000 customers of all sizes, in all industries, in more than 140 countries.

With the addition of Exa, Dassault Systèmes’ 3DEXPERIENCE platform will provide customers with a proven portfolio of Lattice Boltzmann fluid simulation technologies, fully industrialized solutions and over 350 highly experienced simulation professionals.

Simulation of fluid flow, such as the cooling of an engine or the lift of a wing, is a necessary component of simulating the physical behavior of products, nature and life. For the many situations where fluid flow conditions change rapidly, simulation of dynamically variable flows is critical to accurate assessments of a product and its behavior in its environment. For these applications, the combination of Exa’s accuracy and timeliness provides results that are superior to those of alternative CFD methods.

“Exa’s unique Lattice Boltzmann simulation technology combined with our extensive professional and industry expertise has enabled us to deliver significant value to the leading companies in the global transportation and other flow-based product industries,” said Stephen Remondi, President and Chief Executive Officer of Exa. “We can solve the most challenging fluids problems faster and more accurately than traditional methods for aerodynamics, aeroacoustics, thermal management and other fluids-related applications. The combination of Exa with Dassault Systèmes’ 3DEXPERIENCE platform will provide Exa with the critical mass of manpower and technology required to accelerate the delivery of our shared vision of driving the value of digital engineering knowledge, enabling everyone in the value chain to access the power of simulation for critical business decisions.”

“Both Dassault Systèmes and Exa believe in the value of an integrated focus on science and industry. It is a critical part of our commitment to delivering 3DEXPERIENCE universes that harmonize products, nature and life. Simulation of dynamic fluid flow is an important part of our multiphysics and multiscale simulation strategy,” said Bernard Charlès, Vice Chairman and CEO, Dassault Systèmes. “With Exa’s valuable application knowledge in transportation and mobility and other industry verticals, we will accelerate our delivery of industry solution experiences to benefit our existing and future customers.”

Benefits of the transaction

  • Enhanced Customer Value. The complementary strengths and combined expertise of both companies enables the delivery of the power of digital engineering throughout the value chain, leading to dramatic increases in engineering and manufacturing productivity.
  • Improved Collaboration. Combining the two companies will greatly enhance collaboration with customers, and facilitate the ability to offer integrated solutions and simplify both commercial and technical interactions.
  • Accelerated Delivery of a Shared Vision. As one company, Exa and Dassault Systèmes will continue to deliver innovative new 3D technologies for design, engineering, CAD, modeling, simulation, and data and process management.

Under the terms of the merger agreement, a subsidiary of Dassault Systèmes will commence a  tender offer within the next 10 business days to acquire all of the issued and outstanding shares of Exa common stock for a price of $24.25 per share payable in cash upon completion of the offer. This represents a fully diluted equity value for Exa of approximately $400 million.

Completion of the transaction is subject to customary closing conditions, including required regulatory approvals. The acquisition is expected to close in the fourth quarter of 2017, subject to the satisfaction of customary closing conditions.

Today’s Conference Call Information

Today, Thursday, September 28, 2017, Dassault Systèmes will host a conference call at 11:30 AM New York time/ 4:30 PM London time/ 5:30 PM Paris time. The conference call will be available via the Internet by accessing http://www.3ds.com/investors/. Please go to the website at least 15 minutes prior to the webcast or conference call to register, download and install any necessary audio software. The webcast and conference call will be archived for one year.

Stifel, Nicolaus & Company, Inc. acted as financial advisor and Foley Hoag LLP as legal counsel to Exa in connection with the transaction.

About Exa Corporation

Exa (NASDAQ:EXA) (www.exa.com) Corporation’s visualization and simulation software helps designers and engineers produce better vehicles and equipment. As a design evolves, Exa accurately predicts the performance of that design while providing actionable insight to optimize the performance of the product. With Exa, the need for costly physical prototypes and expensive late-stage changes is reduced.

Now, designers and engineers are freed from the risk of producing compromised products that do not meet market and regulatory requirements. Some of the most successful product companies in the world use Exa, including BMW, Delphi, Denso, Fiat Chrysler, Ford, Hino, Honda, Hyundai, Jaguar Land Rover, Kenworth, Komatsu, MAN, Nissan, Peterbilt, Peugeot, Renault, Scania, Toyota, Volkswagen and Volvo Trucks.

Founded in 1991, the company is headquartered at 55 Network Drive, Burlington, MA, USA 01803. Tel: 1.781.564.0200; Fax: 1.781.564.0299; Email: info@exa.com; URL: www.exa.com; (NASDAQ:EXA)

Important Additional Information Will Be Filed with the Securities and Exchange Commission

The tender offer to be commenced by a subsidiary of Dassault Systèmes for shares of common stock of Exa has not yet commenced, and this press release is neither an offer to purchase nor a solicitation of an offer to sell shares of Exa. At the time the tender offer is commenced, Dassault Systèmes will file with the Securities and Exchange Commission (“SEC”) and mail to Exa’s stockholders a Tender Offer Statement and Exa will file with the SEC and mail to its stockholders a Tender Offer Solicitation/Recommendation Statement in connection with the transaction. These documents will contain important information about Dassault Systèmes, Exa, the transaction and other related matters. Investors and security holders are urged to read each of these documents carefully when they are available. Investors and security holders will be able to obtain free copies of the Tender Offer Statement, the Tender Offer Solicitation / Recommendation Statement and other documents filed with the SEC by Dassault Systèmes and Exa through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of these documents  by writing to Exa Corporation, 55 Network Drive, Burlington, Massachusetts 01803, [attention: Investor Relations].

Cautionary Statement Regarding Forward-Looking Statements

Forward-looking statements made herein with respect to the tender offer and related transactions, including, for example, the timing of the completion of the tender offer and the subsequent merger contemplated by the agreement and plan of merger between Exa and Dassault Systèmes, which we refer to as the merger agreement, or the potential benefits of the tender offer and the merger, reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, the actual outcome of this transaction may differ materially from Exa’s expectations.

The following factors, among others, could cause actual plans and results to differ materially from those described in forward-looking statements. Such factors include, but are not limited to, the effect of the announcement of the tender offer and related transactions on the Exa’s business relationships, operating results and business generally; the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement, and the risk that the merger agreement may be terminated in circumstances that require Exa to pay a termination fee; the outcome of any legal proceedings that may be instituted against Exa or its board of directors related to the transactions contemplated by the merger agreement, including the tender offer and the merger; uncertainties as to the number of Exa stockholders who may tender their stock in the tender offer; the failure to satisfy other conditions to consummation of the tender offer or the merger, including the receipt of regulatory approvals related to the merger (and any conditions, limitations or restrictions placed on these approvals); risks that the tender offer and related transactions disrupt current plans and operations and the potential difficulties in employee retention as a result of the proposed transactions; the effects of local and national economic, credit and capital market conditions on the economy in general, and other risks and uncertainties; and those risks and uncertainties discussed from time to time in Exa’s other reports and other public filings with the SEC.

Additional information concerning these and other factors that may impact the Exa’s expectations and projections can be found in its periodic filings with the SEC, including its Annual Report on Form 10-K for the year ended January 31, 2017. Exa’s SEC filings are available publicly on the SEC’s website at www.sec.gov, on Exa’s website (www.exa.com) under the heading “Company–Investor Relations” or upon request by writing to Exa at Exa Corporation, 55 Network Drive, Burlington, Massachusetts 01803, attention: Investor Relations. Exa disclaims any obligation or undertaking to update or revise the forward-looking statements contained herein, whether as a result of new information, future events or otherwise.

