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$STLHF Trump’s Recent Executive Order Could Boost Lithium Supply in the U.S.

January 10, 2018

NetworkNewsWire Editorial Coverage: A recent report released by the U.S. government has identified as many as 23 minerals that are “critical to the national economy and national security” of the nation. Immediately following the report, President Donald Trump signed an executive order to urgently reduce foreign dependence on these minerals and ramp up domestic production. One critical metal of heavy emphasis on the list is lithium, which the U.S. is currently importing 50% from abroad. This presents an unprecedented opportunity for a country that has so much undeveloped lithium reserves but previously chose to mostly bypass domestic mining in favor of imports. This executive order now changes everything, and with the global demand for lithium used in electric car batteries rising at an unstoppable pace, the global lithium supply landscape is set for a shakeup. Companies poised to lead in the supply of lithium include Standard Lithium Ltd. (TSX.V: SLL) (FRA: S5L) (OTCQX: STLHF) (STLHF Profile), Liberty One Lithium Corp. (TSX.V: LBY) (OTCQB: LRTTF) (FRANKFURT: L1T), Albemarle Corporation (NYSE: ALB), Lithium X Energy Corp. (TSX.V: LIX) (OTC: LIXXF) and Nemaska Lithium Inc. (TSX: NMX) (OTCQX: NMKEF) (FRANKFURT: N0T).

The world is moving fast towards “electrification” of the auto industry to reduce global emissions and pollution. For this, lithium has become a hot commodity for its role as a key ingredient in electric vehicle batteries. The global EV revolution, first started by Tesla, is now getting bigger and more influential than ever. Carmakers like General Motors and Volvo have pledged to end production of gas-powered vehicles altogether in the future (http://nnw.fm/HuFx7). Volkswagen is even willing to thrust $40 billion into EV development by 2022, just to name a few.

This means lithium is going to keep its status as an in-demand critical commodity for a while. According to data from Global Market Insights, Inc., the worldwide market for Li-ion batteries alone is set to exceed USD $60 billion by the year 2024 (http://nnw.fm/Y84e0). It is estimated that one lithium mine needs to be brought on line each year through 2025 to meet its fast-growing demand. With Trump’s new executive order in effect, the next lithium mine could well be in the U.S.

While U.S. Geological Survey (USGS) data reveal that continuing exploration has increased global lithium resources worldwide (http://nnw.fm/CRs1v), lithium producers will have their hands full in meeting rampant demand. Lithium companies like Standard Lithium Ltd. (TSX.V: SLL) (FRA: S5L) (OTCQX: STLHF) are wasting no time to get operations in order to potentially cash in on this EV-driven lithium boom and embrace the U.S. government’s new policy to expand lithium production.

Based in Vancouver, B.C., Standard Lithium stands out as a premier lithium developer focused on the production of high-quality lithium at a low cost. The company is engaged in unlocking the value of large-scale lithium brine resources that are already in existence in the United States and can be quickly brought into production.

Standard Lithium’s approach is based on its stance that new lithium production can be rapidly brought on stream through minimizing project and process risks and through leveraging advances in lithium extraction technologies and processes.

Exploration and Development

Standard Lithium recently announced the expansion of the lithium brine project at its Bristol Dry Lake property in California’s Mojave Desert, where six new evaporation ponds have been installed (http://nnw.fm/9LBwK). The company is taking advantage of record-high evaporation rates in this region to pre-concentrate brines produced from the project, which will then be shipped to its testing and processing facilities at three North American campuses.

Standard Lithium is also in the midst of drilling work at its Bristol Dry Lake property and has completed four exploration boreholes, with two more planned. Preliminary results have equaled and exceeded historic data, and full QA and QC results are scheduled to be released during the first half of 2018.

The Bristol Dry Lake project encompasses an area spanning more than 33,000 acres, including both patented and placer mineral claims and private property. Geophysical data that was recently acquired indicates the basin is deep and expansive, and historical drill samples have shown lithium contents of more than 100mg/l over the drilled interval. Bristol Dry Lake is an established mining area with world-class infrastructure at the project as well as paved road and rail access and water and electricity.

Standard Lithium has forged agreements with National Chloride Corporation of America and TETRA Technologies (NYSE: TTI), two of the established brine producers in this region, to explore and develop the area for potential lithium production. Under the agreements, the company can conduct exploration, brine sampling, extraction, evaporation and process testing.

In order to advance the project, Standard Lithium has amassed a strong team of scientists and process engineers who are applying a hybrid approach that utilizes both conventional and modern extraction processes.

The company has additionally entered into an agreement to explore highly promising brines covering an area of about 30,000 acres in the Smackover Formation, which extends across Texas, Arkansas and Louisiana. This presents a low-risk investment with promising potential returns in a region with well-understood geology that further has a lengthy history of brine production and infrastructure for profitable mineral extraction. In historical analysis of the Arkansas Smackover Formation, a lithium content of 365mg/l was shown.

Potential Industry Comparables

Another Canada-based player looking to help meet the growing global lithium demand is Liberty One Lithium Corp. (TSX.V: LBY) (OTCQB: LRTTF) (FRANKFURT: L1T). Headquartered in Vancouver, B.C., Liberty One currently has plans underway to examine a short list of prospective lithium properties in Latin American and the continental U.S. during Q1 of 2018. The company also recently announced plans to commence an evaluation of its North Paradox property during 2018. Liberty One’s North Paradox property consists of 233 placer claims encompassing 4,480 acres in the Paradox Basin of Grand County, Utah. Liberty One seeks out regions that are ideally situated for lithium brine production via low-cost and well-proven evaporation methods and which are adjacent to functional infrastructure and an experienced labor force.

One of the biggest producers of lithium raw material in the world is Albemarle (NYSE: ALB), which is based in Charlotte, NC, and is a global market leader for lithium compounds. In Q3 2017, Albemarle logged net sales of $343.6 million for lithium and advanced materials, representing a year-over-year increase of 42.9 percent. This is clear evidence of the potential for lithium producers to profit hugely in the face of increasing prices and demand.

Growing global interest in lithium’s rising star is also evidenced in recent acquisition activity. Lithium exploration and development company Lithium X Energy (TSX.V: LIX) (OTC: LIXXF) recently entered into a definitive agreement with Nextview New Energy Lion Hong Kong Limited, through which Nextview will acquire all of Lithium X’s issued and outstanding common shares and warrants. Lithium X has two lithium projects in the prolific “Lithium Triangle” in the Salta province of Argentina and also has ownership interest in Pure Energy Metals, which is developing a lithium project in Nevada.

Another Canada-based player that is specifically focused on serving as a supplier for the lithium battery market is Nemaska Lithium (TSX: NMX) (OTCQX: NMKEF) (FRANKFURT: N0T). Nemaska Lithium is developing a key spodumene lithium hard rock deposit in Quebec, Canada, that is being touted as one of the most important spodumene lithium hard rock deposits in the world, both in terms of volume and grade. The spodumene concentrate that is produced at the company’s Whabouchi mine will be shipped to Nemaska Lithium’s lithium compounds processing plant, which is planned to be built in Shawinigan, Quebec. This facility will transform spodumene concentrate into high-purity lithium hydroxide and carbonate using the company’s proprietary methods, for which Nemaska Lithium holds nine issued patents and various patent applications that are pending in different countries.

The growing value and importance of the lithium market are clear, and companies like those named are primed for profitability as EV dominance blazes forward and lithium demand increases to keep pace. Li-ion manufacturers and end-users of Li-ion batteries, including car manufacturers, are increasingly motivated to ink multiyear deals with lithium producers to spur them to greater and faster investment and production. While the earth’s supply of lithium is plentiful, processing capacity remains an issue—which will continue to spell motivation for end users and profit for lithium producers.

For more information on Standard Lithium, visit Standard Lithium Ltd. (TSX.V: SLL) (FRA: S5L) (OTCQX: STLHF)

For a more in-depth look into Standard Lithium (TSXV: SLL) (FRA: S5L) (OTCQX: STLHF) you can view the full report on Streetsignals.com.

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Wednesday, January 10th, 2018 Uncategorized Comments Off

$VSQTF Blockchain Technology Transforming Future of Transaction Management

January 10, 2018

NetworkNewsWire Editorial Coverage: Blockchain technology has the potential to disrupt many industries in the future by changing the way companies process business transactions. Originally developed to facilitate the exchange of cryptocurrencies like bitcoin, blockchain will provide access to financial services for people all over the globe, especially those who don’t have access to traditional banking. Future Thinkers outlines several industries that are likely to benefit from blockchain technology for their business transactions (http://nnw.fm/MjaO8), including supply chain management, forecasting, the Internet of Things (IoT), insurance, ride sharing, cloud storage, voting, government services, energy management, online retail, real estate and healthcare. Businesses in these industries will adapt their processes to accommodate the number of people concluding transactions online, which is growing exponentially. Victory Square Technologies, Inc. (CSE:VST) (OTC:VSQTF) (FWB:6F6) (VSQTF Profile) is one of the leading companies taking advantage of the growth potential of blockchain technology by investing in and incubating entrepreneurial ventures in this sector. Other companies investing in business opportunities in online payment and blockchain technologies include Net Element, Inc. (NASDAQ: NETE) (NETE Profile), Riot Blockchain, Inc. (NASDAQ: RIOT), Longfin Corp. (NASDAQ: LFIN) and Overstock.com, Inc. (NASDAQ: OSTK).

Victory Square Technologies, Inc. (CSE:VST) (OTC:VSQTF) (FWB:6F6) incubates and invests in entrepreneurs to create partnerships and joint ventures in various fields, including blockchain technology, virtual reality, artificial intelligence, personalized health, gaming and film. The company’s business model enables these entrepreneurs to access its creative workspaces, education programs, distribution partners and global mentorship networks. It also offers operational support to help these emerging companies scale their operations internationally.

Though most people are now familiar with blockchain, Victory Square’s involvement in the technology started before it went “mainstream.” Over three years ago, the company invested in the BTL Group (BTL:CC) (OTC: BTLLF), using its business model to grow the company to a $215 million organization recognized as the first public blockchain technology company. BTL’s core product is called Interbit, a blockchain platform used by some of the world’s largest companies and institutions to explore new business opportunities using private blockchains. BTL has developed blockchain solutions for companies in the energy, finance and gaming sectors.

As it continues to gain traction and pace alongside broader market growth, Victory Square is enhancing its networking efforts and exposure within the blockchain realm. The company recently partnered with the North American Bitcoin Conference, a part of the World Blockchain Forum, which will allow the company to be among the presenters at a major conference in Miami on January 18-19 (http://nnw.fm/0at7R). Organized by Keynote Events, the conference will be attended by more than 1,500 leading shareholders in the blockchain and cryptocurrency sectors and will cover a wide range of related topics such as blockchain, bitcoin and Ethereum, regulations in the field, initial coin offerings and more. The partnership will allow Victory Square the opportunity “to engage with some of the most promising startups and respected blockchain thought-leaders in the world,” according to CEO Shafin Diamond Tejani. A focal point for the company will be participation in the “Pitch Your ICO” sessions, where over 30 leading blockchain companies will present to some of the most notable investors in the industry.

On the topic of ICOs (initial coin offerings), Victory Square has its hand in the game with plans to purchase $500,000 of cryptocurrency tokens in Bluzelle Platform Pte. Ltd.’s token sale (http://nnw.fm/8lSb8) coming up later this month. Bluzelle is a leading decentralized database service recognized as a “technology pioneer” by the World Economic Forum. Backed by experience building enterprise-grade blockchain technology for reputable businesses such as KPMG, Microsoft (NASDAQ: MSFT), HSBC (NYSE: HSBC) and others, Bluzelle is poised to gain considerable traction at its ICO. As an early contributor to the ICO, Victory Square is privy to an additional 25 percent of bonus Bluzelle tokens.

Another recent endeavor is Victory Square’s interest in the game-changing role of blockchain technology in the creation of a global decentralized Internet via software-defined wide-area networking (SD-WAN). The company has signed a letter of intent to acquire a 20 percent stake in SD-WAN company Multapplied Networks Inc. (http://nnw.fm/Rq3a2) – an organization focused on supporting service providers to incorporate SD-WAN technology into their existing services to develop a decentralized Internet. Multapplied Networks is already serving a considerable portfolio of global partners across North America, Europe, Africa, Asia and Australia.

A promising industry with regard to blockchain implementation for secure transactions is the fast-growing sports betting industry – another sector Victory Square is already exploring. The global online gambling market is expected to reach $59.79 billion in 2020 from $37.91 billion in 2017, according to Statista. Of this, the esports segment is responsible for over $696 million in revenue for 2017, a figure expected to increase to $1.5 billion by 2020, according to a Newzoo report (http://nnw.fm/X1llW). While traditional payment services such as digital wallets and banks have been typically wary of supporting the online gambling sector, blockchain technology has the potential to significantly transform the industry by enabling easier payments, a more transparent betting process and overall more positive experiences for the users.

Recognizing the market opportunity within this burgeoning sector, Victory Square’s FansUnite Media Inc. subsidiary has already integrated blockchain technology into its development of a social sports betting platform that enables community members to collaborate, discuss and predict the winners of sporting events using free virtual currency. FansUnite recently introduced FAN tokens for gaming, purchased with cryptocurrency to enable consumers to place bets and earn more tokens by participating in the company’s Bounty program. FansUnite co-founder and CEO Darius Eghdami has expressed confidence that its dynamic and responsive betting platform will enable the company to develop into the gold standard for sports betting sites worldwide.

The success of this blockchain application has encouraged Victory Square to incorporate this technology in its other subsidiaries and divisions. On December 11, 2017, Victory Square announced that its subsidiary, VS Blockchain Assembly Inc., has been developed to provide blockchain and cryptographic services to the other enterprises within its portfolio (http://nnw.fm/7lvQv). It will provide guidance on blockchain technology architecture and development, and facilitate banking, legal and commercialization services. Blockchain Assembly will also assist these companies to raise capital, either through private funding, public markets or token generation events.

Victory Square’s investment strategy also includes a range of endeavors that demonstrate its expertise outside blockchain technology. Victory Square Health Inc., which focuses on developing solutions in personalized health technologies. Victory Square Health has in turn invested in Personalized Biomarkers Inc. (“PBI”), a company that develops test kits to predict the response to therapies prior to prescription. PBI is initially focusing on diabetes, identifying five potential biomarkers and enabling the company to enter a $4 billion market opportunity. In partnership with Insight Diagnostics Inc., Victory Square Health is developing a personalized diagnostic solution for the prevention and management of Type II diabetes.

Victory Square has also been instrumental in the incubation of V2 Games, a studio for the development and publishing of high-quality mobile games. V2 Games is best known for its launch of PAC-MAN Bounce and Beast Brawlers, which has resulted in millions of downloads globally.

Victory Square CEO Tejani has stated his confidence that all these companies within its portfolio will have an influential role to play in the evolution and growth of the company to maximize returns for its investors.

A player new to blockchain but well-versed in payment innovations is Net Element (NASDAQ: NETE), a technology-driven company that specializes in mobile payments and value-added transactional services. It owns Unified Payments, a provider of bankcard payment processing services and value-added solutions in the U.S., as well as owns Aptito, a next generation cloud-based point-of-sale (POS) payments platform, and Restoactive, a digital add-on for POS legacy systems. The company’s stable also includes Payonline, a fully integrated, processor agnostic ecommerce platform. On December 20, 2017, Net Element recently announced that it is launching a blockchain-focused business unit to develop a cryptocurrency-based ecosystem to enable merchants to connect with consumers (http://nnw.fm/0lB6b). This announcement resulted in its shares rocketing more than four-fold to a 16-month high.

Riot Blockchain (NASDAQ: RIOT) targets investments in blockchain technology by identifying unique projects in decentralized markets, with its primary focus on the Bitcoin and Ethereum blockchains. The company’s portfolio includes Verady, which provides cryptocurrency accounting and audit technology services through VeraNet. This application enables companies and individuals to account, audit and report on blockchain assets, while providing a bridge between cryptocurrencies and traditional financial accounting. Riot Blockchain also owns Coinsquare, a leading Canadian digital currency exchange, which provides a user-friendly, secure, cost-efficient and trustworthy way to purchase digital assets. Tesspay also falls within Riot Blockchain’s portfolio, and plans to develop a blockchain-based escrow service for wholesale telecom carriers. The company has also launched a Bitcoin mining operation.

A U.S.-based financial technology company, Longfin (NASDAQ: LFIN), provides finance and foreign exchange hedging solutions for importers, exporters and SMEs worldwide. The company uses blockchain technology to enable trade finance solutions globally for SMEs, manufacturers, processors, importers and exporters using cryptocurrencies. It also provides financing for companies and lower credit rated banks using insurance wrap. Longfin’s vision is to securitize and finance carry trade and asset backed solutions for companies, while aiming to connect with 70 forex and spot exchanges, and over 300 banks across the world. On December 18, 2017, Longfin stock rose almost five-fold on the news that it had bought Ziddu, a blockchain technology provider for micro lending, warehouse finance, trade finance, bullion trading and real-time derivative settlements.

Another company long in support of cryptocurrencies and blockchain technology is Overstock.com (NASDAQ: OSTK). Overstock founder Patrick Byrne recently announced the company’s Medici Ventures has signed a memorandum of understanding to create DeSoto, a company built to work on blockchain. According to a December 27, 2017, the goal of the new company is to develop a blockchain-based system to develop a global property registry system focused on the property rights of people in the developing world. Overstock’s portfolio company “Bitt” also recently launched its new mMoney digital payment product in Barbados. Under the mMoney brand, Bitt is bringing a blockchain-based mobile wallet that allows users to participate in digital transactions on their smart phones from a secure account, a company press release states (http://nnw.fm/3nnAW).

Blockchain technology has generated a large amount of interest and excitement in many industrial sectors for its potential to facilitate faster and more secure business transactions. These companies are some of the leading enterprises well-positioned to capitalize on the future development and adoption of this technology.

For more information on Victory Square, visit Victory Square Technologies, Inc. (CSE:VST) (OTC:VSQTF) (FWB:6F6).

For a more in-depth look into Victory Square (CSE:VST) (OTC:VSQTF) (FWB:6F6), view the full report on Microsmallcap.com.

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Wednesday, January 10th, 2018 Uncategorized Comments Off

$DJACF 2018 Could be a Breakout Year for Cannabis Companies

NetworkNewsWire Editorial Coverage: Entering a new year is exciting, especially when the future holds the promise of expanding marketplaces and business opportunities. From growers and processors to the essential support services and an increasing number of retailers, cannabis companies are looking at 2018 as a breakout year for unprecedented growth. California’s launch of legal marijuana for adult recreational use kicked off January 1, and Canada is set to follow the same path in July 2018. An article in Newsweek reveals at least 12 states are poised to consider legalizing some form of marijuana in 2018 (http://nnw.fm/1ETMq), marking the latest in a quick volley of changes being implemented by lawmakers and the public as more than 60 percent of Americans say they support legalization for adults (http://nnw.fm/pFa4w). Companies nimble enough to take advantage of these promising changes include DOJA Cannabis Company Ltd. (CSE: DOJA) (OTC: DJACF) (DJACF Profile), Growlife, Inc. (OTC: PHOT), United Cannabis Corp. (OTCQB: CNAB), Cannabis Wheaton Income Corp. (TSXV: CBW) (OTC: CBWTF) and Supreme Cannabis Company, Inc. (TSXV:FIRE) (OTC:SPRWF).

Acquisitions, deal-making, and expansion plans are on the minds of many in the cannabis sector as 2018 enters the world. A new Viridian Cannabis Deal Tracker report states the amount of financing raised in 2017 to support the coming cannabis boom is a staggering $2 billion in…

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Wednesday, January 10th, 2018 Uncategorized Comments Off

$PTIE Positive Top-line Results from Nasal Abuse Potential Study with REMOXY™

– Study Meets Primary Endpoint (p<0.01) –

– REMOXY NDA Remains On-Track for Resubmission in Q1 2018 –

AUSTIN, Texas, Jan. 09, 2018 — Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced positive results from a human abuse potential study of its late-stage drug candidate, REMOXY. Study results indicate that in non-dependent, recreational opioid users, nasal administration of REMOXY resulted in significantly lower abuse potential compared to immediate-release (IR) oxycodone. All study subjects reported reduced ‘Drug Liking’ ‘Take Drug Again’ and ‘Drug High’ for REMOXY compared to oxycodone IR. In addition, nasal administration of REMOXY showed lower exposure to oxycodone, lower peak concentrations (C_max) and longer time to peak drug concentration (T_max) against comparator drugs, suggesting comparatively lower abuse potential.

“We believe these data indicate REMOXY may have limited nasal abuse potential relative to comparator drugs,” said Remi Barbier, President & CEO. “We have now successfully completed all studies necessary to resubmit the REMOXY NDA to the FDA, and plan to do so shortly.”

