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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

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$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.

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$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

$ITUS Presentation to Annual Meeting of Stockholders

SAN JOSE, CA –(September 26, 2017) – ITUS Corporation (NASDAQ: ITUS) today announced that the presentation given by its Chief Executive Officer, Dr. Amit Kumar, at its Annual Meeting of Stockholders on September 22, 2017 has been placed on the Company’s website. It can be viewed at http://ir.ituscorp.com/corporate-presentation.

Highlights of the presentation include:

  • The science behind Cchek™
  • The use of our proprietary Artificial Intelligence in cancer screening
  • Summary of our data, showing 90% and greater sensitivity and specificity
  • Opportunity in CAR-T therapeutics
  • Exclusive option to license certain Wistar Institute CAR-T technology
  • Potential for CAR-T effectiveness in solid tumors, as published by Wistar Institute researchers in Clinical Cancer Research, 23(2)January 15, 2017,441-453

Dr. Kumar stated, “We are very excited about the future of ITUS and look forward to providing additional updates as we continue to advance our early cancer detection technology and as we hope to expand our fight against cancer through CAR-T therapeutics.”

ITUS Corporation
ITUS, a cancer-focused biotechnology company, through its wholly owned subsidiary, Anixa Diagnostics Corporation, is developing the Cchek™ platform, a series of non-invasive blood tests for the early detection of solid tumor based cancers, which is based on the body’s immunological response to the presence of a malignancy. ITUS also continually examines emerging technologies in complementary or related fields for further development and commercialization. Additional information is available at www.ITUScorp.com.

Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

ITUS Corporation: FOCUSED ON INNOVATION™

Contact:
Mike Catelani
(408) 708-9808
MCatelani@ITUScorp.com

Tuesday, September 26th, 2017 Uncategorized Comments Off on $ITUS Presentation to Annual Meeting of Stockholders

$IZEA Reports Seven-Figure Contract with Fortune 500 Company

ORLANDO, Fla.

IZEA, Inc. (NASDAQ: IZEA), operator of IZEAx®, the premier online marketplace connecting brands and publishers with influential content creators, is reporting several high-profile contract wins.

During the third quarter, IZEA has received a seven-figure contract renewal with a Fortune 500 financial services company for custom content and influencer marketing services. The company has also signed contracts in excess of a quarter million dollars with a Fortune 500 media company, a multi-national food conglomerate and a consumer products manufacturer. In addition, IZEA has established a new master services agreement with a top 10 global retailer and the related contract for a six-figure influencer marketing campaign.

“We are excited by our continued progress establishing meaningful, brand-direct relationships,” said Ted Murphy, IZEA’s Chairman and CEO. “Our recent wins underscore the value we are creating for marketers and our unique position in the marketing landscape. We believe our commitment to service, bolstered by our technology investments in areas such as artificial intelligence and augmented reality, will lead to ongoing opportunity with the world’s leading brands.”

IZEA will be announcing Q3 bookings on October 10, 2017.

About IZEA

IZEA operates IZEAx, the premier technology platform that connects marketers with influential content creators. IZEAx automates influencer marketing and custom content development, allowing brands and agencies to scale their marketing programs. IZEA creators range from leading bloggers and social media personalities, to A-list celebrities and professional journalists. Creators are compensated for developing and distributing text, videos, photos and status updates through social media. Marketers receive influential content and engaging, shareable stories that drive awareness. For more information about IZEA, visit www.izea.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based largely on IZEA’s expectations and are subject to a number of risks and uncertainties, certain of which are beyond IZEA’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, competitive conditions in the content and social sponsorship segment in which IZEA operates, failure to popularize one or more of the marketplace platforms of IZEA and changing economic conditions that are less favorable than expected. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this respect will in fact occur.

 

IZEA, Inc.
Justin Braun, 407-215-6218
Associate, Marketing Communications
Justin.braun@izea.com

Tuesday, September 26th, 2017 Uncategorized Comments Off on $IZEA Reports Seven-Figure Contract with Fortune 500 Company

$IPCI Receives Complete Response Letter from the FDA for Rexista™ NDA

FDA Response Provides Path toward Commercialization of Rexista™

TORONTO, Sept. 25, 2017 — Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:IPCI) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled- and targeted-release oral solid dosage drugs, today provided an update on its RexistaTM, henceforth referred to as Oxycodone Hydrochloride Extended-Release Tablets (“Oxycodone ER”), program.

The Company has received a Complete Response Letter (“CRL”) from the United States Food and Drug Administration (“FDA”) for its Oxycodone ER New Drug Application (“NDA”). In its CRL, the FDA provided certain recommendations and requests for information, including that Intellipharmaceutics complete the relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration. The FDA also requested additional information related to the inclusion of the blue dye in the Oxycodone ER formulation, which is intended to deter abuse. The FDA has determined that it cannot approve the application in its present form.

“We are very encouraged by the FDA’s response as it clarifies our path forward for Oxycodone ER,” said, Dr. Isa Odidi, CEO of Intellipharmaceutics. “We had already planned the additional Category 2 and Category 3 studies the FDA has requested and we do not expect they will impact our anticipated commercialization timeline for Oxycodone ER.”

Intellipharmaceutics has been given one year to respond to the CRL, and can request additional time if necessary. The FDA has also requested that Intellipharmaceutics submit an alternate proposed proprietary name for Oxycodone ER.

Dr. Odidi concluded, “We will continue to work closely with the FDA to provide them with the additional information they requested, including data supporting the label claims related to Oxycodone ER’s abuse-deterrent properties. We believe our Oxycodone ER product can play an important preventative role in the midst of a serious opioid abuse crisis particularly impacting North America. The Company will be providing regular updates as we execute on our Oxycodone ER NDA resubmission plan.”

There can be no assurance that Intellipharmaceutics will not be required to conduct further studies for Oxycodone ER, that the FDA will approve any of the Company’s requested abuse-deterrent label claims or that the FDA will ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.

About Intellipharmaceutics

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled- and targeted-release oral solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has Abbreviated New Drug Application (“ANDA”) and NDA 505(b)(2) drug product candidates in its development pipeline. These include our Oxycodone ER product, an abuse deterrent oxycodone based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules).

Cautionary Statement Regarding Forward-Looking Information

Certain statements in this document constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or “forward-looking information” under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs and market penetration. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “plans”, “plans to”, “anticipates”, “believes”, “estimates”, “predicts”, “confident”, “prospects”, “potential”, “continue”, “intends”, “look forward”, “could”, or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the estimated proceeds (and the expected use of any proceeds) we may receive from any offering of our securities,  the potential dilutive effects of  any future financing, potential liability from and costs of defending pending or future litigation, our ability to maintain compliance with the continued listing requirements of the principal markets on which our securities are traded, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates and the difficulty in predicting the timing and results of any product launches, the timing and amount of profit-share payments from our commercial partners, and the timing and amount of any available investment tax credits the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property for our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and/or commercial partners with the ability to fund patent litigation and with acceptable product development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and commercial partners, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, delays in product approvals that may be caused by changing regulatory requirements, the difficulty in predicting the timing of regulatory approval and launch of competitive products, the difficulty in predicting the impact of competitive products on volume, pricing, rebates and other allowances, the number of competitive product entries, and the nature and extent of any aggressive pricing and rebate activities that may follow, the inability to forecast wholesaler demand and/or wholesaler buying patterns, the timing and amount of insurance reimbursement regarding our products, changes in laws and regulations affecting the conditions required by the FDA for approval, testing and labeling of drugs including abuse or overdose deterrent properties, and changes affecting how opioids are regulated and prescribed by physicians, changes in laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, changes in U.S. federal income tax laws currently being considered, including, but not limited to, the U.S. changing the method by which foreign income is taxed and resulting changes to the passive foreign investment company laws and regulations which may impact our shareholders, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third-party sourced products and materials, challenges related to the development, commercialization, technology transfer, scale-up, and/or process validation of manufacturing processes for our products or product candidates, the manufacturing capacity of third-party manufacturers that we may use for our products, potential product liability risks, the recoverability of the cost of any pre-launch inventory should a planned product launch encounter a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential issues, the successful compliance with FDA, Health Canada and other governmental regulations applicable to us and our third party manufacturers’ facilities, products and/or businesses, our reliance on commercial partners, and any future commercial partners, to market and commercialize our products and, if approved, our product candidates, difficulties, delays, or changes in the FDA approval process or test criteria for ANDAs and NDAs challenges in securing final FDA approval for our product candidates, including our Oxycodone ER product in particular, if a patent infringement suit is filed against us, with respect to any particular product candidates (such as in the case of Oxycodone ER), which could delay the FDA’s final approval of such product candidates, healthcare reform measures that could hinder or prevent the commercial success of our products and product candidates, the FDA may not approve requested product labeling for our product candidate(s) having abuse-deterrent properties targeting common forms of abuse (oral, intra-nasal and intravenous), risks associated with cyber-security and the potential for vulnerability of our digital information or the digital information of a current and/or future drug development or commercialization partner of ours, and risks arising from the ability and willingness of our third-party commercialization partners to provide documentation that may be required to support information on revenues earned by us from those commercialization partners. Additional risks and uncertainties relating to us and our business can be found in the “Risk Factors” section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S. which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events, and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Trademarks used herein are the property of their respective holders.

