Archive for December, 2016

$CPSH, #HortonCapitalPartners Delivers Proactivity Letter

– Outlines Six Point Plan for Significant Value Creation at CPS Technologies – Urges Board to Be More Proactive and Transparent and Better Stewards of Capital – Sees Path to Share Price Appreciation of 150% within Next 12 Months

PHILADELPHIA, Dec. 22, 2016  — Horton Capital Partners Fund, LP (“Horton”), one of the largest outside shareholders of CPS Technologies Corp. (“CPS” or the “Company”) (NASDAQ: CPSH) with ownership of approximately 4% of the common stock of CPS, today announced that it has a delivered a letter (the “Letter”) to the Company’s Board of Directors (the “Board”).

In the Letter, Horton urges the Board to be more proactive by making calculated investments in sales growth and cost reduction initiatives.  Horton also requests that CPS be more transparent by publishing performance goals and holding themselves accountable for achieving them.  Furthermore, Horton implores the Board to be better stewards of capital by evaluating all options for value creation, including M&A (buy or sell) and return of excess capital to shareholders.  Finally, Horton requests that the Company strengthen its Board by adding representatives that can fill experience gaps and proactively manage implementation of value creation measures.

The Letter details an action plan that CPS should follow. Horton believes that if these measures are adopted the price of CPS shares could increase 150% during the next twelve months.

The full text of the Letter is available for viewing at the following link: http://thehortonfund.com/wp-content/uploads/2016/12/cpsbodletter121616Final.pdf

About Horton Capital Partners Fund, LP
Horton Capital Partners Fund, LP is an investment firm making concentrated investments in undervalued and under-appreciated small and micro-capitalization public companies. The Fund seeks to identify value creation opportunities and work with management teams and Boards to enhance growth and shareholder returns.

Investor contact:
Joe Manko (215) 399-5402
www.thehortonfund.com

Media contact:
Damien Park (215) 325-0514
www.hedgerelations.com

Thursday, December 22nd, 2016 Uncategorized Comments Off on $CPSH, #HortonCapitalPartners Delivers Proactivity Letter

$TKAI and #OticPharma Enter into #SPA Share Purchase Agreement

Transaction to create NASDAQ-listed pharmaceutical company focused on the development and commercialization of ear, nose, and throat (ENT) products

Gregory J. Flesher to be Named President and Chief Executive Officer of the Combined Company

Tokai Pharmaceuticals Inc. (NASDAQ:TKAI) and Otic Pharma Ltd., a privately-held, clinical-stage pharmaceutical company focusing on the development and commercialization of products for disorders of the ear, nose, and throat (ENT), today announced that the two companies, together with the shareholders of Otic Pharma, have entered into a definitive share purchase agreement under which the shareholders of Otic Pharma will become the majority owners of Tokai.

The transaction will result in a NASDAQ-listed company focused on the development and commercialization of products for ENT disorders, including Otic Pharma’s lead candidate which is a nasally-administered, combination drug product (OP-02) intended to address the underlying cause of otitis media and Eustachian tube dysfunction (OM/ETD), a condition that affects more than 700 million people around the world every year. The company will operate under the name OticPharma, Inc., and will be led by Gregory J. Flesher, current Chief Executive Office of Otic Pharma Ltd. Current President and Chief Executive Officer of Tokai, Jodie Morrison, will remain as a member of the board of directors.

“Over the last several months, Tokai has conducted an extensive review of strategic alternatives aimed at maximizing value for our shareholders over the long-term,” said Jodie Morrison, President and CEO of Tokai Pharmaceuticals. “We believe the proposed transaction with Otic Pharma, a company that has both a promising pipeline and an experienced leadership team with a track record of creating significant shareholder value in public pharmaceutical companies, advances this goal.”

“Our lead program in otitis media, OP-02, has significant potential,” said Gregory J. Flesher, Chief Executive Officer of Otic Pharma. “OP-02 is an investigational drug product designed to break the cycle of recurrent and chronic otitis media which affect millions of people around the world. We expect to have phase 1 clinical pharmacodynamic data in the first half of 2017 and, with this transaction, to have the capital needed to be able to move directly into phase 2 development to explore the product’s ability to prevent otitis media in children.”

Share Purchase Agreement Details

Under the terms of the agreement, the shareholders of Otic Pharma will receive a total of 32,172,209 shares of newly issued Tokai common stock, while outstanding Otic Pharma options and convertible securities will be assumed by Tokai. Upon the exchange, it is expected that existing Tokai stockholders will own approximately 40% of the combined company, with existing Otic Pharma shareholders owning approximately 60%. The transaction has been unanimously approved by the boards of directors of both companies and shareholders of Otic Pharma. Tokai’s largest stockholder, Apple Tree Partners, who holds approximately 35% of Tokai’s common stock has entered into an agreement in support of the proposed transaction. The transaction is expected to close during the first quarter of 2017, subject to customary closing conditions, including approval by shareholders of Tokai.

Wedbush PacGrow advised Tokai Pharmaceuticals and Piper Jaffray & Co. advised Otic Pharma in the proposed transaction. Wilmer Cutler Pickering Hale and Dorr LLP and Gross, Kleinhendler, Hodak, Halevy, Greenberg & Co. served as legal counsel to Tokai and Gibson, Dunn & Crutcher LLP and Yigal Arnon & Co. served as legal counsel to Otic Pharma.

Management and Organization

Upon the close of the proposed transaction, the board of directors of the combined company will consist of seven members, three to be designated by Tokai and four to be designated by Otic Pharma. Officers of the new company will be Gregory J. Flesher, President and Chief Executive Officer; Christine G. Ocampo, Chief Financial and Compliance Officer; and Dr. Catherine C. Turkel, Chief Development Officer.

Additional Funding

An Otic Pharma investor syndicate, including current shareholders and members of the management team, has committed to invest $7 million of additional capital in connection with the share purchase agreement.

Conference Call Information

Tokai and Otic Pharma will host a conference call in early January to discuss the proposed transaction. Call in information will be provided in a future press release.

About Otic Pharma

Otic Pharma is a clinical-stage pharmaceutical company focusing on the development and commercialization of products for disorders of the ear, nose, and throat (ENT). The company has two platform technologies, each of which has the potential to be developed for multiple ENT indications. The company is currently developing a nasally-administered, combination drug product (OP-02) intended to address the underlying cause of otitis media and Eustachian tube dysfunction (OM/ETD), a condition that affects more than 700 million people around the world every year. Otitis media is one of the most common disease seen in pediatric practice and the most frequent reason children consume antibiotics or undergo surgery. The company also has a foam-based drug delivery technology platform (OP-01) that can be used to deliver drugs into the ear, nose, and sinus cavities. The company is currently developing OP-01 as an improved treatment option for acute otitis externa (“swimmers ear”). For more information on the company, please visit www.oticpharma.com.

About Tokai Pharmaceuticals

Tokai Pharmaceuticals is a biopharmaceutical company previously focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases. The ARMOR2 and ARMOR3-SV clinical trials of Tokai’s drug candidate, galeterone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) have been closed, with only patients in ARMOR2 long-term extension continuing treatment at this time. Plans remain in effect to present data from the ARMOR3-SV trial in a scientific forum once fully available and analyzed. Assessment of plans for galeterone, the ARDA platform and Tokai’s AR-V7 assay work are underway at this time.

Safe Harbor

Additional Information about the Proposed Transaction and Where to Find It

In connection with the proposed transaction, Tokai intends to file with the Securities and Exchange Commission (the “SEC”) a proxy statement in connection with the proposed transaction with Otic Pharma and furnish or file other materials with the SEC in connection with the proposed transaction. The definitive proxy statement will be sent or given to the stockholders of Tokai and will contain important information about the proposed transaction and related matters. BEFORE MAKING ANY VOTING DECISION, TOKAI’S STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT AND THOSE OTHER MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. The proxy statement and other relevant materials (when they become available), and any other documents filed by Tokai with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, security holders will be able to obtain free copies of the proxy statement upon request directed to the Corporate Secretary at 255 State Street, Boston MA 02109, or by phone at 617-225-4305.

Participants in the Solicitation

Tokai, Otic Pharma and each of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Tokai in connection with the proposed transaction. Information regarding the interests of these directors and executive officers in the proposed transaction described herein will be included in the proxy statement described above. Additional information regarding the directors and executive officers of Tokai is included in proxy statement for its 2016 Annual Meeting, which was filed with the SEC on April 29, 2016, and is supplemented by other public filings made, and to be made, with the SEC by Tokai.

Forward-looking Statements

Any statements in this press release that are not historical facts, including statements regarding the structure, timing and completion of the proposed transaction; Tokai’s continued listing on NASDAQ prior to and after the proposed transaction; expectations regarding the capitalization, cash balances and working capital, resources and ownership structure of the company after the transaction; expectations regarding the sufficiency of the company’s resources to fund the advancement of any development program or the completion of any clinical trial; the nature, strategy and focus of the company after the transaction; the safety, efficacy and projected development timeline and commercial potential of any product candidates; the expectations regarding voting by Tokai stockholders: and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “may,” 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: risks and uncertainties associated with stockholder approval of and the ability to consummate the proposed transaction; whether the anticipated cash resources will be sufficient to fund operations for the period anticipated and to conduct the anticipated studies; whether the necessary approvals to commence clinical trials of Otic’s product candidates can be obtained on a timely basis or at all; and whether the results of clinical trials will warrant submission for regulatory approval, any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if any of such product candidates obtains such approval, it will be successfully distributed and marketed. Risks and uncertainties facing Tokai are discussed in the “Risk Factors” section of its quarterly report on Form 10-Q for the three months ended September 30, 2016 Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the companies expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Tokai Investors:
Argot Partners
David Pitts or Maeve Conneighton, 212-600-1902
david@argotpartners.com
maeve@argotpartners.com
or
Otic Pharma Investors:
The Trout Group
Gita Ogawa, 646-378-2949
Gogawa@troutgroup.com

Thursday, December 22nd, 2016 Uncategorized Comments Off on $TKAI and #OticPharma Enter into #SPA Share Purchase Agreement

$DPRX and #PLxPharma Announce #Merger Agreement

Merger combines the full resources of both companies behind PLx Pharma’s Aspertec™ – an FDA-approved aspirin product with antiplatelet efficacy clinically demonstrated to provide improved reliability and predictability.

NEW YORK and HOUSTON, Dec. 22, 2016  — Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) and PLx Pharma Inc. (PLx Pharma), a privately held late-stage specialty pharmaceutical company, announced today that they have entered into a definitive agreement under which PLx Pharma will merge with a wholly-owned subsidiary of Dipexium in an all-stock transaction.  Following closing, Dipexium will be renamed PLx Pharma Inc., and will operate under the leadership of the PLx management team with Michael Valentino serving as Executive Chairman of the company’s Board of Directors and Natasha Giordano serving as President and Chief Executive Officer.