Design & Methods:
This Category 3 nasal abuse potential study was conducted in accordance with the U.S. Food and Drug Administration’s (FDA) Guidance for Industry for Abuse-Deterrent Opioids. In a randomized, double-blind, active- and placebo-controlled, single-dose, 4-way crossover study, 38 recreational opioid users with a history of intranasal drug abuse were enrolled in the study. The primary endpoint was ‘Drug Liking’. Secondary endpoints included ‘Take Drug Again’, ‘Drug High’ and pupil size. There were four treatment arms: REMOXY 40 mg intact; REMOXY 40 mg microwaved; oxycodone IR 40 mg; and placebo. All treatments were administered nasally. Thirty-six subjects completed the study. In addition, the first 20 subjects who completed the double-blind portion of the study also participated in a supplemental FDA Category 2 treatment arm to measure pharmacokinetic parameters following the nasal administration of 40 mg crushed OxyContin^®.

Top-Line Study Results:
REMOXY intact and microwaved each demonstrated lower VAS scores on the primary endpoint, Drug Liking (p<0.01) versus oxycodone IR, indicating that oxycodone IR was significantly preferred over REMOXY.

On secondary endpoints, REMOXY intact and microwaved each demonstrated lower scores versus oxycodone IR on Take Drug Again, Drug High and pupil size (each p<0.001 or better).

On all pharmacokinetic parameters, REMOXY resulted in significantly lower exposure to oxycodone compared to oxycodone IR and crushed OxyContin. Peak oxycodone concentrations (C_max) were at least 4-fold lower for REMOXY, microwaved or intact, compared to crushed OxyContin or oxycodone IR. Additionally, time to reach peak oxycodone concentrations was 3.5 times as long for REMOXY compared to crushed OxyContin. The C_max values for nasally administered REMOXY, microwaved REMOXY, crushed OxyContin and oxycodone IR were 14.9, 11.9, 63.6 and 64.7 ng/ml, respectively. T_max values were 3.1, 3.1, 0.88 and 1.6 hours, respectively.

Finally, the Abuse Quotient (AQ=C_max/T_max) is an essential measurement of abuse potential, with lower scores suggesting comparatively lower potential for abuse.

In this study, AQ measurements were:
<5.0     for REMOXY, intact or microwaved
72.3     for OxyContin crushed
40.4     for oxycodone IR

About REMOXY ER (extended-release oxycodone capsules CII)
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation of oxycodone. The proposed indication for this drug candidate is for “the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” We developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY’s thick, sticky, high-viscosity gel-cap formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking.

About Opioid Abuse
Opioid drugs such as oxycodone are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remains a serious, persistent problem. Drug overdose deaths exceeded 64,000 in 2016, according to the Center for Disease Control (CDC). For over a decade, Pain Therapeutics has pioneered Abuse-Deterrent Formulations (ADFs) to help in the fight against prescription drug abuse. ADFs attempt to raise the bar on prescription drug abuse by making it more difficult, longer or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made abuse-proof.

About Pain Therapeutics, Inc.
We develop proprietary drugs that offer significant improvements to patients and physicians. Our expertise consists of developing new drugs and guiding these through various regulatory and development pathways in preparation for their eventual commercialization. We generally focus our drug development efforts around disorders of the nervous system. The FDA has not yet established the safety or efficacy of our drug candidates.

Our pipeline of drug assets includes:

REMOXY ER (extended-release oxycodone capsules CII) – Proprietary abuse-deterrent, twice-daily oral oxycodone for severe chronic pain. NDA resubmission planned for Q1 2018.

FENROCK^™ (transdermal fentanyl patch system) – Proprietary, abuse-deterrent skin patch for severe pain. Early-stage program, substantially funded by a research grant award from National Institute on Drug Abuse (NIDA).

PTI-125 – Proprietary small molecule drug for the treatment of Alzheimer’s disease. Phase I clinical-stage program, substantially funded by a research grant award from the National Institutes of Health (NIH).

PTI-125-DX – Blood-based diagnostic/biomarker to detect Alzheimer’s disease. Early-stage program, substantially funded by a research grant award from the NIH.

NOTE: REMOXY^™ ER and FENROCK^™ are trademarks of Pain Therapeutics, Inc.

Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Pain Therapeutics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements regarding the planned resubmission of the REMOXY NDA in a timely matter. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the ability to resubmit the REMOXY NDA in Q1 2018. For further information regarding these and other risks related to our business, investors should consult our filings with the U.S. Securities and Exchange Commission.

For More Information Contact:
Ruth Araya
Pain Therapeutics, Inc.
IR@paintrials.com
(512) 501-2485

Tuesday, January 9th, 2018 Uncategorized Comments Off

$CIIX CEO Warren Wang, New Audio Interview at SmallCapVoice.com

AUSTIN, Texas, Jan. 09, 2018 — SmallCapVoice.com, Inc. (SCV) and ChineseInvestors.com, Inc. (OTCQB:CIIX) (‘CIIX’ or the ‘Company’), the premier financial information website for Chinese-speaking investors, today announced that a new audio interview with the Company is now available. The interview can be heard at https://smallcapvoice.com/blog/1-5-18-smallcapvoice-interview-with-chineseinvestors-com-inc-ciix.

ChineseInvestor.com, Inc.’s CEO Warren Wang, called in to SmallCapVoice.com to discuss the business model and new markets for the company, the recent news and milestones achieved in 2017, what investors can expect from the Company in 2018, and more. In December 2017 the Company announced plans to spin off its wholly-owned foreign enterprise, CBD Biotechnology Co. Ltd., and its wholly-owned subsidiary, ChineseHempOil.com, Inc., to be registered as a separate publically traded company allowing CIIX to focus on its new Cryptocurrency Division and its Core Financial Education Business.

In the interview, Mr. Wang stated, “2017 was a very big year for ChineseInvestors.com and its shareholders. First, we were able to track a lot of new investors and shareholders. Second, we established CBD Biotechnology and ChineseHempOil.com, Inc. in China and in the US. From this Company alone, we expect to generate over 2 million dollars in 2018. We also entered into the cryptocurrency education markets in 2018. I am very excited about our growth, new markets and I know we are definitely making progress.”

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 they are interested in. 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 their services, please visit http://smallcapvoice.com/blog/the-small-cap-daily-small-cap-newsletter/.

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

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities 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.

Corporate Communications Contact:

NetworkNewsWire (NNW)

New York, New York

www.NetworkNewsWire.com

212.418.1217 Office

Editor@NetworkNewsWire.com

For SmallCapVoice.com

Stuart T. Smith

512-267-2430

info@smallcapvoice.com

Tuesday, January 9th, 2018 Uncategorized Comments Off

$DJACF Closes $12.5 Million Private Placement led by $APHQF

KELOWNA, BC, Jan. 9, 2018 – DOJA Cannabis Company Limited (“DOJA” or the “Company“) (CSE: DOJA) is pleased to announce the closing of its previously announced non-brokered private placement of subscription receipts (the “Subscription Receipts“) whereby Aphria Inc. (“Aphria“) (TSX:APH and US OTC: APHQF) and Koicha Partners LP acquired from DOJA an aggregate of 8,992,807 Subscription Receipts of the Company at a price per Subscription Receipt of $1.39 for gross proceeds of $12,500,001.73 (the “Offering“).

The financing supports the strategic positioning of Hiku Brands Company Ltd. (“Hiku“), the anticipated combined company resulting from the merger (the “Merger“) of DOJA and TS Brandco Holdings Inc. (“Tokyo Smoke“), an award-winning lifestyle brand and retail-focused cannabis company (see DOJA’s press release of December 21, 2017). The merger of DOJA and Tokyo Smoke creates the first retail-focused, craft cannabis producer, and with a portfolio of highly recognizable brands, Hiku is strategically positioned to become the preeminent craft cannabis brand house in the Canadian adult-use cannabis market.

“We’re thrilled to have strategic partners in Aphria and Koicha Partners,” said Trent Kitsch, CEO of DOJA. “Once the merger with Tokyo Smoke goes through, this strategic investment will strengthen Hiku, financially as well as through its brand recognition and product and market reach. Expanding Hiku’s retail footprint, targeting provinces allowing private cannabis retail, and building a portfolio of recognizable consumer brands and products will be key differentiators for Hiku.”

The Subscription Receipts will be automatically convertible into units of the Company (the “Units“) upon the satisfaction of certain escrow release conditions, with each Unit comprised of one common share of the Company (a “Common Share“) and one Common Share purchase warrant of the Company (a “Warrant“). Each Warrant will entitle the holder to acquire one additional Common Share (a “Warrant Share“) for a period of two years from the closing date of the Merger at an exercise price of $2.10 per Warrant Share. If, following the closing of the Merger, the volume weighted average price of the Common Shares on the Canadian Securities Exchange is equal to or greater than $3.05 for any twenty (20) consecutive trading days, the Company may, upon providing written notice to the holders of the Warrants, accelerate the expiry date of the Warrants to the date that is 30 days following the date of such written notice. The Company intends to use the net proceeds of the Offering to expand its cannabis production capacity, grow its retail footprint, and add select brands to its portfolio through highly strategic and complementary acquisitions.

All securities issued in connection with the Offering are subject to a four month hold period expiring May 10, 2018.

The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any State in which such offer, solicitation or sale would be unlawful.

For further details on the Offering and the Merger, please refer to the Company’s press release dated December 21, 2017.

About DOJA
DOJA™ is a premium cannabis lifestyle brand growing high-quality handcrafted cannabis flower. DOJA’s wholly-owned subsidiary is a licensed producer of cannabis under the Access to Cannabis for Medical Purposes Regulations (the “ACMPR“) that has requested its Pre-Sales License Inspection, the last step prior to receiving a license to sell cannabis under the ACMPR. DOJA’s state-of-the-art ACMPR licensed production facility is located in the heart of British Columbia’s picturesque Okanagan Valley. DOJA was founded by the proven entrepreneurial team that started SAXX Underwear®.

About Tokyo Smoke
Founded in 2015 by Alan and Lorne Gertner, Tokyo Smoke is an award-winning cannabis lifestyle brand that brings sophistication and design to the fast-growing industry. With immersive experiences and design-first, non-dispensary retail spaces selling coffee, cannabis accessories and design products, the brand has six locations in Canada, with plans to expand nationwide. Recently named “Brand of the Year” at the Canadian Cannabis Awards, Tokyo Smoke has showcased excellence in brand storytelling, and has developed an international reputation as the go-to destination for engaging content offerings within the industry. With the acquisition of fellow designer cannabis brand Van der Pop, and by partnering with Aphria Inc. (TSX: APH and US OTC: APHQF) and WeedMD (TSXV: WMD), Tokyo Smoke continues to be the leading Canadian brand in the cannabis space.

About Hiku
Upon completion of the Merger, Hiku will be focused on handcrafted cannabis production, immersive retail experiences, and building a portfolio of iconic, engaging cannabis lifestyle brands. Hiku will be differentiated as the only Canadian craft cannabis producer with a significant national retail footprint and a growing brand house including premium cannabis lifestyle brands DOJA, Tokyo Smoke, and Van der Pop.

Hiku’s wholly-owned subsidiary, DOJA Cannabis Ltd., is a federally licensed producer pursuant to the ACMPR, owning two production facilities in the heart of British Columbia’s Okanagan Valley. Upon completion of the Merger, the company will operate a network of retail stores selling coffee, clothing and curated accessories, across British Columbia, Alberta and Ontario.

For more information, please visit www.hikubrands.com

About Aphria
Aphria Inc., one of Canada’s lowest cost producers, produces, supplies and sells medical cannabis. Located in Leamington, Ontario, the greenhouse capital of Canada. Aphria is truly powered by sunlight, allowing for the most natural growing conditions available. Aphria is committed to providing pharma-grade medical cannabis, superior patient care while balancing patient economics and returns to shareholders.

Statement Regarding Forward-Looking Information

This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause DOJA’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

Forward-looking statements in this document include statements concerning the use of proceeds from the Offering, the completion of the Merger, the anticipated business of Hiku and all other statements that are not historical facts. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others:

that there is no assurance that the parties will obtain the requisite director, shareholder and regulatory approvals for the Merger;
there is no assurance that the Merger will close on the terms anticipated or at all;
following completion of the Merger, Hiku may require additional financing from time to time in order to continue its operations; financing may not be available when needed or on terms and conditions acceptable to Hiku;
new laws or regulations could adversely affect Hiku’s business and results of operations; and
competitive, regulator and other factors may adversely impact Hiku’s ability to accomplish its business objectives.

THE FORWARD-LOOKING INFORMATION CONTAINED IN THIS NEWS RELEASE REPRESENTS THE EXPECTATIONS OF THE COMPANY AS OF THE DATE OF THIS NEWS RELEASE AND, ACCORDINGLY, IS SUBJECT TO CHANGE AFTER SUCH DATE. READERS SHOULD NOT PLACE UNDUE IMPORTANCE ON FORWARD-LOOKING INFORMATION AND SHOULD NOT RELY UPON THIS INFORMATION AS OF ANY OTHER DATE. WHILE THE COMPANY MAY ELECT TO, IT DOES NOT UNDERTAKE TO UPDATE THIS INFORMATION AT ANY PARTICULAR TIME EXCEPT AS REQUIRED IN ACCORDANCE WITH APPLICABLE LAWS.

The Canadian Securities Exchange has not approved nor disapproved the contents of this news release.

please contact Jeff Barber, Chief Financial Officer by email at investors@doja.life or by phone at 1-(877) 763-DOJA extension 101.Copyright CNW Group 2018

Tuesday, January 9th, 2018 Uncategorized Comments Off

$VSQTF & Blockchain Investors Consortium Up-and-Comer $2M Investment Prize Pool

VANCOUVER, British Columbia, Jan. 09, 2018 — Further to its news release of December 6, 2017, Victory Square Technologies Inc. (“Victory Square” or the “Company”) (CSE:VST) (OTC:VSQTF) (FWB:6F6) and the Blockchain Investors Consortium (“BIC”) are partnering to offer a $2M investment prize pool for the top three blockchain technology companies at each of the highly-touted d10e conferences held in the coming year.

Up-and-coming blockchain companies pitching at d10e conferences held in 2018 in Seoul (South Korea), Tel Aviv (Israel), Silicon Valley (USA), Bodrum (Turkey), Malta, Astana (Kazakhstan) and Vilnius (Lithuania) will be eligible for the unique prizing opportunities.

“D10e was created to provide a platform for promising blockchain companies to showcase their ventures to a worldwide audience of investors and cryptocurrency enthusiasts,” said Mike Costache, Founder of the Blockchain Investors Consortium. “We pride ourselves on ensuring that the companies selected to pitch at each event have reputable teams, sound token models and global disruptive potential. And we’re proud to do so in partnership with Victory Square Technologies.”

D10e has hosted the preeminent decentralization conference series around the world with over 13 events since 2014. Past d10e presenters have collectively raised over $750 million through token sales and include some of the largest brands in blockchain. Past event locations have included Singapore, San Francisco (USA), Amsterdam (Netherlands), Kyiv (Ukraine), Warsaw (Poland), and more. At each event, hundreds of companies from around the world submit an online application to pitch, of which 20 are selected to present live in the startup pitch competition, and the top three companies are selected as winners.

“By partnering with the BIC and d10e to provide these investment prizes, we’re proud to have the opportunity to connect in such a meaningful way with the real up-and-comers in blockchain and cryptocurrency,” said Shafin Diamond Tejani, Chief Executive Officer of Victory Square. “Throughout the process, which we want to be fun and challenging for these emerging stars, we’re gaining early access to a wide array of the most promising blockchain technology companies in the world, as selected by established thought leaders in the industry. That will help us expand our blockchain portfolio over the next 12 months and is on track to provide us with investments in over 60 of the most disruptive companies.”

Victory Square will be awarding a $100,000 equity investment or token allocation split equally between the top three companies selected by a panel of judges who are leaders in the dynamic blockchain and cryptocurrency space. Past judges have included Mike Costache, Brock Pierce, David Orbin, Eddy Travia, Ruslan Gavrilyuk, and many other prominent advocates of decentralization and champions of blockchain technology.

Victory Square provided the investment prize to the top three companies at the most recent d10e conferences in Gibraltar, Davos (Switzerland), Ljubljana (Slovenia) and Bucharest (Romania). The winning companies included:

Debitum – a decentralized alternative financing ecosystem.
Guardium – the world’s first blockchain-based emergency response platform.
Neuromation – a distributed synthetic data platform.
OSA Hybrid Platform – AI and blockchain synergy in retail.
Hacken – the connection between blockchain and cybersecurity communities.
InsurePal – distributed social proof insurance.
Persona – decentralized identity management.
TheMine – mining as a service.
Native Protocol – tokenized community banking.
Chainium – intersection of blockchain and the global equity market.
AidCoin – decentralized charity donations.

D10e expects to host approximately 16 events over the next year. The sponsored investment prize will also provide a new referral source for VS Blockchain Assembly, the Victory Square portfolio company that provides advisory and post-build services for blockchain companies conducting Initial Coin Offerings and Token Generation Events.

For further information about the Company, please contact:

Howard Blank, Director
Email: ir@victorysquare.com
Telephone: 604-928-6066

ABOUT VICTORY SQUARE TECHNOLOGIES INC.
Victory Square Technologies is a blockchain-focused venture builder that funds and empowers entrepreneurs to implement innovative blockchain solutions. Victory Square portfolio companies are disrupting every sector of the global economy including Virtual Reality, Artificial Intelligence, Personalized Health, Gaming and Film. Victory Square has a proven process for identifying game-changing entrepreneurs and providing them with the partners, mentorship and support necessary to accelerate their growth and help them scale globally. For more information, please visit www.victorysquare.com.

ABOUT THE CANADIAN SECURITIES EXCHANGE (CSE)
The Canadian Securities Exchange, or CSE, is operated by CNSX Markets Inc. Recognized as a stock exchange in 2004, the CSE began operations in 2003 to provide a modern and efficient alternative for companies looking to access the Canadian public capital markets. The CSE has not reviewed, nor approved or disapproved the content of this news release.

FORWARD-LOOKING INFORMATION
This news release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of Victory Square. Forward-looking information is based on certain key expectations and assumptions made by the management of Victory Square, including future plans. Although Victory Square believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Victory Square can give no assurance that they will prove to be correct. Forward- looking statements contained in this news release are made as of the date of this news release. Victory Square disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

Tuesday, January 9th, 2018 Uncategorized Comments Off

$ALDR Eptinezumab Reduces Migraine Risk Meets Primary and All Key Secondary Endpoints

— Highly statistically significant results with rapid prevention beginning Day One, 50%, 75%, 100% responder rates by month one sustained for three months —

— 15% of patients had no migraines for a full three months —

— Conference call and webcast to be held today, January 8, at 8:30 a.m. ET —

BOTHELL, Wash., Jan. 08, 2018 — Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced that eptinezumab, its lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP), met the primary endpoint in its pivotal Phase 3 PROMISE 2 clinical trial with very high statistical significance vs. placebo (p<0.0001) for both dose levels tested in the trial following a single quarterly infusion. In addition, eptinezumab met all key secondary endpoints with very high statistical significance vs. placebo including prevention beginning Day One (p<0.0001) and 50 percent (p<0.0001) and 75 percent (p<0.0001) responder rates month one through month three. Furthermore, 15% of eptinezumab patients had no migraines (i.e., 100 percent response) for a full three months (p<0.0001 unadjusted). Safety and tolerability were similar to previously reported eptinezumab studies.

“These clinically significant data clearly demonstrate that eptinezumab delivered by infusion provided rapid, effective and sustained migraine relief,” said Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder. “With these PROMISE 2 results, we remain on track to submit our Biologics License Application (BLA) in the second half of 2018. If approved, eptinezumab has the potential to advance the treatment paradigm in chronic migraine prevention and be a meaningful treatment option for millions of the most severely impacted patients.”

PROMISE 2 Top-Line Results Following a Single Eptinezumab Administration

Primary endpoint met: reduction of 8.2 monthly migraine days from baseline compared to 5.6 days for placebo, p<0.0001
Key secondary and other endpoints met
- Rapid Day One prevention: 52 percent reduction in migraine risk beginning Day One post-infusion compared to 27 percent for placebo, p<0.0001¹
- Responder rates for month one through month three:
  - 61 percent of patients achieved 50 percent or greater reduction in migraine days from baseline compared to 39 percent for placebo, p<0.0001
  - 33 percent of patients achieved a 75 percent or greater reduction in migraine days from baseline, compared to 15 percent for placebo, p<0.0001
  - 15 percent of patients had no migraines (i.e., 100 percent response) for a full three months, compared to 5 percent for placebo, p<0.0001 (post hoc, unadjusted)
- All other pre-specified key secondary endpoints were met with very high statistical significance

The observed safety profile in this study, to date, is consistent with previously reported eptinezumab studies. Adverse event rates among eptinezumab-treated subjects were similar to placebo-treated subjects. The most commonly reported adverse events for eptinezumab, occurring at an incidence of 2.0% or greater, were nasopharyngitis (common cold) (6.3 percent), upper respiratory infection (4.0 percent), nausea (3.4 percent) and urinary tract infection (3.1 percent), arthralgia (joint pain) (2.3 percent), dizziness (2.6 percent), anxiety (2.0 percent) and fatigue (2.0 percent). Full safety data will be available at the completion of the study.