Unless the context otherwise requires, all references to “we,” “us,” “our,” “Intellipharmaceutics,” and the “Company” refer to Intellipharmaceutics International Inc. and its subsidiaries.

CONTACT INFORMATION

Company Contact:Intellipharmaceutics International Inc.
Andrew Patient
Chief Financial Officer
416.798.3001
investors@intellipharmaceutics.com
Investor Contact:ProActive Capital
Kirin Smith
646.863.6519
ksmith@proactivecapital.com
Monday, September 25th, 2017 Uncategorized Comments Off on $IPCI Receives Complete Response Letter from the FDA for Rexista™ NDA

$PLSE Announces $30 Million Private Placement

HAYWARD, Calif.

Pulse Biosciences, Inc. (Nasdaq:PLSE), a medical technology company developing a proprietary therapeutic tissue treatment based on its Nano-Pulse Stimulation (NPS) platform, today announced that it has entered into a stock purchase agreement with Robert W. Duggan, an accredited investor and experienced life sciences executive, for the purchase of 2,000,000 shares of the Company’s common stock at a price of $15.02 per share, the last reported sale price of the Company’s common stock on the immediately preceding trading day, September 22, 2017. The private placement is expected to yield gross proceeds of $30,040,000.

Robert W. Duggan, a current shareholder of the Company and the former Chairman and CEO of Pharmacyclics Inc. (now Pharmacyclics LLC, a wholly-owned subsidiary of AbbVie Inc.), was the sole investor in the private placement. “I am very pleased with both the operational progress made during the past year, as well as the expanding potential of the Company’s Nano-Pulse Stimulation technology,” commented Mr. Duggan.

“We are excited to have the continued strong support from an experienced life sciences executive and investor of Bob’s caliber,” said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer. “The additional capital raised in this financing affords us the opportunity to accelerate our efforts to bring our novel NPS technology to the clinic for the benefit of patients.”

The private placement being announced today represents the third financing in the last 16 months, commencing with the Company’s May 2016 IPO, in which $23 million was raised at $4.00 per share, and following the February 2017 $5 million private placement at $6.10 per share. Pursuant to the terms of the stock purchase agreement, the Company has agreed to file a registration statement to register resale of the shares in 2018. No warrants were provided, or other discounts afforded, to the investor, and the private placement is being facilitated directly by the Company. As such, no investment banking or placement fees are being incurred. The private placement is expected to close on or about September 25, 2017, subject to the satisfaction of customary closing conditions.

This announcement is neither an offer to sell nor a solicitation to buy the foregoing securities, nor shall there be any offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

The shares of common stock have not been registered under the Securities Act of 1933, as amended (the “Act”), or any state securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Act and applicable state laws.

About Pulse Biosciences

Pulse Biosciences is a medical technology company developing a therapeutic tissue treatment platform based on Nano-Pulse Stimulation, a proprietary cell signaling technology. Nano-Pulse Stimulation is a non-thermal, precise, focal drug-free tissue treatment technology that directly affects the cell membrane and intracellular structures to stimulate unique behaviors in cells. NPS can initiate a cell death process that allows for the treatment of tissue cells with minimal inflammatory response which improves healing outcomes and supports the replacement of treated tissue cells with healthy tissue cells. In cancerous lesions, NPS has been shown in preclinical models to induce immunogenic cell death (ICD) exposing the unique antigens of the treated cells to the immune system, resulting in the generation of cytotoxic T-cells and the mounting of an adaptive immune response targeted against those cells. Pulse Biosciences is investigating a variety of applications for its technology that exploits the technology’s unique biologic effect, including immuno-oncology, dermatology, and veterinary medicine. More information is available at www.pulsebiosciences.com.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding regulatory clearance, the mechanism of action of NPS treatments, planned future clinical trials, and other matters related to its pipeline of product candidates and other future events, including the closing of the private placement, estimated transaction expenses and the registration of the shares issued in the private placement. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available.

 

Investors:
Pulse Biosciences, Inc.
Brian Dow
Sr. Vice President and Chief Financial Officer
IR@pulsebiosciences.com
or
The Trout Group
Mike Zanoni, 646-378-2924
mzanoni@troutgroup.com
or
Media:
Sam Brown, Inc.
Christy Curran, 615-414-8668
christycurran@sambrown.com

Monday, September 25th, 2017 Uncategorized Comments Off on $PLSE Announces $30 Million Private Placement

$ARDM Announces FDA Acceptance of NDA for Linhaliq with Priority Review Status

HAYWARD, Calif.

Aradigm Corporation (NASDAQ: ARDM) (the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for Linhaliq™ for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic infections with Pseudomonas aeruginosa (P. aeruginosa).

The granting of Priority Review for the Linhaliq NDA accelerates the timing of the FDA review of the application compared to a standard review. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Linhaliq NDA is January 26, 2018.

“We are pleased with the FDA’s acceptance of our NDA filing with Priority Review,” said Dr. Igor Gonda, Chief Executive Officer, Aradigm Corporation. “We look forward to working with the FDA during the review process to support approval of Linhaliq and provide a much needed treatment for NCFBE patients with chronic lung infection with P. aeruginosa.”

Aradigm received Orphan Drug Designation for liposomal ciprofloxacin for inhalation for the management of bronchiectasis and for Linhaliq for the management of bronchiectasis. Additionally, for Linhaliq, Aradigm was granted Qualified Infectious Disease Product (QIDP) Designation for the treatment of NCFBE patients with chronic lung infections with P. aeruginosa followed by Fast Track Designation.

About Non-Cystic Fibrosis Bronchiectasis

Non-cystic fibrosis bronchiectasis (NCFBE) is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. NCFBE represents an unmet medical need with high morbidity and mortality that affects more than 150,000 people in the U.S. and over 200,000 people in Europe. NCFBE patients who have chronic infections with P. aeruginosa have a 6.5-fold increase in hospitalization, three times higher mortality, and a worse quality of life compared with those without P. aeruginosa infections. There is currently no drug approved for the treatment of this condition.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm has completed two Phase 3 clinical trials with Linhaliq, an investigational proprietary formulation of ciprofloxacin for inhalation, for the treatment of NCFBE and submitted a New Drug Application to the FDA for this indication. Aradigm’s inhaled ciprofloxacin formulations, including Linhaliq, are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria (NTM), and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.

Forward-Looking Statements

Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the risk that Linhaliq may not receive regulatory approval or be successfully commercialized, as well as the other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 filed with the SEC on March 30, 2017, and the Company’s Quarterly Reports on Form 10-Q.

More information about Aradigm can be found at www.aradigm.com.

Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation. Linhaliq is a registered trademark of Grifols, S.A.

 

Aradigm Corporation
Nancy Pecota, 510-265-8800
Chief Financial Officer

Monday, September 25th, 2017 Uncategorized Comments Off on $ARDM Announces FDA Acceptance of NDA for Linhaliq with Priority Review Status

$IZEA Announces Artificial Intelligence CurationEngine™

ORLANDO, Fla.

New IZEAx feature uses machine learning to process millions of pieces of content and render judgements on social media influencers

IZEA, Inc. (NASDAQ: IZEA), operator of IZEAx®, the premier online marketplace connecting brands and publishers with influential content creators, has announced the release of CurationEngine™. The new system provides programmatic analysis and judgements on members of influencer networks within IZEAx in order to increase network quality and identify influencers who may not meet brand safety requirements.

“Over the past eleven years, humans on our team have curated hundreds of thousands of social media influencer accounts, analyzing millions of pieces of content in the process,” said Ted Murphy, Founder and CEO of IZEA. “As our network size and number of platform connections has grown, it has become impossible to process the volume of information with humans alone. Using artificial intelligence and machine learning, we have taught machines to replicate the curation process with speed and scale.”

IZEA utilized the historical evaluation criteria matched with the outcome data generated from its human curation team over multiple years to produce the proprietary processes and technology found in CurationEngine. IZEA’s substantial training set of human judgements provided the baseline measure for machine judgements. CurationEngine learns over time, leveraging ongoing human feedback and spot checks of the judgements made by the programmatic system.

Prior to the release of IZEA’s CurationEngine, the company had a perpetual backlog of influencers and content to render judgements on. “The challenge with the curation of an influencer network is that the content stream is never ending,” said Chris Staymates, Vice President of Engineering at IZEA. “It is not enough to look at an influencer at a point in time, their content needs to be constantly analyzed and reanalyzed in context in order to ensure ongoing network integrity.”

The introduction of CurationEngine has also allowed IZEA to reduce the size of their curation team and associated personnel expense over time. “What was once a constantly growing group of people to handle an ever-increasing load has now been reduced to a few human workers teaching their machine co-worker,” said Murphy. “We were never going to be able to process all the data with humans, no matter how many people we hired. Now we can curate the entire network in the cloud, in a matter of hours, for less than $50. The machines are only going to get smarter, faster, and cheaper over time.”