The combined company will initially be focused on completion of manufacturing scale-up and label finalization for the previously conditionally approved AspertecTM 325 mg aspirin dosage form thereby satisfying the open conditional items, and filing of a supplemental new drug application (sNDA) for Aspertec 81 mg maintenance dose form.  Aspertec is being developed to provide high-risk cardiovascular and neurology patients with more reliable and predictable antiplatelet efficacy as compared to enteric coated aspirin while also reducing the adverse gastric events common in an acute setting.

Natasha Giordano, President and Chief Executive Officer of PLx Pharma, said, “This merger will provide PLx Pharma with the initial resources necessary to advance our contemplated development efforts for Aspertec and begin the critical pre-commercialization activities necessary to prepare the market for this important cardiovascular product.”

PLx stockholders will receive newly issued shares of common stock of Dipexium in connection with the merger contemplated by the merger agreement.  Dipexium will issue approximately 36 million new shares of its common stock to PLx stockholders under the exchange ratio formula defined in the merger agreement.  Upon the closing of the merger, existing PLx stockholders are expected to own 76.75% of Dipexium common shares outstanding and existing Dipexium stockholders are expected to own 23.25% of Dipexium common shares outstanding.  The exchange ratio is defined in the merger agreement and is subject to potential adjustment.

“This transaction with PLx Pharma reflects the continued commitment of Dipexium’s Board of Directors and management team to deliver value to Dipexium stockholders,” said David Luci, President and Chief Executive Officer of Dipexium.  “The merger brings with it the PLx Pharma management team, comprised of highly accomplished and seasoned executives who have launched and successfully commercialized many market leading over-the-counter products, among them Mike Valentino as Executive Chairman of PLx Pharma, who previously launched multiple major Rx-to-OTC switches including Benadryl, Motrin Jr., Rogaine Extra Strength, Lamisil, Nasalcrom, Voltaren,  and most recently, as CEO of Adams Respiratory Therapeutics, Inc., Mucinex®.”

The boards of directors of both Dipexium and PLx Pharma have unanimously approved the proposed transaction, which is subject to customary closing conditions, including approval by the stockholders of each of Dipexium and PLx Pharma.  The merger is expected to close during the second quarter of 2017, subject to customary closing conditions.

Raymond James & Associates is acting as financial advisor to Dipexium and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as its legal counsel. Janney Montgomery Scott LLC is acting as financial advisor to PLx and Jackson Walker LLP is acting as its legal counsel.

About Dipexium

Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) is a late-stage pharmaceutical company focused on the development and commercialization of Locilex (pexiganan cream 0.8%), a novel, broad-spectrum, topical antibiotic peptide, which recently announced that Locilex failed to meet the primary and secondary endpoints in its OneStep-1 and OneStep-2 Phase 3 clinical trials.  For more information, please visit www.dipexiumpharmaceuticals.com.

About PLx

PLx Pharma Inc. is a late-stage specialty pharmaceutical company initially focused on developing its clinically validated and patent-protected PLxGuard™ delivery system to provide safer and more effective aspirin products. The PLxGuard™ delivery system works by targeting delivery of active pharmaceutical ingredients (API) to various portions of the GI tract.  PLx believes this has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce acute gastrointestinal (GI) side effects—including erosions, ulcers and bleeding—associated with aspirin and ibuprofen, and potentially other drugs. To learn more about PLx and its pipeline, please visit www.plxpharma.com.

Additional Information Will Be Filed with the SEC

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities of Dipexium or PLx or the solicitation of any vote or approval. In connection with the proposed transaction, Dipexium will file with the SEC a Registration Statement on Form S-4 containing a joint proxy statement/prospectus. The joint proxy statement/prospectus will contain important information about Dipexium, PLx, the transaction and related matters. Dipexium and PLx will mail or otherwise deliver the joint proxy statement/prospectus to their respective stockholders when it becomes available. Investors and security holders of Dipexium and PLx are urged to read carefully the joint proxy statement/prospectus relating to the merger (including any amendments or supplements thereto) in its entirety when it is available, because it will contain important information about the proposed transaction.

Investors and security holders of Dipexium will be able to obtain free copies of the joint proxy statement/prospectus for the proposed merger (when it is available) and other documents filed with the SEC by Dipexium through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders of Dipexium will be able to obtain free copies of the joint proxy statement/prospectus for the proposed merger (when it is available) by contacting Dipexium Attn: David Luci, davidluci@dipexium.com. Investors and security holders of PLx will be able to obtain free copies of the joint proxy statement/prospectus for the merger by contacting PLx, Attn: Natasha Giordano, ngiordano@plxpharma.com.

Dipexium and PLx, and their respective directors and certain of their executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the agreement between Dipexium and PLx. Information regarding Dipexium’s directors and executive officers is contained in Dipexium’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, which was filed with the SEC on March 22, 2016, and will also be available in the joint proxy statement/prospectus that will be filed by Dipexium with the SEC in connection with the proposed transaction. Information regarding PLx’s directors and officers and a more complete description of the interests of PLx’s directors and officers in the proposed transaction will be available in the joint proxy statement/prospectus that will be filed by Dipexium with the SEC in connection with the proposed transaction.

Forward-Looking Statements

Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the potential closing date of the transaction, the amount of Dipexium’s net cash at closing, the prospects for commercializing or selling any products or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Dipexium, PLx or the management of either company, before or after the aforementioned merger, may identify forward-looking statements. Dipexium and PLx caution that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Dipexium or PLx to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of Dipexium’s or PLx’s proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that Dipexium or PLx may lack the financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect Dipexium’s business, financial conditions and results of operations are contained in Dipexium’s filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. The forward-looking statements represent Dipexium’s and PLx’s estimate as of the date hereof only, and Dipexium and PLx specifically disclaim any duty or obligation to update forward-looking statements.

Other risks and uncertainties are more fully described in Dipexium’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC, and in other filings that Dipexium makes and will make with the SEC in connection with the proposed transactions, including the proxy statement described above under “Additional Information will be Filed with the SEC.” Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made herein speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date after the date stated herein.

Investor Contact:

Dipexium Pharmaceuticals, Inc.
David Luci, President and CEO, 212-269-2834
davidluci@dipexium.com

Thursday, December 22nd, 2016 Uncategorized Comments Off on $DPRX and #PLxPharma Announce #Merger Agreement

$MNTX Announces Business Update

Backlog, Book to Bill, Order Rate Rising at Manitex Straight-Mast Cranes

BRIDGEVIEW, IL–(Dec 21, 2016) – Manitex International, Inc. (NASDAQ: MNTX), a leading international provider of cranes and container handling equipment, today provided an update regarding trends in business activity in the second half of 2016 that suggest an improved outlook for 2017.

As previously reported quote volume had improved during the third quarter 2016 and that the 8-week rolling quote activity was approximately 70% ahead from the same period in 2015. As we approach year end, we now note that the backlog for straight mast cranes in the fourth quarter to date has doubled since the third quarter and management anticipates ending the fourth quarter with a book to bill ratio for straight mast cranes exceeding 1.0.

VP of Sales, Steve Keifer commented, “As was noted in our third quarter earnings call, we have seen improvements in certain of our markets that have resulted in higher quoting activity and increased bookings for our boom trucks in the second half of this year at Manitex. We are particularly encouraged to see growth in orders from dealers who are replenishing decreased inventory levels as they respond to improving market activity.”

David J. Langevin, Chairman and CEO, commented, “The downturn we’ve weathered has given us an opportunity to focus on optimizing our business portfolio and make us a stronger competitor, with opportunities to expand our margins, improve our balance sheet, and accelerate our path to sustainable shareholder value creation. We are cautiously optimistic about the trend of increased opportunities in the marketplace that have the potential to drive improved financial results as we head into 2017.”

About Manitex International, Inc.

Manitex International, Inc. is a leading worldwide provider of highly engineered specialized equipment including boom trucks, cranes, container handling equipment and reach stackers, and other related equipment. Our products, which are manufactured in facilities located in the USA and Italy, are targeted to selected niche markets where their unique designs and engineering excellence fill the needs of our customers and provide a competitive advantage. We have consistently added to our portfolio of branded products and equipment both through internal development and focused acquisitions to diversify and expand our sales and profit base while remaining committed to our niche market strategy. Our brands include Manitex, CVS Ferrari, PM, Badger, Sabre, and Valla. ASV, our Joint Venture with Terex Corporation, manufactures and sells a line of high quality compact track and skid steer loaders.

Forward-Looking Statements

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains statements that are forward-looking in nature which express the beliefs and expectations of management including statements regarding the Company’s expected results of operations or liquidity; statements concerning projections, predictions, expectations, estimates or forecasts as to our business, financial and operational results and future economic performance; and statements of management’s goals and objectives and other similar expressions concerning matters that are not historical facts. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “we believe,” “we intend,” “may,” “will,” “should,” “could,” and similar expressions. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks, uncertainties and other factors that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These factors and additional information are discussed in the Company’s filings with the Securities and Exchange Commission and statements in this release should be evaluated in light of these important factors. Although we believe that these statements are based upon reasonable assumptions, we cannot guarantee future results. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Contact:

Manitex International, Inc.
David Langevin
Chairman and Chief Executive Officer
(708) 237-2060
Email Contact

Darrow Associates, Inc.
Peter Seltzberg
Managing Director
Investor Relations
(516) 419-9915
Email Contact

Wednesday, December 21st, 2016 Uncategorized Comments Off on $MNTX Announces Business Update

$IMMY & #FocusScript Exclusively Offer the #CorrectCompound™ Program

The Correct Compound™ program combines the cost savings of the Imprimis Cares® portfolio of compounded medications with FocusScript’s accredited and credentialed network, proprietary Compound Drug Formulation Logic program (CDF-Logic™) and world-class suite of prescription drug processing tools

SAN DIEGO and CREVE COEUR, Mo., Dec. 21, 2016  — Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) and Focus Script, LLC, a leading independent specialized pharmacy claims management company, today announced the joint launch of the Correct Compound™ program. The Correct Compound program is a specialized compound pharmacy care solution that provides a customizable formulary through the CDF-Logic™ program with low-cost alternative compounded medications through Imprimis Cares®, directed by the oversight of a comprehensive high-performance billing and claims management platform.  By combining FocusScript’s CDF-Logic program with the innovative Imprimis Cares portfolio of low-cost alternative formulations, pharmacy benefit managers (PBMs) and payors can confidently provide access to high-quality specialized compounds while focusing on new opportunities to reduce overall prescription drug costs.

Through the Correct Compound program:

  1. Imprimis and FocusScript will jointly offer FocusScript’s proprietary CDF-Logic program of a customizable compound formulary and the Imprimis Cares portfolio of low-cost alternative compounded formulations to PBMs, managed care organizations and other healthcare payors.
  2. FocusScript will manage and process Correct Compound claims across FocusScript’s preferred network of over 200 compounding pharmacies which are accredited and credentialed through the UCAP program, administered in an exclusive partnership with the National Association of Boards of Pharmacy (NABP).
  3. FocusScript will provide its custom, proprietary system for pre-processing claims for optimal pricing, broad analytics and real-time oversight of fraud, waste and abuse.