For inquiries, please contact:
Garo Toomajanian, ICR Incorporated, Tel: +1 617-956-6728
E-mail: Garo.Toomajanian@icrinc.com
Suresh Sundaram, Exa Corporation, Tel: +1 617-388-6841
E-mail: suresh@exa.com

Thursday, September 28th, 2017 Uncategorized Comments Off on $EXA to be Acquired by Dassault Systèmes

$ZYNE Positive Top Line Results in ZYN002 Open Label Phase 2

ZYN002 successfully met the primary endpoint and showed clinically meaningful improvements

Zynerba to host conference call and webcast today, September 28 at 8:30 am ET

DEVON, Pa., Sept. 28, 2017 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative pharmaceutically-produced transdermal cannabinoid treatments, today announced positive top line results from an open label exploratory Phase 2 FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial evaluating ZYN002 cannabidiol (CBD) gel in pediatric and adolescent patients with Fragile X syndrome (FXS). The study successfully met its primary endpoint, achieving a 46% improvement (p<0.0001) in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week twelve compared to baseline. ZYN002 also achieved clinically meaningful improvements in all measures of the Aberrant Behavior Checklist for Fragile X (ABC-FXS), which address the key symptoms of FXS including social avoidance, temper tantrums, repetitive movements, and hyperactivity.

“The data from the FAB-C trial are very exciting and demonstrate that ZYN002 may have a profound effect on improving many of the most disabling symptoms of Fragile X, such as anxiety and difficult behaviors,” said Steven Siegel, MD, PhD Professor and Chair, Psychiatry and Behavior Sciences, Keck School of Medicine of USC. “Fragile X is a challenging genetic autism spectrum disorder, with complex symptomatology that significantly impacts patients and their families. Many children with Fragile X and their families struggle with the lack of approved drugs to safely treat their symptoms. This study suggests that ZYN002 is ready for the next phase of development, and I believe that this drug holds great promise as a potential treatment for these very difficult-to-treat symptoms.”

With these data, Zynerba anticipates that it will meet with the U.S. Food and Drug Administration (FDA) in the first half of 2018 with the goal of moving quickly into a pivotal Phase 2/3 program in pediatric and adolescent patients with FXS in 2018. The FDA has granted Zynerba Orphan Drug designation for the use of CBD as treatment of patients with FXS. Orphan Drug designation is granted to novel drugs that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S., and provides benefits including a seven-year period of U.S. marketing exclusivity upon marketing approval for the designated indication and may provide a rapid path to market authorization.

“We are thrilled with the positive clinical results of ZYN002 in the FAB-C trial; it is a major step forward for the hundreds of thousands of patients worldwide with Fragile X who currently have no approved therapeutic options to treat their symptoms,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “The clinically meaningful improvements in Fragile X symptoms and the excellent tolerability seen in the FAB-C trial are compelling. These data will allow us to discuss the pathway to approval in a meeting with the FDA, which we expect to take place during the first half of 2018. I want to thank the patients, families, physicians, study coordinators, and the Zynerba team for their support of this important study.”

“The symptoms of Fragile X can be overwhelming to a patient and caregiver, so I’m very enthusiastic about the responses to ZYN002 that we saw during this study,” said Honey Heussler, FRACP, Associate Professor at Children’s Health Queensland, Medical Director Child Development and lead investigator in the FAB-C study. “These data are extremely promising, particularly the improvements in anxiety, social avoidance, and irritability as measured by scales including ADAMS, ABC-FXS, and PARS-R. Tolerability is essential in these patients, so I’m very pleased to see that ZYN002 was well tolerated in Fragile X patients.”

Study Design
Twenty patients (3:1 males) aged 6 to 17 years of age (mean = 10.7) with Fragile X as confirmed by molecular documentation of FMR1 full mutation were enrolled in the open label FAB-C study. ZYN002 was added on to other medications being administered. The first six weeks of the study were designed to titrate dosing in patients. Dosing was initiated at 50 mg daily and could be increased to 250 mg daily. Weeks 7 through 12 of the study was a maintenance period where patients were treated at the dose established at week six. At the completion of the study, patients could enter an open label extension study for up to 12 months.

Top-line data: Primary endpoint
The primary endpoint for the trial was the change in the total score of the Anxiety, Depression, and Mood Scale (ADAMS) from baseline to week 12. The ADAMS is a 28-item scale designed to assess general anxiety, social avoidance, compulsive behavior, manic/hyperactive behavior, and depressed mood. It has been validated in patients with FXS.

Results for the primary endpoint are summarized as follows:

Baseline Week 12 Change in Score % improvement p Value
ADAMS: Total Score 33.4 18.1 -14.1 45.81 % <0.0001

 

The subscales of ADAMS are as follows:

Baseline Week 12 Change in Score % Improvement p Value
ADAMS:  General Anxiety Subscale 10.0 4.6 -4.8 54.00 % <0.0001
ADAMS:  Social Avoidance Subscale 10.2 4.8 -5.1 52.94 % 0.0002
ADAMS: Compulsive Behavior Subscale 2.8 1.4 -1.2 50.00 % 0.0262
ADAMS: Manic / Hyperactive Behavior Subscale 9.4 6.1 -2.7 35.11 % 0.0003
ADAMS: Depressed Mood Subscale 2.8 2.0 -0.9 28.57 % 0.1417

 

Top-line data: Secondary endpoints
The Company evaluated multiple secondary endpoints including the Aberrant Behavior Checklist – FXS Specific (ABC-FXS), a Clinical Global Impression of Improvement (CGI-I), the Pediatric Anxiety Rating Scale (PARS-R), Visual Analog Scales for Anxiety, Hyperactivity and Tantrum/Mood Lability, the Vineland Adaptive Behavior III, a Quality of Sleep measurement and the Pediatric Quality of Life (PedsQL™). The results of the secondary endpoints reinforce the results demonstrated in the ADAMS.

Results from the ABC-FXS are summarized as follows:

Baseline Week 12 Change in Score  % improvement p Value
ABC: Irritability – “Has Temper Tantrums” 18.2 10.6 -7.1 41.76 % 0.0096
ABC: Hyperactivity – “Disrupts Group Activities” 14.5 9.7 -4.1 33.10 % 0.0194
ABC: Socially Unresponsive/Lethargic –  “Does Not Pay Attention” 8.7 4.1 -5.1 52.87 % 0.0034
ABC: Social Avoidance – “Seeks Isolation” 5.1 2.3 -2.8 54.90 % 0.0005
ABC: Stereotypy –  “Repetitive Movements” 7.9 3.2 -4.9 59.49 % 0.0006
ABC: Inappropriate Speech – “Repeats Words or Phrases” 6.1 3.5 -2.4 42.62 % 0.0018

 

Safety data
ZYN002 was shown to be very well tolerated, and the safety profile was consistent with previously released data from clinical trials. Two patients discontinued due to worsening of pre-existing eczema. Four other patients experienced an adverse event. No adverse events were considered severe. No patient experienced drug-related GI events during the 12-week treatment period, and no THC was detected in the plasma. Thirteen of the 18 patients who completed the study have enrolled in the open label extension.

Conference call information
Zynerba management will host a live conference call and webcast today at 8:30 am Eastern Time to discuss the results of this clinical trial. The call can be accessed by dialing (866) 573-0180 (U.S. and Canada) or (430) 775-1345 (international) and referencing conference ID 90858811. To access the live webcast or the replay, visit the investor page of the Company’s website at http://ir.zynerba.com/. The webcast will be recorded and available on the Company’s website for 30 days.

About Fragile X syndrome
Fragile X syndrome is an autism spectrum disorder affecting 1 in 4,000 males and 1 in 8,000 females. It is the most common inherited intellectual disability in males and a significant cause of intellectual disability in females. It is caused by a mutation in the Fragile X Mental Retardation gene located on the X chromosome and leads to dysregulation of the endocannabinoid pathway including the reduction in endogenous cannabinoids (2-AG and anandamide). The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities, social anxiety and memory problems. In the US, there are about 71,000 patients suffering with FXS.