CurationEngine is available at no additional cost to all licensees of IZEAx and is included as part of IZEA’s recently announced Private Networks.

About IZEA

IZEA operates IZEAx, the premier technology platform that connects marketers with influential content creators. IZEAx automates influencer marketing and custom content development, allowing brands and agencies to scale their marketing programs. IZEA creators range from leading bloggers and social media personalities, to A-list celebrities and professional journalists. Creators are compensated for developing and distributing text, videos, photos and status updates through social media. Marketers receive influential content and engaging, shareable stories that drive awareness. For more information about IZEA, visit www.izea.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based largely on IZEA’s expectations and are subject to a number of risks and uncertainties, certain of which are beyond IZEA’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, competitive conditions in the content and social sponsorship segment in which IZEA operates, failure to popularize one or more of the marketplace platforms of IZEA and changing economic conditions that are less favorable than expected. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this respect will in fact occur.

 

IZEA, Inc.
Justin Braun, 407-215-6218
Associate, Marketing Communications
Justin.braun@izea.com

Monday, September 25th, 2017 Uncategorized Comments Off on $IZEA Announces Artificial Intelligence CurationEngine™

$ORPN Announces Effectiveness of Five to One Reverse Split

TEL AVIV, Israel, Sept. 25, 2017 — Bioblast Pharma Ltd. (NasdaqCM:ORPN), a clinical-stage, orphan disease-focused biotechnology company, announced the effectiveness of a five to one reverse split of its share capital. As previously reported, the reverse split was approved by the Company’s shareholders at an Extraordinary General Meeting of Shareholders of the Company held on September 18, 2017.

The reverse split is intended to increase the per-share trading price of the Company’s ordinary shares to satisfy the $1.00 minimum bid price requirement for continued listing on the NASDAQ Capital Market. As a result of the reverse split and a related amendment to the Company’s articles of association which is now effective, every five ordinary shares, par value NIS 0.01 per share, shall be consolidated into one ordinary share, par value NIS 0.05. No fractional ordinary shares will be issued as a result of the reverse split and any fractional shares will be rounded up to the nearest whole number.

Trading of the Company’s ordinary shares on the NASDAQ Capital Market will continue, on a split-adjusted basis, with the opening of the market on Monday, September 25, 2017, under new CUSIP number M20156119. Immediately subsequent to the reverse split, there will be approximately 3,342,261 of the Company’s ordinary shares issued and outstanding.

The Company has retained its transfer agent, Vstock Transfer, LLC (“Vstock”), to act as its exchange agent for the reverse split. Vstock will provide shareholders of record as of the effective date a letter of transmittal providing instructions for the exchange of their certificates. Shareholders owning shares via a broker or other nominee will have their positions automatically adjusted to reflect the reverse split, subject to brokers’ particular processes, and will not be required to take any action in connection with the reverse split.

For more information regarding the Company’s reverse split, please refer to the proxy statement filed by the Company with the U.S. Securities and Exchange Commission as an exhibit to its Report on Form 6-K on August 14, 2017.

About Bioblast

Bioblast Pharma is a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases.  Bioblast is traded on the NASDAQ under the symbol “ORPN.” For more information, please visit our website: www.BioblastPharma.com, the content of which is not incorporated herein by reference.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss our ability to continue to satisfy the $1.00 minimum bid price requirement for continued listing on the NASDAQ Capital Market. In addition, historic results of scientific research and clinical and preclinical studies do not guarantee that the conclusions of future research or studies will suggest identical or even similar conclusions or that historic results referred to in this press release would not be interpreted differently, in light of additional research and clinical and preclinical study results. Because such statements deal with future events and are based on Bioblast Pharma Ltd.’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Bioblast Pharma could differ materially from those described in or implied by the statements in this press release, including those discussed under the heading “Risk Factors” in Bioblast Pharma’s annual report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on February 24, 2017, and in any subsequent filings with the SEC. Except as otherwise required by law, Bioblast Pharma disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

Investor Contact
Chaime Orlev
CFO and VP Finance and Administration
Bioblast Pharma Ltd
Chaime.orlev@bioblastpharma.com
Phone:  972 3 795 5555

Monday, September 25th, 2017 Uncategorized Comments Off on $ORPN Announces Effectiveness of Five to One Reverse Split

$VNRX Announces the Initial Sale of its New Nu.Q Research Kits

ISNES, Belgium, Sept. 22, 2017 — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”) today announced its strategy for a new range of Clinical Research Use Only (RUO) kits based on its proprietary Nucleosomics™ technology and the receipt of an order of RUO kits from a large multinational pharmaceutical company.

Chief Executive Officer of Volition, Cameron Reynolds, commented, “This is a very important milestone for Volition as it represents our first revenue from the Nu.Q™ platform. The RUO kits could be used to develop a companion diagnostic to a pharmaceutical company’s therapeutic product, so could represent an additional potential revenue stream beyond the commercialization of our blood-based cancer tests on the same platform of assays. After the initial sale of the RUO kits, a significant licensing arrangement is possible if the assays become a crucial component of another company’s product.”

The RUO kits use the same platform as Volition’s cancer diagnosis panels but may be used for many other purposes, for example as an aid to drug development and treatment selection. This first sale followed a request for a bespoke kit and precedes the launch of the first series of Volition’s products. Volition aims to offer off-the-shelf kits initially with a Total Nucleosome assay in the first quarter of 2018, followed in the second quarter of 2018 by a range of kits initially developed for its own internal cancer diagnostic development programs. The RUO range will allow researchers to explore patterns of epigenetic modifications in circulating nucleosomes across a broad range of clinical applications including cancers, inflammatory and infectious diseases.

Dr. Mark Eccleston, Volition’s Business Development Director, commented, “There has been a lot of interest in collaborating with Volition for evaluating nucleosome profiles in a range of applications beyond our core focus in diagnostics. Our suite of Nu.Q™ RUO assays will provide researchers with a complete solution for profiling cell free nucleosomes from cell to serum. This will raise the profile of our approach and broaden the application base beyond our current focus in cancer. The RUO kits will provide external validation of our technology and an expanded user base. We expect this to lead to future licensing opportunities from new clinical applications of our Nucleosomics™ technology.”

About Volition

Volition is a multi-national life sciences company developing simple, easy to use blood-based cancer tests to accurately diagnose a range of cancers. The tests are based on the science of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.

As cancer screening programs become more widespread, Volition’s products aim to help to diagnose a range of cancers quickly, simply, accurately and cost effectively. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life.

Volition’s research and development activities are currently centered in Belgium, with additional offices in London, Texas and Singapore, as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.

For more information about Volition, visit Volition’s website (http://www.volitionrx.com)  or connect with us via:

Twitter: https://twitter.com/volitionrx
LinkedIn: http://www.linkedin.com/company/volitionrx
Facebook: https://www.facebook.com/VolitionRx/
YouTube: https://www.youtube.com/user/VolitionRx

The contents found at Volition’s website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document.  The addresses for Volition’s website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.

Media / Investor Contacts

Louise Day, VolitionL.day@volitionrx.com

+44 (0)7557 774620

Scott Powell, VolitionS.powell@volitionrx.com

+1 (646) 650 1351

Tirth Patel, Edison Advisorstpatel@edisongroup.com

+1 (646) 653 7035

Rachel Carroll, Edison Advisorsrcarroll@edisongroup.com

+44 (0)20 3077 5711

Safe Harbor Statement

Statements in this press release may be “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, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,” “targets,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “may,” “will” and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of Volition’s bodily-fluid-based diagnostic tests as well as Volition’s ability to develop and successfully commercialize such test platforms for early detection of cancer. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in Volition’s development pipeline or any other diagnostic products Volition might develop; Volition will face fierce competition and Volition’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Nucleosomics®, NuQ®, Nu.Q™ and HyperGenomics® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners. Additionally, unless otherwise specified, all references to “$” refer to the legal currency of the United States of America.

Friday, September 22nd, 2017 Uncategorized Comments Off on $VNRX Announces the Initial Sale of its New Nu.Q Research Kits

$EKSO Appoints Ted Wang to its Board of Directors

RICHMOND, Calif., Sept. 22, 2017 — Ekso Bionics Holdings, Inc. (NASDAQ:EKSO) (“Ekso” or “Ekso Bionics”), an industry leader in exoskeleton technology for medical and industrial use, today announced the appointment of Ted Wang, PhD. to its Board of Directors, effective immediately.

“Ted’s strong track record of successful strategic, operational, and financial management, combined with his deep knowledge of Ekso’s technology and end markets, make him extremely qualified to help guide our leadership team,” said Thomas Looby, Ekso’s President and Chief Executive Officer.