Mark L. Baum, CEO of Imprimis, stated, “We are excited about today’s launch of the Correct Compound program with FocusScript, the nation’s largest compounding claims management company.  Their team of seasoned professionals has extensive managed care and clinical experience, and has established deep relationships with leading PBMs and managed care organizations throughout the U.S.  The Correct Compound program, which will be available through a network of FocusScript accredited pharmacies, was designed to assist small and large payors in driving down drug costs while providing patients with high-quality, innovative prescription drug solutions.  This partnership allows Imprimis to leverage the value we have built in our Imprimis Cares brand and maintain our focus and resources on our rapidly-growing ophthalmology business.  We believe FocusScript’s pharmacy network, relationships with payors and comprehensive prescription drug adjudication tools should help us increase our reach and lower costs that are typically associated with the billing and adjudication process of prescription medications.”

Cynthia A. Meiners, President and CEO of FocusScript, stated, “Rising prescription drug costs continue to be a major concern for payors, and we are pleased to work with Imprimis to introduce the Correct Compound program designed to meet the evolving needs of the managed care industry to continue to provide patients and physicians options in the face of rising costs.  Mark and his team have been leading the charge to help combat exorbitant drug prices by quickly bringing to market a portfolio of innovative and affordable compounded medications.  By focusing on providing solutions in complex areas where there are disproportionate impacts, we share in the common goal to lower drug costs and make affordable and accessible high quality specialized medications.”

About FocusScript

Founded in 2014, FocusScript is dedicated to aligning the right people, shared values and technology needed to organize and oversee the delivery of quality standards, rational pricing and reasonable business practices to small but significant pharmacy markets such as compounding. The company provides access to a network of more than 200 pharmacies that provide specialized and compounded medications, and has steadily added payor clients since its launch.  Through an exclusive partnership with the National Association of Boards of Pharmacy (“NABP”), FocusScript’s network of compounding pharmacies are assessed through the United Credentialing and Accreditation Program (“UCAP”).  Using NABP’s Verified Pharmacy Program (“VPP”) as its foundation, the UCAP program includes a rigorous review of business and quality practices, attestation to a code of conduct, and compounding specific requirements.  For more information, visit www.focusscript.com.

About Imprimis Pharmaceuticals

Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is a pharmaceutical company dedicated to producing and dispensing high quality innovative compounded medications in all 50 states.  The company’s unique business model increases patient access and affordability to many critical medicines.  Headquartered in San Diego, California, Imprimis owns and operates three production and dispensing facilities located in California, New Jersey and Pennsylvania. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Other than drugs compounded at a registered outsourcing facility, all Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws.

FocusScript Media Contact
Kate Traynor
Sloane & Company
ktraynor@sloanepr.com
212.446.1871

Imprimis Media Contact
Paul Rabin
paul@pascalecommunications.com
516.503.0271

Imprimis Investor Contact
Bonnie Ortega
bortega@imprimispharma.com
858.704.4587

Wednesday, December 21st, 2016 Uncategorized Comments Off on $IMMY & #FocusScript Exclusively Offer the #CorrectCompound™ Program

$PBMD Data From #IMP321 #AIPAC #ClinicalTrial in #Breastcancer

SYDNEY, AUSTRALIA–(Dec 21, 2016) – Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (“Prima” or the “Company”) today announced interim data from the AIPAC Phase IIb clinical trial for IMP321 in metastatic breast cancer (Active Immunotherapy PAClitaxel). The initial data confirms previous trial results showing IMP321 is safe and well tolerated.

In this Phase IIb study of IMP321 plus paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer, data from all 15 patients in the safety run-in phase demonstrated that IMP321 is safe and well tolerated at both the 6mg and 30mg dosage levels. Immune monitoring data has also confirmed that IMP321, as an Antigen Presenting Cell (APC) activator, is working to generate the desired immune responses. The data demonstrated activation and an increased level of blood monocytes, dendritic cells and CD8 T-cells.

Prima’s Chief Medical Officer, Dr Frédéric Triebel, said: “Following the initial data released in June, we are now very pleased to confirm the safety, pharmacokinetics and pharmacodynamics of IMP321 across the initial patient cohorts at both dosage levels. This is another important step in de-risking our AIPAC trial as we look to commence the enlarged randomised and double-blind phase in the new year. We also look forward to providing further insights into efficacy of these safety run in patients by the middle of 2017.”

Subject to the confirmation of the dose escalation committee on the 30th December, Prima will now commence the randomised phase of the trial in January 2017. Patients will receive paclitaxel treatment plus placebo or paclitaxel in conjunction with IMP321.

About IMP321

IMP321 is a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint LAG-3. IMP321 represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response.

IMP321 has been shown in an open-label Phase I study1, to be able to double the expected six-month response rate in HER-2 negative metastatic breast cancer patients receiving standard-of-care paclitaxel; from a 25% historic response rate2, to 50% when combined with IMP321.

1 See Brignone et.al., J. Transl. Med. 2010, 8:71.
2 Miller et. al., N. Engl. J. Med. 2007, 357: 2666-76.

About Prima BioMed

Prima BioMed is a globally active biotechnology company that is striving to become a leader in the development of immunotherapeutic products for the treatment of cancer. Prima BioMed is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders.

Prima’s current lead product is IMP321, based on the LAG-3 immune control mechanism which plays a vital role in the regulation of the T cell immune response. IMP321, which is a soluble LAG-3Ig fusion protein, is an APC activator boosting T cell responses. IMP321 is currently in a Phase II clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC (clinicaltrials.gov identifier NCT 02614833) and in a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT 02676869). A number of additional LAG-3 products including antibodies for immune response modulation in autoimmunity and cancer are being developed by large pharmaceutical partners.

Prima BioMed is listed on the Australian Securities Exchange and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au.

For further information please contact:

U.S. Investors:
Matthew Beck
The Trout Group LLC
+1 (646) 378-2933
mbeck@troutgroup.com

Australian Investors/Media:
Mr Matthew Gregorowski
Citadel-MAGNUS
+61 2 8234 0105
mgregorowski@citadelmagnus.com

Wednesday, December 21st, 2016 Uncategorized Comments Off on $PBMD Data From #IMP321 #AIPAC #ClinicalTrial in #Breastcancer

$MRUS & $INCY Global #Strategic #Research Collab. #Bispecific #Antibodies

  • Collaboration designed to leverage Merus’ Biclonics® bispecific antibody technology to expand Incyte’s discovery capabilities and large-molecule portfolio
  • Incyte to make up-front payment of $120 million and purchase $80 million of Merus common shares; Merus eligible to receive potential development, regulatory and commercial milestones and sales royalties
  • Merus conference call scheduled today at 8:30 a.m. ET, 2:30 p.m. CET

Incyte Corporation (NASDAQ:INCY) and Merus N.V. (NASDAQ:MRUS) announced today that they have entered into a global, strategic collaboration agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform. The Collaboration and License Agreement grants Incyte the exclusive rights for up to eleven bispecific antibody research programs, including two of Merus’ current preclinical immuno-oncology discovery programs.

Biclonics® retain the IgG format of antibodies that are produced naturally by the immune system and, by binding to two targets, enable multiple modes of action that cannot otherwise be obtained with conventional monoclonal antibodies.

“By virtue of a unique ability to simultaneously engage multiple protein targets, we believe bispecific antibodies have the potential to play an important role in the future of biotherapeutics,” said Reid Huber, Ph.D., Incyte’s Chief Scientific Officer. “This collaboration with Merus expands our large molecule discovery capabilities into an innovation-rich area of research, creating additional opportunities for us to deliver on our commitment to improving and extending the lives of patients with cancer and other serious diseases.”

“This transformative, global collaboration further underscores the potential of Merus’ Biclonics® technology platform and establishes a strong relationship with Incyte, a leader in innovative drug development,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “We look forward to expanding our pipeline under this agreement, as we efficiently exploit our preclinical discovery engine and progress our most advanced, proprietary assets in the clinic.”

Terms of the Collaboration

Under the terms of the collaboration, Incyte has agreed to pay Merus an upfront payment of $120 million. In addition, Incyte has agreed to purchase 3.2 million shares of Merus stock at $25 per share, for a total equity investment of $80 million.

The parties have agreed to collaborate on the development and commercialization of up to 11 bispecific antibody programs. For one current preclinical program, Merus will retain all rights to develop and commercialize approved products in the United States, and Incyte will develop and commercialize approved products arising from the program outside the United States. Following any regulatory approval of a product candidate for this particular pre-clinical program, each company has agreed to pay the other tiered royalties ranging from 6 to 10 percent on net sales of products in their respective territories.

Merus also has the option to co-fund development of product candidates arising from two other programs. For any program for which Merus exercises its co-development option, Merus would be responsible for 35 percent of global development costs in exchange for a 50 percent share of U.S. profits and losses and tiered royalties ranging from 6 to 10 percent on ex-U.S. sales by Incyte for these programs. Merus also has the right to elect to provide up to 50 percent of detailing activities for product candidates arising from one of these programs in the United States.

For each of the other eight programs, Incyte has agreed to independently fund all development and commercialization activities. For these programs, Merus will be eligible to receive potential development, regulatory and sales milestone payments of up to $350 million per program, which could result in an aggregate milestone opportunity of approximately $2.8 billion if all development, regulatory and sales milestones are achieved across all such eight other programs in all territories. Merus will also be eligible to receive tiered royalties ranging from 6 to 10 percent on global sales of any approved products under these eight programs.

Merus will retain rights to both of its clinical candidates and MCLA-158, as well as its technology platform and future programs emerging from Merus’ platform that are outside the scope of this agreement.

The transaction is expected to close in the first quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott Rodino Act and customary closing conditions.

Conference Call and Webcast Information

Merus will host a conference call today to discuss this strategic research collaboration at 8:30 a.m. ET, 2:30 p.m. CET. Participants may access the call by dialing 866-978-9968 in the U.S. or 646-722-4972 outside the U.S. and referencing conference ID number 72944512#. The conference call will also be available by webcast on the Investor Relations page of Merus’ website, www.merus.nl. An audio replay of the call will be available from 11:30 a.m. ET on December 20, 2016 until 11:30 a.m. ET on January 3, 2017. To access the replay from both within and outside the U.S., dial 866-535-8030. The participant passcode is 680343#.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

About Merus N.V.

Merus is a clinical-stage immuno-oncology company developing innovative human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have several of the same features of conventional monoclonal antibodies, such as long half-life and low immunogenicity.