“These results represent an important part of the significant step forward that patients who suffer from migraine, many of whom have been living with the disease for decades with limited relief, are about to experience,” said Peter Goadsby, M.D., Ph.D. D.Sc., Neurologist and Headache Specialist at the University of California, San Francisco Medical Center. “The new data demonstrate that eptinezumab administered via infusion delivers rapid onset and sustained benefit following one administration. Rapid onset of effect is a true paradigm shift in migraine preventive treatment. I’m excited about the potential for my patients to experience early and meaningful periods of migraine freedom if new treatments become approved.”

More than 2,600 patients have been treated with eptinezumab in its clinical development program, including the PROMISE 1 and PROMISE 2 trials. The eptinezumab development program was designed to redefine physician and patient expectations for migraine prevention, including rapid, meaningful, sustained migraine relief. Alder plans to submit a BLA to the U.S. Food and Drug Administration (FDA) for eptinezumab in the second half of 2018. If approved by the FDA, eptinezumab will be the first-to-market migraine prevention infusion therapy, with 100 percent of the treatment dose available upon administration.

About Eptinezumab PROMISE Clinical Trial Program
PROMISE 2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2) is a Phase 3, randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for chronic migraine prevention. In the study, 1,072 patients were randomized to receive eptinezumab (300 mg or 100 mg), or placebo administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced at least 15 headache days per month, of which at least eight met criteria for migraine. Patients that participated in the trial had an average of 16.1 migraine days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine days over the 12 week, double-blind treatment period. Secondary study endpoints assessed through 12 weeks included reduction in migraine prevalence day 1 and days 1-28, reduction of at least 50%, 75%, and 100% from baseline in mean monthly migraine days, change from baseline in mean monthly acute migraine-specific medication days, and reductions from baseline in patient-reported impact scores on the Headache Impact Test (HIT-6).

PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) was a Phase 3 randomized, double-blind, placebo-controlled global trial evaluating the safety and efficacy of eptinezumab for episodic migraine prevention. In the study, 888 patients were randomized to receive eptinezumab (300 mg, 100 mg or 30mg), or placebo administered by infusion once every 12 weeks. To be eligible for the trial, patients must have experienced ≤14 headache days per month, of which at least four met the criteria for migraine. The primary endpoint was the mean change from baseline in monthly migraine days over the 12 week, double-blind treatment period. Full 24-week data from PROMISE 1 was presented at the 18th Congress of the International Headache Society in September 2017.

About Eptinezumab
Eptinezumab is a monoclonal antibody (mAb) inhibiting calcitonin gene-related peptide (CGRP), which is believed to play a key role in mediating and initiating migraine. Eptinezumab’s mAb design combined with delivery via quarterly infusion allows for strong and immediate inhibition of CGRP biology.² Eptinezumab is currently in multiple global, randomized pivotal, Phase 3 studies to assess its efficacy and safety in migraine prevention.

About Migraine^3,4,5
Migraine affects 36 million Americans and is considered the 6th most disabling disease in the world. It is a disabling neurological disease characterized by recurrent episodes of moderate to severe headache accompanied by nausea, vomiting, and sensitivities to light and sound. The occurrence of migraine can be unpredictable with a profound impact on activities of daily living. This disease can last decades, often during what should be the most productive years of patients³ lives. Migraine can remit or progress to chronic migraine over time and persist as chronic migraine for years or decades, but it commonly oscillates between periods of frequent episodic and chronic migraine. Current preventive treatments for migraine fail to meet the needs of most patients and most patients discontinue use within 6 months to 1 year due to lack of efficacy and/or side effects.^5,6 There is a significant need for new, effective, and well-tolerated treatment options.

Conference Call and Webcast
Alder will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss the PROMISE 2 top-line data. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 8388707. The webcast and accompanying slides may be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com and will be available for replay following the call for at least 30 days.

About Alder BioPharmaceuticals
Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company committed to transforming the treatment paradigm for patients with migraine and other serious neurological or inflammatory conditions. Leveraging its pioneering monoclonal antibody technologies, Alder discovers and develops novel therapeutic antibodies designed to deliver highly differentiated, best-in-class clinical profiles. Alder’s lead pivotal-stage product candidate, eptinezumab, is being evaluated as potentially the first-to-market migraine prevention infusion therapy. Eptinezumab is a monoclonal antibody (mAb) inhibiting calcitonin gene-related peptide (CGRP), which is believed to play a key role in mediating and initiating migraine. Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy. ALD1910 is a monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), another protein that is active in mediating the initiation of migraine. Clazakizumab, Alder’s third program, is a monoclonal antibody candidate that inhibits interleukin-6 and is licensed to Vitaeris, Inc. For more information, please visit http://www.alderbio.com.

Forward Looking Statements
This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of eptinezumab; the potential BLA submission for eptinezumab; the belief that eptinezumab has the potential to advance the treatment paradigm in chronic migraine and be a meaningful treatment option; the availability of additional data from the referenced clinical trial; the belief that rapid onset of effect is a paradigm shift in migraine preventative treatment; the high unmet need for preventative migraine treatments; and the potential benefit to patients if new treatments are approved. Words such as “demonstrate,” “on track,” “potential,” “advance,” “paradigm,” “shift,” “option,” “will,” “step forward,” “about,” “plans,” “need,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder’s current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder’s ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder’s compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder’s ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder’s development and commercialization activities; the sufficiency of Alder’s capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Alder’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2017, which was filed with the Securities and Exchange Commission (SEC) on November 7, 2017, and is available on the SEC’s website at www.sec.gov. Additional information will also be set forth in Alder’s other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Alder expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Alder’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Media Contacts:
Ashley Cadle
TogoRun
(310) 463-0143
a.cadle@togorun.com

Investor Relations Contact:
Michael Schaffzin
Stern Investor Relations, Inc.
(212) 362-1200
michael@sternir.com

References

Day One prevalence rate comparison between eptinezumab vs. placebo
Baker B, Schaeffler B, Cady R, et al; Rational design of a monoclonal antibody (mAb) inhibiting calcitonin gene-related peptide, ALD403 (Eptinezumab), intended for the prevention of migraine. Poster presented at the American Academy of Neurology (AAN) 2017 Annual Meeting.
Migraine Research Foundation. Migraine Facts. http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed June 17, 2017.
Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015; 55(S2):103-122.
Bigal ME, Krymchantowski AV, Lipton RB. Barriers to satisfactory migraine outcomes. What have we learned, where do we Stand? Headache. 2009;49(7):1028–1041.
Hepp, Z, Dodick DW, Varon SF, et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia 2015;35(6):477-88.

Monday, January 8th, 2018 Uncategorized Comments Off

$TNDM Reports Successful Completion of First Pilot Study Using t:slim X2 Insulin Pump

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today reported the successful completion of the first pilot study using a hybrid closed loop system featuring its t:slim X2™ Insulin Pump with embedded algorithms from TypeZero Technologies and integration with Dexcom® G6 Continuous Glucose Monitoring (CGM). This pilot study was the first of three in the National Institute of Health (NIH)-funded International Diabetes Closed Loop (IDCL) Trial using the t:slim X2 Pump running the algorithm directly on the pump. The second study is now moving forward with enrollment at seven clinical sites and is anticipated to begin in the first quarter of 2018. The IDCL Trial is expected to conclude with a pivotal study in 2018, and Tandem plans to use this data in a PMA submission to the U.S. Food and Drug Administration.

The hybrid closed loop system predicts high and low blood sugar levels and adjusts insulin delivery accordingly throughout the day, while still allowing the user to manually bolus for meals. In addition to basal insulin adjustments, the system also automates correction boluses. The hybrid closed loop software developed by TypeZero includes a series of algorithms developed from initial research conducted at the University of Virginia. To date, this technology has been used in more than 30 clinical studies involving more than 450 participants, with data referenced in a number of journal articles.¹

“The first successful use of the commercial version of our hybrid closed loop system is a huge step forward, and the speed of the development cycle for this product has been impressive for our industry,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “We look forward to starting the pivotal study later this year and continue to prepare for a launch in the first half of 2019, subject to FDA approval.”

“We have enjoyed introducing patients to this latest advancement in technology, featuring an easy-to-use system and an algorithm with a successful track record in past clinical trials of improving blood glucose control while simultaneously decreasing hypoglycemia,” said Sue Brown, Associate Professor at the Center for Diabetes Technology at the University of Virginia and the endocrinologist in charge of the IDCL trials using this embedded technology. “This study was an exciting step forward in closed-loop technology for people with diabetes.”

“Sensor accuracy is a critical component for automated insulin delivery, and we are excited to have the first integration of Dexcom’s next-generation G6 CGM technology in this hybrid closed loop system,” said Steve Pacelli, Executive Vice President of Strategy and Corporate Development at Dexcom. “We are proud to partner with Tandem in the IDCL trial and are thrilled to see this integrated product moving forward into multi-center studies.”

The IDCL Trial started in late 2016 and is expected to include up to 360 adults with type 1 diabetes across all of its studies. Earlier phases of the IDCL used a Tandem insulin pump and Dexcom G5 sensor as part of a blood glucose control system that combined these devices with a smartphone running TypeZero’s inControl closed loop algorithms. The latest series of studies, now using the fully-integrated system, began with the supervised 36 to 48-hour pilot study in 5 subjects conducted at the University of Virginia. The next study, scheduled to take place in early 2018, will be a two-week, at-home study with enrollment at seven centers across the United States. A pivotal trial is planned to take place at these same centers following successful completion and review of the two-week study.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The Company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem manufactures and sells the t:slim X2™ Insulin Pump, the only pump capable of remote feature updates using a personal computer, now available with Dexcom G5® Mobile CGM integration, and the t:flex® Insulin Pump, the first pump designed for people with greater insulin requirements. Tandem is based in San Diego, California.

Tandem Diabetes Care and t:flex are registered trademarks, and t:slim X2 is a trademark of Tandem Diabetes Care, Inc. Dexcom, Dexcom G5 and Dexcom G6 are registered trademarks of Dexcom, Inc. All other trademarks are the property of their respective owners.

Forward Looking Statement

This press 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, 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. These forward-looking statements relate to, among other things, the timing of anticipated enrollment, commencement and completion of the remaining studies that comprise the IDCL trial, whether the data from the IDCL trial will be adequate to support a future regulatory filing by Tandem and the anticipated launch of an integrated product in the first half of 2019. These statements are subject to numerous risks and uncertainties, including the risk that each of the remaining studies that comprise the IDCL trial will be completed as currently contemplated, Dexcom’s ability to secure regulatory approval for the Dexcom G6 CGM, and Tandem’s ability to rely on the data from the IDCL trial to support a future regulatory filing, as well as other risks identified in Tandem’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and other documents that we file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The companies undertake no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.

_________

¹ Recent Publications Highlighting Research Using TypeZero AP Technology: (a) Ly T, Buckingham B, DeSalvo et al. Day-and-Night Closed-Loop Control Using the Unified Safety System in Adolescents With Type 1 Diabetes at Camp. Diabetes Care 2016 Aug; 39(8): e106-e107. (b) Anderson S, Raghinaru D, Pinsker J, et al. Multinational Home Use of Closed-Loop Control Is Safe and Effective. Diabetes Care. 2016 Jul;39(7):1143-50. (c) Boris P. Kovatchev, Eric Renard, Claudio Cobelli, et al. Safety of Outpatient Closed-Loop Control: First Randomized Crossover Trials of a Wearable Artificial Pancreas. Diabetes Care. 2014 Jul; 37(7): 1789–1796.

Tandem Diabetes Care
Media:
Steve Sabicer, 714-907-6264
ssabicer@thesabicergroup.com
or
Investors:
Susan Morrison, 858-366-6900 x7005
smorrison@tandemdiabetes.com

Monday, January 8th, 2018 Uncategorized Comments Off

$NVTR Announces Preliminary Unaudited Fourth Quarter and Full Year 2017 Revenue

PLANO, Texas, Jan. 08, 2018 — Nuvectra Corporation (NASDAQ:NVTR), a neurostimulation medical device company, today announced preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2017.

Preliminary unaudited fourth quarter consolidated revenue is expected to be in the range of $11.5 to $12.0 million, compared to $4.2 million in the fourth quarter of 2016. Preliminary unaudited Algovita revenue for the fourth quarter of 2017 is expected to be in the range of $10.0 to $10.5 million, compared to $2.0 million in the fourth quarter of 2016.

Nuvectra’s preliminary unaudited full year 2017 consolidated revenue is expected to be in the range of $31.5 to $32.0 million, compared to $12.5 million for full year 2016.

The preliminary unaudited revenue results included in this press release are prior to the completion of review and audit procedures by the Company’s independent registered public accounting firm and are therefore subject to adjustment. The Company plans to release its fourth quarter and full year 2017 financial results in early March 2018.

About Nuvectra Corporation

Nuvectra^TM is a neurostimulation company committed to helping physicians improve the lives of people with chronic conditions. The Algovita^® Spinal Cord Stimulation (SCS) System is our first commercial offering and is CE marked and FDA approved for the treatment of chronic intractable pain of the trunk and/or limbs. Our innovative technology platform also has capabilities under development to support other indications such as sacral neuromodulation (SNM) for the treatment of overactive bladder, and deep brain stimulation (DBS) for the treatment of Parkinson’s Disease. In addition, our NeuroNexus subsidiary designs, manufactures and markets leading-edge neural-interface technologies for the neuroscience clinical research market. Visit the Nuvectra website at www.nuvectramed.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements,” including statements we make regarding the outlook for Nuvectra as an independent publicly-traded company. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions, and therefore they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and may be outside of our control. Our actual performance may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us is based only on information currently available to us and speaks only as of the date on which it is made. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include: (i) our ability to successfully commercialize Algovita and to develop, complete and commercialize enhancements or improvements to Algovita; (ii) our ability to successfully compete with our current SCS competitors and the ability of our U.S. sales representatives to successfully establish market share and acceptance of Algovita, (iii) the uncertainty of obtaining regulatory approvals in the United States and Europe for our Virtis SNM system, (iv) our ability to successfully launch and commercialize the Virtis SNM system if it receives regulatory approval (v) our ability to demonstrate the features, perceived benefits and capabilities of Algovita to physicians and patients in competition with similar products already well established and sold in the SCS market; (vi) our ability to anticipate and satisfy customer needs and preferences and to develop, introduce and commercialize new products or advancements and improvements to Algovita in order to successfully meet our customers’ expectations; (vii) the outcome of our development plans for our neurostimulation technology platform, including our ability to identify additional indications or conditions for which we may develop neurostimulation medical devices or therapies and seek regulatory approval thereof; (viii) our ability to identify business development and growth opportunities and to successfully execute on our strategy, including our ability to seek and develop strategic partnerships with third parties to, among other things, fund clinical and development costs for new product offerings; (ix) the performance by our development partners, including Aleva Neurotherapeutics, S.A., of their obligations under their agreements with us; (x) the scope of protection for our intellectual property rights covering Algovita and other products using our neurostimulation technology platform, along with any product enhancements or improvements; (xi) our ability to successfully build, attract and maintain an effective commercial infrastructure and qualified sales force in the United States; (xii) our compliance with all regulatory and legal requirements regarding implantable medical devices and interactions with healthcare professionals; (xiii) any supplier shortages related to Algovita or its components and any manufacturing disruptions which may impact our inventory supply as we expand our business, (xiv) any product recalls, or the receipt of any warning letters, mandatory corrections or fines from any governmental or regulatory agency; (xv) our ability to satisfy the conditions and covenants, including trailing six month revenue milestones, of our Credit Facility; and (xvi) our ability to raise capital through means other than or in addition to the Credit Facility should it become necessary to do so, through a public offering of our common stock, private equity or debt financings, strategic partnerships, or other sources. Please see the section entitled “Risk Factors” in Nuvectra’s Annual Report on Form 10-K and in our other quarterly and periodic filings for a description of these and other risks and uncertainties. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Company Contacts:
Nuvectra Corporation

Walter Berger, COO & CFO
(214) 474-3102
wberger@nuvectramed.com

Investor Contacts:
The Ruth Group

Tram Bui / Brian Johnston
(646) 536-7035 / 7028
investors@nuvectramed.com

Monday, January 8th, 2018 Uncategorized Comments Off

$MYSZ Showcases Body Measurement Technology with “MySizeID – The Movie”

To be shown at the CES international innovation conference in Las Vegas

AIRPORT CITY, Israel, January 8, 2018 —

My Size, Inc. (the “Company” or “My Size”) (NASDAQ: MYSZ; TASE: MYSZ), the developer and creator of smartphone measurement applications will be presenting “MySizeID – The Movie” at the CES international innovation conference in Las Vegas. “MySizeID – The Movie” is a video, produced by the Directors’ Cut production house, which demonstrates the capabilities of the Company’s new, innovative body measurement technology that may change the manner in which consumers purchase clothing online. To watch the video – press here.

My Size’s body measurement technology, MySizeID, will enable consumers to measure their body using their smartphones which will allow the application to recommend the correct size for clothing purchased online. The application involves that use of a technological innovation that the Company believes will significantly reduce the margin of error experienced by consumers who purchase the wrong size online and thereby increase consumer confidence in online purchases on matters relating to size.

“We are very happy to launch both the new and innovative technology and the unique film demonstrating its advantages at the trade show,” said My Size CEO, Ronen Luzon. “We believe that the MySizeID technology can significantly transform online commerce and change the manner in which people purchase clothes, while saving time and money due to incorrectly selecting clothes of the wrong size. ”

The Company will be participating in the international CES innovation tradeshow in Las Vegas on January 9-12, 2018 (Booth # 51702). For more information regarding CES – press here.

About My Size, Inc.

My Size, Inc. (TASE: MYSZ) (NASDAQ: MYSZ) has developed a unique measurement technology based on sophisticated algorithms and cutting edge technology with broad applications including the apparel, e-commerce, DIY, shipping and parcel delivery industries. This proprietary technology is driven by several algorithms which are able to calculate and record measurements in a variety of novel ways. To learn more about My Size, please visit our website. www.mysizeid.com. Follow us on Facebook, LinkedIn and Twitter.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of the words “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” and similar expressions that are intended to identify forward-looking statements. All forward-looking statements speak only as of the date of this press release. You should not place undue reliance on these forward-looking statements. Although we believe that our plans, objectives, expectations and intentions reflected in or suggested by the forward-looking statements are reasonable, we can give no assurance that these plans, objectives, expectations or intentions will be achieved. Forward-looking statements involve significant risks and uncertainties (some of which are beyond our control) and assumptions that could cause actual results to differ materially from historical experience and present expectations or projections. Actual results to differ materially from those in the forward-looking statements and the trading price for our common stock may fluctuate significantly. Forward-looking statements also are affected by the risk factors described in the Company’s filings with the U.S. Securities and Exchange Commission. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.

Press Contact:
Eran Yoels
Rimon, Cohen and Co.
Eran@rcspr.co.il
+972-52-440-8020

Monday, January 8th, 2018 Uncategorized Comments Off

$STLHF Acquires Lithium Brine Exploration Rights in Arkansas’ Smackover

VANCOUVER, British Columbia, Jan. 08, 2018 — Standard Lithium Ltd. (“Standard Lithium” or the “Company”) (TSXV:SLL) (OTCQX:STLHF) (FRANKFURT:S5L) is pleased to announce that the Company has signed an Option Agreement with TETRA Technologies Inc. (TETRA), a non-affiliated NYSE-listed company, to acquire the rights to conduct exploration, production and lithium extraction activities on up to 33,000 acres of brine leases located in an area where the Smackover Formation is known to be highly productive in southern Arkansas, USA.

Standard Lithium’s Chief Executive Officer, Mr. Robert Mintak commented, “In our search for opportunities of significance, this is one that could really move the needle. We believe the Smackover may be one of the lithium industry’s most promising regions to develop, given the potential resource size and large-scale brine-handling infrastructure in the region. This agreement highlights our excellent working relationship with TETRA, and signing this deal allows Standard Lithium access to the last available large lease package in the key brine production zone of the Smackover.”