Dr. Wang is the Chief Investment Officer of Puissance Capital Management, a global asset manager founded in 2015 with offices in the U.S. and China. Puissance was the lead investor in Ekso’s recently completed rights offering.  Prior to founding Puissance, Dr. Wang was a Partner of Goldman Sachs & Co. in New York. During his 18-year tenure at Goldman Sachs he held many leadership positions including as a member of the Goldman Sachs Risk Committee. Prior to joining Goldman Sachs, he co-founded Xeotron Corp., a company specializing in DNA biochips in Texas. Dr. Wang holds a Ph.D. in Physics from the University of Minnesota, an MBA from the University of Texas, Austin, and a BS from Fudan University, China.

Dr. Wang commented, “I am excited to join the Ekso Bionics Board, and I look forward to helping the company realize the potential and promise of its innovative exoskeleton portfolio. Ekso has an extraordinary opportunity to expand its presence in key international markets, and I am committed to working with the Ekso management team to execute on that opportunity.”

Dr. Wang will replace Dan Boren, who joined the Ekso Board in April 2013 and resigned effective September 19, 2017.

“On behalf of management and the entire Board of Directors, I want to thank Dan for his years of service and his role as Chairman of Ekso’s Nominating and Governance Committee,” said Mr. Looby, “We appreciate Dan’s commitment and dedication to the Company.”

About Ekso Bionics

Ekso Bionics is a leading developer of exoskeleton solutions that amplify human potential by supporting or enhancing strength, endurance and mobility across medical, industrial and defense applications. Founded in 2005, the company continues to build upon its unparalleled expertise to design some of the most cutting-edge, innovative wearable robots available on the market. Ekso Bionics is the only exoskeleton company to offer technologies that range from helping those with paralysis to stand up and walk, to enhancing human capabilities on job sites across the globe, to providing research for the advancement of R&D projects intended to benefit U.S. defense capabilities. The company is headquartered in the Bay Area and is listed on the Nasdaq Capital Market under the symbol EKSO. For more information, visit: www.eksobionics.com.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of human exoskeletons, (ii) estimates or projection of financial results, financial condition, capital expenditures, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain adequate financing to fund the Company’s operations and necessary to develop or enhance our technology, the significant length of time and resources associated with the development of the Company’s products, the Company’s failure to achieve broad market acceptance of the Company’s products, the failure of our sales and marketing organization or partners to market our products effectively, adverse results in future clinical studies of the Company’s medical device products, the failure to obtain or maintain patent protection for the Company’s technology, failure to obtain or maintain regulatory approval to market the Company’s medical devices, lack of product diversification, existing or increased competition, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC. To learn more about Ekso Bionics please visit us at www.eksobionics.com. The Company does not undertake to update these forward-looking statements.

Investor Contact:
Matthew Ventimiglia
212-599-1265
investors@eksobionics.com

Media Contact:
Carrie Yamond
917-371-2320
cyamond@lazarpartners.com

Friday, September 22nd, 2017 Uncategorized Comments Off on $EKSO Appoints Ted Wang to its Board of Directors

$ARDM to Present at the Ladenburg Thalmann 2017 Healthcare Conference on September 26

HAYWARD, Calif.

Aradigm Corporation (Nasdaq:ARDM) (“Aradigm” or the “Company”) today announced that Aradigm management will present at the Ladenburg Thalmann 2017 Healthcare Conference on Tuesday, September 26, 2017, at 2:00 p.m. ET. The event will be held at the Sofitel New York in New York, New York.

Interested parties can access a live audio webcast and slide presentation at www.aradigm.com. An archived presentation will be available on the Company’s Web site for 30 days.

About Aradigm

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm has completed two Phase 3 clinical trials with Linhaliq™, an investigational proprietary formulation of ciprofloxacin for inhalation, for the treatment of NCFBE and submitted a New Drug Application to the FDA for this indication. Aradigm’s inhaled ciprofloxacin formulations, including Linhaliq, are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.

More information about Aradigm can be found at www.aradigm.com.

Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.

 

Aradigm Corporation
Nancy Pecota, 510-265-8800
Chief Financial Officer

Friday, September 22nd, 2017 Uncategorized Comments Off on $ARDM to Present at the Ladenburg Thalmann 2017 Healthcare Conference on September 26

$CIIX NetworkNewsWire Announces Publication on Cannabis Industry Forecasts

NEW YORK, NY–(Sep 22, 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, “Cannabinoid Consumer Market Booming as CBD Enjoys Growth in Public Sentiment.” It discusses various cannabis-based public companies determined to expand with the booming cannabis market.

To view the full publication, visit: https://www.networknewswire.com/cannabinoid-consumer-market-booming-cbd-enjoys-growth-public-sentiment/

“Branching out into the unique adaptations of the hemp oil business made perfect business sense for ChineseInvestors.com (CIIX) (www.ChineseInvestors.com), a leading financial information website for Chinese-speaking consumers and investors. CIIX has already established two wholly-owned subsidiaries based in China and the United States. CBD Biotechnology Co., Ltd., located in the free trade zone of Shanghai, China, has plans to deliver a hemp-infused skin care line in China before the end of 2017, while ChineseHempOil.com, Inc., located in the U.S., has launched its first hemp oil product line, ‘OptHemp.’

“While the demand for hemp-based cannabidiol has skyrocketed, so have the number of companies jumping into the market, Marijuana Business Daily reports (http://nnw.fm/7ENhH). There are now hundreds, if not thousands of hemp CBD companies flooding the market looking to take advantage of the profits to be made in the global cannabis industry. For companies like ChineseInvestors.com, which has been in business since 1999, capitalizing on the convergence of CBD and the nutrition and health products market in mainland China was a no-brainer.”

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

Friday, September 22nd, 2017 Uncategorized Comments Off on $CIIX NetworkNewsWire Announces Publication on Cannabis Industry Forecasts

$NVFY Anticipates Robust Third Quarter 2017 Financial Results

LOS ANGELES, Sept. 21, 2017 — Nova LifeStyle, Inc. (NASDAQ:NVFY) or (the “Company,” “Nova”), a U.S.-based innovative designer and distributor of modern LifeStyle products is pleased to announce that based upon market surveys, follow-up interviews, and performance index comparisons, US News Express has selected Diamond Sofa, a Nova LifeStyle company as one of the top 5 Asian American Brands.

Established in California in 1992, Diamond Sofa is one of the best recognized furniture brands in the United States, embracing innovative designs and urban contemporary styles.

Nova LifeStyle Anticipates Robust Profit in Third Quarter 2017

Nova LifeStyle’s third quarter profit has increased substantially compared to the prior year period.  Based on a preliminary review of third quarter results, Nova anticipates robust third quarter financial performance driven by an increase in consumer demand and new product launches.

The Company also successfully completed a milestone business transformation in late 2016 when Nova divested its factories and franchise stores, thus transforming Nova’s business model from a manufacturing-oriented, asset-heavy enterprise into an asset-light operation focused on modern product design, efficient distribution and marketing.

The Company’s product stock keeping units (“SKUs”) have grown over 200% since 2016.  The Company’s products have been experiencing strong ordering activity at leading online retailers Amazon.com, Wayfair Inc. and Hayneedle.com.  Diamond Sofa has also maintained a long-term relationship with four furniture subsidiaries owned by Warren Buffet’s Berkshire Hathaway Inc.

For more information about Nova LifeStyle products and brands please visit http://www.novalifestyle.com or http://www.diamondsofa.com.

About Nova LifeStyle
Nova LifeStyle, Inc., a NASDAQ Global Market listed company headquartered in California, is a fast growing, innovative designer, manufacturer and distributor of modern LifeStyle furniture; primarily sofas, dining rooms, cabinets, office furniture and related components, bedrooms, and various accessories in matching collections. Visit Nova’s website: www.NovaLifeStyle.com.

Safe Harbor Statement
All statements in this press release that are not historical are forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. There can be no assurance that actual results will not differ from the company’s expectations. You are cautioned not to place undue reliance on any forward-looking statements in this press release as they reflect Nova’s current expectations with respect to future events and are subject to risks and uncertainties that may cause actual results to differ materially from those contemplated. Potential risks and uncertainties include, but are not limited to, the risks described in Nova’s filings with the Securities and Exchange Commission.

Company Contact:
Investor Relations:
The Equity Group Inc.
In U.S.
Adam Prior, Senior Vice President
+1 (212) 836-9606
aprior@equityny.com

Thursday, September 21st, 2017 Uncategorized Comments Off on $NVFY Anticipates Robust Third Quarter 2017 Financial Results

$CYCC to Present at the Ladenburg Thalmann 2017 Healthcare Conference

BERKELEY HEIGHTS, N.J., Sept. 21, 2017 — Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) (Cyclacel or the Company), a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, announced today that the Company will present at the Ladenburg Thalmann 2017 Healthcare Conference on September 26 at 2:30 p.m. EDT, in Track 2-Odeon at the Sofitel Hotel, New York. Spiro Rombotis, President & Chief Executive Officer, will provide an overview of the Company and progress in key programs.

A live webcast of the presentation will be available through the Company’s corporate website: www.cyclacel.com. The webcast will be archived for 90 days.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. Cyclacel’s transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced cancers. The DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.