For more information, please visit the Company’s website at www.merus.nl.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether and when the planned collaboration with Merus and the purchase of common shares of Merus by Incyte will close; whether and when this planned collaboration will effectively expand Incyte’s discovery capabilities and large-molecule portfolio; whether any of the programs under the collaboration will be successful or will produce any products that will be approved for use in humans anywhere or will be commercialized anywhere successfully or at all; and whether and when any of the milestone payments or royalties under this collaboration will ever be paid by Incyte. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: obtaining approval for this planned collaboration; research and development efforts related to the collaboration programs; the possibility that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; other market or economic factors; unanticipated delays; our ability to compete against parties with greater financial or other resources; greater than expected expenses; and such other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including our Form 10-Q for the quarter ended September 30, 2016. Incyte disclaims any intent or obligation to update these forward-looking statements.

Merus Forward-Looking Statements

Except for the historical information set forth herein, this press release contains predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether and when the planned collaboration with Incyte and Incyte’s purchase of Merus common shares will close; Merus’ expectations regarding the expansion of Merus’ pipeline as a result of the collaboration, efficiently exploiting its preclinical discovery engine, and advancing later-stage assets in the clinic; the potential of bispecific antibodies for biotherapeutics; the value of the collaboration for Merus’ Biclonics® technology platform; whether any of the programs under the collaboration will be successful; and whether and when Merus will receive any of the expected or potential payments under this collaboration and the amounts of such payments to Merus. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from our expectations, including unanticipated developments in and risks related to: obtaining HSR approval for this planned collaboration; research and development efforts related to the collaboration programs; the clinical development process, which is expensive and unpredictable; the possibility that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; other market or economic factors; unanticipated delays; our ability to compete against parties with greater financial or other resources; our ability to commercialize and market our products, if approved; greater than expected expenses; and the other important factors detailed in our final prospectus filed with the Securities and Exchange Commission, or SEC, on May 20, 2016 relating to our Registration Statement on Form F-1, and our other reports filed with the SEC. Merus disclaims any intent or obligation to update these forward-looking statements. These forward-looking statements should not be relied upon as representing Merus’ views as of any date subsequent to the date of this press release.

 

Incyte
Media
Catalina Loveman, +1-302-498-6171
cloveman@incyte.com
or
Investors
Michael Booth, DPhil, +1-302-498-5914
mbooth@incyte.com
or
Merus
Media
Eliza Schleifstein, +1-973-361-1546
eliza@argotpartners.com
or
Investors
Kimberly Minarovich, +1-646-368-8014
kimberly@argotpartners.com

Wednesday, December 21st, 2016 Uncategorized Comments Off on $MRUS & $INCY Global #Strategic #Research Collab. #Bispecific #Antibodies

$NETE Announces #Strategic #Partnership with #E2Exchange

Partnership geared to strengthen E2E member offerings and give fast-growing companies access to global payment services

MIAMI, FL–(Dec 21, 2016) – Net Element, Inc. (NASDAQ: NETE) (“Net Element”), a provider of global mobile payment technology solutions and value-added transactional services, today announces its strategic partnership with E2Exchange Ltd (“E2Exchange” or “E2E”), a scale-up-focused organization that supports entrepreneurs and facilitates entrepreneur-to-entrepreneur information exchange, equity-funding transactions, and recruitment.

As part of this strategic partnership, members of E2Exchange will benefit from access to Net Element’s global multi-channel payment services offering. It is contemplated that the Company will contribute content for the benefit of E2E members as well as participate in relevant events. Additionally, Net Element CEO Oleg Firer has joined E2E’s advisory board.

Entrepreneurs who operate companies, regardless of size, use E2E to make connections, find investment and deal opportunities, source non-executive directors, and exchange cutting-edge ideas. E2E is also involved with education and high-level lobbying to further the interests of entrepreneurial business. In furthering these goals, Sir Richard Branson, honorary president of E2E, presides over the board of directors comprising some of the UK’s highest profile business leaders.

Shalini Khemka, founder and chief executive officer of E2E, says, “We are very excited to have entered into this strategic partnership with Net Element. Our fast-growing community of members can now access Net Element’s extensive range of payment acceptance services and its experience in streamlining payment processes for fast growing companies. This will be tremendously beneficial for our members in addressing global payments as they seek to expand and enhance their businesses.”

With significant success growing its own international presence, Net Element will lend its experience and expertise to assist E2E members as they work to achieve their specific growth strategies.

“We are honored to partner with the growing E2E network,” commented Oleg Firer, CEO of Net Element. “We look forward to helping E2E members address their global commerce needs, and I am excited to join the E2E advisory board and help companies evaluate their payment needs as they grow internationally.”

About E2Exchange
E2Exchange Ltd (“E2Exchange” or “E2E”) is an established network of highly successful entrepreneurs: creating an exchange between entrepreneurs, investors, experienced non-executive directors, business leaders, government influencers and professional service providers. E2E guides entrepreneurs through the vital decisions to overcome barriers to growth by creating connectivity, raising investment, recruiting non-execs and providing exceptional services. Founded in 2011, E2E is a dynamic community of over 12,000 entrepreneurs, investors, non-execs and partners. E2E is a hub for the progress of the UK’s entrepreneurial community — businesses at the scale-up stage — helping to accelerate growth for the benefit of their businesses as well as the UK economy. E2E has a board of world-class entrepreneurs providing sage advice, with the battle scars to prove it. E2E also wants to develop the next generation of entrepreneurs by inspiring early. Further information is available at www.e2exchange.com.

About Net Element
Net Element, Inc. (NASDAQ: NETE) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US it aims to grow transactional revenue by innovating SME productivity services such as its cloud based, restaurant point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Further information is available at www.netelement.com.

Forward-Looking Statements
Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to whether the relationship with E2Exchange will positively impact the Company. Additional examples of such risks and uncertainties are : (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.

Contacts:
Net Element, Inc.
media@netelement.com
+1 (786) 923-0502

E2Exchange
eloise.cazalet@newgatecomms.com
+44 20 7680 6562

Wednesday, December 21st, 2016 Uncategorized Comments Off on $NETE Announces #Strategic #Partnership with #E2Exchange

$KNDI Final Results of Government Subsidy Review

Jinhua, China–(December 20, 2016) – Kandi Technologies Group, Inc. (NASDAQ GS: KNDI) (the “Company” or “Kandi”) today announced that the final results of the review of subsidy payments for electric vehicles (“EV”s) manufactured by Kandi Electric Vehicles Group Co., Ltd. (the “JV Company,” a 50/50 joint venture between Kandi and Zhejiang Geely Holding Group) from 2013 to 2014 were released. The results came from the Ministry of Finance of China, the National Development and Reform Commission, the Ministry of Industry and Information Technology of China, and the Ministry of Science and Technology of China (collectively, the “Government”). According to the final results, the Government will re-calculate subsidy payments for EVs that were manufactured during the 2013-2014 period pursuant to the 2016 subsidy eligibility guidelines. This re-calculation is the result of certain complications in the JV Company’s advanced reusable battery exchange model that necessitated further clarification to the Government. As a result of dialogue with the Government, the JV Company has made modifications to its battery exchange model and has obtained Government approval in February of 2016. Based on subsidy guidelines, our EV models were eligible to receive Government subsidies of RMB 50,000.00 (approximately USD 7,195.00) in 2013, RMB 47,500.00 (approximately USD 6,835.00) in 2014, and RMB 45,000.00 (approximately USD 6,475.00) in 2016 on a per car basis. Applying the 2016 subsidy eligibility guidelines for those EVs it manufactured from 2013 to 2014, the JV Company estimates it will need to write off approximately USD 6.6 million of previously recorded account receivables. EVs that were manufactured in 2015 and 2016 remain eligible for the same amount of Government subsidies.

Mr. Hu Xiaoming, Chairman and Chief Executive Officer of Kandi, commented, “after discussion with governmental authorities, the confusion surrounding the EVs manufactured and sold by the JV Company during 2013 and 2014 that used the reusable battery exchange model were finally properly resolved. Although our partner received a slight penalty from the Government, the JV Company itself incurred roughly USD 6.6 million in lost subsidies which converts into USD 3.3 million losses to Kandi on the equity method of accounting basis. The Government subsidy review did not cause the major losses, but it has had a significantly negative effect on our business this year; however, now that it is over, it may have a strong positive impact on healthy growth of the renewable energy vehicle industry in the future. Going forward, we will be able to focus on our core business expansion and we believe Kandi’s future growth will increase shareholder value.”

Note: All the currency conversions from RMB to USD referred to in this press release is based on the exchange rate of 1RMB = 0.1439 USD, published by www.xe.com on the date before the release of this press release.

About Kandi Technologies Group, Inc.

Kandi Technologies Group, Inc. (KNDI), headquartered in Jinhua, Zhejiang Province, is engaged in the research and development, manufacturing and sales of various vehicle products. Kandi has established itself as one of China’s leading manufacturers of pure electric vehicle (“EV”) products (through its joint venture), EV parts and off-road vehicles. More information can be viewed at the Company’s corporate website at http://www.kandivehicle.com. The Company routinely posts important information on its website.

Safe Harbor Statement

This press release contains certain statements that may include “forward-looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including the risk factors discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on the SEC’s website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

Follow us on Twitter: @ Kandi_Group
Company Contact:

Ms. Kewa Luo
Kandi Technologies Group, Inc.
Phone: 1-212-551-3610
Email: IR@kandigroup.com

Tuesday, December 20th, 2016 Uncategorized Comments Off on $KNDI Final Results of Government Subsidy Review

$KLREU & Tema Oil and Gas to Combine to form #RosehillResources

Concurrent Private Placement will Position Rosehill Resources with Significant Growth Capital

HOUSTON, Dec. 20, 2016  — KLR Energy Acquisition Corp. (“KLR Energy”) (NASDAQ: KLRE, KLREU, KLREW), an oil and gas exploration and production focused special purpose acquisition entity, today announced that it has entered into a Business Combination Agreement with Tema Oil and Gas Company (“Tema”), a private company with assets in the core of the Delaware Basin in Loving County, Texas. The transaction was unanimously approved by the respective boards of directors of the companies and is expected to close in the first half of 2017, subject to certain closing conditions, including receipt of KLR Energy shareholder approval. Upon completion of the business combination, KLR Energy will change its name to Rosehill Resources Inc. (“Rosehill Resources”) and will apply to continue to trade on The NASDAQ Capital Market under the new ticker symbols ROSE, ROSEU, ROSEW. Rosehill Resources intends to significantly accelerate drilling on Tema’s high-quality operated acreage position and pursue strategic acquisitions.

In connection with the business combination, certain institutional investors will purchase $75 million of Rosehill Resources Series A Preferred Stock at $1,000 per share and warrants (the “Private Placements”).  In addition, Tema’s parent, Rosemore, Inc. (“Rosemore”) and KLR Energy’s sponsor have agreed to purchase up to $20 million of Series A Preferred Stock or Class A Common Stock in certain circumstances to backstop redemptions.  Together, the proceeds of the Private Placements and backstop by Rosemore and KLR Energy’s sponsor will be used to fund a portion of the cash consideration required to effect the business combination and for general corporate purposes. Following the closing of the transaction, Rosemore and its affiliates will collectively be the single largest stockholder of Rosehill Resources. KLR Energy is expected to retain a significant equity stake in Rosehill Resources and will have two representatives on Rosehill Resources’ Board of Directors.