About Our Technology
Cannabinoids are a class of chemical compounds found in the Cannabis plant. The two primary cannabinoids contained in Cannabis are cannabidiol, or CBD, and ∆9-tetrahydrocannabinol, or THC. Clinical and preclinical data support the potential for CBD in treating epilepsy, arthritis and Fragile X Syndrome, and THC has positive effects on treating pain. Zynerba is developing therapeutic medicines that utilize innovative transdermal technologies that, if successful, may allow for sustained and controlled delivery of therapeutic levels of CBD and THC. Transdermal delivery of cannabinoids may have benefits over oral dosing because it allows the drug to be absorbed through the skin directly into the bloodstream. This avoids first-pass liver metabolism, potentially enabling lower dosage levels of active pharmaceutical ingredients with a higher bioavailability and improved safety profile. Transdermal delivery also avoids the gastrointestinal tract, lessening the opportunity for GI related adverse events and the potential degradation of CBD by gastric acid into THC, which may be associated with unwanted psychoactive effects. Using an established chemical pharmaceutical process for manufacturing, Zynerba replicates the CBD and THC found in the Cannabis plant. We believe that this will allow us to meet stringent global regulatory agencies’ standards while ensuring that we can efficiently supply the amount of product required to meet the demand of the large markets that we are targeting.

About ZYN002
Zynerba’s ZYN002 CBD gel is the first and only pharmaceutically-produced CBD formulated as a patent-protected permeation-enhanced gel and is being studied in children with Fragile X Syndrome, osteoarthritis and in adult epilepsy patients with focal seizures. ZYN002 is a clear, permeation-enhanced gel that is designed to provide controlled drug delivery transdermally with once- or twice-daily dosing.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) is dedicated to improving the lives of people with severe health conditions where there is a high unmet medical need by developing and commercializing pharmaceutically-produced transdermal cannabinoid medicines designed to meet the rigorous efficacy and safety standards established by global regulatory agencies. Through the discovery and development of these life-changing medicines, Zynerba seeks to improve the lives of patients battling severe, chronic health conditions including epilepsy, Fragile X syndrome, osteoarthritis, fibromyalgia and peripheral neuropathic pain. Learn more at www.zynerba.com and follow the Company on Twitter at @ZynerbaPharma.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will obtain approval for ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if ZYN002 or ZYN001 are approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. In addition, the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the success, cost and timing of the Company’s product development activities, studies and clinical trials; the success of competing products that are or become available; the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; and the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates. This list is not exhaustive and these and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Zynerba Contacts
Jim Fickenscher, CFO and VP Corporate Development
484.581.7483
fickenscherj@zynerba.com

Will Roberts, VP Investor Relations and Corporate Communications
484.581.7489
robertsw@zynerba.com

Media contact
Theresa Dolge
Tonic Life Communications
Office: 215-928-2748
Theresa.Dolge@toniclc.com

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$AMMA Acquires Victory Fighting Championship

NEW YORK

Heartland mixed martial arts leader becomes top acquisition to date

Alliance MMA, Inc. (“Alliance MMA” or the “Company”) (NASDAQ:AMMA), the only publicly-traded mixed martial arts (MMA) company, unifying elite regional promotions and aspiring MMA champions, announced today it has acquired the assets of Victory Fighting Championship. VFC produces events in Nebraska, Kansas, Iowa, South Dakota and forthcoming shows in Dallas/Ft. Worth – the nation’s 5th largest media market.

On April 14, Yuri Villefort (10-5), right, defeated Kassius Holdorf (10-4), left, for the Victory FC Welterweight title at VFC 56 in Omaha, Nebraska. (Photo Credit: Victory FC / Alliance MMA)

Headquartered in Omaha, Nebraska, VFC has produced more than 60 live MMA events since its founding in 2002. The Midwest’s MMA leader also has global distribution, being broadcast exclusively on UFC FIGHT PASS – the Ultimate Fighting Championship’s OTT digital streaming platform which reaches subscribers in more than 155 countries.1

Operated by owner and CEO Ryan Stoddard, VFC has served as the launching pad for former UFC lightweight champion Benson Henderson, as well as UFC standouts Jake Ellenberger, Tecia Torres, Travis Browne, Chris Camozzi, Spencer Fisher, Josh Neer, and many others.

“With this acquisition, we are taking leaps toward achieving goals on multiple fronts,” said Paul Danner, Chief Executive Officer of Alliance MMA. “VFC’s organizational footprint, in terms of scale and distribution on UFC FIGHT PASS, provides an incredible opportunity for Alliance MMA to produce content – including live content – that fans want to see.

“In addition, as we continue to pursue a presence in all the right geographies, we will build upon VFC’s rock-solid foundation. Under the leadership of Ryan Stoddard, whose vision of expansion aligns with ours, we feel VFC’s unique brand of entertainment and proven quality can best translate to several new cities in the near future.”

“We at Victory are excited to join Alliance MMA, which promises to strengthen our promotion in many ways including access to an expanded slate of superlative venues,” said Ryan Stoddard, General Manager of Victory Fighting Championship. “I believe in the ascendant business model of Alliance MMA and felt this offered the most rewarding outcome both for our promotion and for fighters interested to climb the ladder to get to the majors.”

VFC joins Alliance MMA’s growing umbrella of regional promotions, operating in 13 of the top 30 Nielsen Designated Market Areas (DMA), including each of the top five. With the goal of unifying elite regional promotions and fostering the development of aspiring MMA champions, Alliance MMA also promotes MMA events through New Jersey-based Cage Fury Fighting Championship (CFFC), Washington-based Combat Games MMA (COGA), Illinois-based Hoosier Fight Club (HFC), Tennessee-based V3Fights, Maryland-based Shogun Fights, Ohio-based Iron Tiger Fight Series, Florida-based Fight Time Promotions, Georgia-based National Fighting Championship (NatFight), and Southern California-based SoCa Fights.

About Alliance MMA, Inc.

Alliance MMA (NASDAQ: AMMA) is a professional mixed martial arts (MMA) company that brings together the best regional productions. Alliance MMA’s mission is to identify and cultivate the next generation of fighters and champions for the Ultimate Fighting Championship (UFC) and other premier MMA promotions.

With some of the world’s leading MMA promotions under the Alliance MMA umbrella, the organization aims eventually to host in excess of 125 events per year, showcasing more than 1,000 fighters. Alliance MMA is also dedicated to generating live original sports media content, attracting an international fan base, and securing major brand sponsorship revenue for live MMA events, digital media, and Alliance MMA fighters.

MMA is the world’s fastest-growing sport with worldwide fans of approximately 300 million according to sports marketing research firm Repucom. MMA is a full contact sport that allows a wide range of fighting techniques, including striking and grappling from various martial arts and disciplines including Boxing, Wrestling, Brazilian Jiu Jitsu, Karate, and Muay Thai. Professional MMA fights are legal and regulated by state athletic commissions in all 50 states.

Alliance MMA, Inc. was incorporated in 2015 for the purpose of acquiring businesses that engage in the promotion of mixed martial arts (MMA) events. In 2016, the company completed an initial public offering that culminated in a listing on the NASDAQ stock exchange. Alliance MMA is the only mixed martial arts promotion company that is publicly-traded.

For more information, visit www.alliancemma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. These statements relate to anticipated future events, future results of operations or future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “intends,” “expects,” “plans,” “goals,” “projects,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these terms or other comparable terminology. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, those discussed under the heading “Risk Factors” in our registration statement on Form S-1 (Registration No. 333-213166) declared effective by the Securities and Exchange Commission on September 2, 2016. Alliance MMA encourages you to review other factors that may affect its future results in Alliance MMA’s registration statement and in its other filings with the Securities and Exchange Commission.

Footnotes:
1. http://www.ufc.com/news/ufc-fight-pass-incivta-deal

 

Alliance MMA, Inc.
Media:
Matt Cassidy, 484-340-2871
mcassidy@alliancemma.com
or
Investors:
James Platek, 212-739-7825
jplatek@alliancemma.com

Thursday, September 28th, 2017 Uncategorized Comments Off on $AMMA Acquires Victory Fighting Championship

$CIIX Again Names Paul Dickman as CFO, Pursues Exploding $7.2 Billion Legal Cannabis Market

September 28, 2017

  • CIIX is pursuing the $7.2 billion legal cannabis market with hemp-based cannabidiol (CBD) products; CIIX showed a 76% year-over-year operating revenues gain in FY2017
  • Dickman previously served as CFO from 2010-2016; Warren Wang, CIIX’s CEO, said Dickman will “build an infrastructure that supports long-term growth”
  • CIIX has plans to launch a hemp-based line of skin care products in China by year-end 2017 and is already marketing a line of hemp-infused cannabidiol products, “OptHemp,” through its U.S. subsidiary

ChineseInvestors.com, Inc. (OTCQB: CIIX) announced in an 8K SEC filing (http://nnw.fm/UA4wB) that Paul Dickman has returned as its chief financial officer, effective September 25, 2017. He served earlier as CFO of the company from July 2010 through October 2016. In his new position, he remains on the company’s board of directors and, as CFO, will now also be responsible for leading CIIX’s financial operations as well as instituting the company’s financial plan and strategies.