Project Highlights:

Up to 33,000 acres of brine leases in key brine production fairway in southern Arkansas, adjacent to producing Albemarle leases;
Historical data from Standard Lithium lease area shows 370-424 mg/L lithium in brines (Moldovanyi and Walter, 1992);
Arkansas currently produces the equivalent of 42.6 million m³ (9,380,000,000 gallons) of brine per year (based on Arkansas Oil and Gas Commission reported average brine production from 2010-2016), almost entirely from the Smackover Formation;
Low risk, well understood geology and chemistry;
Significant infrastructure, roads, power, water, trained workforce in region; and
Existing brine extraction, processing and re-injection permitting regime.

President and Chief Operating Officer, Dr. Andy Robinson also commented, “the Company chose the Smackover Formation as a key development target, precisely because it combines a very large resource potential, with well-studied and documented geology and hydrogeology, along with a permitting regime that has a long history of approving operations that remove, process and re-inject massive volumes of brine. Combined with a wealth of existing infrastructure in the project area (power, rail, gas, water, trained workforce, cheap reagents etc.), this makes Standard’s new opportunity in Southern Arkansas the perfect location to locate a modern lithium brine processing operation. Due to the wealth of already-available data from our new project area, we can start the process of compiling a maiden resource estimate for this large lease package extremely quickly, with a minimum of additional intrusive investigation.”

Transaction Terms
Under the terms of the Option Agreement with TETRA, the Company will be granted the rights in consideration for a series of cash payments, as well as certain ongoing royalties tied to lithium production from the properties. In consideration of the execution of the Option Agreement, the Company has made a non-refundable cash payment to TETRA of US$500,000, with further cash payments owing to TETRA as follows:

US$500,000 on or before the date that is thirty (30) calendar days following the Agreement Date;
an additional US$600,000 on or before the date which is twelve (12) months following the Agreement Date;
an additional US$700,000 on or before the date which is twenty-four (24) months following the Agreement Date;
an additional US$750,000 on or before the date which is thirty-six (36) months following the Agreement Date; and
an additional annual payment of US$1,000,000 on or before each annual anniversary of the Agreement Date, beginning with the date that is forty-eight (48) months following the Agreement Date, until the earlier of the expiration of the 10 year exploratory period or, if the Company exercises the Option, the Company begins payment of the Royalty.

Upon commercial production, the Company will pay TETRA a two and one-half percent (2.5%) royalty on gross revenue derived from the sale of lithium produced from the properties, subject to a minimum annual royalty payment of US$1,000,000.

Quality Assurance

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

About Standard Lithium Ltd.

Standard’s value creation strategy encompasses acquiring a diverse and highly prospective portfolio of large-scale domestic brine resources, led by an innovative and results-oriented management team with a strong focus on technical skills. The Company is currently focused on the immediate exploration and development of the Bristol Dry Lake Lithium Project located in the Mojave region of San Bernardino County, California; the location has significant infrastructure in-place, with easy road and rail access, abundant electricity and water sources, and is already permitted for extensive brine extraction and processing activities. The Company is also commencing resource evaluation on up to 33,000 acres of brine leases located in the Smackover Formation.

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

On behalf of the Board,

Standard Lithium Ltd.

Robert Mintak, CEO & Director

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

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

Neither the Company, nor TETRA Technologies makes any representations as to the value of lease rights associated with TETRA Technologies Smackover brine leases (the “Properties”), the availability of any particular resource or minerals on the Properties, or the merits of any proposed exploration work to be completed on the Properties. TETRA Technologies expressly disclaims any responsibility for the adequacy or accuracy of disclosure made by the Company in respect of the Properties. Readers are cautioned that a “Qualified Person” (as that term is defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects) has not done sufficient work to specify any mineral resource or reserve on the Properties.

For further information, contact Anthony Alvaro at (604) 240 4793

Monday, January 8th, 2018 Uncategorized Comments Off

$MNTA Positive Top-Line Phase 1 Data Showing Proof of Mechanism for M281

M281 data shows safety and tolerability with no serious adverse events

CAMBRIDGE, Mass., Jan. 05, 2018 — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well tolerated, and decreased circulating IgG levels up to 89% with a mean reduction of 84%.

M281 is a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG₁) monoclonal antibody, engineered to reduce circulating pathogenic IgG antibodies, in excess of that achieved by any current treatments, by completely blocking endogenous IgG recycling via FcRn.

“I could not be more pleased that M281’s ability to lower IgG to target levels with a favorable safety profile worked precisely as we had designed. These data support M281’s potential as a best-in-class anti-FcRn therapeutic for the high unmet medical needs in immune-mediated disorders,” said Craig Wheeler, President and CEO, Momenta Pharmaceuticals. “M281 has been engineered as an effectorless, high affinity, pH insensitive monoclonal antibody to provide benefits that impact patients’ lives. We plan to finalize our development strategy and initiate a proof of concept clinical trial in the second half of 2018, pending regulatory feedback.”

The Phase 1 randomized, double-blind, placebo-controlled study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of M281.

SAD: The single ascending dose portion of the study enrolled five cohorts with a total of 34 healthy adult volunteers and showed that a single dose of M281 achieved up to an 80% reduction of circulating IgG antibodies.

MAD: The multiple ascending dose portion of the study assessed M281 in two cohorts, administered in four weekly doses to 16 healthy adult volunteers and showed predictable pharmacokinetics, and commensurate, controllable and reproducible reductions in circulating IgG. The data showed greater than 80% reduction in circulating IgG antibodies with a mean reduction of 84%.

M281 was well tolerated at all dose levels and no serious adverse events or unexpected safety findings were observed in either portion of the study.

Momenta plans to present the top line MAD results of the Phase 1 study at the 2018 J.P. Morgan Annual Healthcare Conference. Full data from the Phase 1 study will be presented at an upcoming Company presentation and future medical congresses.

About Momenta’s Novel Therapeutics Portfolio
Momenta’s novel therapeutics portfolio focuses on immune-mediated disorders with high unmet medical need and is developing three unique clinical phase assets (M281, M254, M230) purposefully designed to target the effects of pathogenic antibodies, whilst advancing discovery across rare immune-mediated disorders. M281 is a fully human anti-neonatal Fc receptor (FcRn) immunoglobulin G (IgG₁) monoclonal antibody, engineered to reduce circulating pathogenic IgG antibodies, in excess of that achieved by any current treatments, by completely blocking endogenous IgG recycling via FcRn. M254 is a hyper-sialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg) to remediate limitations of that therapeutic approach. Specifically, sialylation of the Fc region of IgG augments the anti-inflammatory attributes of IVIg. M230 (CSL730), being developed in collaboration with CSL, is a novel recombinant trivalent human IgG1 Fc multimer designed to block tissue damage mediated by immune complexes, through its enhanced avidity and affinity for Fc receptors.

About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilars and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for autoimmune indications.

To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.

Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

Forward Looking Statements
Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about future development plans, proof of mechanism or proof of concept in future clinical trials or regulatory feedback related to M281. Forward-looking statements may be identified by words such as “believe,” “continue,” “plan to”, “potential,” “will,” and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including those referred to under the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com

MEDIA CONTACT:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com

Friday, January 5th, 2018 Uncategorized Comments Off

$VUZI Blade™ Augmented Reality Smart Glasses to be Officially Unveiled at CES 2018

ROCHESTER, N.Y., Jan. 5, 2018 — Vuzix® Corporation (VUZI), (“Vuzix” or the “Company”), a leading supplier of Smart Glasses and Augmented Reality (AR) technologies for the consumer and enterprise markets, is pleased to announce the official unveiling of the Vuzix Blade™, which was awarded four International CES Innovation 2018 awards in the areas of Fitness, Sports and Biotech; Wireless Handset Accessories; Portable Media Players and Accessories as well as Computer Accessories.

The Vuzix Blade AR Smart Glasses provide a wearable smart display with a see-through viewing experience utilizing Vuzix’ proprietary waveguide optics and Cobra II display engine. It’s like having your computer or smartphone screen information right in front of you, wherever you go. The Vuzix Blade weighing in at less than 3 oz. represents the first pair of smart glasses that provide the wearer with a sizable virtual screen and brilliant pallet of colors via a thin completely see-through lens, in a fashionable form factor. The Vuzix Blade features adjustable FOV location and brightness, and is prescription ready, enabling any wearer both indoors and out to enjoy a comfortable visual experience. The Vuzix Blade, which can be paired seamlessly to Android or iOS phones enables individuals or workers to leave their phone in their pocket while visually presented with location aware content driven by the user’s phone. Built for today’s world and usable for work or play, the Vuzix Blade AR Smart Glasses offer the wearer heads up and hands-free mobile computing and connectivity, in an unprecedented form factor.

Today Vuzix released its latest video on the Vuzix Blade™ AR Smart Glasses which can be seen on the Vuzix YouTube channel.

The Vuzix Blade is the natural evolution of AR, providing the user with the wide range of features and capabilities available today, in a form factor that people will want to wear. Directions, menus, weather, events, stocks, video conferencing, sports updates, social feeds, bio-metrics and more, right in front of you, literally. AR smart glasses that right out of the box provide hands-free access to all the alerts from your phone, while allowing you to leave your phone in your pocket. The large Vuzix Developer community will be able leverage the open Android platform of the Vuzix Blade to bring new and creative ideas to life. Supported by Vuzix new App Store, Developers can offer or sell their applications to all Vuzix Blade users, expanding an ecosystem of AR applications for real world use today.

For consumers, the Vuzix Blade is the perfect companion to your android or iOS smartphone allowing users to always be connected, stay informed and never miss a photo shot. The Vuzix Blade’s companion app will allow users to seamlessly pair their Vuzix Blade Smart Glasses to their smartphone to leverage applications and manage notifications, while leaving their phone in their pocket. Experience overlay information such as mapping directions, restaurant menus, and weather information, capture POV video and pictures, answer phone calls and texts right from the glasses, and more. The intuitive and feature packed Vuzix Blade OS allows the user to simply and intuitively navigate via simple swipes and taps, or leverage voice controls and external AI systems.

While the Vuzix M300 smart glasses are the device of choice in many enterprise deployments, there is a sector of business, especially B2C, in which the form factor is a deterrent. Visual appearance and portability are a crucial requirement when it comes to servicing retail customers in big box retail chains, supermarkets, restaurants, department stores, and other client facing work environments. The Vuzix Blade with its fashionable form factor and all-day wear-ability fills this gap. For the enterprise user, the Vuzix Blade will pair with their smart phone or connect directly to a Wi-Fi network, allowing for custom secure industrial applications. Although not as powerful as the stand alone Vuzix M300 smart glasses, the Vuzix Blade will open new and organic growth opportunities within the enterprise space.

“The official unveiling of the Vuzix Blade™ AR Smart Glasses from its production ready tooling is a pivotal moment for Vuzix and for the AR industry as a whole, as it introduces the first truly wearable pair of light weight AR smart glasses for consumers and enterprise,” said Paul Travers, President and CEO of Vuzix. “What differentiates the Vuzix Blade from all existing or proposed AR smart glasses and mixed reality head mounted computers, is that it’s built for today’s user. With a fashionable form factor, a brilliant display, and a broad range of features that allow the user to experience AR at work or play, the Vuzix Blade is the first pair of smart glasses that people would actually enjoy wearing. Just as important, it is the only AR-enabled pair of smart glasses that work right out of the box, without the need for programming – just connect to your device, customize your settings and go. Either at work or at leisure, the Vuzix Blade Smart Glasses are the most compact and sleek AR-enabled smart glasses available today.”

To schedule a meeting with Vuzix representatives during CES 2018, please contact our PR representative Jiten Dadlani at jitendadlani@maxborgesagency.com or Matt Margolis at matt_margolis@vuzix.com.

About Vuzix Corporation

Vuzix is a leading supplier of Smart-Glasses and Augmented Reality (AR) technologies and products for the consumer and enterprise markets. The Company’s products include personal display and wearable computing devices that offer users a portable high-quality viewing experience, provide solutions for mobility, wearable displays and virtual and augmented reality. Vuzix holds 59 patents and 42 additional patents pending and numerous IP licenses in the Video Eyewear field. The Company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2018 and several wireless technology innovation awards among others. Founded in 1997, Vuzix is a public company (NASDAQ: VUZI) with offices in Rochester, NY, Oxford, UK and Tokyo, Japan.

Forward-Looking Statements Disclaimer

Certain statements contained in this news release are “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward looking statements contained in this release relate to the new Vuzix Blade product and its technology demonstrations at CES, the advancements of Vuzix products, and among other things the Company’s leadership in the Smart Glasses and AR display industry. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and MD&A filed with the United States Securities and Exchange Commission and applicable Canadian securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Media and Investor Relations Contact:

Matt Margolis, Director of Corporate Communications and Investor Relations, Vuzix Corporation matt_margolis@vuzix.com Tel: (585) 359-5952

Andrew Haag, Managing Partner, IRTH Communications
vuzi@irthcommunications.com Tel: (866) 976-4784

Vuzix Corporation, 25 Hendrix Road, Suite A, West Henrietta, NY 14586 USA,
Investor Information – IR@vuzix.com www.vuzix.com

For further sales, and product information, please visit:

North America:
http://www.vuzix.com/contact/

Europe/UK:
https://www.vuzix.eu/contact/

Asia:
http://www.vuzix.jp/contact.html

Friday, January 5th, 2018 Uncategorized Comments Off

$SKY and Champion Home Builders Announce Agreement on Business Combination

ELKHART, Ind. and TROY, Mich., Jan. 5, 2018 — Skyline Corporation (“Skyline”) (AMEX: SKY) and Champion Enterprises Holdings, LLC (“Champion”), the parent company of Champion Home Builders, Inc., today announced that they have entered into a definitive agreement for the two companies to combine their operations. Under the terms of the agreement, Champion will contribute 100% of the shares of its operating subsidiaries, Champion Home Builders, Inc. and CHB International B.V., to Skyline. In exchange, Skyline is currently expected to issue approximately 47.8 million shares to Champion, representing 84.5% of the common stock of the combined company on a fully-diluted basis. Prior to closing, Skyline expects to declare a dividend to its existing shareholders of its excess net cash available for distribution under the agreement after certain transactional expenses.

Among the numerous benefits the combined company is expected to bring to all stakeholders include:

Significantly increased size and scale, with pro forma combined revenue of greater than $1 billion over the past twelve months*
Strong pro forma balance sheet and significant cash flow to support continued flexibility and long-term strategic growth
Significant annual synergies

The combined company will be known as Skyline Champion Corporation and trade on the NYSE American under the ticker symbol “SKY.” The Board of Directors will comprise eleven members, nine of which will be directors designated by Champion and two of which will be designated by Skyline. Upon closing of the transaction, Champion Chief Executive Officer, Keith Anderson, will serve as Chief Executive Officer of Skyline Champion Corporation. Additionally, Laurie Hough, Champion Chief Financial Officer, will serve as Chief Financial Officer of the combined company. Skyline anticipates nominating John Firth, current Chairman of the Board of Skyline, and Rich Florea, current Chief Executive Officer of Skyline, as Directors of the combined company and Art Decio, an original founder of Skyline and member of the Board of Directors since 1959, as a senior advisor to the combined company’s Board of Directors. Skyline Champion Corporation’s principal offices will remain in Elkhart, Indiana with additional executive offices in Troy, Michigan.

The business combination will create the nation’s largest publicly traded factory-built housing company, with greater than $1 billion in pro forma revenue over the past twelve months.* The combined company will have an expansive operational footprint throughout North America, with 36 manufacturing facilities, 24 of which are in the top 20 states for manufactured housing shipments. Skyline Champion Corporation will offer manufactured, modular and park model homes as well as commercial structures. Additionally, the combined company will have 21 owned factory-direct retail locations and provide transportation services to the manufactured housing industry from 10 locations across the United States.

It is anticipated that the transaction will generate significant annual synergies to be achieved through direct cost savings, reduced overhead costs and operational improvement opportunities. Additional synergies also are expected through cross-selling and distribution optimization by leveraging the combined company’s owned and independent dealer network.

Rich Florea, Chief Executive Officer of Skyline said, “The combination of Skyline and Champion represents a unique opportunity for two well-respected companies with strong brand history to come together and continue providing high-quality homes for customers, while also providing the greatest long-term value for shareholders. The combined company will have a strong presence throughout North America and will operate at a significant scale in addition to offering a broader choice of homes to customers. We believe Skyline Champion Corporation will be well positioned for impressive growth in the coming years, to the benefit of employees, shareholders and customers.”

Keith Anderson, Chief Executive Officer of Champion commented, “Getting to know the Skyline team has reaffirmed our belief that the two companies are a great fit for a combination. Both companies share a deep commitment to providing quality products and outstanding customer service. We will remain focused on executing our strategy as an even stronger company. I am particularly pleased that Art Decio has agreed to serve as a senior advisor to the Board. Art is a legendary figure in manufactured housing and we are fortunate to have the benefit of his lifelong commitment to quality and integrity in our industry.”

Art Decio, Skyline’s largest shareholder, has agreed to vote in favor of and fully support the transaction.

Art commented, “Champion and Skyline are tremendous brands in our industry, both dating back to the 1950s. Walter and Henry, Champion’s founders, built a tremendous company that will be a great partner with Skyline. Both Skyline and Champion share similar corporate cultures and have earned a reputation for uncompromising integrity across their relationships with communities, retailers, suppliers and customers. Skyline Champion Corporation will be well positioned to continue to grow and serve its customers with the best products the industry has to offer.”

The transaction, which is expected to be completed in the first half of 2018, is subject to the receipt of regulatory approvals and other customary closing conditions as well as the approval of Skyline shareholders. In connection with the transaction, Skyline intends to file with the SEC a proxy statement and other relevant materials and documents regarding the proposed transaction.

Jefferies LLC served as financial advisor to Skyline and Barnes & Thornburg LLP acted as Skyline’s legal counsel. Ice Miller LLP acted as legal counsel to Skyline’s Special Committee of the Board. RBC Capital Markets, LLC served as financial advisor to Champion and Ropes & Gray LLP acted as Champion’s legal counsel.

In connection with the transaction, Skyline and Champion have received a joint commitment from RBC Capital Markets, LLC and Jefferies LLC, contingent upon the closing of the transaction, to consolidate and upsize existing revolving credit facilities for use by the combined company.

About Skyline Corporation:

Skyline Corporation and its consolidated subsidiaries design, produce, and market manufactured housing, modular housing, and park models to independent dealers, developers, campgrounds, and manufactured housing communities located throughout the United States and Canada. The company has eight manufacturing facilities in seven states. Skyline Corporation was originally incorporated in Indiana in 1959, as successor to a business founded in 1951, and is one of the largest producers of manufactured and modular housing in the United States. For more information, visit http://www.skylinecorp.com.

About Champion Enterprises Holdings, LLC:

Champion Enterprises Holdings, LLC was formed in 2010 as the parent company of Champion Home Builders, Inc. which was founded in 1953. Champion Home Builders specializes in a wide variety of manufactured and modular homes, park-model RVs and modular buildings for the multi-family, hospitality, senior and workforce housing sectors. The company operates 28 manufacturing facilities throughout North America. Additionally, Champion operates a factory-direct retail business, Titan Factory Direct, with 21 retail locations spanning the southern U.S., and Star Fleet Trucking, providing transportation services to the manufactured housing industry from 10 dispatch locations across the United States. Champion is majority owned by funds affiliated with Bain Capital Credit (https://www.baincapitalcredit.com), Centerbridge Partners, L.P. (https://www.centerbridge.com), and MAK Capital. For more information, visit https://www.championhomes.com.

Forward-Looking Statements

Statements in this press release regarding the proposed transaction between Skyline and Champion, the expected timetable for completing the proposed transaction, the completion of the consolidation and upsize of the revolving credit facilities and the potential benefits created by the proposed transaction are intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by use of statements that include, but are not limited to, phrases such as “believe,” “expect,” “future,” “anticipate,” “intend,” “plan,” “foresee,” “may,” “should,” “will,” “estimates,” “potential,” “continue,” or other similar words or phrases. Similarly, statements that describe objectives, plans, or goals also are forward-looking statements. Such forward-looking statements involve inherent risks and uncertainties, many of which are difficult to predict and are generally beyond the control of Skyline, Champion or Skyline Champion Corporation. Skyline cautions readers that a number of important factors could cause actual results to differ materially from those expressed in, implied, or projected by such forward-looking statements. Risks and uncertainties include, but are not limited to: the failure of the proposed transaction, or consolidation and upsize of the revolving credit facilities, to close, Skyline Champion Corporation’s inability to realize the expected benefits from the proposed transaction, general economic conditions; availability of wholesale and retail financing; the health of the U.S. housing market as a whole; federal, state, and local regulations pertaining to the manufactured housing industry; the cyclical nature of the manufactured housing industry; general or seasonal weather conditions affecting sales; potential impact of natural disasters on sales and raw material costs; potential periodic inventory adjustments by independent retailers; interest rate levels; the impact of inflation; the impact of high or rising fuel costs; the cost of labor and raw materials; competitive pressures on pricing and promotional costs; Skyline’s relationships with its shareholders, customers, and other stakeholders; catastrophic events impacting insurance costs; the availability of insurance coverage for various risks to Skyline; market demographics; and management’s ability to attract and retain executive officers and key personnel and other risks and uncertainties more fully described in Skyline’s Annual Report on Form 10-K for the year ended May 31, 2017, as filed with the SEC, as well as the other filings that Skyline makes with the SEC. Investors and stockholders are also urged to read the risk factors set forth in the proxy statement carefully when they are available.