“This transaction represents exactly the type of business combination target we were seeking to provide to our investors when we took KLR Energy public earlier this year. Upon completion of the business combination, Rosehill Resources will be a pure-play, Delaware Basin focused exploration and production company with a strong balance sheet and outstanding growth potential. The management team of Rosehill Resources has a robust track record of value creation, a long history of successful energy investing and demonstrated financial discipline,” said Gary Hanna, Chief Executive Officer of KLR Energy, who will serve as chairman of the board of directors of Rosehill Resources following the business combination.  Tema’s management team will run Rosehill Resources post-transaction, led by J. A. (Alan) Townsend, President of Tema, who will serve as Chief Executive Officer of Rosehill Resources. “Rosehill Resources will have an excellent existing production base, a strong balance sheet with significant liquidity and a deep bench of technical, land and operations expertise,” said Townsend. “Tema has approximately 200 potential drilling locations on its existing acreage. That is about nine years of inventory assuming a 2-rig drilling program and doesn’t include significant upside potential through a downspacing program. Following the business combination, we will immediately begin to accelerate development of the Tema assets while also pursuing focused acquisitions.”

The anticipated pro forma enterprise value of the combined company is approximately $445 million, implying a projected adjusted EBITDA multiple of 9.8x and 5.8x for calendar 2017 and 2018, respectively, and post-closing equity and preferred capitalization of $507 million at $10.40 per share (the foregoing assuming no stockholder redemptions). Rosehill Resources expects to have $117 million of projected liquidity to fund its development plan.

Rosehill Resources Operating Highlights

  • 4,771 net acres in the core of the Delaware Basin, greater than 80% held by production and 99% operated
  • Net production expected to be greater than 6,000 barrels of oil equivalent per day in January, 2017
  • 70.1 million net barrels of oil equivalent of total 3P reserves as of June 2016, based on Ryder Scott reserve report
  • Approximately 200 potential drilling locations on current leaseholds, includes stacked pay consisting of 10 benches totaling 3000 ft. of reservoir thickness
  • Expected 9 years of inventory (using a 2-rig program) with significant upside through downspacing program
  • Aligned veteran leadership, averaging 30+ years E&P operating experience, deep technical knowledge of the Delaware Basin and a 10+ year track record of drilling horizontal shale wells

Business Combination

Pursuant to the Business Combination Agreement, Tema will contribute oil and gas properties and related assets to Rosehill Operating and KLR Energy will acquire 39% of the equity on a fully diluted basis of Rosehill Operating for $35 million in cash, and the assumption of $55 million in debt and the contribution of remaining cash proceedsadditional cash resulting from KLR Energy’s initial public offering and the Private Placement.  Including which, including the $310 million in equity of Rosehill Operating retained by Tema, this assumes an enterprise value of Rosehill Operating of $400 million.

In order to facilitate the transaction, Rosemore and KLR Energy’s sponsor have agreed to backstop redemptions by the public stockholders of KLRE in excess of 30% of the outstanding shares of Class A Common Stock by purchasing Class A Common Stock or Series A Preferred Stock in an amount up to $20 million.

The closing of the transaction is subject to approval of KLR Energy stockholders and the satisfaction of customary conditions. The transaction is expected to close in the first half of 2017.

The description of the transaction contained herein is only a summary and is qualified in its entirety by reference to the combination, contribution and subscription agreements relating to the transaction.

Private Placement

In connection with the business combination, KLR Energy also announced that it has entered into Subscription Agreements with certain institutional investors to issue and sell in private placements a total of 75,000 shares of Series A Preferred Stock and 5,000,000 warrants (each entitling the holder to purchase one share of Class A Common Stock for $11.50) for gross proceeds of $75 million. The Series A Preferred Stock is entitled to 8.0% annual dividends, payable in cash or in-kind, and is convertible into shares of Rosehill Resources’ Class A Common Stock based on a conversion price of $11.50 per share.  The proceeds of the private placement will be used to fund the cash portion of the consideration required to effect the combination and for general corporate purposes, including to finance development and potential acquisition activities following completion of the business combination.  The private placement is conditioned upon, and is expected to close concurrently with, the business combination.

Advisors

BMO Capital Markets and KLR Group, LLC (“KLR Group”) acted as capital market advisors and private placement agents to KLR Energy. Vinson & Elkins LLP acted as legal counsel to KLR Energy and KLR Group. Petrie Partners, LLC acted as financial advisor and Norton Rose Fulbright US LLP acted as legal counsel to Rosemore and Tema.

Investor Webcast and Presentation Information

A webcast discussing the transaction can be accessed at http://www.netroadshow.com/nrs/wp/default.html?show=40Da26. Interested investors and other parties may also view the accompanying investor presentation filed today with the Securities and Exchange Commission (the “SEC”), which can be viewed on the SEC website at www.sec.gov or on KLR Energy’s website at www.KLRgroup.com.

About KLR Energy Acquisition Corp.

KLR Energy is a blank check company, also commonly referred to as a Special Purpose Acquisition Company, or SPAC, formed for the purpose of entering into a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses or entities. KLR Energy is sponsored by KLR Energy Sponsor, LLC, an affiliate of KLR Group Holdings, LLC and KLR Group.

About Tema Oil and Gas Company

Tema is a rapidly growing, privately held, exploration and production company with producing assets in Texas and New Mexico. Current investment activity is focused in the Permian Basin and other high-potential proven basins. Tema’s strategy for growth is building a portfolio of high-quality acreage in proven resource play basins to provide a foundation of predictable production growth. Through active acquisition, exploitation and exploration across portions of Texas and New Mexico, the staff at Tema has continued the growth and success of the company since its formation in 1999. Tema is a wholly owned subsidiary of Baltimore, MD-based Rosemore, Inc., founded by descendants of Louis Blaustein, the 1910 founder of the American Oil Company.

About KLR Group

KLR Group is a full-service boutique investment bank focused on the energy industry founded in 2012 and led by Edward Kovalik, Stephen Lee and Reid Rubinstein.  With offices in Houston and New York, KLR Group is committed to providing clients access to a broad range of financial services, advice and solutions typically available only to the largest public companies. These solutions include public and private, corporate and asset-level financings across the capital spectrum, advisory services, equity research, sales and trading, and merchant banking. To learn more about KLR Group, please visit www.KLRGroup.com.

Forward-Looking Statements

This communication includes certain statements that may constitute “forward-looking statements” for purposes of the federal securities laws. Forward-looking statements include, but are not limited to, statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: KLR Energy’s ability to consummate the business combination and related private placement; the benefits of the business combination; the future financial performance of KLR Energy following the business combination; changes in Tema’s reserves and future operating results; and expansion plans and opportunities. These forward-looking statements are based on information available as of the date of this communication, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing KLR Energy’s views as of any subsequent date, and KLR Energy does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.  You should not place undue reliance on these forward-looking statements. As a result of a number of known and unknown risks and uncertainties, KLR Energy’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include: (i) the occurrence of any event, change or other circumstances that could delay the business combination or give rise to the termination of the contribution agreement; (ii) the outcome of any legal proceedings that may be instituted against KLR Energy following announcement of the proposed business combination and transactions contemplated thereby; (iii) the inability to complete the business combination due to the failure to obtain approval of the stockholders of  KLR Energy, or other conditions to closing in the contribution agreement; (iv) the risk that the proposed business combination disrupts current plans and operations of KLR Energy or Tema as a result of the announcement and consummation of the transactions described herein; (v) KLR Energy’s ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition and the ability of KLR Energy to grow and manage growth profitably following the business combination; (vi) costs related to the business combination; (vii) changes in applicable laws or regulations; (viii) the possibility that KLR Energy or Tema may be adversely affected by other economic, business, and/or competitive factors , including, but not limited to, future trends in energy markets and commodity prices; and (ix) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by KLR Energy.

Additional information concerning these and other factors that may impact our expectations and projections can be found in our periodic filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, and in the proxy statement to be filed by KLR Energy with the SEC when available. Our SEC filings are available publicly on the SEC’s website at www.sec.gov. KLR Energy and Tema disclaim any obligation to update the forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Disclaimer

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

Additional Information about the Transaction and Where to Find It

In connection with the proposed business combination, KLR Energy will file a preliminary proxy statement with the SEC and will mail a definitive proxy statement and other relevant documents to its stockholders. Investors and security holders of KLR Energy are advised to read, when available, the preliminary proxy statement, and amendments thereto, and the definitive proxy statement in connection with KLR Energy’s solicitation of proxies for its stockholders’ meeting to be held to approve the business combination and related transactions because the proxy statement will contain important information about the transactions, the parties thereto and risk factors that may affect investors. The definitive proxy statement will be mailed to stockholders of KLR Energy as of a record date to be established for voting on the business combination. Stockholders will also be able to obtain copies of the proxy statement, without charge, once available, at the SEC’s website at www.sec.gov or by directing a request to: KLR Energy Acquisition Corp., 811 Main Street, 18th Floor, Houston, Texas 77002, Attn: Gary C. Hanna.

Participants in Solicitation

KLR Energy, Tema, and their respective directors, executive officers and other members of their management and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of KLR Energy stockholders in connection with the proposed business combination. Investors and security holders may obtain more detailed information regarding the names, affiliations and interests in KLR Energy of directors and officers of KLR Energy in KLR Energy’s Registration Statement on Form S-1, as amended, which was initially filed with the SEC on January 19, 2016. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to KLR Energy’s stockholders in connection with the proposed business combination will be set forth in the proxy statement for the proposed business combination when available. Information concerning the interests of KLR Energy’s and Tema’s participants in the solicitation, which may, in some cases, be different than those of KLR Energy’s and Tema’s stockholders generally, will be set forth in the proxy statement relating to the business combination when it becomes available.

Tuesday, December 20th, 2016 Uncategorized Comments Off on $KLREU & Tema Oil and Gas to Combine to form #RosehillResources

$ACAD Positive Top-Line Results #Pimavanserin in #ADPsychosis

Data Support Moving Forward With Further Development in Alzheimer’s Disease Psychosis

Conference Call and Webcast to Be Held Today, December 20, 2016, at 8:30 a.m. Eastern Time

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced positive top-line results from its Phase II exploratory study (-019 Study) of pimavanserin in patients with Alzheimer’s disease psychosis (AD Psychosis). As a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors, pimavanserin has a different biological mechanism than other marketed antipsychotics. Pimavanserin has been approved by the United States Food and Drug Administration (FDA) for hallucinations and delusions associated with Parkinson’s disease psychosis and currently is being studied in several other disease states, including AD Psychosis. The FDA has not approved any drug to treat AD Psychosis.

In this Phase II exploratory study, pimavanserin met the primary endpoint showing a statistically significant reduction in psychosis versus placebo as measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Psychosis score at week 6 of dosing (p=0.0451). Pimavanserin was generally well tolerated and the safety profile was consistent with what has been observed in previous studies.