CIIX is aggressively pursuing the $7.2 billion legal cannabis market (http://nnw.fm/S17sa) with hemp-based cannabidiol (CBD) products targeted at the global Chinese-speaking community. By the end of 2017, it plans to market a hemp-infused skin care line in China through its CBD Biotechnology Co., Ltd. subsidiary. It is already marketing its OptHemp line of hemp oil-based products through its U.S. subsidiary, ChineseHempOil.com, Inc.

CIIX’s goal is to become the primary Chinese publicly traded company offering real-time financial information on its website. It conducts research & development on cannabidiol, as well as providing global retail distribution to the Chinese-speaking community. It has an online store based in the free trade zone of Shanghai, China, and plans to open a brick-and-mortar unit in San Gabriel, California. It markets hemp-based, legalized cannabidiol and other health products as well as planning the debut of a subscription website which will have the latest news on cryptocurrencies, such as bitcoin.

CIIX’s year-over-year operating revenues grew by 76% in FY2017. The consumer market for hemp-derived cannabidiol products is projected to grow at a 55% compound annual growth rate (CAGR) from $170 million in 2016 to $1 billion within three years (http://nnw.fm/oApL5). Consilium Global Research projects that CIIX sales will reach $14.8 million by FY2020, skyrocketing at a CAGR of nearly 100% (http://nnw.fm/73IRz). It also projects that the global CBD industry will reach $2.1 billion in consumer sales by 2020, propelled by a CAGR of about 80%.

“We are incredibly fortunate that Paul has agreed to return as our Chief Financial Officer,” Warren Wang, founder and CEO of CIIX, stated in a news release. “We look forward to his contributions in the financial and contractual management of the Company’s growth. Moreover, Paul shares our passion for excellence, innovation and entrepreneurial thinking. I am confident that Paul will serve effectively as our CFO just as he did in the past, helping us to build an infrastructure that supports long-term growth.”

For more information, visit the company’s website at www.ChineseInvestors.com

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$CHMA First Patient in Randomized Phase 3 Octreotide Clinicals; Acromegaly

Phase 3 MPOWERED Trial Surpasses 50% Patients Randomized

WALTHAM, Mass., Sept. 27, 2017  — Chiasma, Inc. (Nasdaq:CHMA), a clinical-stage biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today provided an update on both of its international Phase 3 clinical trials of its octreotide capsules product candidate, conditionally trade-named Mycapssa®, for the maintenance therapy of adult patients with acromegaly.

The company announced the randomization of the first patient in its new Phase 3 trial referred to as “CHIASMA OPTIMAL” (Octreotide capsules vs. Placebo Treatment In MultinationAL centers), meeting its previous guidance that enrollment in the study would begin during the second half of 2017.

The CHIASMA OPTIMAL study is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA)’s Division of Metabolism and Endocrinology Products. A SPA is a process by which an applicant and the FDA reach an agreement on the protocol design, endpoints and analysis of a Phase 3 clinical study prior to initiation, in order to determine if the study adequately addresses scientific and regulatory requirements for FDA approval.

Chiasma also announced it has recently surpassed 50% patients randomized in its international Phase 3 clinical trial, referred to as MPOWERED (Maintenance of Acromegaly Patients with Octreotide Capsules Compared With Injections – Evaluation of REsponse Durability). It is a global, randomized, open-label and active-controlled, 15-month trial.

“This is an important day for Chiasma, as we achieved two significant milestones toward advancing octreotide capsules as a maintenance treatment for adult acromegaly patients,” said Mark Fitzpatrick, president and CEO of Chiasma. “Beginning enrollment in our CHIASMA OPTIMAL Phase 3 study is an important step toward our goal of resubmitting a New Drug Application with the FDA. We also are encouraged by our progress in enrolling patients in MPOWERED, Chiasma’s international Phase 3 study of octreotide capsules, to potentially support regulatory approval in Europe. We strongly believe in Mycapssa as a potential new treatment option for adult patients with acromegaly, and we look forward to continuing this important mission.”

Octreotide capsules are an investigational new oral drug proposed for the maintenance therapy of adult patients with acromegaly. Acromegaly is most commonly caused by a benign tumor of the pituitary gland that produces excess growth hormone (GH), ultimately leading to significant health problems and early death if untreated. GH regulates multiple metabolic processes and stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, which stimulates the growth of bones and other tissues. If approved, octreotide capsules may be the first oral somatostatin analog treatment option available for acromegaly patients, where the current standard of care is somatostatin analog injections.

About the CHIASMA OPTIMAL Phase 3 Trial
OPTIMAL is a randomized, double-blind, placebo-controlled, nine-month clinical trial in 50 adult acromegaly patients (at least 20% of whom must be recruited from the United States) whose disease is biochemically controlled, based upon levels of IGF-1, a byproduct of increased GH levels caused by acromegaly, on injectable somatostatin analogs at baseline (average IGF-1 ≤1.0 x upper limit of normal (ULN)). The patients must also have confirmed active acromegaly following their last surgical intervention based upon an elevated IGF-1 at that time of ≥1.3×ULN. The trial will be randomized on a 1:1 basis to octreotide capsules or placebo. Patients will be dose titrated from 40mg per day to up to a maximum of 80mg per day, equaling two capsules in the morning and two capsules in the evening. Patients meeting predefined withdrawal criteria during the course of the trial will revert to their original treatment of injections and will be monitored for the remainder of the trial.

The primary endpoint of the study is the proportion of patients who maintain their biochemical response compared to placebo at the end of the nine-month, double-blind, placebo-controlled period as measured using the average of the last two IGF-1 levels ≤ 1.0×ULN. Hierarchical secondary endpoints that will be considered by the FDA in evaluating the totality of evidence for octreotide capsules treatment effect include: proportion of patients who maintain GH response at week 36, compared to screening; time to loss of response of IGF-1 > 1.0×ULN; time to loss of response of IGF-1 > 1.3×ULN; change in mean GH from screening to end of treatment; and change in IGF-1 from baseline to end of treatment. Chiasma anticipates the release of top-line data from this Phase 3 clinical trial by the end of 2019.

About the MPOWERED Phase 3 Trial
Chiasma is conducting an international Phase 3 clinical trial under a protocol accepted by the European Medicines Agency (EMA) for the company’s octreotide capsules product candidate for the maintenance therapy of adult patients with acromegaly. The trial, referred to as MPOWERED (Maintenance of Acromegaly Patients with Octreotide Capsules Compared With Injections – Evaluation of REsponse Durability), is a global, randomized, open-label and active-controlled, 15-month trial. It is expected to enroll up to 150 adult acromegaly patients, of which it expects to randomize at least 80 patients who are responders to octreotide capsules following a six-month run-in to either octreotide capsules or injectable somatostatin receptor ligands (octreotide or lanreotide), and then followed for an additional nine months. The trial was initiated in March 2016 and is designed to evaluate the proportion of patients who maintain their biochemical response to octreotide capsules and patient-reported outcomes in patients treated with octreotide capsules, compared to patients treated with standard of care injectable somatostatin receptor ligands. The company anticipates the release of top-line data from this Phase 3 clinical trial in 2020.