If any of these risks or uncertainties materializes or if any of the assumptions underlying such forward-looking statements proves to be incorrect, the developments and future events concerning Skyline, Champion and Skyline Champion Corporation set forth in this press release may differ materially from those expressed or implied by these forward-looking statements. You are cautioned not to place undue reliance on these statements, which speak only as of the date of this document. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. Skyline assumes no obligation to update such forward-looking statements to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events, unless obligated to do so under the federal securities laws.

Additional Information for Shareholders

In connection with the matters to be approved by Skyline’s shareholders pursuant to the proposed exchange transaction described in this document, Skyline will prepare a proxy statement to be filed with the SEC. When completed, a definitive proxy statement and a form of proxy will be mailed to the shareholders of Skyline. Skyline’s shareholders are urged to read the proxy statement regarding the proposed exchange transaction because it will contain important information about the matters to be approved by Skyline’s shareholders in connection with the proposed exchange and important information about the proposed exchange transaction itself. Skyline’s shareholders will be able to obtain, without charge, a copy of the proxy statement (when available) and other relevant documents filed with the SEC from the SEC’s website at www.sec.gov. Skyline’s shareholders also will be able to obtain, without charge, a copy of the proxy statement and other relevant documents (when available) by directing a request by mail or telephone to Skyline Corporation, 2520 By-Pass Road, P.O. Box 743, Elkhart, Indiana 46514, Attention: Corporate Secretary, or by calling (574) 294-6521, or from Skyline’s website at www.skylinecorp.com under the tab “Investors – SEC Filings.” The information available through Skyline’s website is not and shall not be deemed part of this document or incorporated by reference into other filings Skyline makes with the SEC. This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities.

Skyline, Champion and their respective directors and certain of their officers may be deemed to be participants in the solicitation of proxies from Skyline’s shareholders with respect to the special meeting of shareholders that will be held to consider the matters to be approved by Skyline’s shareholders in connection with the exchange transaction. Information about Skyline’s directors and executive officers and their ownership of Skyline’s common stock is set forth in the proxy statement for Skyline’s 2017 annual meeting of shareholders, as filed with the SEC on Schedule 14A on August 22, 2017. Shareholders may obtain additional information regarding the interests of Skyline and its directors and executive officers, and proposed Skyline Champion Corporation and its anticipated directors and executive officers, in the proposed Exchange, which may be different than those of Skyline’s shareholders generally, by reading the proxy statement and other relevant documents regarding the proposed Exchange, when filed with the SEC.

Friday, January 5th, 2018 Uncategorized Comments Off

$ALQA Announces Definitive Asset Purchase Agreement with Celularity, Inc.

YARDLEY, Pa., Jan. 05, 2018 – Alliqua BioMedical, Inc. (NASDAQ:ALQA) (“Alliqua or the “Company”), a regenerative technologies company committed to restoring tissue and rebuilding lives, today announced a definitive agreement with Celularity, Inc. (“Celularity”), under which Celularity will acquire all of the property, assets and rights relating to the Company’s advanced biologic wound care business – including Biovance® amniotic membrane allograft and Interfyl® Human Connective Tissue Matrix – and the Company’s UltraMist® Therapy System and other therapeutic ultrasound platform products for an aggregate cash consideration of $29.0 million. No debt or significant liabilities are being assumed by Celularity in the transaction. Alliqua BioMedical’s Board of Directors unanimously approved entering into the agreement.

“This is a transformative transaction for Alliqua,” said David Johnson, Chief Executive Officer of Alliqua. “First, we will be able to strengthen our balance sheet by paying our debt in full. Second, we believe we will have an appropriate amount of working capital to drive our operating business forward in a positive way. Finally, we will evaluate the appropriate options to allocate capital to maximize shareholder value.”

“The acquisition of Alliqua’s commercial infrastructure and product portfolio in the field of regeneration advances Celularity’s goal of bringing back under one entity the proprietary end-to-end regenerative pipeline that was pioneered by Celularity’s predecessor company, Anthrogenesis Corporation,” mentioned Dr. Robert Hariri, Founder and CEO of Celularity. “This acquisition further positions Celularity to become the world leader in cell therapy and regenerative medicine, which have the potential to treat or cure many of today’s most debilitating illnesses.”

The asset purchase agreement includes all intellectual property and all license, marketing, development and supply agreements related to these businesses. The Company’s contract manufacturing assets and operations are not included in the asset purchase agreement. The transaction is subject to certain customary closing conditions, including, among other things, Alliqua BioMedical stockholder approval. There are no financing conditions associated with the transaction.

Cowen served as Alliqua’s exclusive financial advisor in connection with this transaction.

The above description of the definitive agreement does not purport to be complete and is qualified in its entirety by reference to the definitive agreements, which Alliqua included as an exhibit to its Form 8-K filed today with the Securities and Exchange Commission.

Additional Information and Where to Find It

This communication is being made in respect of the proposed asset purchase transaction involving Alliqua and Celularity. Alliqua will prepare a proxy statement statement for its stockholders containing the information with respect to the asset purchase transaction specified in Schedule 14A promulgated under the Securities Exchange Act of 1934, as amended, and describing the proposed asset purchase transaction. When completed, a definitive proxy statement will be mailed to Alliqua’s stockholders. Alliqua and Celularity may be filing other documents with the SEC as well. INVESTORS ARE URGED TO CAREFULLY READ THE PROXY STATEMENT REGARDING THE PROPOSED ASSET PURCHASE TRANSACTION AND ANY OTHER RELEVANT DOCUMENTS IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED ASSET PURCHASE TRANSACTION. You may obtain copies of all documents filed with the SEC regarding this transaction, free of charge, at the SEC’s website, http://www.sec.gov.

About Alliqua BioMedical, Inc.

Alliqua is a regenerative technologies company committed to restoring tissue and rebuilding lives. Through its sales and distribution network, together with its proprietary products, Alliqua offers solutions that allow clinicians to utilize the latest advances in regenerative technologies to bring improved patient outcomes to their practices.

Alliqua currently markets the human biologic regenerative technologies, Biovance® and Interfyl®. The Company also markets its UltraMist® Therapy System, which delivers painless, noncontact low-frequency ultrasound below the wound bed to promote the healing process.

Alliqua can provide a custom manufacturing solution to partners in the medical device and cosmetics industry, utilizing its hydrogel technology. The Company has locations in Yardley, Pennsylvania, Langhorne, Pennsylvania and Eden Prairie, Minnesota.

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

About Celularity, Inc.

Celularity, headquartered in Warren, New Jersey, is a biotechnology company that has leading-edge technology and an associated intellectual property portfolio that uniquely positions Celularity to harness the power of the placenta. Their asset portfolio consists of more than 800 granted patents worldwide, as well as pre-clinical and clinical assets including CAR constructs for allogeneic CAR-T/NK products, and commercial stage biosourcing and functional regeneration businesses. For more information, please visit www.celularity.com. Follow Celularity on Social Media: @Celularity.

Legal Notice Regarding Forward-Looking Statements:

This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of our control that can make such statements untrue, including, but not limited to, the asset purchase transaction not being timely completed, if completed at all; prior to the completion of the asset purchase transaction, Alliqua’s or Celularity’s respective businesses experiencing disruptions due to transaction-related uncertainty or other factors making it more difficult to maintain relationships with employees, business partners or governmental entities; and the parties being unable to successfully implement integration strategies or realize the anticipated benefits of the acquisition, including the possibility that the expected synergies and cost reductions from the proposed acquisition will not be realized or will not be realized within the expected time period. In addition, other factors that could cause actual results to differ materially are discussed in our filings with the SEC, including our most recent Annual Report on Form 10-K filed with the SEC, and our most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise.

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

Friday, January 5th, 2018 Uncategorized Comments Off

$TIG Takeda Announces Intention to Acquire

OSAKA, Japan, January 5, 2018 —

Expands Takeda‘s Late Stage Pipeline and Leadership in Gastroenterology

Acquisition Highlights

Deal reinforces Takeda’s commitment to patients living with Inflammatory Bowel Disease (IBD), an area of high unmet medical need
Acquisition extends existing collaboration between Takeda and TiGenix to develop and commercialize Cx601 (darvadstrocel)
- On December 15, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for Cx601 for the treatment of complex perianal fistulas in Crohn’s disease, one of the most disabling manifestations of the disease
- A global, pivotal Phase III trial for U.S. registration has been initiated with investigational medicine Cx601 for the treatment of complex perianal fistulas in patients with non-active/mildly active luminal Crohn’s disease
Acquisition would expand Takeda’s late stage gastroenterology pipeline and strengthen presence in the U.S. specialty care market

Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced its intention to acquire TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”), an advanced biopharmaceutical company developing novel stem cell therapies for serious medical conditions, and as a result has entered into an offer and support agreement with TiGenix which provides for a recommended potential voluntary public takeover bid for TiGenix. The Takeda agreement has the unanimous support of the TiGenix board of directors (including its CEO). The acquisition is a natural extension of an existing partnership agreement between Takeda and TiGenix, which aims to bring new treatment options to patients with gastrointestinal disorders.

“As a leader in gastroenterology, Takeda recognizes the complex physical, emotional and social barriers that people living with fistulizing Crohn’s disease experience,” said Andrew Plump, Chief Medical and Scientific Officer, Takeda. “Limited treatment options exist today and I believe we can be most effective in serving this population by working in collaboration with partners whose unique skill sets allow us to more efficiently explore innovative approaches, including stem cell therapies. I have had the opportunity to work alongside the TiGenix team throughout our collaboration and know that we have shared goals and varied, but complementary expertise. I am thrilled at the prospect of welcoming them as part of our organization.”

In July 2016, Takeda and TiGenix entered into an exclusive ex-U.S. license, development and commercialization agreement for Cx601, the leading investigational therapy in TiGenix’s pipeline. Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) locally administered for the treatment of complex perianal fistulas in patients with non-active/mildly active luminal Crohn’s disease, who have had an inadequate response to at least one conventional or biologic therapy. In December 2017, the CHMP of the EMA adopted a positive opinion recommending a marketing authorization for Cx601 in this indication, the first allogeneic stem cell therapy to achieve this. A decision from the EMA on the marketing authorization for Cx601 is expected in the first half of 2018.

Complex perianal fistulas are considered one of the most disabling manifestations of Crohn’s disease and can cause intense pain, infection and incontinence.^[2^], Despite modern and surgical advancements, they currently remain challenging for clinicians to treat and can have a severe impact on the lives of those affected.^[³^]

A global, pivotal Phase III trial investigating Cx601 for the treatment of complex perianal fistulas in patients with non-active/mildly active luminal Crohn’s disease has been initiated for U.S. registration. In the U.S., Takeda intends to work with the U.S. FDA to facilitate the development and potential approval of Cx601. Takeda is also exploring the steps required for regulatory filing of Cx601 for patients in Japan, Canada and emerging markets.

Through the potential voluntary public takeover bid, Takeda intends to acquire 100% of the securities with voting rights or giving access to voting rights of TiGenix not already owned by Takeda or its affiliates at an acquisition price of EUR 1.78 per share in cash and an equivalent price per American Depositary Share, warrant and convertible bond, representing a transaction value of approximately EUR 520 million on a fully diluted basis. The bid will be subject to certain conditions precedent as further described below.

Subject to its fiduciary duties and review of the final bid prospectus, the bid is unanimously supported by TiGenix’s board of directors (including its CEO). Takeda and TiGenix entered into an offer and support agreement confirming TiGenix’s support and the terms and conditions of the bid set forth in this press release. Gri-Cel S.A., holding 32,238,178 TiGenix shares, and its affiliate Grifols Worldwide Operations Ltd., holding 7,189,800 TiGenix shares in the form of American Depositary Shares, have irrevocably confirmed that they will tender their shares and American Depositary Shares into the potential public takeover bid.

Transaction terms

The acquisition is structured as an all cash voluntary public takeover bid by Takeda with respect to 100% of the securities with voting rights or giving access to voting rights of TiGenix that are not already owned by Takeda or its affiliates. The transaction is subject to the following conditions precedent: (i) the tender into the offer, in aggregate, of a number of securities that, together with all securities owned by Takeda and its affiliates, represents or gives access to 85% or more of the voting rights represented or given access to by all of the outstanding securities on a fully diluted basis as of the end of the first acceptance period, (ii) the absence of a material adverse effect occurring at any time after the date of this announcement, (iii) Cx601 obtaining marketing authorization in the E.U. from the European Medicines Agency (EMA) and (iv) the expiration, lapse or termination as appropriate of any applicable waiting periods (including any extensions thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in respect of the offer.

Following closing of the potential voluntary public takeover bid, Takeda intends to launch a squeeze-out if the applicable conditions for such squeeze-out are met to delist the shares of TiGenix from Euronext Brussels and NASDAQ. After the squeeze-out, TiGenix would become a wholly-owned subsidiary of Takeda.

This communication does not constitute a formal notification of a voluntary public takeover bid. In case Takeda would decide to formally launch the voluntary public takeover bid, full details of such public takeover bid will be covered by the prospectus to be filed with the Belgian Financial Services and Markets Authority and the offer documents which will be available at http://www.sec.gov. In the event that Takeda would decide not to proceed with the potential voluntary public takeover bid, then Takeda and TiGenix will issue a further public announcement to that effect.

   
     (1)  Tender offeror             Takeda Pharmaceutical Company Limited

    (2)  Target company             TiGenix NV (Euronext Brussels and NASDAQ: TIG)

    (3) Class of shares to be
        acquired                    - all outstanding ordinary shares (with the
                                    exception of ordinary shares represented by
                                    American Depositary Shares);
                                    - all outstanding American Depositary Shares
                                    (each representing 20 ordinary shares);
                                    - all outstanding warrants to acquire
                                    ordinary shares; and
                                    - all outstanding convertible bonds.

    (4) Tender offer price          EUR 1.78 per share (and an equivalent price
                                    per American Depositary Share, warrant and
                                    convertible bond)

    (5) Acquisition amount           Approximately EUR 520 million (estimate)
        (Aggregate tender offer     * The amount is an estimated amount calculated
        price)                      by multiplying the number of TiGenix's
                                    ordinary shares (on a fully diluted basis and
                                    excluding the shares owned by Takeda or its
                                    affiliates) by the tender offer price per
                                    share. It does not include advisory fees.

    (6)  Payment                    Funding from existing cash balances

    (7)  Period of tender offer     To be determined, subject to regulatory
                                    approvals being obtained.

     (8)  Minimum number of shares   Consummation of the voluntary public takeover
         to be purchased            bid will occur if a number of securities is
                                    tendered that, together with all securities
                                    owned by Takeda and its affiliates, represents
                                    or gives access to 85% or more of the voting
                                    rights represented or given access to by all
                                    of the outstanding securities on a fully
                                    diluted basis as of the end of the first
                                    acceptance period and other customary
                                    conditions precedent have been satisfied.

    (9)  Financial advisor to       Centerview Partners UK LLP
         Takeda          

    (10) Legal counsel to Takeda    DLA Piper UK LLP
                                    DLA Piper US LLP

    (11) Financial advisor to
         TiGenix                    Cowen and Company, LLC

    (12) Legal counsel to TiGenix   Osborne Clarke CVBA
                                    Davis Polk & Wardwell LLP

Overview of TiGenix

   
     (1)   Company name      TiGenix NV (Euronext Brussels and NASDAQ: TIG)

     (2)   Headquarters      Romeinse straat 12 box 2, 3001 Leuven, Belgium

     (3) Representative      Eduardo Bravo, Managing Director and Chief Executive
         Officer
     (4) Business            TiGenix is a biopharmaceutical company focused on the
         description         development and commercialization of therapeutics from
                             its platforms of allogeneic, or donor-derived, expanded
                             stem cells
     (5) Share capital       EUR 27,428,719

     (6) Date of             21 February 2000
        establishment

     (7) Major shareholders  Gri-Cel, S.A./Grifols Worldwide
         and percentage      Operations Ltd.**                                   14.4%
         of shares held*     Cormorant Asset Management LLC                       5.3%
                             Takeda Pharmaceuticals
                             International AG                                     4.2%
                             JPMorgan Securities LLC                              2.9%
                             Others: BNP Paribas Investment Partners SA

     (8) Relationships
         between Takeda      Capital relationship      Investee
                             Personnel relationship    Not applicable
                             Transactional
                             relationship              Licensor

     (9) Operating results and financial condition for the last three years (consolidated)

    Accounting period       Fiscal year        Fiscal year         Fiscal year
                             ended December      ended December      ended December
                                31, 2016             31, 2015            31, 2014
    Net assets
    (EUR in thousands)           79,679               13,145              34,757

    Total assets
    (EUR in thousands)          136,201               79,171              53,921

    Net assets per share
    (EUR)                         0.40                 0.08                0.22

    Revenue
    (EUR in thousands)           26,790                2,240               6,286

    Operating profit
    (EUR in thousands)          (3,027)             (24,076)            (12,563)

    Net profit/(loss)
    (EUR in thousands)            3,802             (35,069)            (12,990)

    Net earnings/(loss) per
    share
    (EUR)                          0.02               (0.21)              (0.08)

*Gri-Cel, S.A. and Grifols Worldwide Operations Ltd. holding as per irrevocable undertaking given to Takeda. Cormorant Asset Management holding as per TiGenix Schedule 13G dated February 14, 2017. Cormorant Asset Management liquidation of 129,032 American Depositary Shares as per Cormorant Asset Management’s filing Form 13F (OMB 3235-0006). Percentage of shares is calculated by dividing the respective shareholdings by the number of total shares outstanding of the target company of 274,287,190 as reported on November 30, 2017.

**The potential voluntary public takeover bid is supported by Gri-Cel S.A. and its affiliate Grifols Worldwide Operations Ltd. Gri-Cel S.A. and Grifols Worldwide Operations Ltd. have irrevocably confirmed that they will tender their shares and American Depositary Shares in the potential voluntary public takeover bid.

Change in ownership before and after acquisition

   
    (1) Number of shares already acquired   11,651,778 shares

                                            Percentage of voting rights: 4.2% of
                                            total shares outstanding (3.9% on a
                                            fully diluted basis)

    (2) Estimated number of shares to be
        acquired (on a fully diluted basis) 290,288,172 shares***
                                            Percentage of voting rights: 96.1%
                                            (planned)
                                            (min. bid threshold is 85%)
                                            ***Excludes shares already held by
                                            Takeda or its affiliates.

Schedule

   
    (1) Governance meeting resolution       January 4, 2018

    (2) Support and Offer Agreement
        signature date                      January 5, 2018

    (3) Commencement date and settlement    To be determined, subject to regulatory
        date of the tender offer            approvals being obtained.

    (4) Completion of acquisition           To be determined, subject to regulatory
                                            approvals being obtained and completion
                                            or waiver of any conditions precedents.

Takeda Financial Outlook

As the completion of the acquisition is expected to occur near the end of Q1 CY2018 or the beginning of Q2 CY2018, Takeda expects minimal impact on its FY2017 earnings. We will incorporate the financial impact in our FY2018 consolidated earnings forecast, which will be announced at the FY2017 year-end earnings conference in May 2018.

Takeda‘s Commitment to Gastroenterology

Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases and motility disorders. Our GI research & development team is also exploring solutions in celiac disease, advanced liver disease and microbiome therapies.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Around 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.

Forward-Looking Statements

This press release contains “forward-looking statements.“ Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,“ “expect,“ “project,“ “continue,“ “believe,“ “plan,“ “estimate,“ “pro forma,“ “intend,“ “potential,“ “target,“ “forecast,“ “guidance,“ “outlook,“ “seek,“ “assume,“ “will,“ “may,“ “should,“ and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management of Takeda and TiGenix that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.

The forward-looking statements contained in this press release speak only as of the date of this press release, and neither TiGenix nor Takeda undertakes any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.