“Alzheimer’s disease patients suffer from a number of debilitating symptoms, of which psychosis carries a poor prognosis and is associated with earlier placement into nursing homes,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “Data from the -019 Study provide solid evidence that pimavanserin can improve psychosis in another major neurological disorder and provide strategic momentum for the further development of pimavanserin to address the needs of AD Psychosis patients.”

About the Phase II -019 Study
The Phase II -019 Study was a double-blind, placebo-controlled exploratory trial designed to evaluate the efficacy and safety of pimavanserin as a treatment for patients with AD Psychosis. A total of 181 patients were enrolled in the study in the United Kingdom and randomized on a one-to-one basis to receive either 34 mg of pimavanserin or placebo once daily. The primary endpoint of the study was antipsychotic efficacy as measured by the mean change in the NPI-NH Psychosis score (combined hallucinations and delusions domains) from baseline to week 6 of dosing. Patients continued dosing through week 12 to gather information on secondary endpoints, including changes in cognition.

Pimavanserin demonstrated efficacy on the primary endpoint of the -019 Study with a 3.76 point improvement in psychosis at week 6 compared to a 1.93 point improvement for placebo, representing a statistically significant treatment improvement in the NPI-NH Psychosis score (p=0.0451). Baseline mean scores for the pimavanserin and placebo treated groups were 9.52 and 10.00, respectively.

Atypical antipsychotics have been associated with a statistically significant worsening of cognitive function in patients with Alzheimer’s disease. In the -019 Study, over the course of 12 weeks of treatment, pimavanserin did not impair cognition as measured by the Mini-Mental State Examination (MMSE) score and was similar to placebo. On the secondary endpoint of mean change in NPI-NH Psychosis score at week 12, pimavanserin maintained the improvement on psychosis observed at the week 6 primary endpoint, but did not statistically separate from placebo.

In the -019 Study, pimavanserin was generally well tolerated and the safety profile was consistent with what has been observed in previous studies. Based on a preliminary analysis of safety data, the most common adverse events reported were falls, urinary tract infection and agitation. The mortality rate was the same in the pimavanserin and placebo treatment groups. The mean age of patients in the study was 86 years.

The data analysis of the Phase II -019 Study is ongoing and ACADIA plans to present data from this study at a future medical conference.

Conference Call and Webcast Information
ACADIA will host a conference call and webcast today, December 20, 2016 at 8:30 a.m. Eastern Time to discuss top-line results from its Phase II trial with pimavanserin in patients with Alzheimer’s disease psychosis. The conference call can be accessed by dialing 844-821-1109 for participants in the U.S. and Canada and 830-865-2550 for international callers (reference passcode 43052480). The conference call will be webcast live on ACADIA’s website, www.acadia-pharm.com, under the investors section and will be archived there until January 3, 2017. A telephone replay also may be accessed through January 3, 2017 by dialing 855-859-2056 for participants in the U.S. and Canada and 404-537-3406 for international callers (reference passcode 43052480).

About Alzheimer’s Disease Psychosis (AD Psychosis)
According to the Alzheimer’s Association, around 5.4 million people in the United States are living with Alzheimer’s disease and approximately half are diagnosed with the disease. Studies suggest that 25 to 50 percent of patients diagnosed with Alzheimer’s disease may develop psychosis, commonly consisting of hallucinations and delusions. AD Psychosis is associated with more rapid cognitive and functional decline, greater caregiver burden, and earlier institutionalization. The FDA has not approved any drug to treat AD Psychosis.

About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist (SSIA) preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in AD Psychosis. Pimavanserin is being evaluated in an extensive clinical development program by ACADIA across multiple other indications including Alzheimer’s disease agitation, schizophrenia – inadequate response, schizophrenia – negative symptoms, and major depressive disorder. Pimavanserin (34 mg) was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the FDA in April 2016 under the trade name NUPLAZID®. NUPLAZID is not approved for patients with AD Psychosis.

About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA maintains a website at www.acadia-pharm.com to which we regularly post copies of our press releases as well as additional information and through which interested parties can subscribe to receive e-mail alerts.

Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to the progress and timing of ACADIA’s drug discovery and development programs; the benefits to be derived from NUPLAZID (pimavanserin) and ACADIA’s product candidates, including whether pimavanserin can improve psychosis in another major neurological disorder or be used to treat AD Psychosis; whether the data from the -019 Study support moving forward with further development in AD Psychosis or provide strategic momentum for the further development of pimavanserin to address the needs of AD Psychosis patients; and ACADIA’s plans to present data from the -019 Study. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery, development, approval and commercialization, and in collaborations with others, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA’s annual report on Form 10-K for the year ended December 31, 2015 as well as ACADIA’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

Important Safety Information and Indication for NUPLAZID (pimavanserin) tablets

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis.

NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.

Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).

Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.

Renal Impairment: No dosage adjustment for NUPLAZID is needed in patients with mild to moderate renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment.

Hepatic Impairment: Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population.

Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration: Recommended dose: 34 mg per day, taken orally as two 17-mg tablets once daily, without titration.

For additional Important Safety Information, including boxed warning, please see the full Prescribing Information for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.

 

Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, (858) 558-2871
ir@acadia-pharm.com
or
Media Contact:
Taft Communications
Jon Shure, (240) 426-4282
jon@taftcommunications.com

Tuesday, December 20th, 2016 Uncategorized Comments Off on $ACAD Positive Top-Line Results #Pimavanserin in #ADPsychosis

$AKBA #OtsukaPharmaceutical Announce #US #Collaboration Over #Vadadustat

– Funds Vadadustat Global Phase 3 PRO2TECT and INNO2VATE Studies –

– Committed Capital and Potential Milestone Payments Could Exceed $1 Billion –

– Akebia and Otsuka Share Revenue and Commercialization Costs Equally –

– Akebia to Host Conference Call at 8:30 a.m. Eastern Time Today –

Akebia Therapeutics, Inc. (NASDAQ: AKBA) and Otsuka Pharmaceutical Co., Ltd. today announced they have entered into a collaboration and license agreement in the U.S. for vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer currently in development for the treatment of anemia associated with chronic kidney disease (CKD). Anemia related to CKD affects an estimated 1.8 million patients in the U.S. and arises from the kidney’s failure to produce adequate amounts of erythropoietin, a key hormone stimulating the production of red blood cells.1 Left untreated, anemia significantly accelerates patients’ overall deterioration of health with increased morbidity and mortality. 2

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161220005487/en/

The collaboration provides capital for the global development program for vadadustat, and commercial resources for a U.S. launch of vadadustat upon approval by the Food and Drug Administration. Under the terms of the agreement, Akebia will receive $265 million in committed funds plus development and commercial milestones, representing a total transaction value that could exceed $1 billion. The companies intend to contribute equally to commercialization efforts and share equally all costs and revenue in the U.S., where sales of erythropoiesis stimulating agents (ESAs), the current standard of care, are estimated to be $3.5 billion.3 Akebia will continue to lead the ongoing global Phase 3 development program for vadadustat.

“Vadadustat has the potential to significantly change the current standard of care for patients with anemia associated with CKD and addresses a high unmet need for those suffering with this disease,” said Mr. Tatsuo Higuchi, President and Representative Director of Otsuka. “With Akebia’s renal expertise, this collaboration will enable Otsuka to expand our cardio-renal portfolio while demonstrating our commitment to delivering new treatment options to patients worldwide.”

Under the terms of the agreement, Otsuka will pay $265 million or more in committed capital. This includes a payment of $125 million upon signing and a payment of approximately $35 million in the first quarter of 2017. The agreement also provides for Otsuka to pay $105 million or more of the costs of the global development program for vadadustat. Additionally, Otsuka will pay potential development and commercial milestones up to $765 million.

“This collaboration achieves our goal of funding our global PRO2TECT and INNO2VATE Phase 3 studies for vadadustat while retaining significant long-term value for Akebia,” stated John P. Butler, President and Chief Executive Officer of Akebia.

Mr. Butler added, “Our alliance with Otsuka, one of the world’s innovative pharmaceutical leaders, also allows us to prepare an optimal launch of vadadustat, as we will equally share commercial responsibility. Otsuka brings a well-established commercial presence and infrastructure in the U.S., and we share a strong commitment to improving patients’ lives by delivering important new therapeutic options. This deal also underscores the confidence that we and others have placed in the underlying value of vadadustat and in our ability to bring innovative therapies to patients.”

In addition to the collaboration with Otsuka, Akebia has established a collaboration with Mitsubishi Tanabe Pharma Corporation for the development and commercialization of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and other countries in Asia. For other geographies, including the European Union, Akebia continues advancing discussions with multiple parties regarding a potential collaboration.

Conference Call and Webcast
Akebia management will host a conference call to review the details of the transaction beginning at 8:30 a.m. Eastern Time today, Tuesday, December 20, 2016. A live audio webcast of the presentation will be available on the company’s website at http://ir.akebia.com/events.cfm. An archived presentation will be available for 90 days.

To access the conference call, follow these instructions:

Dial: (877) 458-0977 (U.S.); (484) 653-6724 (international)
Conference ID: 39235865

About Vadadustat
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in development for the treatment of anemia related to chronic kidney disease. Vadadustat exploits the same mechanism of action used by the body to adapt naturally to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery.

About Anemia Associated with CKD
Approximately 30 million people in the U.S. have chronic kidney disease (CKD), with an estimated 1.8 million of these patients suffering from anemia. Anemia results from the body’s inability to coordinate red blood cell production in response to lower oxygen levels due to the progressive loss of kidney function with inadequate erythropoietin production. Left untreated, anemia significantly accelerates patients’ overall deterioration of health with increased morbidity and mortality. Anemia is currently treated with injectable recombinant erythropoiesis stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks.4

About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through hypoxia-inducible factor biology. Akebia’s lead product candidate, vadadustat, is an oral therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients. Akebia’s global Phase 3 program for vadadustat, which includes the PRO2TECT studies for non-dialysis patients with anemia secondary to chronic kidney disease and the INNO2VATE studies for dialysis-dependent patients, is currently ongoing. For more information, please visit our website at www.akebia.com.

About Otsuka
Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), based in Princeton, N.J., discovers and develops new compounds that address unanswered medical needs and advance human health, with a focus on neuroscience, oncology, and cardio-renal treatments. For more information about Otsuka in the U.S., visit www.otsuka-us.com and on Twitter at @OtsukaUS.

Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd., headquartered in Tokyo, Japan, with 2015 consolidated sales of $11.9 billion. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en.

Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements include those about Akebia’s strategy, future plans and prospects, including statements regarding the potential indications and benefits of vadadustat, the satisfaction of Akebia’s funding needs for the PRO2TECT and INNO2VATE Phase 3 programs, the potential commercialization of vadadustat if approved by the FDA, anticipated contributions from Otsuka pursuant to the Collaboration and License Agreement, and the progress toward securing a collaboration for other geographies. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including the risk that existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the ability of Akebia to successfully complete the clinical development of vadadustat; the funding required to develop Akebia’s product candidates and operate the company, and the actual expenses associated therewith; the actual costs incurred in the Phase 3 studies of vadadustat and the availability of financing to cover such costs; the timing and content of decisions made by the FDA and other regulatory authorities; the rate of enrollment in clinical studies of vadadustat; the actual time it takes to initiate and complete clinical studies; Akebia’s ability to satisfy its obligations under the Collaboration and License Agreement; early termination of the Collaboration and License Agreement by Akebia or Otsuka; Akebia’s ability to negotiate commercially reasonable terms with an additional collaboration partner; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; and Akebia’s ability to obtain, maintain and enforce patent and other intellectual property protection for vadadustat. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Annual Report on Form 10-Q for the quarter ended September 30, 2016, and other filings that Akebia may make with the Securities and Exchange Commission in the future. Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

__________________

1Stages 1-4: JAMA 2007 Coresh et al. (Prevalence of CKD in the US). NHANES 1988-94 and 1999-2004.
Stage 5: USRDS 2013 report (ESRD).
Iseki K and Kohagura. Anemia as a risk factor for chronic kidney disease K. Kidney Int Suppl. 2007;107:S4-9.
2Culleton B, Manns B, Zhang J, Tonelli M, Klarenbach S, et al. Impact of anemia on hospitalization and mortality in older adults. Blood 2006;107(10):3841-3846.
Portolés J, Gorriz J, Rubio E, de Alvaro F, García F, et al. The development of anemia is associated to poor prognosisinNKF/KDOQI stage 3 chronic kidney disease. BMC nephrology 2013;14(1):2.
3Global sales of injectable erythropoiesis-stimulating agents as reported in public filings.
4Singh AK. What is causing the mortality in treating the anemia of chronic kidney disease: erythropoietin dose or hemoglobin level? Curr Opin Nephrol Hypertens 2010;19:420-424

 

Akebia
AJ Gosselin, 617-844-6130
Manager, Corporate Communications
agosselin@akebia.com
or
Otsuka Pharmaceutical Development & Commercialization, Inc. (in U.S.)
Kimberly Whitefield, 609-535-9259
Corporate Communications
kimberly.whitefield@otsuka-us.com
or
Otsuka Pharmaceutical Co., Ltd. (in Japan)
Jeffrey Gilbert, 81-3-6361-7379
Leader, Pharmaceutical Public Relations
Gilbert.jeffrey@otsuka.jp

Tuesday, December 20th, 2016 Uncategorized Comments Off on $AKBA #OtsukaPharmaceutical Announce #US #Collaboration Over #Vadadustat

$TVIA Suspends Supply to #Soylent

TerraVia Holdings, Inc. (NASDAQ:TVIA) has made the decision to suspend supply to Soylent of all its ingredients, effective immediately.

The decision to suspend supply is based on the high level of concern that Soylent’s actions in addressing its issues with Powder 1.6 indicate a pattern of behavior that is damaging TerraVia’s business. In accordance with food industry best practice, TerraVia has tried to work collaboratively with Soylent to appropriately investigate the cause of GI issues experienced by a small number1 of their customers. To TerraVia’s knowledge, there has not been a rigorous investigation of the root causes of the GI problems before releasing a new version with Powder 1.7, and, to date, Soylent has made no data available that would substantiate its decision to remove algal flour from its products.

“We are surprised and disappointed that Soylent rushed to imply that algal flour is to blame and removed the ingredient without providing any evidence that they conducted a full investigation of their formulations and the more than 40 ingredients in their products, as would be standard practice in the food industry,” said TerraVia CEO Apu Mody.

According to food industry expert, George A. Burdock, Ph.D., “This conclusion is premature without additional investigation,” and, “I do not believe whole algal flour or any single ingredient (at normal, sub-clinical use levels) can be identified as the causative agent – there is just no evidence to indicate a cause-effect relationship for a single ingredient in such complex mixture.”

TerraVia’s whole algal flour is classified as Generally Recognized as Safe (GRAS) in compliance with FDA regulations concerning substances for food use. TerraVia’s algal flour has been used in more than 20 million servings of products and has never been shown to be the cause of adverse reactions.

As of last week, TerraVia has fulfilled its existing supply commitments for all its ingredients used by Soylent.

“As a company, we work every day to ensure the integrity of our ingredients and our customers’ high quality products,” said Mody. “We uphold food industry best practices and remain committed to partnering with our valued customers who align with these same principles.”

1 less than 0.1%, according to Soylent Blog dated November 19, 2016.

About TerraVia

TerraVia is a plant-based food, nutrition and specialty ingredients company that harnesses the power of algae, the mother of all plants and earth’s original superfood. With a portfolio of breakthrough ingredients and manufacturing, the Company is well positioned to help meet the growing need of consumer packaged goods and established and emerging food manufacturers to improve the nutritional profile of foods without sacrificing taste, and to develop select consumer brands. The Company also manufactures a range of specialty personal care ingredients for key strategic partners. Headquartered in South San Francisco, the Company’s mission is to create products that are truly better for people and better for the planet. For additional information, please visit TerraVia’s website at www.terravia.com.

 

TerraVia
Katie Ringer
Corporate Communications
press@terravia.com

Tuesday, December 20th, 2016 Uncategorized Comments Off on $TVIA Suspends Supply to #Soylent

$FRED w/ $WBA Agrees to #Acquire 865 Rite Aid $RAD Stores

Purchase Would Create Third-Largest U.S. Drug Store Chain and Support Healthcare Growth Strategy

Fred’s Inc. (“Fred’s Pharmacy” or “the Company”) (NASDAQ: FRED) today announced that the Company has signed an agreement with Walgreens Boots Alliance, Inc. (NASDAQ: WBA) and Rite Aid Corporation (NYSE: RAD) to purchase 865 stores and certain assets related to store operations located across the eastern and western United States for $950 million in cash. Closing of the transaction is expected to take several months after Walgreens Boots Alliance’s proposed acquisition of Rite Aid is completed and is subject to approval by the Federal Trade Commission as well as customary regulatory approvals and closing conditions. Shareholder approval is not required. The transaction, if approved, is targeted to close during the first half of 2017 and will position Fred’s Pharmacy as the third-largest drugstore chain in the United States and create a new national competitor. In connection with this transaction, the Company has received financing commitments to fund the purchase price, transaction-related costs, ongoing business operations and anticipated capital investments.

Fred’s Pharmacy Chief Executive Officer Michael K. Bloom, commented, “This will be a transformative event for Fred’s Pharmacy that will accelerate our healthcare growth strategy through our acquisition of 865 new stores located in highly attractive markets. We believe that this transaction will also create tremendous opportunities for both our new and existing front of store and pharmacy team members. We look forward to realizing the considerable benefits this transaction will bring to our customers, patients, payors, supplier partners, team members and shareholders.”

Bloom continued, “We have been working for several months on integration plans to ensure a seamless transition for Rite Aid customers, patients, team members and supplier partners by leveraging our world-class senior leadership team’s significant expertise in managing major healthcare acquisitions and integrations. We assembled this highly experienced team in 2015, implemented upgrades to our infrastructure in 2016, and now, in 2017, we look forward to the continued optimization of our business, fueled by today’s milestone announcement. We believe the purchase of these stores will not only complement recent investments in our team members, processes, and technological infrastructure, but also positively impact our business and maximize shareholder value.”

In aggregate, the 865 stores are generally representative of Rite Aid’s pre-divesture store performance with respect to both sales and EBITDA. Fred’s Pharmacy expects that the acquired stores would be accretive to earnings and generate substantial cash flow.

Fred’s Pharmacy will continue to employ, contingent on consummation of the transaction, store and certain field and regional team members related to the operations of the acquired stores. Upon completion of the acquisition, the Company will operate the acquired stores and will retain the Rite Aid banner through a 24-month transition.

A.T. Kearney served as a strategic advisor to the CEO and Board of Directors and provided financial and operational diligence related to the transaction. BofA Merrill Lynch and Regions Bank have committed to provide financing to Fred’s Pharmacy. Peter J. Solomon Company, LLC provided a fairness opinion to the Board of Directors of the Company in connection with the transaction.

About Fred’s Pharmacy

Fred’s Pharmacy and its subsidiaries operate 647 discount general merchandise stores and three specialty pharmacy-only locations in 15 states in the southeastern United States. Included in the store count are 18 franchised locations. Also, there are 371 full service pharmacy departments located within Fred’s stores, including four franchised locations. For more information about the Company, visit Fred’s website at www.fredsinc.com.

Comments in this news release that are not historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. A reader can identify forward-looking statements because they are not limited to historical facts or they use such words as “outlook,” “guidance,” “may,” “should,” “could,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “forecast,” “goal,” “intend,” “committed,” “continue,” or “will likely result” and similar expressions that concern the Company’s strategy, plans, intentions or beliefs about future occurrences or results. These risks and uncertainties include, but are not limited to, those associated with the Company’s announced strategic plan, the success of announced acquisition activities and future growth trends in businesses acquired; general economic trends; risks related to the possibility that the transactions may not close, including because one or more closing conditions to the transactions, including certain regulatory approvals, may not be satisfied or waived, on a timely basis or otherwise, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transactions, or may require conditions, limitations or restrictions in connection with such approvals; the risk that the businesses and acquired stores, as applicable, will not be integrated successfully; the risk of litigation and/or regulatory actions related to the proposed transactions; changes in consumer demand or purchase patterns; delays or interruptions in the flow of merchandise between the Company’s distribution centers and its stores or between the Company’s suppliers and same; a disruption in the Company’s data processing services; cyber-security threats; costs and delays in acquiring or developing new store sites; and the factors listed under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent quarterly filings on Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements speak only as of the date made. Fred’s undertakes no obligation to release revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events, except as required to be reported under the rules and regulations of the Securities and Exchange Commission. There can be no assurance that the requisite regulatory approvals will be obtained, or that the transactions will be completed within the required time period.

 

Fred’s Inc.
Rick Hans, 901-362-3733, ext. 2232
Executive Vice President and Chief Financial Officer

Tuesday, December 20th, 2016 Uncategorized Comments Off on $FRED w/ $WBA Agrees to #Acquire 865 Rite Aid $RAD Stores

$MKGI Shareholder Update — 2016 Milestones and Transactional Business

WESTON, FL–(Dec 20, 2016) – Monaker Group (OTCQB: MKGI), a technology-driven travel company focused on the alternative lodging rental (ALR) market, today released a “Shareholder Update”. Key highlights include:

  • Proprietary booking engine is completed and conforms to all Online Travel industry standards allowing for easy business to business integration.
  • Over 1 million “real-time” bookable properties integrated and more than 2 million ALR properties under contract.
  • Company anticipates Roll-out of Business Travel Partners and NextTrip.com consumer platform in January 2017.
  • The NextTrip site will be industry leader with real-time bookable properties and a host of travel products and services allowing for “one-stop” travel shopping.
  • Mobile App for both Android and IOS versions scheduled for end of January 2017.