About Chiasma
Chiasma is focused on improving the lives of patients who face challenges associated with their existing treatments for rare and serious chronic diseases. Employing its Transient Permeability Enhancer (TPE®) technology platform, Chiasma seeks to develop oral medications that are currently available only as injections. The company has reached agreement with the FDA on the design of a new Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade-named Mycapssa®, for the maintenance therapy of adult patients with acromegaly. Chiasma is headquartered in the United States with a wholly owned subsidiary in Israel. Mycapssa and TPE are registered trademarks of Chiasma.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s commitment to develop new treatment options for patients with rare and serious chronic diseases, specifically acromegaly, the company’s efforts to potentially obtain regulatory approval in the United States by conducting the new Phase 3 OPTIMAL clinical trial under a Special Protocol Assessment, the company’s efforts to potentially obtain regulatory approval in Europe by conducting the ongoing MPOWERED Phase 3 clinical trial, the timing of receipt of top-line data and submission of regulatory filings, including the company’s ability to obtain top-line data from the OPTIMAL trial by the end of 2019 and the company’s ability to obtain top-line data from the MPOWERED trial in 2020. Any forward-looking statements in this press 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, risks associated with the regulatory review and approval process generally; risks associated with Chiasma’s Phase 3 clinical trial to support regulatory approval of octreotide capsules in the E.U.; risks associated with Chiasma conducting an additional randomized, double-blind and controlled Phase 3 clinical trial to support regulatory approval of octreotide capsules in the United States, including risks related to the enrollment, timing and associated expenses; risks associated with Special Protocol Assessment agreements, including the risk that Special Protocol Assessment agreements are not a guarantee of approval and the FDA may not approve octreotide capsules even if the Phase 3 trial is successful; risks associated with the ability of the company’s suppliers to pass future regulatory inspections; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with Chiasma’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk that octreotide capsules, if approved, will not be successfully commercialized; the risk of competition from currently approved therapies and from other companies developing products for similar uses; risks associated with Chiasma’s financial position, including its ability to manage operating expenses and/or obtain additional funding to support its business activities; risks associated with Chiasma’s dependence on third parties; and risks associated with defending any litigation, including the risk that we incur more costs than we expect and uncertainty involving the outcome. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Chiasma’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 filed with the Securities and Exchange Commission (SEC) on August 10, 2017, and in subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Chiasma undertakes no duty to update this information unless required by law.

Contact:
Andrew Blazier
Sharon Merrill Associates
(617) 542-5300
chma@investorrelations.com

Wednesday, September 27th, 2017 Uncategorized Comments Off on $CHMA First Patient in Randomized Phase 3 Octreotide Clinicals; Acromegaly

$ASTC & @DHSgov ‏Transportation Security R&D Agreement

AUSTIN, Texas

Astrotech (NASDAQ: ASTC) subsidiary 1st Detect has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Homeland Security (DHS) Science and Technology Directorate (S&T) Transportation Security Laboratory (TSL).

The TSL will assess 1st Detect’s explosives trace detection system, the TRACER 1000 MS-ETD. Using TSL’s credible, unbiased and objective development, test and evaluation (DT&E) process, TSL and 1st Detect will examine ways to improve trace detection capabilities in support of transportation security.

“We are excited to have reached this milestone, which is an important step toward deployment in airports, public buildings and sports venues worldwide,” said Thomas B. Pickens III, CEO of 1st Detect and parent company Astrotech.

“We are pleased to be collaborating with the TSL in validating our mass spectrometer-based explosives trace detection system, designed to protect passengers and our country’s infrastructure from evolving threats such as explosives and narcotics. With a reduced false positive rate and the unique ability to dynamically update its threat library, the TRACER 1000 is expected to enhance security while optimizing checkpoint efficiency,” added Raj Mellacheruvu, COO of 1st Detect and Astrotech.

About Astrotech

Astrotech Corporation (NASDAQ: ASTC) is an innovative science and technology company that invents, acquires, and commercializes technological innovations sourced from research institutions, laboratories, universities, and internally, and then funds, manages, and builds proprietary, scalable start-up companies for profitable divestiture to market leaders to maximize shareholder value. Sourced from Oak Ridge Laboratory’s chemical analyzer research, 1st Detect develops, manufactures, and sells chemical analyzers for use in the security, defense, healthcare, food and beverage, and environmental markets. Sourced from decades of image research from the laboratories of IBM and Kodak, Astral Images sells film-to-digital image enhancement, defect removal and color correction software, and post processing services providing economically feasible conversion of television and feature 35mm and 16mm films to the new 4K ultra-high definition (UHD), high-dynamic range (HDR) format necessary for the new generation of digital distribution. Sourced from NASA’s extensive microgravity research, Astrogenetix is applying a fast-track, on-orbit discovery platform using the International Space Station to develop vaccines and other therapeutics. Demonstrating its entrepreneurial strategy, Astrotech management sold its state-of-the-art satellite servicing operations to Lockheed Martin in August 2014. Astrotech has operations throughout Texas and is headquartered in Austin. For more information, please visit www.astrotechcorp.com.

This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, whether we can successfully develop our proprietary technologies and whether the market will accept our products and services, as well as other risk factors and business considerations described in the Company’s Securities and Exchange Commission filings including the annual report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. The Company assumes no obligation to update these forward-looking statements.

 

Company Contact:
Astrotech Corporation
Nicole Conser, 512-485-9530
Marketing Director
or
IR Contact
LHA Investor Relations
Cathy Mattison and Kirsten Chapman, 415-433-3777
ir@astrotechcorp.com

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$MTSL Received 2017 TEMIA Best Practice Award for Technology Expense Management

RA’ANANA, Israel and RIVER EDGE, New Jersey, Sept. 27, 2017 — MTS – Mer Telemanagement Solutions Ltd. (NASDAQ Capital Market: MTSL), a global provider of telecommunications expense management (TEM) and enterprise mobility management (EMM) solutions, and video advertising solutions for online and mobile platforms, announced today that TEMIA, an industry association for Technology Expense Management, has awarded MTS with the TEMIA Best Practice Award for 2017.

MTS’s TEM Suite is a fully integrated Technology Lifecycle Management solution that includes enterprise mobility management (EMM), mobile device management (MDM), and mobile application management (MAM) cloud suite and flexible managed services offering. With MTS TEM Suite, companies of all sizes and industries can benefit from increased operational efficiency, cost reduction, security governance, policy compliance, optimized inventory and procurement. TEM Suite’s modular design and flexible managed services allows companies to outsource their entire Technology Lifecycle, or only outsource select processes depending on each company’s unique business needs.  The solution includes integration that provides 360-degree visibility into communications, cloud and IT environments.

“We are honored to have our Map-to-WinSM approach recognized by TEMIA with the 2017 Best Practice Award for Technology Expense Management,” said Josef Brikman, President at MTS. “Being recognized as an industry best practice leader reflects our continued commitment to provide our customers with a true technology lifecycle management solution that helps them manage their communications and IT assets in an optimal manner.”

“The Map-to-Win approach is to deliver a best-in class solution that meets the customer needs with on-time successful delivery. Customers’ satisfaction ensures repeat business, customer growth, and confidence in both MTS and the TEM industry. That’s a win-win situation for everyone.” concluded Mr. Brikman.

Joe Basili, Managing Director for TEMIA, said, “This award shines a spotlight on MTS. Competitors voted to determine the winner. Competitors are the toughest critics, while they also are best positioned to determine which organizations truly exemplify the award criteria.”

About MTS

Mer Telemanagement Solutions Ltd. (MTS) is a provider of video advertising solutions for online and mobile platforms through Vexigo, as well as a provider of innovative products and services for telecom expense management (TEM) and enterprise mobility management (EMM). Headquartered in Israel, MTS markets its solutions through wholly owned subsidiaries in Israel, the United States and Hong Kong and through distribution channels.

Vexigo (www.vexigo.com) is a global provider of online video advertising software and services delivering compelling results through a propriety in-house technology and an easy-to-use and very effective publishing platform specifically designed for content publishers.

For more information, please visit the MTS web site: www.mtsint.com.