About TiGenix

TiGenix NV (Euronext Brussels and NASDAQ: TIG) is an advanced biopharmaceutical company developing novel therapies for serious medical conditions by exploiting the anti-inflammatory properties of allogeneic, or donor-derived, stem cells.

TiGenix´s lead product, Cx601, has successfully completed a European Phase III clinical trial for the treatment of complex perianal fistulas – a severe, debilitating complication of Crohn’s disease. Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) started in 2017. TiGenix has entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to develop and commercialize Cx601 for complex perianal fistulas outside the U.S. TiGenix’s second adipose-derived product, Cx611, is undergoing a Phase I/II trial in severe sepsis – a major cause of mortality in the developed world. Finally, AlloCSC-01, targeting acute ischemic heart disease, has demonstrated positive results in a Phase I/II trial in acute myocardial infarction (AMI). TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain) and Cambridge, MA (USA). For more information, please visit http://www.tigenix.com.

About Cx601

Cx601 is an investigational administration of allogeneic (or donor derived) expanded adipose-derived stem cells (eASCs) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease that have previously shown an inadequate response to at least one conventional therapy or biologic therapy. Crohn’s disease is a chronic inflammatory disease of the intestine and complex perianal fistulas are a severe and debilitating complication.

Cx601 was granted orphan drug designation by the European Commission in 2009 and by the FDA in 2017. TiGenix completed a European Phase III clinical trial (ADMIRE-CD) in August 2015 in which the primary endpoint was met, with a significantly greater proportion of patients treated with Cx601 (50%, n=107) versus control (34%, n=105) achieving combined remission as defined by clinical assessment of closure of all treated external openings that were draining at baseline and absence of collections > 2 cm of the treated perianal fistulas confirmed by masked central MRI at week 24 (97·5% CI 0·2-30·3; p=0·024).^[¹^] The most commonly reported treatment emergent adverse events were proctalgia, anal abscess and nasopharyngitis. A follow-up analysis was completed showing that the efficacy and safety profile of Cx601 were maintained at 52 weeks.^[⁴^] The 24-week results of the Phase III ADMIRE-CD trial were published in The Lancet in July 2016.^[¹^] Based on the positive 24 weeks Phase III study results, TiGenix submitted a Marketing Authorization Application to the EMA, with the CHMP adopting a positive opinion recommending the granting of a marketing authorization.

A global Phase III clinical trial (ADMIRE-CD II) intended to support a future U.S. Biologic License Application (BLA) started in 2017, based on a trial protocol that has been agreed with the U.S. FDA through a special protocol assessment procedure (SPA) (clinicaltrials.gov; NCT03279081). ADMIRE-CD II is a randomized, double-blind, placebo-controlled study designed to confirm the efficacy and safety of a single administration of Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients. In July 2016, TiGenix entered into a licensing agreement with Takeda, a global pharmaceutical company active in gastroenterology, under which Takeda acquired exclusive rights to develop and commercialize Cx601 for complex perianal fistulas in Crohn’s patients outside of the U.S.

Disclaimer

This communication does not constitute an offer to purchase securities of TiGenix nor a solicitation by anyone in any jurisdiction in respect of such securities, any vote or approval. If Takeda decides to proceed with an offer to purchase TiGenix’s securities through a public tender offer, such offer will and can only be made on the basis of an approved offer document by the FSMA and tender offer documents filed with the U.S. Securities and Exchange Commission (“SEC“), which holders of TiGenix’s securities should read as they will contain important information. This communication is not a substitute for such offer documents. Neither this communication nor any other information in respect of the matters contained herein may be supplied in any jurisdiction where a registration, qualification or any other obligation is in force or would be with regard to the content hereof or thereof. Any failure to comply with these restrictions may constitute a violation of the financial laws and regulations in such jurisdictions. Takeda, TiGenix and their respective affiliates explicitly decline any liability for breach of these restrictions by any person.

Important Additional Information for U.S. investors

The voluntary takeover bid described herein has not yet commenced. This communication is for informational purposes only and is neither a recommendation, an offer to purchase nor a solicitation of an offer to sell any securities of TiGenix.

At the time the voluntary public takeover bid is commenced, shareholders of TiGenix are urged to read the offer documents which will be available at http://www.sec.gov . At the time the voluntary public takeover bid is commenced, it shall be comprised of two separate offers – (i) an offer for all securities with voting rights or giving access to voting rights, issued by TiGenix (except for ADSs) (the “Securities“), in accordance with the applicable law in Belgium, and (ii) an offer to holders of TiGenix’s American Depositary Shares issued by Deutsche Bank Trust Company Americas acting as depositary (“ADSs“), and to holders of Securities who are resident in the U.S. in accordance with applicable U.S. law (the “U.S. Offer“).

The U.S. Offer will only be made pursuant to an offer to purchase and related materials. At the time the U.S. Offer is commenced, Takeda will file, or cause to be filed, a tender offer statement on Schedule TO with the SEC and thereafter, TiGenix will file a solicitation/recommendation statement on Schedule 14D-9, in each case with respect to the U.S. Offer.

Holders of TiGenix ADSs and Securities subject to the U.S. Offer who wish to participate in the U.S. Offer, are urged to carefully review the documents relating to the U.S. Offer that will be filed by Takeda with the SEC since these documents will contain important information, including the terms and conditions of the U.S. Offer. Holders of TiGenix ADSs and Securities subject to the U.S. Offer who wish to participate in the U.S. Offer, are also urged to read the related solicitation/recommendation statement on Schedule 14D-9 that will be filed with the SEC by TiGenix relating to the U.S. Offer. You may obtain a free copy of these documents after they have been filed with the SEC, and other documents filed by TiGenix and Takeda with the SEC, at the SEC’s website at http://www.sec.gov. In addition to the offer and certain other tender offer documents, as well as the solicitation/recommendation statement, TiGenix files reports and other information with the SEC. You may read and copy any reports or other information filed by TiGenix at the SEC Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. TiGenix’s filings at the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov .

YOU SHOULD READ THE FILINGS MADE BY TAKEDA AND TIGENIX WITH THE SEC CAREFULLY BEFORE MAKING A DECISION CONCERNING THE U.S. OFFER.

References

^[1^] Panés J, García-Olmo D, Van Assche G, et al., Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn’s disease: a phase 3 randomized, double-blind controlled trial. The Lancet. 2016; 388(10051): 1281-1290.

^[²^] Marzo M, Felice C, Pugliese D, et al., Management of perianal fistulas in Crohn’s disease: An up-to-date review. World J Gastroenterol. 2015; 21(5): 1394-1395.

^[³^] Mahadev S, Young JM, Selby W, et al., Quality of life in perianal Crohn’s disease: what do patients consider important? Dis Colon Rectum. 2011; 54(5): 579-585.

^[⁴^] Panés J, et al., Long-term efficacy and safety of stem cell therapy (Cx601) for complex perianal fistulas in patients with Crohn’s disease. Gastroenterology. Published online 18^th December 2017. http://dx.doi.org/10.1053/j.gastro.2017.12.020.
Media Contacts:
Kazumi Kobayashi
Media in Japan
T: +81-3-3278-2095
kazumi.kobayashi@takeda.com

Elissa Johnsen
Media outside of Japan
T: +1-224-554-3185
elissa.johnsen@takeda.com

Luke Willats
Media in Europe
T: +41-44-555-1145
luke.willats@takeda.com

Friday, January 5th, 2018 Uncategorized Comments Off

$APOP Announces Breakthrough Clinical Results

First Group of Patients in Clinical Trial With Cellect’s ApoGraft Stem Cell Transplant Follow up Results 100% Acceptance and Zero Related Adverse Events Dr. Shai Yarkoni, Cellect CEO commented: “These interim results further support that we are closer than ever to a world where stem cells are used to replace sick organs and damaged tissues.” Cellect’s technology, ApoGraft™, aims to become a game changer in stem cell use for regenerative medicine

TEL AVIV, Israel, Jan. 4, 2018 — Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of a novel stem cell selection technology, announced that it has successfully completed transplantation of the first group of three patients using Cellect’s ApoGraft™ technology in the Company’s Phase I/II clinical trial and that after one month follow-up, all three patients have demonstrated complete acceptance of the stem cell transplant with no adverse events related to the study treatment, as determined by the clinical investigator, and no reported serious adverse events or suspected unexpected serious adverse reactions.

The Phase I/II, dose escalating, 4-cohort, open label clinical trial of up to twelve patients is designed to evaluate the safety, tolerability and efficacy of functionally selected donor derived mobilized peripheral blood cells that underwent the Company’s ApoGraft™ process and were transplanted into patients with hematological malignancies in an allogeneic hematopoietic stem cell transplantation. The primary endpoint of the study is overall incidence, frequency and severity of adverse events potentially related to ApoGraft™ at 180 days from transplantation. The Company plans on recruiting a further three patients for the second cohort of patients following review of the independent data and safety monitoring board.

The Company believes that these interim results of ApoGraft present the first signs of a breakthrough in stem cell transplantation. The product is transplantable within less than 12 hours from donation through a simple process performed on the bedside after selective physiological elimination of immune reaction-causing cells. The ApoGraft transplantation is intended to result in complete recovery of the patient’s immune system with no related safety concerns in contrast to the significant morbidity or even death causing standard medical procedure.

Dr. Shai Yarkoni, Cellect’s CEO said, “Our ApoGraft™ technology shows consistently successful results in the use of stem cell transplants for treating patients suffering from life-threatening conditions. We see our position strengthened with each patient treated. We aim for stem cell based regenerative medicine to become a safe and affordable treatment for most of mankind’s diseases.”

Stem cells are the building blocks and raw material of 21^st century regenerative medicine enabling a world where damaged tissues and organs may be replaced and regenerated rather than fixed with drugs, radiation and surgery. However, up to 50 percent of stem cell transplant procedures, such as bone marrow transplants and others, result in life-threatening rejection disease and other immune responses such as Graft-versus-Host-Disease (GvHD). Cellect’s ApoGraft™ technology aims to turn stem cell transplantations into a simple and safe, yet cost effective procedure by reducing the associated severe side effects, such as rejection and many other risks.

About GvHD

Despite improved prophylactic regimens, acute GvHD disease still occurs in an estimated 25% to 50% of recipients of allogeneic stem cell transplantation. The incidence of acute or chronic GvHD in these patients is increasing due to the increased number of allogeneic transplantations survivors, older recipient age, use of alternative donor grafts and use of peripheral blood as the source of stem cells. GvHD accounts for an estimated 15% of deaths and is considered the leading cause of non-relapse mortality after allogeneic bone marrow transplantation.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology for the selection of stem cells from any given tissue that aims to improve a variety of stem cell-based therapies.

The Company’s technology is expected to provide research, hospitals and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The current clinical trial is aimed at bone marrow transplantations in cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect’s aim at making its ApoGraft™ technology a game changer in stem cell transplantations, Cellect’s intent regarding the effects of the ApoGraft™ transplantation, Cellect’s expectations regarding the implications of the results reported in this press release, and Cellect’s aims and expectations regarding the future of its ApoGraft™ technology and stem cell based regenerative medicine. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from procedures, scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. and in the Company’s period filings with the SEC.

Contact:
Cellect Biotechnology Ltd.
Eyal Leibovitz
Chief Financial Officer
www.cellect.co
+972-9-974-1444

Thursday, January 4th, 2018 Uncategorized Comments Off

$CCXI Conditional Marketing Authorization Application Accepted

Conditional marketing authorization application for treatment of patients with ANCA-associated vasculitis validated for start of procedure by EMA
Significant milestone further strengthens Kidney Health Alliance
ChemoCentryx to receive regulatory milestone payment from VFMCRP

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA AND CHEMOCENTRYX ANNOUNCE THAT THE EUROPEAN MEDICINES AGENCY HAS ACCEPTED FOR REVIEW THE REGISTRATION DOSSIER IN SUPPORT OF A CONDITIONAL MARKETING AUTHORIZATION FOR AVACOPAN IN THE TREATMENT OF PATIENTS WITH ANCA-ASSOCIATED VASCULITIS.

ZURICH, Switzerland and MOUNTAIN VIEW, Calif, Jan. 04, 2018 — Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc., (Nasdaq:CCXI), announced today a significant milestone in their Kidney Health Alliance: ChemoCentryx’s application for avacopan in the treatment of patients with anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis) for regulatory review of its Conditional Marketing Authorization (CMA) application was accepted by the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now start to assess the CMA application. Under the terms of its kidney health alliance with VFMCRP, ChemoCentryx will receive a milestone payment triggered by this validation of the avacopan CMA application by the EMA.

Avacopan is an orally-administered small molecule that is a highly selective inhibitor of the terminal effector complement C5a receptor (C5aR). Avacopan is currently in late-stage clinical development for the treatment of orphan and rare renal diseases, including ANCA vasculitis. In a randomized, double-blind, placebo-controlled Phase II study in ANCA vasculitis patients, known as the CLEAR trial, avacopan demonstrated that blocking C5aR at the terminal effector pathway of the complement cascade provides therapeutic efficacy and a favorable risk/benefit profile with a rapid onset of action. Avacopan is currently being studied in the pivotal Phase III ADVOCATE trial for the treatment of ANCA vasculitis and is on track to complete enrollment by mid-2018. ChemoCentryx, which is responsible for the discovery and development of avacopan, owns and retains the commercial rights to the drug in the United States and China, and VFMCRP has licensed the rights to commercialize the drug in all other countries.

“The EMA’s validation of the Conditional Marketing Authorization application for avacopan represents another critical step in Europe toward realizing our vision of becoming a global leader in nephrology therapies. Avacopan is a much more selective, targeted means of treating ANCA than the current standard of care,” said Stefan Schulze, Vifor Pharma President of the Executive Committee and COO. “We believe this treatment has real potential for transforming the way that ANCA vasculitis is treated and that it will be of tremendous value to patients who have to live with this rare renal inflammatory disease.”

ANCA vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils to lead to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with high-dose corticosteroid administration for prolonged periods of time, which can be associated with significant clinical risk including death from infection. The CLEAR data show that avacopan may markedly reduce the reliance on glucocorticoids in the treatment of ANCA vasculitis. Furthermore, avacopan by targeting the underlying inflammatory disease process while permitting otherwise normal functioning of other components of the immune system, may provide a basis for a totally new of way of improving ANCA vasculitis outcomes.

“A new treatment paradigm for ANCA vasculitis has been a goal for clinicians and patients for decades,” said Professor David Jayne, Vasculitis Director, Addenbrooke’s Hospital, University of Cambridge, UK. “For half a century, we have used high-dose glucocorticoids as part of the treatment of ANCA vasculitis, despite their well-documented toxicities that contribute to the long term morbidity and incapacity associated with vasculitis. In the Phase II CLEAR study, it was demonstrated that inhibition of C5aR may make the chronic use of these toxic steroids obsolete, because the target of avacopan, the C5aR, is an important and specific driver of the destructive inflammation of ANCA vasculitis. The current data are very promising and we look forward to the results from the ADVOCATE Phase III trial.”

“The value and promise of avacopan for patients with ANCA vasculitis has today been reinforced by the EMA validation of the avacopan CMA application,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “We at ChemoCentryx, together with our outstanding partners at Vifor Pharma, are unswerving in our devotion to creating new medicines for patients suffering from devastating kidney diseases. To ANCA patients, we say this: your cause is our cause; we are determined to succeed. Achieving this pivotal regulatory milestone is a big step toward our ultimate success.”

In June 2016, avacopan was granted access to the EMA’s Priority Medicines (PRIME) regulatory initiative for the treatment of patients with ANCA vasculitis. Access to the PRIME initiative is granted by the EMA to support the development and accelerate the review of new therapies to treat patients with unmet medical need.

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, or ANCA vasculitis, is a group of highly inflammatory autoimmune and progressive rare diseases caused by the over-activation of the complement system, which activates neutrophils to destroy blood vessels through inflammation. Patients with granulomatosis with polyangiitis (GPA; formerly Wegener’s) or microscopic polyangiitis (MPA), two forms of ANCA vasculitis have various presentations from asymptomatic abnormal lab results to relapsing-remitting states characterized with recurring flares, accruing into irreversible organ system damage, failure and death.

ANCA vasculitis is the lead indication in ChemoCentryx’s orphan and rare disease program which has the objective of making chronic high dose glucocorticoids irrelevant. In addition to being at major risk of severe necrotizing inflammation of vessel walls leading to multiple organ system failure, in particular end stage renal insufficiency as well as mortality, newly diagnosed patients as well as those in remission suffer from impaired quality of life, which amongst several general health-reported parameters, fatigue is major determinant. The disease affects people of working age and significantly impacts multiple aspects of their physical function, emotional well-being, and overall productivity.

ANCA vasculitis affects approximately 40,000 people in the U.S. (with approximately 4,000 new cases each year) and less than 50,000 people in Europe (with an estimated 5,000 new cases each year), and is currently treated with courses of immunosuppressants (cyclophosphamide or rituximab) combined with high dose steroid administration. These induction protocols achieve only partial sustained remission rates of approximately 70%, with up to 30 percent of patients relapsing within six to 18 months, and approximately half of all patients relapsing within three to five years. Patients with renal involvement have a worse prognosis than patients without renal involvement, and 23% of ANCA vasculitis patients who require dialysis or transplant at time of diagnosis die within six months. As early as six months after diagnosis, 8% of patients develop end-stage renal disease and a total of 42% of patients with renal involvement die or develop end-stage renal disease at two years.

The current standard of care for ANCA vasculitis is associated with significant safety issues, underscoring the need for new therapies that specifically target disease mechanisms more selectively. First year mortality is approximately 11% to 18%, with most of the deaths occurring within the first three months, during the time when glucocorticoids are used at high doses. The single major cause of premature mortality is not disease-related, but rather infection that is thought largely to be a consequence of steroid administration. Indeed, the multiple adverse effects of courses of steroid treatment (both initial courses and those that are repeated as a consequence of relapse) are major causes of both short-term and long-term morbidity and mortality. Such therapy related adverse events contribute significantly to patient care costs, as well as to the diminution of quality of life for patients.

By damaging the body’s small blood vessels, ANCA vasculitis affects many organ systems, mostly the kidneys, eyes, lungs, sinuses and nerves. This damage is caused by the destructive activity of inflammatory leukocytes in the body, with neutrophils considered to be the terminal effector cell. In ANCA vasculitis, neutrophils are attracted to sites of vascular destruction as well as activated at those sites by the activity of the complement system product known as C5a and its receptor, C5aR, which is the target of avacopan. By blocking the C5aR, avacopan is thought to reduce vasculitis by reducing neutrophil activation, accumulation, and adhesion, as well as vascular permeability.

Avacopan is an orally-administered small molecule that is a selective inhibitor of the terminal effector and neutrophil chemoattractant complement C5a receptor, or C5aR. It allows tempering of ANCA responses and thereby to prevent both complement C5a activation while leaving other host defense mechanisms (such as the membrane attack complex, being distinct from C5b) of the immune system unaffected. Avacopan is in phase III development for the treatment of anti-neutrophil cytoplasmic auto-antibody-associated vasculitis (ANCA vasculitis). In clinical studies to date, avacopan was shown to be safe, well tolerated and provided effective control of the disease while successfully allowing elimination of high-dose steroids, part of the standard of care for patients with ANCA vasculitis. Avacopan is also being developed in patients with atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy (C3G). In C3G, avacopan targets the C5a receptor, blocking the effects of C5a which contributes to the inflammatory hypercellularity in the glomeruli, a main feature of C3G. The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for all three of these diseases: C3G, ANCA vasculitis, and aHUS. The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), and C3G. Avacopan was also granted access to the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) initiative, which supports accelerated assessment of investigational therapies addressing unmet medical need.

ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases, and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. ChemoCentryx is currently focusing on its late stage drug candidates for patients with rare kidney diseases. Besides avacopan (described above), the Company’s other late stage drug candidate is CCX140, an inhibitor of the chemokine receptor known as CCR2, which is currently being developed for patients with focal segmental glomerulosclerosis (FSGS), a debilitating kidney disease. ChemoCentryx’s Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialize avacopan and CCX140 in markets outside of the U.S. and China. ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other Inflammatory and autoimmune diseases and in cancer.

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for specialty pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa; and OM Pharma. Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, visit www.viforpharma.com.

Vifor Fresenius Medical Care Renal Pharma Ltd., a common company of Vifor Pharma Group and Fresenius Medical Care, develops and commercialises innovative and high quality therapies to improve the life of patients suffering from chronic kidney disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55% by Vifor Pharma Group and 45% by Fresenius Medical Care. For more information about Vifor Fresenius Medical Care Renal Pharma and its parent companies, please visit www.vfmcrp.com, www.viforpharma.com and www.freseniusmedicalcare.com.