Forward-looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts
Company:  Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations:  Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com

Thursday, September 21st, 2017 Uncategorized Comments Off on $CYCC to Present at the Ladenburg Thalmann 2017 Healthcare Conference

$AKTX Announces Regulatory Progress Following FDA Meeting

Plans to start Coversin Phase III in PNH in Q1 2018

NEW YORK and LONDON, Sept. 21, 2017 — Akari Therapeutics (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, announces that, following advice from a recent FDA Type B End of Phase II Meeting, it plans to advance its lead investigational drug, Coversin™, towards Phase III clinical studies in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Q1 2018.

“Following our recent FDA meeting, we are working to initiate a Phase III clinical trial of Coversin in PNH in Q1 2018,” said Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics. “We will continue to work closely with the FDA, benefitting from our Fast Track status in the U.S., and with the EMA towards submission of a BLA and MAA, respectively, for Coversin in PNH.”

Akari plans to carry out two Phase III clinical studies: CAPSTONE, in naïve PNH patients where eculizumab (Soliris®; Alexion) is not the standard of care, with co-primary clinical endpoints based on hemoglobin and transfusion data, and ASSET, a Phase III clinical study switching PNH patients from eculizumab, the current standard of care treatment in PNH in the U.S., to treatment with Coversin.

The FDA indicated that providing safety and efficacy data from the Company’s clinical trials for the proposed number of unique PNH patients on Coversin for more than one year seems reasonable, subject to review of the actual data upon submission. The number proposed includes patients having C5 polymorphisms conferring eculizumab resistance.

“Akari continues to build momentum in its complement focused therapy by advancing Coversin towards Phase III in PNH and Phase II in aHUS. With Coversin delivered subcutaneously, patients may have greater independence due to self-administration. Phase II studies are also planned for a number of other indications where Coversin’s actions on both the complement and leukotriene (LTB4) pathways play a role. Its two leading targets in this area are atopic keratoconjunctivitis (AKC), a rare eye disorder and severe bullous pemphigoid (BP), a rare skin disorder,” added Solomon.

About Akari Therapeutics
Akari is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, in particular those where the complement system or leukotrienes or both complement and leukotrienes together play a primary role in disease progression. Akari’s lead drug candidate Coversin is a C5 complement inhibitor currently being evaluated in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to its C5 inhibitory activity, Coversin independently and specifically inhibits leukotriene B4 (LTB4) activity. Akari intends to evaluate Coversin in two conditions, the skin and eye diseases bullous pemphigoid and atopic keratoconjunctivitis, where the dual action of Coversin on both C5 and LTB4 may be beneficial. Akari is also developing other tick derived proteins, including long acting versions.

Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for Coversin may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; our inability to obtain additional capital on acceptable terms, or at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs; and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 20-F filed on March 31, 2017. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
For more information

Investor Contact:

The Trout Group
Tricia Truehart
ttruehart@troutgroup.com
+1 646 378 2953

Media Contact:

Mary-Jane Elliott / Sukaina Virji
Consilium Strategic Communications
+44 (0)20 3709 5700
Akari@consilium-comms.com

Thursday, September 21st, 2017 Uncategorized Comments Off on $AKTX Announces Regulatory Progress Following FDA Meeting

$CIIX Cannabinoid Consumer Market Booming as CBD Enjoys Growth in Public Sentiment

September 21, 2017

NetworkNewsWire Editorial Coverage: Medical cannabis sales are set to impress even the most timid investor, with projected sales of nearly $5 billion in 2017, or about 67% of the $7.2 billion legal cannabis market. Hemp-derived cannabidiol (CBD) product sales are also expected to be a billion-dollar business within three years, growing at a projected 55% compound annual growth rate from 2016’s $170 million in revenue, according to an article in Forbes(1). As the cannabis industry continues to flourish, many publicly traded companies are finding ample opportunities to thrive. Standout companies determined to grow with the industry include ChineseInvestors.com (CIIX) (CIIX Profile), CV Sciences, Inc. (CVSI), Terra Tech Corp. (TRTC), Medical Marijuana, Inc. (MJNA) and Hemp, Inc. (HEMP)

It’s worthwhile to note that significant changes in the acceptance of medical and recreational marijuana also includes the alternative forms of CBD-infused and hemp-derived products, which most people now understand do not contain THC, the psychoactive compound found in marijuana. A massive amount of research into the health benefits of CBD and its effect on mental health disorders is also underway in the scientific community.

Branching out into the unique adaptations of the hemp oil business made perfect business sense for ChineseInvestors.com (CIIX) (www.ChineseInvestors.com), a leading financial information website for Chinese-speaking consumers and investors. CIIX has already established two wholly-owned subsidiaries based in China and the United States. CBD Biotechnology Co., Ltd., located in the free trade zone of Shanghai, China, has plans to deliver a hemp-infused skin care line in China before the end of 2017, while ChineseHempOil.com, Inc., located in the U.S., has launched its first hemp oil product line, “OptHemp.” Customers of ChineseHempOil.com can also purchase the company’s hemp-based products, foods and beverages using bitcoin (http://nnw.fm/w3pbB). The company’s annual financial results, released Tuesday, show a 76% YoY increase in revenues along with an array of new business ventures successfully being introduced to investors.

Among its offerings is the first marijuana social media mobile app designed for Chinese-speaking customers worldwide with a beta version slated for release in November. Its direct-to-consumer e-commerce business is projecting a compound annual growth rate (CAGR) of nearly 100% through FY2020, with revenues reaching $14.8 million. CIIX is positioning itself as a global leader with a goal of becoming the largest Chinese publicly traded company in the legalized CBD market targeting the world’s Chinese-speaking communities (http://nnw.fm/yA6bN).

Another company seeking to make a difference in the rapidly expanding CBD marketplace of cannabis-related products is CV Sciences, Inc. (CVSI), a preeminent supplier and manufacturer of hemp-derived phytocannabinoids including CBD oil. The company plans to exhibit its PlusCBD Oil ™ product brand at the Natural Products Expo East September 14-16 in Baltimore, Maryland. The trade show brings together over 28,000 industry professionals and 1,400 exhibitors. CV Sciences’ product brand is sold at approximately 1,300 health food stores and continues to grow its shelf presence in various retail outlets across the county. In a news release, company spokesman Stuart Tomc said, “It’s evident that hemp-derived CBD products are doing better and growing faster than almost every other category in the supplement industry (http://nnw.fm/H2kId).”

Terra Tech Corp. (TRTC), a vertically integrated, cannabis-focused agriculture company, is also expanding its retail operations. Terra Tech Corp. operates multiple dispensaries as well as cultivation and extraction facilities in California and Nevada. Terra Tech CEO Derek Peterson said the company’s recent acquisition of Tech Center Drive Management LLC, which operates The Reserve OC medical cannabis dispensary in Santa Ana, California, represents another milestone.

“California has emerged as one of the United States’ leading legal cannabis markets, with adult-use planned to come online in 2018,” Peterson said in a news release. “Terra Tech will continue to identify opportunities to expand both its retail and cultivation capabilities in these core markets to drive forward our growth strategy and build value for shareholders (http://cnw.fm/h42vC).”

Medical Marijuana, Inc. (MJNA), the first-ever publicly traded cannabis company in the United States, announced that August 2017 was the company’s largest revenue month in its history. Its wholly owned subsidiaries Kannaway® and HempMeds® Mexico also experienced the best revenue month in their respective histories, Kannaway CEO Blake Schroeder said in a news release (http://cnw.fm/Evae6), noting the company’s plans to launch a series of new products in Q4 2017 as it gears up for its regional convention in Denver, Colorado, this fall. Expansion plans for entering the European market are expected to contribute to the company’s explosive growth, Schroeder added.

Making significant progress in its bid to be known as the world’s number one industrial hemp producer and exporter, HEMP, Inc. (HEMP) has appointed Dr. Robert Ian Bruck, director and founder of the North Carolina State University Environmental Technology Program, as Dean of Hemp, Inc.’s Hemp University. Bruck, who holds two doctorates and years of experience in the fields of plant pathology and ecology, will be responsible for the management and development of curriculum at The Hemp University. Educating not only the public but public policy makers about the business and scientific aspects of industrial hemp – from how to grow it to the many complexities of CBD – is a critical element of moving the cannabis industry forward., according to a company news release (http://cnw.fm/p1hbY).

While the demand for hemp-based cannabidiol has skyrocketed, so have the number of companies jumping into the market, Marijuana Business Daily reports (http://nnw.fm/7ENhH). There are now hundreds, if not thousands of hemp CBD companies flooding the market looking to take advantage of the profits to be made in the global cannabis industry. For companies like ChineseInvestors.com, which has been in business since 1999, capitalizing on the convergence of CBD and the nutrition and health products market in mainland China was a no-brainer.

In a news release (http://nnw.fm/OpHR2), Keevin Gillespie, newly appointed acting president of the company’s ChineseHempOil.com subsidiary, expressed his enthusiasm for the company’s future.

“As the many potential health benefits of hemp continue to be revealed through scientific research and development, I believe the Chinese community will embrace this rediscovered ancient remedy,” Gillespie stated. “I look forward to creating brand awareness and exposure for the Company’s ‘OptHemp’ product line, developing the Company’s network marketing division and generating significant new revenue streams for the Company in the coming year.”