About TEMIA

TEMIA’s ongoing mission is to raise awareness, to improve the quality and value of solutions and to cultivate shared industry knowledge for Technology, Managed Services, Expense Management, Telecommunications Management, Telecom Expense Management, TEM, Mobile Expense Management, Managed Mobility Solutions, MMS, Mobile Device Management MDM and Enterprise Mobility Management, EMM solutions. TEMIA seeks to do this through the development and promotion of open industry standards, and industry knowledge among solutions providers, business partners, telecom service providers, and enterprise clients. Further, TEMIA members subscribe to a Code of Ethics, which clearly establishes standards and differentiates their level of commitment to their clients.

Learn more about TEMIA online at www.temia.org

Twitter: @TEMIAssoc | LinkedIn Group: http://www.linkedin.com/groups/2015779

Certain matters discussed in this news release are forward-looking statements that involve a number of risks and uncertainties including, but not limited to, risks in product development plans and schedules, rapid technological change, changes and delays in product approval and introduction, customer acceptance of new products, the impact of competitive products and pricing, market acceptance, the lengthy sales cycle, proprietary rights of the Company and its competitors, risk of operations in Israel, government regulations, dependence on third parties to manufacture products, general economic conditions and other risk factors detailed in the Company’s filings with the United States Securities and Exchange Commission.

Company Contacts
MTS Contact:
Linda Laffan
Marketing Communications
(800)-745-8725
lindal@mtsint.com     

TEMIA Contact:                                                                                                
Joseph Basili
Managing Director
973-763-6265
joe.basili@temia.org

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$BLPH Announces $23 Million Private Placement

Financing will support the continued development of the company’s INOpulse platform with Phase 3 clinical trials in Pulmonary Arterial Hypertension and Phase 2 trials in Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) and Pulmonary Hypertension associated with COPD

WARREN, N.J., Sept. 27, 2017 — Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, announced today that it has entered into a definitive securities purchase agreement with new and existing investors to raise aggregate gross proceeds of approximately $23.4 million through a private placement of its common stock and warrants. The financing was led by Puissance Capital Management and Venrock Healthcare Capital Partners and supported by certain of Bellerophon’s existing investors including New Mountain Capital and Linde North America, Inc.

Bellerophon will sell approximately 19.4 million shares of common stock and warrants to purchase approximately 19.4 million shares of common stock for aggregate gross proceeds of approximately $23.4 million before deducting offering expenses. The warrants will have a per share exercise price of $1.242, will be exercisable after six months and expire five years from the date of issuance. The closing of the sales of these securities is expected to occur on or about September 29, 2017.

Proceeds from the private placement will be used by Bellerophon primarily for general corporate purposes, including manufacturing expenses, clinical trial expenses, research and development expenses and general and administrative expenses.

The securities to be sold in this private placement will not be registered under the Securities Act of 1933, as amended, or any state securities laws, and will be sold pursuant to Regulation D of the Securities Act. The securities may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. Bellerophon has agreed to file a registration statement covering the resale of the shares of common stock acquired by the investors and shares of common stock issuable upon exercise of the warrants acquired by the investors.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

About Bellerophon
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary diseases. The Company is currently developing three product candidates under its INOpulse program, a proprietary pulsatile nitric oxide delivery system. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company has commenced Phase 3 clinical trials. The second is for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) and the third candidate is for the treatment of pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD), both of which are in Phase 2 development.  For more information, please visit www.bellerophon.com.

Forward-Looking Statements
Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent filings with the Securities and Exchange Commission. The closing of the offering is subject to market and customary closing conditions and there can be no assurance as to whether or when the offering will close. In addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Contacts
At Bellerophon:
Fabian Tenenbaum, Chief Executive Officer
(908) 574-4767

At LifeSci Advisors:
Brian Ritchie
(212) 915-2578
britchie@lifesciadvisors.com

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$OSTK ICO ATS Security Token JV with tZERO, RenGen and Argon Group

First SEC and FINRA compliant ATS to transform the initial coin offering market

SALT LAKE CITY, Sept. 27, 2017 — tZERO, a subsidiary of Overstock.com, Inc. (NASDAQ:OSTK),  RenGen LLC and the Argon Group today announced an exclusive joint venture that teams the market-leading strengths of each company to launch an Alternative Trading System (ATS) that will transform the trading of security tokens issued in Initial Coin Offerings (ICO) in compliance with SEC and FINRA regulations (Joint Venture). This rapidly emerging asset class of blockchain-based digital tokens has raised more than $2 billion so far this year (per Coindesk.com’s ico-tracker) and cryptocurrencies overall (including digital tokens) have a current market cap of $137 billion (per Coinmarketcap.com), making this a huge growth industry. Digital tokens and cryptocurrencies are also changing the face of emerging growth company financing. In the first half of this year, more money was invested in fintech through cryptocurrencies than through venture capital (over $1.2 billion, per CNBC).

“With ICO blockchain offerings surpassing traditional early stage VC funding and U.S. regulators seeking legitimate venues to support security token offerings, with this JV tZERO continues to maintain its leading edge in blockchain financial technology,” said Patrick M. Byrne, CEO of Overstock. “tZERO has been at the forefront of the blockchain revolution for years, working closely with regulators since 2015 – launching the world’s first SEC compliant ATS for blockchain assets, the first private blockchain bond offering, and the first ever public issuance of a blockchain security,” continued Dr. Byrne.

“Now, by combining our expertise with Argon’s advisory services and RenGen’s electronic trading, deep liquidity and market making capabilities, we are in a position to launch the only U.S. SEC compliant token trading venue,” concluded Dr. Byrne.

The landmark Joint Venture aims to redefine the way the ICO market looks at security tokens, and enhance liquidity to accelerate market development. Lack of liquidity has been a significant impediment to security token market development. This topic has received much attention since the issuance of the SEC Report on the DAO Release No. 81207 / July 25, 2017, where the SEC made clear that any digital token with an income stream is a security, and furthermore that security tokens may only be traded on an ATS or a National Securities Exchange.

“We have long been advocating that issuing digital tokens as securities gives issuers and purchasers the greatest certainty about the legal regime that applies to the sale and the widest range of options to provide an attractive return for investors,” said Emma Channing, CEO and General Counsel of the Argon Group. “The key issue to date has been the need for an appropriate marketplace to provide liquidity. This joint venture between tZERO, RenGen and Argon has the potential to completely change the face of ICOs.”

The Joint Venture will be built in an exclusive collaboration that draws on the distinct strengths of each company, combining tZERO’s groundbreaking, blockchain-based trading platform with RenGen’s ability to provide liquidity, market making and algorithm technology, and the Argon Group’s premier ICO advisory experience and security token clients. The Joint Venture will also take advantage of SaftLaunch for AML and KYC capabilities.

“This Joint Venture allows us to continue achieving our goal of leveraging our existing U.S. equity market infrastructure and smart order routing technologies within the blockchain space,” said Joe Cammarata, President of tZERO.

“I have long believed that securitization is one of the best use cases for blockchain technology – and the transformative ICO market has proven so,” said Suleyman Duyar, Managing Partner, RenGen LLC. “Patrick Byrne and tZERO had great foresight in developing and registering the first digital ATS, and now, in partnership with Argon, an industry-leading ICO consultancy, we are excited to bring our high-volume participation in cryptocurrencies, technology and trading expertise to this promising venture. It is a very exciting time to be an investor in ICOs.”

Media Contacts:

Alex Sotiropolous, 212-754-5615, asotiropoulos@intermarket.com
Kelly Ferraro, 646-277-1291, kelly.ferraro@icrinc.com
Alex Thompson, 646-277-1234, alex.thompson@icrinc.com

About Overstock.com

Overstock.com, Inc. Common Shares (NASDAQ:OSTK) / Series A Preferred (Medici Ventures’ t0 platform :OSTKP) / Series B Preferred (OTCQX:OSTBP) is an online retailer based in Salt Lake City, Utah that sells a broad range of products at low prices, including furniture, décor, rugs, bedding, and home improvement. In addition to home goods, Overstock.com offers a variety of products including jewelry, electronics, apparel, and more, as well as a marketplace providing customers access to hundreds of thousands of products from third-party sellers. Additional stores include Worldstock.com, dedicated to selling artisan-crafted products from around the world. Forbes ranked Overstock in its list of the Top 100 Most Trustworthy Companies in 2014. Overstock regularly posts information about the company and other related matters under Investor Relations on its website, http://www.overstock.com.