ChemoCentryx forward-looking statements
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include statements regarding whether avacopan will be shown to be effective in the pivotal Phase III ADVOCATE trial in the treatment of ANCA vasculitis and other rare renal diseases, whether avacopan will receive conditional marketing approval by the EMA for the treatment of ANCA vasculitis and whether patient enrollment of the ADVOCATE Phase III trial will be completed by mid-2018. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the ChemoCentryx’s filings with the Securities and Exchange Commission (“SEC”). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in ChemoCentryx’s periodic reports filed with the SEC, including ChemoCentryx’s Annual Report on Form 10-K filed with the SEC 14 March 2017 and its other reports which are available from the SEC’s website (www.sec.gov) and on ChemoCentryx’s website (www.chemocentryx.com) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

FURTHER INFORMATION

Media Relations	Investor Relations
Victoria Maier	Julien Vignot
Senior Manager External Communications	Head of Investor Relations
Tel.: +41 58 851 80 16	Tel.: +41 58 851 66 90
E-mail: media@viforpharma.com	E-mail: investors@viforpharma.com

ChemoCentryx Contacts:
Susan M. Kanaya
Executive Vice President, Chief Financial and Administrative Officer
E-mail: investor@chemocentryx.com

Media:
Stephanie Tomei
Tel.: +1 408-234-1279
E-mail: media@chemocentryx.com

Investors:
Steve Klass
Burns McClellan
Tel.: +1 212-213-0006
E-mail: sklass@burnsmc.com

Thursday, January 4th, 2018 Uncategorized Comments Off

$HTGM Preliminary Fourth Quarter and Full Year 2017 Unaudited Financial Results

Fourth quarter 2017 revenue expected to be between $6.9 and $7.2 million
Full year 2017 revenue expected to be between $13.8 and $14.1 million
Initial full year 2018 revenue guidance of $20.0 to $25.0 million

TUCSON, Ariz., Jan. 04, 2018 – HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM) (HTG), a provider of instruments, reagents and services for molecular profiling applications, today announced preliminary and unaudited financial results for the fourth quarter and full year ended December 31, 2017, and provided initial full year 2018 revenue guidance.

Preliminary 4th Quarter and Full Year 2017 Unaudited Financial Results and Revenue Guidance for 2018:

Total revenue for the fourth quarter of 2017 is expected to be between $6.9 and $7.2 million, an increase of 373% to 394% over the fourth quarter of 2016.
Total revenue for the full year 2017 is expected to be between $13.8 and $14.1 million, an increase of 169% to 175% over total revenue for the full year 2016.
Collaboration revenue drove fourth quarter and full year 2017 revenue. Operating expenses for the fourth quarter are expected to be slightly higher than operating expenses in the third quarter of 2017 on an absolute dollar basis. Gross margin and net loss in the fourth quarter are expected to be improved over the third quarter of 2017, primarily as a result of collaboration profit-sharing revenue expected to be recognized in the fourth quarter.
Cash and cash equivalents are expected to be approximately $10.0 million as of December 31, 2017.
HTG is providing initial revenue guidance for the year ending December 31, 2018 in the range of $20.0 to $25.0 million.

“Our strategy of developing high value diagnostic tests through our collaborations with Qiagen and top-tier biopharmaceutical companies is a primary reason for the strong revenue growth we saw in 2017, and helped propel us to a strong year end,” said TJ Johnson, President and CEO of HTG. “We expect this momentum to continue and believe our clinical and pre‑clinical collaborations, along with our independent development programs, will support continued revenue growth in 2018.”

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the quarter and year ended December 31, 2017 and are subject to revision based upon the Company’s year-end closing procedures and the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2017, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period. The Company expects to announce full 2017 financial results in advance of its quarterly conference call, currently planned for Thursday, March 22, 2018.

About HTG:
Headquartered in Tucson, Arizona, the mission of HTG is to empower precision medicine at the local level. The company’s HTG EdgeSeq technology, which automates highly multiplexed molecular profiling of small samples for next-generation sequencing, received its first US patent in 2014. Continuous improvements led to the 2017 launch of HTG’s new direct-target sequencing chemistry for DNA analysis offered in the company’s VERI/O services laboratory. Additional information is available at www.htgmolecular.com.

Safe Harbor Statement:
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our revenue expectations, including collaboration profit-sharing revenue expected to be recognized in the fourth quarter of 2017, and other expected financial results as of and for the fourth quarter and year ended December 31, 2017, our initial revenue guidance for the year ending December 31, 2018 and the expected benefits of our collaborations to our future revenues. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, the risk that we may not realize the benefits expected under our collaboration agreements with Qiagen or other biopharmaceutical companies; the risk that our actual revenue or other financial results for the fourth quarter and/or full year 2017, including collaboration profit-sharing revenue, may differ materially from our estimated results for these periods as a result of the completion of year-end closing procedures, final adjustments, final profit-sharing reconciliation with Qiagen, or other developments arising between now and the time that our financial results are finalized; the risk that we may not achieve our revenue expectations for 2018 (including, without limitation, due to variations from our expectations in the amount or timing of work we perform under one or more companion diagnostic development programs with large pharma customers, which development programs comprise an increasing portion of our business and therefore have the ability to significantly impact the timing and amount of revenue recognized in one or more fiscal periods); risks associated with our ability to successfully commercialize our products; the risk that our products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all; our ability to manufacture our products to meet demand; the level and availability of first party payor reimbursement for our products; our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of first parties; competition in our industry; our ability to attract and retain qualified personnel; and product liability claims. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:

LifeSci Advisors, LLC
Ashley Robinson
Phone: (617) 775-5956
Email: arr@lifesciadvisors.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: (520) 547-2827 x130
Email: tjjohnson@htgmolecular.com

Thursday, January 4th, 2018 Uncategorized Comments Off

$CNET Announces Strategic Partnership With Jingtum Technology, Up 698 Percent

BEIJING, Jan. 04, 2018 — ChinaNet-Online Holdings, Inc. (Nasdaq:CNET) (“ChinaNet” or the “Company”), an integrated online advertising, precision marketing and data-analysis and management services platform, today announced a strategic partnership with Wuxi Jingtum Network Technology (“Jingtum” or “Jingtum Technology”), the credible blockchain ecology builder and announced the expansion into the blockchain industry and its related technology. Both companies will utilize their respective advantages and exchange each other’s work together to jointly develop blockchain applications.

Through the contribution of underlying technologies in the blockchain, Jingtum Technology aims to develop a new generation of value-based internet technologies in China helping to upgrade from an information-based network to a value-based exchange network, establishing a credible ecology and promoting preparation as Chinese enterprises enter a new era of digital assets.

Jingtum’s system is a decentralized and ecologically interactive internet trading network based on blockchain technology. The system addresses data trust issues through cryptography and distributed coherency mechanisms while maintaining rich transactional and contractual features.

This strategic partnership between ChinaNet and Jingtum is focused on blockchain technology to build a credible, fair and transparent platform for business opportunities and transactions. Both companies will aim to develop credible, traceable, and highly secured blockchain applications for business entities. Both companies agree that blockchain technology enjoys extremely large demand in applications for small and medium-sized enterprises including product traceability, product certification, disintermediation, customer identification, and brand communication. The most fundamental value and significance is that the enterprise brand and reputation can be converted into digital form and enter the global digital asset trading market for transactions and circulation. It is believed that the application of blockchain in the field of business development and marketing can help SMEs across the world to build a new business ecosystem based on algorithmic trust.

Mr. Handong Cheng, CEO of ChinaNet-Online, stated, “With the introduction of blockchain technology, the platform-centric services in the past will gradually shift towards decentralization, solving trust issues in business cooperation and services and enhancing user vitality and stickiness.” Mr. Cheng continued, “ChinaNet-Online will also gradually shift from information services to transaction services for business opportunities to create a multi-industry cross-chain value-based internet sharing entity. This partnership will help ChinaNet to further integrate blockchain technology into our CloudX artificial intelligence and simultaneously create the public chain of marketing and advertising for small and medium enterprises, eventually branching out from these areas to gradually cover other applications such as business transactions payments, education and training to create a healthy and sustainable business ecosystem and entrepreneurial environment.”

Mr. Yuanwen Wu, CEO of Jingtum Technology, Dean of the Blockchain Research Institute of WOGC of the United Nations and Deputy Secretary-general of Zhongguancun Big Data Industry Alliance said “The application of blockchain technology specifically tailored for SMEs will create a brand-new world of value business opportunities.”

About ChinaNet-Online Holdings, Inc.
ChinaNet-Online Holdings, a parent company of ChinaNet Online Media Group Ltd., incorporated in the BVI (ChinaNet), is an integrated online advertising, precision marketing and data-analysis and management services platform. ChinaNet provides prescriptive analysis for its clients to improve business outcomes and to create more efficient enterprises. The Company leverages an optimization framework, provided by its comprehensive data-analysis infrastructure, to blend data, mathematical, and computational sciences into an outcome management platform for which it monetizes on a per client basis. ChinaNet uniquely optimizes and prescribes its clients decision making processes based on its proprietary ecosystem. For more information, visit www.chinanet-online.com.

About Wuxi Jingtum Network Technology
Wuxi Jingtum Network Technology Co., Ltd. is a high-tech company, located in Wuxi New Area National Software Park focusing on developing the blockchain technology platform to provide both business and personal digital asset interconnection, interflow, sharing, and co-management of technical ecosystem architecture for enterprises and personal digital assets. Founded in 2014, Jingtum Technology officially operated in China and started the business application of blockchain technology in China. Jingtum’s core staff are from top Silicon Valley and Chinese blockchain technical companies and other key major internet segments, such as financial, telecommunications, security, and big data industries. In 2015, Jingtum built the first commercial application based on blockchain technology in China. Jingtum has the only blockchain technology in China that has been pilot ran on large-scale applications with the local government on digital assets. They are also currently co-founding DAB, www.goetcc.com. For more information, please log in the website www.jingtum.com.

Safe Harbor
This release contains certain “forward-looking statements” relating to the business of ChinaNet Online Holdings, Inc., which can be identified by the use of forward-looking terminology such as “believes,” “expects,” “anticipates,” “estimates” or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including business uncertainties relating to government regulation of our industry, market demand, reliance on key personnel, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission. These forward-looking statements are based on ChinaNet’s current expectations and beliefs concerning future developments and their potential effects on the Company. There can be no assurance that future developments affecting ChinaNet will be those anticipated by ChinaNet. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the control of the Company) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. ChinaNet undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact:
MZ North America
Ted Haberfield, President
Direct: +1-760-755-2716
Email: thaberfield@mzgroup.us
Web: www.mzgroup.us

Thursday, January 4th, 2018 Uncategorized Comments Off

$DFFN to Present at the 10th Annual Biotech Showcase™ Conference

CHARLOTTESVILLE, Va., Jan. 03, 2018 — Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) (“Diffusion” or “the Company”), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, today announced that David Kalergis, Chairman and Chief Executive Officer, will present an overview of the Company and recent advancements of its lead product candidate, trans sodium crocetinate (TSC), at the 10th Annual Biotech Showcase™ Conference to be held on January 8–10, 2018 at the Hilton San Francisco Union Square Hotel.

Mr. Kalergis is scheduled to present on Monday, January 8, 2018 at 2:30 p.m. Pacific time.

The presentation will be webcast live and available only during the time of the Company’s live presentation. To access the live webcast, investors may visit the investor relations section of Diffusion Pharmaceuticals website at www.diffusionpharma.com.

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients by improving the effectiveness of current standard-of-care (SOC) treatments including radiation therapy and chemotherapy. Diffusion is developing its lead product candidate, trans sodium crocetinate (TSC), for use in cancers where tumor hypoxia (oxygen deprivation) diminishes the effectiveness of SOC treatments. TSC targets the cancer’s hypoxic micro-environment, re-oxygenating treatment-resistant tissue and making the cancer cells more vulnerable to the therapeutic effects of SOC treatments without the apparent addition of any serious side effects.

A Phase 3 randomized, controlled registration trial with TSC and SOC chemotherapy and radiation compared with SOC alone in 236 newly diagnosed, inoperable glioblastoma multiforme patients, is now open for enrollment. The trial, which has been named INTACT (INvestigating Tsc Against Cancerous Tumors), was preceded by a Phase 2 clinical program completed in the fourth quarter of 2015 that evaluated 59 patients with newly-diagnosed glioblastoma multiforme, a type of brain cancer. This open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with SOC, including a 36% improvement in overall survival compared with the control group at two years. A particularly strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was nearly four-fold higher compared with the controls.

Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in preclinical and clinical studies. Diffusion believes its therapeutic potential is not limited to one specific tumor type, thereby making it potentially useful to improve SOC treatments of other life-threatening cancers. Given TSC’s safety profile and animal data, Diffusion believes that, with appropriate funding support, it can move directly into Phase 2 studies in other cancers. The Company also believes that TSC has potential application in other indications involving hypoxia, such as neurodegenerative diseases and emergency medicine. For example, a stroke program is now under discussion with doctors from the University of California in Los Angeles, the University of Southern California, and the University of Virginia, with whom Diffusion has established a joint team developing a program to test TSC, with an in-ambulance trial of TSC in ischemic and hemorrhagic stroke under consideration. Planning for such a trial is ongoing.

Contacts:
David Kalergis, CEO
Diffusion Pharmaceuticals Inc.
(434) 220-0718
dkalergis@diffusionpharma.com
or
LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

Wednesday, January 3rd, 2018 Uncategorized Comments Off

$INSY to Present at J.P. Morgan Healthcare Conference

PHOENIX, Jan. 03, 2018 – INSYS Therapeutics, Inc. (NASDAQ:INSY), announced today that Saeed Motahari, president and chief executive officer, and Andrew Long, chief financial officer, will present at the 36^th annual J.P. Morgan Healthcare Conference as follows:

Date:				Thursday, Jan. 11, 2018
Time:				7:30 a.m. Pacific Standard Time
Location:				San Francisco – Westin St. Francis Hotel

The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Investors section of company’s website at https://www.insysrx.com/, under Presentations & Events. The presentation slides will be available during the conference, accessible at the same webpage.

In addition to making a presentation, management will also provide an overview of the company’s business in one-on-one meetings with investors who are registered to attend the conference.

About INSYS
INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products.


CONTACT:	Corporate Communications	Investor Relations
	Joe McGrath	Jackie Marcus or Chris Hodges
	INSYS Therapeutics	Alpha IR Group
	480-500-3101	312-445-2870
	jmcgrath@insysrx.com	INSY@alpha-ir.com

Wednesday, January 3rd, 2018 Uncategorized Comments Off

$ZUMZ Post Earnings Research Report

LONDON, UK / January 03, 2018 / Active-Investors.com has just released a free earnings report on Zumiez Inc. (NASDAQ: ZUMZ). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ZUMZ. The Company released its financial results on November 30, 2017, for the third quarter of the fiscal year 2017. The Lynnwood, Washington-based Company posted a growth of 11.0% in net sales during the reported quarter, outperforming market expectations.Register today and get access to over 1000 Free Research Reports by joining our site below:

www.active-investors.com/registration-sg

Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Zumiez most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=ZUMZ

Earnings Highlights and Summary

Zumiez reported net sales of $245.76 million in Q3 FY17, which came in above the $221.39 million reported in the prior year’s same quarter. The Company’s net sales numbers beat market forecasts of $242.9 million. The Company recorded comparable sales growth of 7.9% during Q3 FY17, versus a 4.0% comparable sales growth in Q3 FY16.

The clothing retailer reported a net income of $11.92 million, or $0.48 per diluted share, in Q3 FY17 compared to $10.70 million, or $0.43 per diluted share, in Q3 FY16. Moreover, Wall Street had also expected the Company to report a net income of $0.48 per diluted share.

As on November 25, 2017, the Company operated 699 stores, with 608 stores in the United States, 51 stores in Canada, 33 stores in Europe, and 7 stores in Australia.

Operating Metrics

In Q3 FY17, Zumiez spent $162.39 million of cost of goods sold versus $145.21 million in the last year’s comparable quarter. The Company’s gross profit grew to $83.37 million in Q3 FY17 from $76.18 million in Q3 FY16, whereas gross margin was 33.9% during the reported quarter versus 34.4% in Q3 FY16. The Company incurred selling, general, and administrative expenses (SG&A) of $64.56 million in Q3 FY17 compared to $59.27 million in Q3 FY16. The Company’s operating profit increased to $18.81 million during the reported quarter from $16.91 million in Q3 FY16, while its operating margin improved to 7.7% in Q3 FY17 from 7.6% in Q3 FY16.

Cash Flow and Balance Sheet

In the nine months ended October 28, 2017, the Company’s net cash provided by operating activities was $13.87 million compared to $3.98 million in the first quarters of FY16. As on October 28, 2017, the Company had $10.66 million in cash and cash equivalents compared to $18.00 million as on October 29, 2016. Furthermore, inventories stood at $156.99 million as on October 28, 2017, versus $150.62 million as on October 29, 2016.

Earnings Outlook

In its guidance for Q4 FY17, Zumiez’s management expects net sales to be in the range of $291 million to $297 million, while net income per diluted share is forecasted to be approximately $0.78 to $0.84 with comparable sales growth between 3% and 5%. Furthermore, the Company stated that it was on track on inaugurating 19 new stores in FY17, with up to 3 stores in Canada, 5 stores in Europe, and 2 stores in Australia.

Stock Performance Snapshot

January 02, 2018 – At Tuesday’s closing bell, Zumiez’s stock declined 3.96%, ending the trading session at $20.00.

Volume traded for the day: 753.49 thousand shares, which was above the 3-month average volume of 468.87 thousand shares.

Stock performance in the last three-month – up 7.82%; and previous six-month period – up 58.10%

After yesterday’s close, Zumiez’s market cap was at $514.00 million.

Price to Earnings (P/E) ratio was at 19.76.

The stock is part of the Services sector, categorized under the Specialty Retail, Other industry. This sector was up 1.7% at the end of the session.

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Wednesday, January 3rd, 2018 Uncategorized Comments Off

$APHB Positive Interim Results for AB-SA01 and AB-PA01 in Antibiotic-resistant Infections

SAN DIEGO

Seven patients with serious, life-threatening infections, not responding to antibiotics, were treated with AB-SA01 or AB-PA01, with six patients, 86%, achieving treatment success
Treatment was well tolerated in all patients, with over 500 doses administered intravenously or by inhalation
AmpliPhi expects to continue its expanded access clinical strategy in 2018, review data with the FDA in mid-2018, and initiate a Phase 2 or registrational clinical program potentially as early as the second half of 2018
Management will host webcast/conference call today at 4:30 p.m. EST/1:30 p.m. PST

AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced topline results for the first seven patients treated under its ongoing single-patient expanded access program. Six of the seven patients (86%) achieved treatment success (physician’s assessment), defined as complete resolution or significant improvement of baseline signs and symptoms. All patients were severely ill and unresponsive to antibiotic treatment at the time of enrollment.

“I am very encouraged by these initial results for treatment with AB-SA01 or AB-PA01 in severely ill patients who were not responding to antibiotics,” stated Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. “We look forward to treating up to an additional 20 patients during the first half of 2018 and discussing our findings with the FDA to determine a development path forward to registration. Our ongoing dialogue with infectious disease thought leaders continues to indicate growing support for our program.”

“Bacteriophage therapeutics have the potential to be a safe and potent modality for treating serious bacterial infections, and also provide an option for those with antibiotic resistant or relapsing infection. Encouraging initial results make it important to proceed to full clinical evaluation and further development of this therapeutic approach,” said Dr. Jonathan Iredell, Director of Infectious Diseases at the Westmead Hospital in Sydney and Professor of Medicine and Microbiology at the University of Sydney and Westmead Institute of Medical Research.

“The treatment with bacteriophages of severely ill patients with antibiotic-resistant infections warrants further clinical investigation and holds promise as a new approach to this critical unmet medical need,” said Robert T. Schooley, M.D., Professor in the infectious disease division at the University of California, San Diego. “The FDA also recognizes that multi-drug resistant infections are a real problem and I believe they see this approach as one that clearly needs to be evaluated.”

“Bacteriophage therapies have been around for the past hundred years,” said Igor P. Bilinsky, Ph.D., COO of AmpliPhi. “It is only now, enabled by advances in biologics manufacturing and DNA sequencing, that we are able to produce GMP grade phage products that could be suitable for intravenous administration. This is an important step for developing phages as a novel, precisely targeted therapeutic modality for patients with serious infections who have few or no other treatment options and for helping humanity solve the growing crisis of antibiotic resistance.”