Editorial Sources:
1) Forbes http://nnw.fm/rv2xH

For more on CIIX please visit: ChineseInvestors.com (CIIX) or 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.

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Thursday, September 21st, 2017 Uncategorized Comments Off on $CIIX Cannabinoid Consumer Market Booming as CBD Enjoys Growth in Public Sentiment

$MKGI to Present at Third Annual Robins Equity Research Roundup on September 26, 2017

WESTON, FL and PORTLAND, OR–(Sep 21, 2017) – Monaker Group (OTCQB: MKGI), a travel industry technology leader, has been invited to present at the Third Annual Robins Equity Research Roundup, being held on September 26-27, 2017 at the Shilo Inns and Suites in Portland, Oregon. The conference is sponsored by the team at Catalyst Research Management Group, RIA.

Bill Kerby, CEO of Monaker, is scheduled to present on Tuesday, September 26th at 11:15am Pacific time. He will be joined by Richard Marshall, the company’s director of corporate development, for one-on-one meetings with institutional analysts and investors the same day.

The CEO will present its Monaker Booking Engine (MBE), a new cloud-based technology platform that delivers ALR reservations that can be instantly confirmed. As recently announced, the company is nearing the first commercial launch of the cloud-based MBE by a major travel industry partner.

MBE contains over one million instantly-bookable vacation rental properties that are available on nexttrip.com or to other travel businesses using Monaker’s proprietary application program interface (API). The API supports a “white label solution” that allows travel distributors to access and customize vacation rental properties for their website — a unique capability recognized as an industry first.

About Monaker Group

Monaker Group is a technology-driven travel company focused on delivering innovation to alternative lodging rentals (ALR) market. The Monaker Booking Engine (MBE) delivers instant booking of more than 1.4 million vacation rental homes, villas, chalets, apartments, condos, resort residences and castles. MBE offers travel distributors and agencies an industry-first: a customizable, instant-booking platform for alternative lodging. For more information, visit www.monakergroup.com.

Important Cautions Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties concerning the plans and expectations of Monaker Group. These statements are only predictions and actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties, some of which are out of our control. The potential risks and uncertainties include, among others, or the expectations of future growth may not be realized and the company may not meet applicable NASDAQ Capital Market uplisting requirements and/or may not be approved for uplisting. These forward-looking statements are made only as of the date hereof, and Monaker Group undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are expressly qualified in their entirety by the “Risk Factors” and other cautionary statements included in Monaker Group’s annual, quarterly and special reports, proxy statements and other public filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, the company’s Annual Report on Form 10-K for the period ended February 28, 2017 which has been filed with the SEC and is available at www.sec.gov.

Contact Information

Monaker Group
Richard Marshall – Director of Corporate Development
Tel: (954) 888-9779
rmarshall@monakergroup.com

Investor Relations Contact
Ronald Both or Grant Stude, CMA
Tel (949) 432-7557
MKGI@cma.team

Thursday, September 21st, 2017 Uncategorized Comments Off on $MKGI to Present at Third Annual Robins Equity Research Roundup on September 26, 2017

$ABUS LNP Licensee Alnylam Announces Positive Phase 3 Results

Arbutus’ LNP Technology Further Validated with New Results

Arbutus to Receive Single Digit Royalties on Sales of Patisiran

VANCOUVER, British Columbia and WARMINSTER, Pa., Sept. 20, 2017 — Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading hepatitis B virus (HBV) therapeutic solutions company, announced today that the Company’s lipid nanoparticle (LNP) licensee Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. Patisiran is enabled by Arbutus’ lipid nanoparticle (LNP) technology. The program represents the most clinically advanced application of Arbutus proprietary LNP delivery technology. Per the terms of the LNP license agreement for patisiran, Arbutus will be owed single digit royalties on sales of patisiran. Alnylam stated that it intends to file a New Drug Application (NDA) in late 2017 and a Marketing Authorisation Application (MAA) in early 2018.

Dr. Mark J. Murray, Arbutus’ President and CEO, said, “We are very pleased by the successful outcome of Alnylam’s APOLLO Phase 3 study of patisiran. This is an important achievement for patients and for the field of RNAi therapeutics. These data provide further validation of the utility of our leading LNP technology. Our LNP technology represents the most proven delivery technology for the systemic delivery of nucleic acid-based therapeutics.”

About Arbutus’ Lipid Nanoparticle Delivery (LNP) Technology

Arbutus’ LNP technology represents the most clinically validated nucleic acid delivery technology. Arbutus’ LNP formulations are manufactured by a proprietary method, which is robust, scalable, and highly reproducible and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application. Arbutus has built a strong intellectual property portfolio directed to various aspects of LNPs and LNP formulations, including 46 patents issued in the United States alone and patent applications throughout the United States and Europe. Arbutus continues to explore opportunities to generate value from its LNP platform technology, which is well suited to deliver therapies based on RNAi, mRNA, and gene editing constructs. The broad applicability of this platform to nucleic acid therapeutic development has established Arbutus as a leader in this new area of innovative medicine.

About Arbutus

Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection. Arbutus is headquartered in Vancouver, BC, and has facilities in Warminster, PA. For more information, visit www.arbutusbio.com.

Forward-Looking Statements and Information

This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about receiving single digit royalties on sales of patisiran; Alnylam filing a New Drug Application (NDA) in late 2017 and a Marketing Authorisation Application (MAA) in early 2018; exploring opportunities to generate value from Arbutus’ LNP platform technology; and discovering, developing and commercializing a cure for chronic hepatitis B virus (HBV) infection.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the continued demand for Arbutus’ assets, including its LNP technology; continued positive preclinical and clinical efficacy data; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: patisiran may not generate significant royalties for Arbutus, or at all; Alnylam may not file the applications on a timely basis, or at all; demand for Arbutus’ assets may lower; Arbutus’ LNP technology may not continue to produce positive preclinical and clinical efficacy data; economic and market conditions may worsen; and market shifts may require a change in strategic focus.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K and Arbutus’ continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Contact Information

Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604-419-3200
Email: acutler@arbutusbio.com

Tiffany Tolmie
Manager, Investor Relations
Phone: 604-419-3200
Email: ttolmie@arbutusbio.com

Media
David Schull
Russo Partners
Phone: 858-717-2310
Email: david.schull@russopartnersllc.com

Wednesday, September 20th, 2017 Uncategorized Comments Off on $ABUS LNP Licensee Alnylam Announces Positive Phase 3 Results

$ALNY & $SNY Positive Topline Results, APOLLO Phase 3

CAMBRIDGE, Mass. & PARIS

– Investigational RNAi Therapeutic Patisiran Meets Primary and All Secondary Endpoints, with Highly Significant Reduction In Neuropathy Progression and Improvement in Quality of Life at 18 Months Relative to Placebo –

– Alnylam Intends to File New Drug Application (NDA) in Late 2017 and Marketing Authorisation Application (MAA) in Early 2018

– Full Results to be Presented at 1st European ATTR Amyloidosis Meeting in November –

– Alnylam to Host Conference Call Today at 8:30 a.m. ET

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score (mNIS+7) at 18 months. The key secondary endpoint was improvement in quality of life assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN).

“We are very proud to report the first ever positive Phase 3 results for an RNAi therapeutic, marking the potential arrival of an entirely new class of medicines. This moment is the culmination of a 15-year journey of tireless work by countless contributors who have overcome enormous scientific and business challenges to make RNAi therapeutics a reality,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “This is an incredibly exciting milestone for Alnylam and RNAi, and most importantly for patients and their treating physicians and families. We extend our deepest gratitude to all the patients, investigators and study staff who participated in the APOLLO study – they made this important scientific progress possible.”

The APOLLO trial enrolled 225 hATTR amyloidosis patients with polyneuropathy, representing 39 genotypes, at 44 study sites in 19 countries around the world. Patients were randomized 2:1 to patisiran or placebo, with patisiran administered intravenously at 0.3 mg/kg once every three weeks for 18 months. For both the mNIS+7 and Norfolk QOL-DN endpoint measures provided below, a lower score indicates a better clinical result.