About tZERO

t0.com, Inc. (“tZERO“)  is a majority owned subsidiary of Overstock.com, focusing on the development and commercialization of financial technology (FinTech) based on cryptographically-secured, decentralized ledgers – more commonly known as blockchain technologies. Since its inception, tZERO has pioneered the effort to bring greater efficiency and transparency to capital markets through the integration of blockchain technology. More information is available at tZER0.com.

About The Argon Group

The Argon Group (the “Group”) is an investment bank with a focus on digital finance – the emerging cryptocurrency and token-based capital markets. The Group provides financial advisory, placement, and technology services to companies seeking to raise equity, debt, and non-dilutive capital. The Group develops technical placement solutions, including digital tokens powered by advanced smart contracts, which Argon operates through a digital asset placement platform TokenHub.com. For more information, please email info@argongroup.com, follow @theargongroup, visit www.argongroup.com.

About RenGen LLC

RenGen LLC is an investment, technology and financial services firm focusing on innovative blockchain technologies. We are high volume participants in ICOs and an active cryptocurrency secondary market participant. Our issuance portal SaftLaunch.com offers a unique service for companies seeking to issue an ICO or raise funds through a SAFT agreement, including a proprietary AML/KYC solution and positions us to co-invest into the best early stage projects in the pre-ICO phase.

Wednesday, September 27th, 2017 Uncategorized Comments Off on $OSTK ICO ATS Security Token JV with tZERO, RenGen and Argon Group

$IMNP Positive Results from Ongoing Phase 2, Bertilimumab in Bullous Pemphigoid

ENGLEWOOD CLIFFS, N.J.

Results from six subjects demonstrate a large and statistically significant reduction in bullous pemphigoid activity despite aggressive prednisone tapering, with no serious adverse events.

Immune Pharmaceuticals, Inc. (NASDAQ:IMNP) a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, today announced preliminary results from the first six subjects enrolled in its ongoing, open-label phase 2 study of bertilimumab in patients with moderate to severe bullous pemphigoid (BP) (study NCT02226146). In February 2017, the company reported results from the first three subjects enrolled in the study. The results from three new subjects confirm and extend previous findings.

The six subjects in the study experienced a decline in the Bullous Pemphigoid Disease Area Index (BPDAI) Total Activity Score of 85% (p=0.0096). The mean BPDAI Total Activity Score declined from a baseline of 56 to 10 by the final assessment on day 84 (except for one subject enrolled under the original protocol who had a final assessment on day 56). The improvement experienced by all six subjects was rapid, with a mean decline in the BPDAI Total Activity Score of 72% achieved by day 42 (p=0.0145). All six subjects in the study achieved a greater than 50% reduction in their BPDAI Total Activity Score by the final assessment, and four of the six patients had a greater than 90% reduction. Bertilimumab was well tolerated in all six subjects and no serious adverse events were reported.

An important goal of this study is to minimize steroid exposure, which causes significant morbidity and mortality in BP patients. Treatment guidelines for moderate-to-severe BP suggest a starting prednisone dose of 0.5-1.0 mg/kg and a slow taper. In contrast, all six subjects in the study experienced rapid improvement in their condition despite a low initial steroid dose and rapid taper. The mean initial prednisone dose was 0.3 mg/kg (equivalent to 26 mg), which was tapered to just 0.1 mg/kg (p=0.0014) by the last assessment. As of the last follow-up, five of the six subjects were receiving a prednisone dose of 10 mg or less.

The attached figure illustrates the mean BPDAI scores and mean prednisone dose observed in the study, as well as the prednisone dose that subjects would have received under the treatment regimen employed by Joly et al in their landmark study of oral and topical corticosteroids (Joly et al, New Engl J Med 2002; 347:143-145). Based on baseline disease severity, subjects in our ongoing phase 2 study would have been expected to be treated with an initial prednisone dose of 0.75 mg/kg (equivalent to a mean dose of 62 mg), tapering by day 84 to 0.4 mg/kg (equivalent to a mean dose of 27 mg). These subjects received approximately 30 mg per day less prednisone over the course of the study than they would have been expected to receive in a standard BP treatment regimen. A reduction in corticosteroid use to this extent would represent a meaningful step forward in the management of this challenging condition.

Dr. Neil Korman, Professor of Dermatology at the Case Western Reserve University School of Medicine, and Chair of Immune’s Scientific Advisory Board, stated “These results are quite impressive. Moderate-to-severe bullous pemphigoid is typically managed with 60 mg of prednisone and a very slow taper over several months. The improvement seen in these subjects despite such a low prednisone dose and a rapid taper strongly suggests bertilimumab is providing a clinically meaningful benefit. If bertilimumab can substantially reduce or perhaps even eliminate the need for systemic corticosteroids in the treatment of bullous pemphigoid and their significant toxicity in this elderly population, it will be a major step forward in the management of what is the most common blistering disease.”

Elliot Maza, President and Chief Executive Officer of Immune Pharmaceuticals, stated, “These promising preliminary results support our strategy of focusing our human capital and financial resources on our bertilimumab and NanoCyclo product candidates while streamlining our operations by divesting our unrelated oncology business. We will continue to enroll subjects into this phase 2 open label BP trial, which has a target enrollment of 12 to 15 patients, as we initiate plans for a larger clinical trial designed to prove that bertilimumab provides a significant benefit to patients suffering from this severe inflammatory disease.”

About Immune Pharmaceuticals

Immune Pharmaceuticals is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Our lead program, bertilimumab, is a first-in-class, humanized monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation. By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, thus helping to relieve associated inflammatory conditions. Currently, we are conducting two phase 2 clinical trials to test bertilimumab in patients suffering from bullous pemphigoid and ulcerative colitis, respectively. Bertilimumab may have application in other diseases, including NASH, atopic dermatitis, immune and inflammatory hepatitis, and asthma.

Safe Harbor Statements Regarding Forward Looking Statements

The statements in this news release made by representatives of Immune Pharmaceuticals, Inc. relating to matters that are not historical facts, including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Immune’s product candidates and the sufficiency of Immune’s cash and other capital resources, the continued development by Immune of bertilimumab or its determination to seek Orphan Drug designation for the pharmaceutical product of bertilimumab are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Immune’s ability to fund such efforts with or without partners. Immune undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Immune’s filings with the Securities and Exchange Commission, including those discussed in Immune’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and periodic reports filed on Form 8-K.

 

Immune Pharmaceuticals Inc.
Elliot Maza
investors@immunepharma.com

Wednesday, September 27th, 2017 Uncategorized Comments Off on $IMNP Positive Results from Ongoing Phase 2, Bertilimumab in Bullous Pemphigoid

$GNUS Issues Shareholder Letter;

BEVERLY HILLS, Calif., Sept. 26, 2017  — Genius Brands recently released a letter to shareholders from Chairman & CEO Andy Heyward. The complete letter follows:

Dear Friends and Shareholders,

Yesterday morning Amazon and Genius Brands International (NASDAQ:GNUS) announced that Amazon Channels will offer an exclusive kids’ animation subscription streaming channel, Kid Genius Cartoons Plus!, to all 80 million+ subscribers of Amazon Prime.  It is the most important transaction in the history of Genius Brands, and its value to the company cannot be overstated. The agreement between Amazon and Genius Brands is a multi-year deal, which will be offered at $3.99/month per subscriber. The launch of Kid Genius Cartoons Plus! this Thursday, September 28, is nothing short of transformational for the company.

There are several key points associated with the agreement with Amazon.

1. Monthly subscriber fees enable Genius Brands to immediately monetize the investment, which has already been made to create its valuable children’s catalogue of animation over the last four years.

2. Industry analysts project that Amazon Prime’s subscriber base is forecast to double within the next five years.   Genius Brands will participate in the growth of that through our channel.