Expanded Access Program Design and Topline Results

The expanded access approach allows critically ill patients to receive experimental, unapproved therapies in an attempt to save lives. Severely ill patients can receive treatment in the U.S. under an emergency IND and in Australia under the Special Access Scheme. AmpliPhi’s lead product candidates, AB-SA01, for Staphylococcus aureus infections, and AB-PA01, for Pseudomonas aeruginosa infections, are being provided through this program. Among the first seven patients treated, four patients received intravenous AB-SA01 and three received AB-PA01 administered intravenously and in some cases as an inhaled therapy. Bacteriophage treatment was administered along with the treating physician’s choice of best available antibiotic therapy. Treated patients suffered from bacteremia, endocarditis and lung infections, and both investigational products were well tolerated in all patients with no treatment-related serious adverse events reported.

Treatment success, defined as complete resolution or significant improvement of baseline signs and symptoms, was reported in six out of seven patients (86%) by physician’s assessment. One patient was determined to be a treatment failure due to death, which occurred during surgery after three days of bacteriophage treatment. The treating physician determined that the one death was unrelated to treatment with bacteriophage therapy. The 28-day all-cause mortality rate was 14%. No additional deaths occurred up to 90 days following initiation of therapy, and patient follow up is continuing. Based on the APACHE II scores (a validated critical care scoring system predictive of mortality) of the seven patients prior to initiation of bacteriophage therapy, the predicted mortality rate for this patient group was 46%.

No bacterial isolates resistant to the bacteriophage therapeutics were detected during the bacteriophage treatment course. Additional analyses of these data are ongoing, and presentations or publications of the detailed results are planned.

Conference Call and Webcast

AmpliPhi will hold a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss these results. The conference call dial-in number is (866) 652-5200 for domestic callers and (412) 317-6060 for international callers, and the passcode is 10115452. A live webcast of the call will be available on the Investor Relations section of www.ampliphibio.com.

A recording of the call will be available for 48 hours beginning approximately two hours after the completion of the call by dialing (877) 344-7529 for domestic callers and (412) 317-0088 for international callers. Please use passcode 10115452 to access the recording. A webcast replay will be available on the Investor Relations section of www.ampliphibio.com for 30 days, beginning approximately two hours after the completion of the call.

About AmpliPhi Biosciences

AmpliPhi Biosciences Corporation is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for patients with serious and life-threatening antibiotic-resistant bacterial infections. AmpliPhi’s lead product candidates target multidrug-resistant Staphylococcus aureus and Pseudomonas aeruginosa, which are included on the WHO’s 2017 Priority Pathogens List. Phage therapeutics are uniquely positioned to address the threat of antibiotic-resistance as they can be precisely targeted to kill select bacteria, have a differentiated mechanism of action, can penetrate and disrupt biofilms (a common bacterial defense mechanism against antibiotics), are potentially synergistic with antibiotics and have been shown to restore antibiotic sensitivity to drug-resistant bacteria. For more information visit www.ampliphibio.com.

Forward Looking Statements

Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements regarding: AmpliPhi’s plan to present additional results for the seven patients dosed with AB-SA01 or AB-PA01; AmpliPhi’s plan to dose up to an additional 20 patients with its bacteriophage therapies during the first half of 2018; AmpliPhi’s plan to present data from expanded access clinical cases to the FDA in mid-2018 and potentially initiate a Phase 2 or registrational clinical trial as early as the second half of 2018; and the potential benefits of phage therapy and the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics or are associated with biofilms. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. Among the factors that could cause actual results to differ materially from those indicated in these forward-looking statements are risks and uncertainties associated with AmpliPhi’s business and financial condition and the other risks and uncertainties described in AmpliPhi’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC, and AmpliPhi’s subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

AmpliPhi Biosciences
Matthew Dansey, (858) 800-4869
md@ampliphibio.com
or
Investor Relations:
Westwicke Partners
Robert H. Uhl, (858) 356-5932
robert.uhl@westwicke.com
or
Media:
Russo Partners, LLC
David Schull or Maggie Beller
(212) 845-4271
David.Schull@RussoPartnersLLC.com
Maggie.Beller@RussoPartnersLLC.com

Wednesday, January 3rd, 2018 Uncategorized Comments Off

$NETE Receives $2.7 Million from Sale of Common Shares

January 3, 2018

NETE received $2,683,835 from sales of common stock in multiple transactions with Cobblestone Capital Partners, LLC
Proceeds are expected to be used for working capital and general corporate purposes
NETE recently launched new blockchain-based business unit to provide value-added services and transaction support in the cryptocurrency market

Net Element, Inc. (NASDAQ: NETE) has received $2.7 million from its share sale, aggregating an additional 536,767 common shares to Cobblestone Capital Partners, LLC in multiple transactions, it disclosed in an SEC 8K filing on December 26, 2017 (http://nnw.fm/uJE9v). NETE is expected to use net proceeds for working capital and general corporate purposes, its prospectus said (http://nnw.fm/5tj6G).

NETE is a global financial technology and value-added solutions group that supports companies in accepting electronic payments in an omni-channel environment spanning across point-of-sale terminals and mobile devices. It maintains three segments: Mobile Payment Solutions, Online Payment Solutions and North America Transaction Solutions. It offers cloud-based proprietary technology products.

Most recently, it launched a new blockchain-based business unit designed to improve the efficiency and simplicity of transactions between buyers and merchants. It will operate in the cryptocurrency market, offering innovative digital payment methods and value-added services, according to NETE CEO Oleg Firer. The new unit will operate in partnership with Bunker Capital.

Firer added that he believes we are at the dawn of an evolution that focuses on innovative digital payment methods (http://nnw.fm/U3Dx3). The goal of the company’s new blockchain unit is to provide compliance assurance and transparency in cryptocurrency transactions. Further, it will enable the provision of value-added services to some 20 million ecommerce clients who are already utilizing Net Element services. NETE also offers analytical tools, online payment methods and technologies in mobile transactions.

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

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Wednesday, January 3rd, 2018 Uncategorized Comments Off

$CIIX Releases Exclusive Audio Interview

NEW YORK, Jan. 03, 2018 — NetworkNewsAudio, via NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company that delivers a new generation of social communication solutions for business, today announces the online availability of its interview with ChineseInvestors.com (OTCQB:CIIX), a leading financial information website for Chinese-speaking investors in the United States and China that is also laying the groundwork to capitalize on unprecedented opportunities in the cryptocurrency and cannabis sectors.

The interview can be heard at http://nnw.fm/ciix-interview-jan-2018

Kicking off the interview, Kraig Rasmussen introduces ChineseInvestors.com CEO and founder Warren Wang, whose 20 years of experience in the financial markets industry includes management, project development, sales, marketing, accounting and administration. Wang reviews the company’s history, describes several recent successes and shares plans for a prosperous 2018.

“After I left the investment banking firm, I decided to establish a Chinese language content, commentary and analysis (service) because I believed Chinese investors would be the richest group in the world,” Wang says, noting his prediction came true once the Chinese government opened the country’s doors to “the world’s people” in 2000.

ChineseInvestors.com now has more than 60 employees with offices in Shanghai, China, California and New York. Through its primary website, www.ChineseInvestors.com, CIIX offers a variety of investor education products and services, including real-time market commentary, analysis and educational related services in Chinese language character sets; consultative services to smaller private companies considering becoming a public company; and advertising and public relations related support services.

“Any assets people are trading with, we provide content and commentary,” Wang says. “The most interesting part we are involved with is cryptocurrency. It’s very, very hot right now, basically because Federal Reserve Chairman Janet Yellen said cryptocurrency is an emerging digital asset …We think that’s a tremendous opportunity (for us) to establish a cryptocurrency division.”

The company’s recent installation of a Bitcoin ATM at its headquarters in San Gabriel, California, provides the perfect illustration to Wang’s assessment that interest is high in cryptocurrencies.

“A lot of people are showing interest with large transactions through that machine,” Wang says. “That’s the first one in a Chinese community in the United States.”

CIIX is also leveraging its financial expertise by entering the cannabidiol or CBD oil industry within China, offering hemp-infused skin care products there. Wang noted the endeavor has been so successful the company is spinning off its subsidiary – CBD Biotechnology and ChineseHempOil.com, Inc. – with the intention of listing the new company’s common stock on the OTCQB. The company’s core market of Chinese-speaking investors continues to request more information about CIIX’s plans to enter the cryptocurrency sector, Wang said, adding shareholders can easily get more information by logging onto the company’s website.

“I am still very excited about that and what we are doing,” Wang says in conclusion. “There is a huge demand from the Chinese community who are trying to learn what this digital asset is all about, so this gives us a tremendous opportunity to bring revenue and possibilities to our shareholders.”

About ChineseInvestors.com

About NetworkNewsAudio

NetworkNewsAudio, a service of NetworkNewsWire (NNW), allows you to sit back and listen to market updates, interviews and company press releases. NetworkNewsAudio keeps you informed on publicly traded companies we’re watching. The audio clips provide snapshots of position, opportunity and momentum. NetworkNewsAudio is a complimentary service of NetworkNewsWire. For more information, visit: https://www.networknewswire.com/networknewsaudio/.

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Forward-Looking Statements

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Wednesday, January 3rd, 2018 Uncategorized Comments Off

$TRVN FDA Acceptance for Review of NDA for OLINVO™ in Severe Acute Pain

CHESTERBROOK, Pa., Jan. 02, 2018 (GLOBE NEWSWIRE) — Trevena, Inc. (NASDAQ:TRVN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for OLINVO™ (oliceridine) Injection. The Company expects that the PDUFA date for the NDA will be in the fourth quarter of 2018. OLINVO is an investigational product for the management of moderate to severe acute pain. It is the first G protein biased ligand of the mu receptor designed to provide IV opioid pain relief with fewer associated adverse effects.

“The NDA file acceptance represents another major step in our progress towards delivering OLINVO to patients and healthcare providers in need of new options for managing moderate to severe acute pain in the hospital setting,” said Maxine Gowen, Ph.D., chief executive officer. “We look forward to working with the FDA as they evaluate the OLINVO application.”

About OLINVO™ (oliceridine) Injection

OLINVO is a next generation IV analgesic for the management of moderate-to-severe acute pain in the hospital and similar settings and has been granted Breakthrough Therapy designation by the FDA. OLINVO was specifically designed to deliver the pain relief of a conventional IV opioid, with fewer associated adverse effects via its biased ligand mechanism of action. In Phase 2 and Phase 3 clinical trials, OLINVO provided rapid and powerful analgesic efficacy while demonstrating a wider therapeutic window compared to morphine, suggesting it may be highly effective and well-tolerated for patients in need of strong analgesia. OLINVO is an investigational product and has not been approved by the FDA or any other regulatory agency. The Company expects OLINVO to be a Schedule II controlled substance.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on providing better, safer therapies to patients in pain. The Company has leveraged breakthrough science to discover and develop its investigational product OLINVO for the management of moderate-to-severe acute pain. The Company has an early stage pipeline of new chemical entities targeting novel mechanisms of action, including for acute migraine, neuropathic pain, and other indications.

Cautionary note on forward looking statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” 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 status, timing, costs, results and interpretation of the Company’s clinical trials; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals, including with respect to the OLINVO NDA and the timing of the PDUFA date; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates, including whether OLINVO will be a new option for managing moderate to severe acute pain in the hospital setting; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

Contacts

Investors:
Jonathan Violin, Ph.D.
Vice President, Corporate Strategy & Investor Relations
610-354-8840 x231
jviolin@trevena.com

Media:
Public Relations
PR@trevena.com

Tuesday, January 2nd, 2018 Uncategorized Comments Off

$BURG to Deploy Mobivity’s Blockchain Technology to Power Cryptocurrency Rewards Program

PHOENIX, Jan. 02, 2018 — Mobivity Holdings Corp. (OTCQB:MFON), makers of the award-winning platform for intelligent and personalized marketing in the real world, and Chanticleer Holdings Inc. (NASDAQ:BURG), the owners and operators of several fast casual restaurant brands, today announced plans to use MobivityMind, a blockchain-architected platform for commerce and customer communication across brands, to power their groundbreaking cryptocurrency customer loyalty and rewards program. Chanticleer Holding’s brands, including BGR (Burgers Grilled Right), Little Big Burger, and American Burger Co., will leverage the MobivityMind platform to reward customers with a currency that can be leveraged across all Chanticleer Holding brands – and beyond. “Eating a burger is now a way to mine for cryptocoins! Every meal enjoyed at any Chanticleer Holdings brand will accrue currency for the consumer that can be used for future meals or traded with other consumers. It transforms traditional consumer rewards into something that the consumer can control,” said Dennis Becker, CEO of Mobivity, and visionary behind the concept.

“We wanted to expand our existing loyalty program with something that really changes the way our customers can leverage their rewards; Mobivity Merit is real cryptocurrency, leveraging the same infrastructure and principles of Bitcoin, Ethereum, Ripple, Litecoin, and more, and will enable our customers to make use of their rewards in entirely new ways,” said Michael D. Pruitt, Chairman, President and CEO of Chanticleer Holdings. “Use your Merit mined by eating at Little Big Burger to get a buffalo chicken sandwich at American Burger Co., or trade them with your vegan friend so he can get a veggie burger at BGR. And that’s just the beginning,” he continued. Mobivity’s Merit allows brands to create one-time use rewards which can be redeemed across brands and traded with virtually no fraud concern by leveraging the decentralized blockchain-based cryptocurrency paradigm. “We’re excited to see how consumers respond to the idea of getting real, transferrable, secure value in exchange for their loyalty to our brands,” added Pruitt.

Most loyalty programs create small, brand-specific data silos and a fragmented experience for consumers. Blockchain, coupled with the MobivityMind platform, can securely store transaction records across brands and allow consumers to build our Merit ‘currency’ that can be used as they go about their lives. Each transaction informs the brand, rewards the consumer, and enriches the consumer’s persistent digital identity. Consumers can take that persistent identity, including their preferences and habits, and leverage it across brands to get better, more personalized service. With MobivityMind, each brand owns the data about their interactions with a consumer, but the consumer owns the data about ALL of their transactions across all brands, stored in the distributed ledger of blockchain technology. “This is the democratization of consumer data, putting the power back in the people’s hands rather than giving it to the data-aggregators who trade it without the knowledge, consent, or benefit to the consumer,” said Corey O’Donnell, SVP of Marketing for Mobivity. “It’s great for brands, great for customers, and great for the economy; as we expand our partnerships the relationship and data exchange between brands and consumers will grow exponentially. It’s a marketers’ dream, but great for consumers at the same time,” he added.

Mobivity and Chanticleer Holdings announced plans to begin the deployment of this new program beginning in mid-2018, and expect it to be fully deployed across all Chanticleer brands before the end of the year. “It’s really exciting to be at the forefront of this kind of revolution in data, marketing and commerce, and to be in partnership with a proven technology innovator like Mobivity. You can see how this technology is going to fundamentally change the relationship between brands and consumers for the better, and we’re thrilled to lead the way,” Pruitt, Chanticleer’s CEO, concluded. “We needed a visionary partner with multiple brands and the desire to be a disruptor to launch Mobivity Merit, and we are thrilled to be working with Chanticleer Holdings as we disrupt commerce and empower consumers,” added Becker, Mobivity CEO.

For more information, or to schedule a briefing on Mobivity solutions, please contact Corey O’Donnell, SVP of Marketing for Mobivity, at (480) 588-2470, or corey.odonnel@mobivity.com.

For investor and media inquiries to Chanticleer Holdings, Inc. please contact (704) 366-5122, or IR@chanticleerholdings.com.

About Chanticleer Holdings, Inc.

Headquartered in Charlotte, NC, Chanticleer Holdings (HOTR), owns, operates and franchises fast-casual and full-service restaurant brands, including American Burger Company, BGR – Burgers Grilled Right, Little Big Burger, Just Fresh and Hooters.

About Mobivity

Mobivity provides a platform for intelligent and personalized marketing in the real world. Real world customer activity in national restaurants, retailers, and personal care brands is difficult to track and connect to digital actions. Mobivity leverages detailed purchase data and communications platforms to improve business results by understanding, predicting, and influencing consumer behavior. We drive better actions and inform decisions by connecting point of sale outcomes to the events and influences that caused them. For more information about Mobivity, visit mobivity.com, or call (877) 282-7660.

Tuesday, January 2nd, 2018 Uncategorized Comments Off

$IGC Reports Promising Spatial Memory Results in Alzheimer’s Study

BETHESDA, Md., Jan. 02, 2018 — India Globalization Capital, Inc. (NYSE-MKT:IGC) provides compelling in vivo data compiled from genetically engineered mice to mimic Alzheimer’s shows marked improvement in spatial memory.

Scope of Studies
Transgenic mice with a gene introduced to mimic Alzheimer’s were used to gauge the impact of IGC-AD1 on learning and memory function. A common model used to study learning and memory behavior in mice is the Morris Water Maze (MWM) test, which specifically evaluates spatial learning and memory. As with many of the results previously disclosed, Dr. Chuanhai Cao, IGC’s Senior Advisor and Associate Professor of Pharmaceutical Sciences at USF’s College of Pharmacy conducted the studies.

Analysis
The MWM study showed that mice treated with IGC-AD1 at various doses exhibited significantly decreased learning trial errors, and markedly decreased escape latency times as compared with the control groups. For example, normal mice with no Alzheimer’s markers took approximately 2 seconds to resolve the MWM, while mice with Alzheimer’s markers took approximately 8 seconds. Alzheimer’s disease model mice treated with the medication took approximately 4 seconds, an improvement of approximately 50% over the control group of untreated Alzheimer’s model mice. “This is exciting as it holds the potential for improvement in spatial memory and short-term memory among Alzheimer’s patients. “A common endpoint of Alzheimer’s is patients getting lost, or not being able to find their way home,” said Ram Mukunda, CEO of IGC.

2018 Key Objectives
“We are preparing the groundwork necessary to get Hyalolex, our lead product formulation for Alzheimer’s ready for Phase 2-B human trials. Independent of this, we expect to make the product available through medical dispensaries in select states of the U.S. In addition, we are working on addressing issues specific to the medical cannabis industry such as transactional difficulties, inadequate product labeling, product identification assurance (PIA) and product origin assurance (POA), using distributed ledgers inherent in blockchain technology. We are ready for an exciting 2018,” concluded Mr. Mukunda.

About MWM
MWM evaluates learning, memory and factors that influence visual acuity, motor function, and motivation. In the MWM task, the animal is required to discover a hidden platform to escape from swimming in a pool of water. To accomplish this task, the animal forms a “spatial orientation map” in the brain using visual stimuli from extra-maze cues in the testing room. During training, learning is assessed by the amount of time elapsed before the animal climbs onto the platform to escape the water (escape latency) and by the percentage of time or path length spent in the quadrant housing the platform (target quadrant) as well as a number of errors that occur in each trial. This is a test of cognitive function.

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 has two lines of business, a legacy infrastructure business and a cannabis pharmaceutical business that has developed a lead product for treating Alzheimer’s patients. The Company recently announced that it is working on using blockchain to address issues specific to the cannabis industry including transactional difficulties, product labeling, product identification assurance (PIA), and product origin assurance (POA). The Company is based in Maryland, USA.

For more information please visit www.igcinc.us and on www.igcpharma.com
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

Tuesday, January 2nd, 2018 Uncategorized Comments Off

Uncategorized

$STLHF Trump’s Recent Executive Order Could Boost Lithium Supply in the U.S.

$VSQTF Blockchain Technology Transforming Future of Transaction Management

$DJACF 2018 Could be a Breakout Year for Cannabis Companies

$PTIE Positive Top-line Results from Nasal Abuse Potential Study with REMOXY™

$CIIX CEO Warren Wang, New Audio Interview at SmallCapVoice.com

$DJACF Closes $12.5 Million Private Placement led by $APHQF

$VSQTF & Blockchain Investors Consortium Up-and-Comer $2M Investment Prize Pool

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$MNTA Positive Top-Line Phase 1 Data Showing Proof of Mechanism for M281

$VUZI Blade™ Augmented Reality Smart Glasses to be Officially Unveiled at CES 2018

$SKY and Champion Home Builders Announce Agreement on Business Combination

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$TIG Takeda Announces Intention to Acquire

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$CCXI Conditional Marketing Authorization Application Accepted

$HTGM Preliminary Fourth Quarter and Full Year 2017 Unaudited Financial Results

$CNET Announces Strategic Partnership With Jingtum Technology, Up 698 Percent

$DFFN to Present at the 10th Annual Biotech Showcase™ Conference

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$APHB Positive Interim Results for AB-SA01 and AB-PA01 in Antibiotic-resistant Infections

SAN DIEGO

$NETE Receives $2.7 Million from Sale of Common Shares

$CIIX Releases Exclusive Audio Interview

$TRVN FDA Acceptance for Review of NDA for OLINVO™ in Severe Acute Pain

$BURG to Deploy Mobivity’s Blockchain Technology to Power Cryptocurrency Rewards Program

$IGC Reports Promising Spatial Memory Results in Alzheimer’s Study

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