  • At 18 months, the mean change from baseline in mNIS+7 was significantly lower in the patisiran group as compared with placebo (p less than 0.00001).
    • The mean and median changes in mNIS+7 impairment scores for patisiran both achieved negative values, indicating an improvement overall and in the majority of patients compared with baseline.
  • Patients in the patisiran group experienced improvement in quality of life compared to placebo, as assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) (p less than 0.00001).
    • The mean and median changes in QOL scores for patisiran also both achieved negative values, indicating an improvement overall and in the majority of patients compared with baseline.
  • All 5 other secondary endpoints also demonstrated statistically significant favorable differences in the patisiran arm compared to placebo (p less than 0.001). These were:
    • NIS-W, the subdomain of mNIS+7 assessing muscle strength;
    • Rasch-built Overall Disability Scale (R-ODS), a patient reported outcome measure of daily living and disability;
    • 10-meter walk test, assessing gait speed;
    • Modified body mass index (mBMI), assessing nutritional status; and
    • COMPASS-31, a questionnaire to assess autonomic symptoms.
  • The overall safety profile of patisiran was encouraging.
    • The patisiran and placebo arms had similar frequencies of adverse events (AEs) (96.6 percent and 97.4 percent, respectively) and serious adverse events (SAEs) (36.5 percent and 40.3 percent, respectively).
    • The frequency of deaths in the study was similar in the patisiran (4.7 percent) and placebo (7.8 percent) arms.
    • Patisiran treatment was associated with fewer discontinuations from treatment compared with placebo (7.4 percent and 37.7 percent, respectively) and discontinuations from treatment due to AEs (4.7 percent and 14.3 percent, respectively).
    • AEs reported in greater than 10 percent of patients and seen more frequently with patisiran compared with placebo were peripheral edema (29.7 percent vs. 22.1 percent, respectively) and infusion-related reactions (18.9 percent vs. 9.1 percent, respectively), both of which were generally mild-to-moderate in severity.

“Patients living with hATTR amyloidosis face an inevitable and painful advancement of their debilitating disease,” said Akshay Vaishnaw, M.D., Ph.D., Executive Vice President, R&D of Alnylam. “We believe the very encouraging APOLLO data demonstrate the potential for investigational patisiran to help improve the lives of hereditary ATTR amyloidosis polyneuropathy patients. Our immediate objective is now to submit these data to global health authorities.”

Based on these positive results, Alnylam expects to file its first New Drug Application in late 2017 and first Marketing Authorisation Application shortly thereafter. Sanofi Genzyme is currently preparing for regulatory filings for patisiran in Japan, Brazil and other countries, to begin in the first half of 2018. Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world.

“This is a significant milestone that supports our belief that RNAi therapeutics have the potential to become an innovative new class of medicines for patients with rare genetic diseases,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “The APOLLO data suggest that patisiran could help improve the lives of people living with hATTR amyloidosis with polyneuropathy, a patient population in urgent need of additional treatment options. We look forward to working with Alnylam to make patisiran available around the globe as quickly as possible.”

Full results, including data from an exploratory analysis of the subgroup of patients with cardiac involvement, will be presented at the 1st European ATTR Amyloidosis Meeting for Patients and Doctors, on November 2, 2017 in Paris, France.

APOLLO is the largest randomized study ever completed in this disease. Nearly all eligible patients who completed APOLLO have rolled over to the APOLLO-Open Label Extension (OLE) study and continue to receive patisiran.

Conference Call Details

Alnylam management will discuss these results via conference call on September 20, 2017 at 8:30 a.m. ET. A slide presentation will also be available on the Investors page of the Company’s website, www.alnylam.com, to accompany the conference call. To access the call, please dial (877) 312-7507 (domestic) or (631) 813-4828 (international) five minutes prior to the start time and refer to conference ID 88881001. A replay of the call will be available beginning at 11:30 a.m. ET on September 20, 2017. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international), and refer to conference ID 88881001.

About the APOLLO Phase 3 Study

The APOLLO Phase 3 study is a randomized, double blind, placebo-controlled, global study designed to evaluate the efficacy and safety of patisiran in hATTR amyloidosis patients with polyneuropathy. The primary efficacy endpoint was change from baseline in the mNIS+7 composite neuropathy impairment score at 18 months. Modified NIS+7 is a composite measure of neurologic impairment that evaluates sensorimotor capabilities, nerve conduction, reflexes, and autonomic function. Secondary endpoints included the Norfolk QOL-DN quality of life score as well as measures of motor strength (NIS-W), disability (R-ODS), gait speed (10-meter walk test), nutritional status (mBMI) and autonomic symptoms (COMPASS-31). Exploratory endpoints included cardiac measures in patients with evidence of cardiac involvement at baseline as well as measures of dermal amyloid burden and nerve fiber density in skin biopsies.

About Patisiran

Patisiran is an investigational medicine that uses the body’s natural processes to lower the levels of the TTR protein that causes TTR amyloidosis. It is designed to target and silence specific messenger RNA, potentially blocking the production of TTR protein before it is made. This may help to enable the clearance of TTR amyloid deposits in peripheral tissues and potentially restore function to these tissues. The safety and efficacy of patisiran have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About hATTR amyloidosis

Hereditary transthyretin (TTR)-mediated (hATTR) amyloidosis is an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and is normally a carrier of vitamin A. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy. hATTR amyloidosis represents a major unmet medical need with significant morbidity and mortality, affecting approximately 50,000 people worldwide. hATTR amyloidosis patients have a life expectancy of 2.5 to 15 years from symptom onset, and the only approved treatment options are liver transplantation for early stage disease and tafamidis (approved in Europe, Japan and certain countries in Latin America, specific indication varies by region). There is a significant need for novel therapeutics to help treat patients with hATTR amyloidosis.

About LNP Technology

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

Alnylam – Sanofi Genzyme Alliance

In January 2014, Alnylam and Sanofi Genzyme, the specialty care global business unit of Sanofi, formed an alliance to accelerate the advancement of RNAi therapeutics as a potential new class of innovative medicines for patients around the world with rare genetic diseases. The alliance enables Sanofi Genzyme to expand its rare disease pipeline with Alnylam’s novel RNAi technology and provides access to Alnylam’s R&D engine, while Alnylam benefits from Sanofi Genzyme’s proven global capabilities to advance late-stage development and, upon commercialization, accelerate market access for these promising genetic medicine products. In the case of patisiran, Alnylam will advance the product in the United States, Canada and Western Europe, while Sanofi Genzyme will advance the product in the rest of the world.

About RNAi

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

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment options. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust discovery platform and deep pipeline of investigational medicines, including three product candidates that are in late-stage development or will be in 2017. Looking forward, Alnylam will continue to execute on its “Alnylam 2020” strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn more at www.sanofigenzyme.com.

Alnylam Forward Looking Statements

Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including, without limitation, Alnylam’s views with respect to the topline results from its APOLLO Phase 3 clinical trial for patisiran, its plans for and the expected timing of regulatory filings seeking approval for patisiran from regulatory authorities in the United States, Europe and ROW countries, its expectations regarding the potential for patisiran to improve the lives of hATTR amyloidosis patients with polyneuropathy and their families, its plans for the commercialization of patisiran if approved by regulatory authorities, and expectations regarding its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, Alnylam’s ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all, actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing, delays, interruptions or failures in the manufacture and supply of its product candidates, obtaining, maintaining and protecting intellectual property, Alnylam’s ability to enforce its intellectual property rights against third parties and defend its patent portfolio against challenges from third parties, obtaining and maintaining regulatory approval, pricing and reimbursement for products, progress in establishing a commercial and ex-United States infrastructure, competition from others using technology similar to Alnylam’s and others developing products for similar uses, Alnylam’s ability to manage its growth and operating expenses, obtain additional funding to support its business activities, and establish and maintain strategic business alliances and new business initiatives, Alnylam’s dependence on third parties for development, manufacture and distribution of products, the outcome of litigation, the risk of government investigations, and unexpected expenditures, as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

Patisiran has not been approved by the U.S. Food and Drug Administration, European Medicines Agency, or any other regulatory authority and no conclusions can or should be drawn regarding the safety or effectiveness of this investigational therapeutic.

Sanofi Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the clinical development of and potential marketing approvals for the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “would be” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development of the product, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve the product or biological application that may be filed for the product as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of the product, the absence of guarantee that the product if approved will be commercially successful, risks associated with intellectual property, future litigation, the future approval and commercial success of therapeutic alternatives, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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

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$PZRX Receives FDA Orphan Drug Designation from FDA for PRX-ASL in ASLD

PhaseRx’s second enzyme replacement therapy to receive orphan drug designation for a Urea Cycle Disorder

SEATTLE, Sept. 20, 2017 — PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, today announced that its second drug development candidate, PRX-ASL, for the treatment of argininosuccinate lyase deficiency (ASLD), has received orphan drug designation by the U.S. Food and Drug Administration (FDA).

ASLD is a rare liver disorder caused by an inherited single-gene deficiency that results in hyperammonemia (elevated ammonia in the blood), and can lead to irreversible neurological impairment, coma and death. PRX-ASL is an intracellular enzyme replacement therapy (i-ERT) designed to replace the missing or defective enzyme in patients with ASLD, thereby correcting the disease. PRX-ASL has shown therapeutic potential in a preclinical model of ASLD, including reduction in the levels of compounds whose elevation are the hallmark of ASLD including plasma citrulline, argininosuccinic acid (ASA) and blood ammonia.

“The FDA’s decision to grant PRX-ASL orphan drug designation for ASLD represents an important milestone in the development of our second therapeutic candidate,” said Robert W. Overell, Ph.D., president and chief executive officer. “PRX-ASL is our second drug to show preclinical proof of concept using our Hybrid mRNA TechnologyTM. Like our lead candidate PRX-OTC, we believe PRX-ASL also has the potential to correct the disease in children, a population that could particularly benefit from treatment for this rare disease.”