3. Amazon Prime carries only one other major kids program service, PBS Kids. However, PBS Kids is a service that programs to toddler and preschooler children, whereas Kid Genius Cartoons Plus! programs to all kids, from toddlers through tweens.

4. Kid Genius Cartoons Plus! has a unique profile, which distinguishes it from other kids’ content services and which made it particularly attractive to Amazon: It is content which has enrichment or as we like to say, “content with a purpose.”  Thus, most of our shows have a positive curriculum basis to them amidst fun and adventure.  For example, in Warren Buffett’s Secret Millionaires Club kids learn lessons in financial literacy; Thomas Edison’s Secret Lab, kids learn science; Baby Genius provides valuable childhood development messages all inside engaging fun stories.  There is no violence, no negative stereotypes and no inappropriate messaging.

5. Warren Buffett was quoted in the announcement stating,  “I am thrilled Secret Millionaires Club is available on Amazon Channels, allowing kids, along with their parents, to learn valuable lessons about finance and business to inspire them to be the best they can be.”

The creation and launch of the channel represents the work of so many talented people inside Genius Brands, in particular Deb Pierson, President of the Kid Genius Cartoons Plus! Channel and Margaret Loesch, Executive Chairman, who has successfully launched multiple kids’ channels, including the Fox Kids Network, which was subsequently sold to the Walt Disney Company for $5.4 billion dollars.

Wednesday morning at 10 A.M. E.T., myself and our CFO, Rebecca Hershinger, will host an investor conference call to discuss the channel further as well as answer any questions.*

We couldn’t possibly be more excited about this transformational event for Genius Brands.

Welcome to Kid Genius Cartoons Plus!

Sincerely,
Andy Heyward
Chairman & CEO
Genius Brands International, Inc.
*Conference Call Information:
When: Wednesday, September 27 at 10 AM ET/7 AM PT.
Dial-in: U.S.: 877-407-8291 and International: 201-689-8345

Investor Relations
Porter, LeVay and Rose
Michael Porter
T: 212-564-4700
mike@plrinvest.com

Tuesday, September 26th, 2017 Uncategorized Comments Off on $GNUS Issues Shareholder Letter;

$LTRX Joins CSIA as a Technology Partner; IoT for Manufacturing Industry

Joins Automation Leaders to Accelerate Innovation, Development and Deployments of Factories of the Future

IRVINE, Calif., Sept. 26, 2017 – Lantronix, Inc. (NASDAQ:LTRX), a global provider of secure data access and management solutions for Internet of Things (IoT) assets, today announced that it has joined the Control System Integrators Association (CSIA), a global trade association that seeks to advance the industry of control system integration.

Lantronix has been delivering robust connectivity solutions for the machine-to-machine (M2M) and IoT industry for more than 25 years with customers across various industrial segments, including manufacturing.  With the advancement of IoT technologies, cloud computing, and data analytics, more and more manufacturers are looking to connect their factory tools and automation systems to gain better real time operational visibility, increase overall equipment effectiveness (OEE), and perform predictive maintenance. Lantronix’ new IoT solutions, including the SGX 5150 IoT device gateway and the MACH10™ multi-dimensional IoT software platform, are ideal solutions for control system integrators to quickly and profitably deliver these benefits to their customers.

“The manufacturing industry is starting to embrace IoT as the enabler for the factory of the future,” said Shahram Mehraban, Lantronix vice president of marketing. “Participation in CSIA and collaboration with its member community gives us the opportunity to accelerate this digital transformation in the manufacturing industry.”

“Industrial IoT is the way of the future for manufacturing and process engineering, and it’s imperative to helping CSIA’s integrator members add value and revenue to their client relationships,” said Tony Veroeven, CSIA Marketing Manager. “We look forward to Lantronix being a part of this trend at CSIA.”

About The Control System Integrators Association
The Control System Integrators Association (CSIA) is a global non-profit professional association that seeks to advance the industry of control system integration for the success of members and their clients. For more information, visit www.controlsys.org.

About Lantronix 
Lantronix, Inc. is a global provider of secure data access and management solutions for Internet of Things (IoT) assets. Our mission is to be the leading supplier of IoT solutions that enable companies to dramatically simplify the creation, deployment, and management of IoT projects while providing secure access to data for applications and people.

With more than two decades of experience in creating robust machine to machine (M2M) technologies, Lantronix is an innovator in enabling our customers to build new business models and realize the possibilities of the Internet of Things. Our connectivity solutions are deployed inside millions of machines serving a wide range of industries, including data center, medical, security, industrial, transportation, retail, financial, environmental and government.

Lantronix is headquartered in Irvine, California. For more information, visit www.lantronix.com.

Learn more at the Lantronix blog, www.lantronix.com/blog, featuring industry discussion and updates. To follow Lantronix on Twitter, please visit www.twitter.com/Lantronix. View our video library on YouTube at www.youtube.com/user/LantronixInc or connect with us on LinkedIn at www.linkedin.com/company/lantronix.

Lantronix Contact:       
E.E. Wang
Director, Corporate Marketing and Investor Relations
media@lantronix.com
investors@lantronix.com
949-614-5879

Tuesday, September 26th, 2017 Uncategorized Comments Off on $LTRX Joins CSIA as a Technology Partner; IoT for Manufacturing Industry

$CDNA MolDX sets AlloSure reimbursement at 2017 AlloMap level

80% of kidney transplant patients will have coverage for a validated, non-invasive test that assesses organ health by directly measuring graft injury

BRISBANE, Calif., Sept. 26, 2017 — CareDx, Inc. (NASDAQ:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, received notice that the Molecular Diagnostics Services (MolDX) Program developed by Palmetto GBA has set AlloSure reimbursement at $2,840.75, which is same reimbursement as AlloMap in 2017.

AlloSure will be reimbursed for kidney transplant patients covered by Medicare across the United States starting October 9, 2017, the effective date of the Palmetto local coverage determination. Approximately 80% of kidney transplant patients are covered by Medicare. Payments will be made by Noridian, which has implemented the MolDX Program and is the Medicare administrator in CareDx’s jurisdiction.

Medicare reimbursement for AlloSure follows a rigorous technical assessment by the MolDX Program. Evidence in support of the AlloSure test included a clinical trial in 14 leading transplant centers and 400 patients with follow-up over 18 months. A prospective observational cohort study will begin in early 2018 to provide additional data on longer term outcomes, as part of a coverage under data development commitment.

A study of over 110,000 patients from the United States Renal Data System showed a 500% increase in cost burden for patients with renal transplant failure. Twenty percent of annual kidney transplants are re-transplants, so a test to accurately measure probability of rejection has been a major medical need. “We are pleased to see Medicare reimburse AlloSure at the same level as AlloMap, highlighting the value of advanced diagnostic tests to measure organ health for transplant recipients. AlloSure testing provides the precision medicine approach needed for individual transplant recipient clinical management,” said Sasha King, Chief Commercial Officer at CareDx.

About CareDx
CareDx, Inc., headquartered in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value solutions for transplant recipients. CareDx offers products across the transplant testing continuum, including AlloMap® and AlloSure® for post-transplant surveillance and Olerup SSP®, Olerup QTYPE®, and Olerup SBT™ for pre-transplant HLA testing.

For more information, please visit: www.CareDx.com.

Forward Looking Statements
This press release contains forward-looking statements about our business, research, development and commercialization efforts, including statements regarding our prospective observational cohort study. These forward-looking statements are based upon information that is currently available to us and our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including risks associated with successful research, development and planned commercialization of our technologies, that are described in our filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed by us with the SEC on April 21, 2017 and the periodic reports that we have subsequently filed with the SEC.  Any of these may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

CONTACTS: 

CareDx, Inc.
Sasha King
Chief Commercial Officer
415-287-2393
sking@caredx.com

Investor Relations
David Clair
Integrated Corporate Relations, Inc.
646-277-1266
david.clair@icrinc.com

Tuesday, September 26th, 2017 Uncategorized Comments Off on $CDNA MolDX sets AlloSure reimbursement at 2017 AlloMap level