The FDA grants orphan drug designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

About ASLD

ASLD is a rare liver disorder caused by an inherited single-gene deficiency that results in hyperammonemia (elevated ammonia in the blood), and can lead to devastating consequences, including cumulative and irreversible neurological impairment, coma and death. The only cure for ASLD is a liver transplant. Currently available drug treatments do not correct the disease, and do not eliminate the risk of life-threatening crises.

About PhaseRx

PhaseRx is a biopharmaceutical company dedicated to developing mRNA products for the treatment of children with inherited enzyme deficiencies in the liver using intracellular enzyme replacement therapy (i-ERT). PhaseRx’s initial product development focus is on urea cycle disorders, a group of rare genetic diseases that generally present before the age of twelve and are characterized by the body’s inability to remove ammonia from the blood with potentially devastating consequences for patients. The company’s i-ERT approach is enabled by its proprietary Hybrid mRNA TechnologyTM platform. PhaseRx is headquartered in Seattle. For more information, please visit www.phaserx.com.

Safe Harbor Statement

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the fact that the company has incurred significant losses since its inception and anticipates that it will continue to incur significant losses for the foreseeable future, (ii) the company being dependent on technologies it has licensed and that it may need to license in the future to develop its products, (iii) the fact that the company will need to raise substantial additional funding to bring its planned products through clinical trials, regulatory approval, manufacturing and marketing and to become profitable, (iv) the fact that the company’s Hybrid mRNA Technology has not previously been tested beyond company preclinical studies, and that mRNA-based drug development is unproven and may never lead to marketable products, (v) the fact that all of the company’s programs are in preclinical studies or early stage research, so the company cannot predict how these results will translate into results in humans, nor can it be certain that any company product candidates will receive regulatory approval or be commercialized, (vi) the fact that development of the company’s product candidates will be expensive and time-consuming, and if the development of company product candidates does not produce favorable results or is delayed, the company may be unable to commercialize these products, (vii) the company expecting to continue to incur significant research and development expenses, which may make it difficult to attain profitability, (viii) the company becoming dependent on collaborative arrangements with third parties for a substantial portion of its revenue, and its development and commercialization activities being delayed or reduced if it fails to initiate, negotiate or maintain successful collaborative arrangements, (ix) the company’s ability to adequately protect its proprietary technology from legal challenges, infringement or alternative technologies and (x) the biotechnology and pharmaceutical industries being intensely competitive, with competition from existing drugs, new treatment methods and new technologies that may prove to be more effective or marketable than the company’s products. More detailed information about the company and the risk factors that may affect the realization of forward looking statements is set forth in the company’s filings with the Securities and Exchange Commission (SEC), including the company’s Annual Report on Form 10-K for the year ended December 31, 2016, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contacts: 

Corporate Communications Contact:
Jason Spark
Canale Communications
Managing Director
jason@canalecomm.com
619.849.6005

Investor Contact:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
robert.uhl@westwicke.com
858.356.5932

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$CIIX Director of Investor Relations, New Audio Interview with SmallCapVoice.com

AUSTIN, Texas, Sept. 20, 2017  — SmallCapVoice.com, Inc. and ChineseInvestors.com (OTCQB:CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors in both the U.S. and China, and a well-known cannabidiol (CBD) health brand engaged in the development, manufacturing, marketing and distribution of consumer products containing CBD, today announce that the Company’s director of investor relations, Alan Klitenic, is featured in an audio interview at SmallCapVoice.com.

The interview outlining CIIX’s current news and efforts can be heard at http://smallcapvoice.com/blog/9-18-17-smallcapvoice-interview-with-chineseinvestors-com-inc-ciix.

Alan Klitenic, director of investor relations for ChineseInvestors.com called in to SmallCapVoice.com, Inc. to discuss the recent news for the company. Topics covered in the interview include the recent news in the Digital Currency Industry, the plans that the Company has regarding launching a Chinese Daily Video News Broadcast from the NYSE floor covering the Digital Currency Market, exciting news about its recent financial performance, and insights on all recent news including the recently announced completion of the record filing process with the Chinese FDA the soon to be launched Hemp Infused Skin Care Line in China starting in October.

During the interview Klitenic stated, “I want to emphatically state that CIIX is ready to make sales in China. We have successfully passed thru the regulatory body, the China FDA. We have manufactured this product: CBD Infused skin care products line with a design patent. This is a real milestone for us at ChineseInvestors.com. We are going to spend money and promote our CBD Hemp Oil and CBD infused skin care products in China going forward from now and thru 2018.”

About SmallCapVoice.com

SmallCapVoice.com is a recognized corporate investor relations firm, with clients nationwide, known for its ability to help emerging growth companies build a following among retail and institutional investors. SmallCapVoice.com utilizes its stock newsletter to feature its daily stock picks, audio interviews, as well as its clients’ financial news releases. SmallCapVoice.com also offers individual investors all the tools they need to make informed decisions about the stocks in which they are interested. Tools like stock charts, stock alerts, and Company Information Sheets can assist with investing in stocks that are traded on the OTC BB and Pink Sheets. To learn more about SmallCapVoice.com and its services, please visit http://smallcapvoice.com/blog/the-small-cap-daily-small-cap-newsletter/

About ChineseInvestors.com (OTCQB:CIIX) 

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

For more information visit ChineseInvestors.com

Subscribe and watch our video commentaries: https://www.youtube.com/user/Chinesefncom

Follow us on Twitter for real-time Company updates: https://twitter.com/ChineseFNEnglsh

Like us on Facebook to receive live feeds: https://www.facebook.com/Chinesefncom;

https://www.facebook.com/Chineseinvestors.com.english

Add us on WeChat: Chinesefn or download iPhone iOS App: Chinesefn.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.

Contact:

ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776

Investor Relations:

Alan Klitenic
+1.214.636.2548

Corporate Communications:

NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

For SmallCapVoice.com

Stuart T. Smith
512-267-2430
info@smallcapvoice.com

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$IGC Readies Line of Medical Dispensary Products Targeting Alzheimer’s Disease

Drug Candidate for Alzheimer’s Shows Promise by Inhibiting Aβ Aggregation without Neuron Damage

BETHESDA, Md., Sept. 18, 2017 – India Globalization Capital, Inc. (NYSE-MKT:IGC) provides an update on compelling in vitro data compiled from genetically engineered cell lines within an Alzheimer’s disease model, showing that at varying concentrations of THC, the aggregation of Aβ protein decreases by as much as 40%.

“As Alzheimer’s progresses, synaptic dysfunction and the death of neurons lead to memory loss. These study results, when combined with the earlier reported data that shows IGC-AD1 reduces Aβ40 and Aβ42 production by as much as 50%, and 40%, without any toxicity, represent a highly significant novel breakthrough that could potentially bring much needed relief from this devastating disease,” states IGC’s CEO Ram Mukunda.

It is believed that a primary cause of AD is the buildup of senile plaque composed of amyloid beta peptides (Aβ plaque) in the cerebral cortex and hippocampus. The key pathogenic event in the onset of AD is Aβ peptide monomers aggregating into prefibrillar oligomers (dimers, trimmers, tetramers and oligomers).  As AD progresses Aβ oligomers directly cause synaptic dysfunction and the death of neurons, consequently leading to a loss of memory.

“A drug that (i) decreases production of Aβ, (ii) inhibits Aβ aggregation into oligomers, (iii) is not toxic to neurons, and (iv) does not cause inebriation (high), could be a powerful weapon against AD and the prevention of AD.  In vitro, our product demonstrates these critical factors and we are pursuing a patent filing that protects this therapy.

AD starts 20 to 25 years before symptoms like memory loss are manifested. Statistically, there is an almost 50% chance of individuals over 80 years contracting AD and over 65% of AD patients are women. Based on the findings of these studies, our plan is two-fold. First, we will position IGC-AD1 as a drug that can be used both as a treatment for AD, and as a prophylactic treatment for the prevention of AD.  Second, we will commercialize a supplement version to be sold as a medical dispensary product.  This will allow our team to work through the FDA approval process for IGC-AD1, while securing market share in the medical dispensary segment. This is a very exciting time for all our shareholders and I look forward to providing updates on our progress in combatting this global disease,” concludes IGC’s CEO Ram Mukunda.

The summary in vitro data indicates that between 2.5nM and 25nM THC concentration, the formation of Aβ1-42 trimers and tetramers in N2aAPP cells are reduced by up to 40% as determined by both fluorescence and immuno blotting assays. Dr. Chuanhai Cao, IGC’s Senior Advisor and Associate Professor of Pharmaceutical Sciences at USF’s College of Pharmacy conducted the studies.

About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a form of dementia.  It is known as America’s most expensive disease, with an estimated cost to the U.S. economy of $236 billion.  AD currently affects more than 5.3 million Americans and over 65% of AD patients are women.  Over the next 20 years, the number of those afflicted with the disease is expected to double.  The forecast is staggering, considering that to date, no effective cure has been found.

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

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

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

Contact:
Claudia Grimaldi
301-983-0998

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