Shareholder Update

Dear Shareholder:

I am pleased to report that 2016 has been a year of major progress for Monaker Group. As the year draws to a close, we can confirm that we expect to launch our alternative lodging rental (ALR) business in January 2017.

This business will have two components. The first is our proprietary Monaker Booking Engine (MBE), which will allow both business travel partners and consumers to access our lodging products. Our other offering, NextTrip.com, is a direct-to-consumer platform that for the first time will provide real-time alternative lodging reservations that include access to all major mainstream travel products and services.

What’s more, we now have signed contracts with dozens of lodging vendors for two million rental properties in the U.S., Europe, Asia, South America and the Caribbean. To date, over one million of these properties have been loaded onto our MBE staging servers and the other half are now being certified and will be uploaded soon. Globally, this will give our Company a meaningful industry presence, emulating sector leaders such as Airbnb with 2.5 million properties and Expedia/HomeAway with an estimated 1.2 million properties.

In arriving at this exciting position, Monaker has this year achieved several key milestones. These include the buildout of our MBE and our “plug and play” application program Interface (API), making it possible for wholesale travel service providers to easily access our ALR inventory in the instantaneous booking format they require. We have also been working to integrate our ALR inventory into multiple travel platforms, distribution groups, and travel websites. Financially speaking, during the past year we also simplified our capital structure and strengthened our balance sheet by eliminating over $10 million of debt and three classes of Monaker’s Preferred shares.

Looking forward, we believe our MBE business solution and NextTrip consumer platform can be true game changers in the ALR industry. Why? The major problem with ALR sites, even Airbnb, is that many of their properties aren’t bookable in real-time, meaning that travelers must often wait quite a while for an owner to confirm bookings. For this same reason, online travel agencies (OTAs), tour operators, and airline and cruise originators — the very customers best served by our MBE business solution — are increasingly requiring ALR sites to offer real-time booking as a prerequisite to integration with their own service platforms.

The second major problem impacting ALR platforms has been that not a single one has ever offered all mainstream travel services — flights, conventional lodging, timeshares, rental cars, cruises, and tour and land packages — on a single site.

Soon, however, NextTrip will solve both these issues, and, along with our MBE platform, should commence transactional business next month. The NextTrip platform has been designed to allow individuals and groups to search, share, converse and recommend vacation destinations, and earn instant “cash back” rewards when they book and contribute to the site. Additionally, the NextTrip Mobile App will be introduced in IOS and Android versions.

With such rich features, we expect that MBE and NextTrip will appeal to a far greater number of travelers and wholesale travel providers than any other ALR service — and help generate significant booking revenue for Monaker in 2017. The bulk of this revenue, we expect, will be derived from our MBE and travel wholesale partners.

Our revenue outlook is further buoyed by data from independent experts, which report that the ALR industry is one of the fastest growing segments in the travel sector and is projected to total $169 billion by 2019.

In conclusion, we are finishing up this fiscal (Feb.28th) year on a very strong note, with a clean capitalization structure, nominal short-term debt, and a dynamic ALR platform that can service both B-to-B and B-to-C clients. On behalf of our entire management team, I extend our heartfelt and sincere thanks to each of you, our loyal shareholders, for your dedication and support.

Best wishes to you and yours for a great Holiday and a prosperous 2017.

Sincerely,

Bill Kerby

Chairman and Chief Executive Officer

About Monaker

Monaker Group is a technology driven Travel Company with multiple divisions and brands, leveraging more than 65 years of operation in leisure travel. Monaker’s flagship is NextTrip.com, the industry’s first booking engine featuring alternative lodging — vacation home rentals, resort residences and unused timeshares — as well as a vast array of airlines, hotels, cruises, rental cars, tours and concierge services all combined in one platform giving customers the power of choice when booking their vacations. The NextTrip site is powered by Monaker’s booking engine utilizing rich content, imagery and high-quality video to maximize the traveler’s experience and assist them in the search, decision and purchasing process of alternative lodging. By combining key features and functionality with advanced proprietary and licensed technology, NextTrip is able to present comprehensive vacation alternatives at best pricing.

With key partnerships and established travel brands used as cornerstones, the Company’s mission is to continue to expand offerings to become the “one stop” vacation center. Headquartered in South Florida, the Company employs a dedicated team of travel and technology professionals. For more information visit the company’s website at www.monakergroup.com

Safe Harbor Statement

This press release contains forward-looking statements that involve risks and uncertainties concerning the plans and expectations of Monaker Group. These statements are only predictions and actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties, some of which are out of our control. The potential risks and uncertainties include, among others, or the expectations of future growth may not be realized. These forward-looking statements are made only as of the date hereof, and Monaker Group undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. All forward looking statements are expressly qualified in their entirety by the “Risk Factors” and other cautionary statements included in Monaker Group’s annual, quarterly and special reports, proxy statements and other public filings with the Securities and Exchange Commission (“SEC”), including, but not limited to, the Company’s Annual Report on Form 10-K for the period ended February 29, 2016 which has been filed with the SEC and is available at the SEC’s website at www.sec.gov.

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

Chesapeake Group
Investor Relations
Tel: (410) 825-3930

Tuesday, December 20th, 2016 Uncategorized Comments Off on $MKGI Shareholder Update — 2016 Milestones and Transactional Business

$PCYO Announces #Water Service #Acquisition for $1,600,000

DENVER, CO / December 19, 2016 / Pure Cycle Corporation (NASDAQ Capital Market: PCYO) (“Pure Cycle” or the “Company”) announced today that the Rangeview Metropolitan District (“Rangeview”) has entered into an agreement that, upon closing, will result in Pure Cycle, in its capacity as the exclusive service provider for Rangeview, acquiring the right to provide water service to Wild Pointe Ranch (“Wild Pointe”), located in unincorporated Elbert County Colorado.

Wild Pointe is located approximately 14 miles south of the Company’s Lowry Range service. The development includes approximately 120 existing residential and commercial service connections which, at buildout, may grow to more than 250 connections. The Company will operate and maintain the water system and will collect future water tap fees for new customers added to the system, along with monthly water service revenues. Annual water service revenues at Wild Pointe currently total approximately $140,000 and are anticipated to grow to about $350,000 at buildout. The completion of the development may add an additional $2.5 million in residential and commercial water tap fees.

The closing is subject to various closing conditions, including Rangeview’s satisfaction with the title to the water rights used to serve Wild Pointe. The title report on the water rights is to be provided within the next 60 days.

“Wild Pointe is strategically located in unincorporated Elbert County, which borders the southern boundary of the Lowry Range. The area has numerous small independent water systems, and we believe we can provide significant efficiency and value by operating these systems in a more unified, regional manner in conjunction with our other systems including, in some cases, bringing new water supplies to the region,” commented Mark Harding, President of Pure Cycle. “This acquisition is part of our continuing strategy to expand and grow our wholesale utility segment both organically at our Sky Ranch development and through strategic acquisitions,” continued Mr. Harding.

Company Information

Pure Cycle owns water assets in the Denver, Colorado metropolitan area. Pure Cycle provides water and wastewater services to customers located in the Denver metropolitan area including the design, construction, operation, and maintenance of water and wastewater systems.

Additional information including our recent press releases and Annual Reports are available at www.purecyclewater.com, or you may contact our President, Mark W. Harding, at 303-292-3456 or at info@purecyclewater.com.

Forward-Looking Statements

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. Forward-looking statements are all statements, other than statements of historical facts, included in this press release that address activities, events or developments that we expect or anticipate will or may occur in the future, such as statements about expected water service connections, revenues and tap fees at buildout. The words “anticipate,” “likely,” “may,” “should,” “could,” “will,” “believe,” “estimate,” “expect,” “plan,” “intend,” and similar expressions are intended to identify forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain and involve risks and uncertainties that could cause actual results to differ materially. Factors that could cause actual results to differ from projected results include, without limitation: the possibility that the parties to the water service agreement may be unable to satisfy the conditions to closing the proposed transactions; the proposed transaction may involve unexpected costs; the risk factors discussed in Part I, Item 1A of our most recent Annual Report on Form 10-K; and those factors discussed from time to time in our press releases, public statement and documents filed or furnished with the U.S. Securities and Exchange Commission. Except as required by law, we disclaim any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Monday, December 19th, 2016 Uncategorized Comments Off on $PCYO Announces #Water Service #Acquisition for $1,600,000

$AUPH Long-Term #Manufacturing Collaboration w/ #Lonza, #Voclosporin

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX: AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced it has entered into a long-term agreement with Lonza for the manufacture of voclosporin active pharmaceutical ingredient (API).

This agreement follows a successful multi-year clinical manufacturing relationship where the companies have been refining the process and analytical methods to produce clinical and commercial supplies of voclosporin.

Under the terms of the agreement, Lonza agrees to produce cGMP-grade voclosporin drug substance for use in Aurinia’s Phase III lupus nephritis (LN) clinical program and for future commercial use. The agreement also provides an option to have Lonza exclusively supply API for up to 20 years.

“Throughout the company’s long relationship with Lonza, we have developed substantial proprietary know-how in manufacturing commercial scale voclosporin. We believe this know-how has the potential to broaden our exclusivity position for voclosporin and ensure high quality, reliable production of the API,” said Lawrence Mandt, VP Regulatory and Quality at Aurinia.

“Our partnership with Lonza is the culmination of years of collaboration in which we have optimized the complex manufacturing process for voclosporin,” said Charles Rowland, Chief Executive Officer of Aurinia. “As we prepare to advance voclosporin into an LN Phase III program, we are investing in the infrastructure to deliver this important therapy to patients living with this devastating disease.”

“We’re looking forward to further developing our partnership with Aurinia to supply this innovative medicine to lupus nephritis patients around the world,” said Gordon Bates, Senior Vice President, Business Unit Head, Chemical and Microbial Manufacturing for Lonza.

“As Voclosporin requires a complex manufacturing process, our expertise in scaling multi-step synthesis at clinical and commercial scale allows us to support Aurinia to and through Phase III clinical trials,” he added. “This latest agreement further demonstrates Lonza’s commitment to developing customized supply solutions for our customers as they meet some of the greatest challenges in patient treatment, in this case for lupus nephritis patients around the world.”

About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens. Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 full-time employees worldwide. The company generated sales of about CHF 3.8 billion in 2015 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. Further information can be found at www.lonza.com

About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.

About Lupus Nephritis (LN)
Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has straightforward disease outcomes where an early response correlates with long-term outcomes, measured by proteinuria. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.

About Aurinia
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN). The company is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com.

Forward Looking Statements
This press release contains forward-looking statements, including statements related to Aurinia’s manufacturing know-how, capabilities and strategy and potential clinical and commercial supplies of voclosporin. It is possible that such results or conclusions may change. Words such as “plans,” “intends,” “may,” “will,” “believe,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Aurinia’s current expectations. Forward-looking statements involve risks and uncertainties. Aurinia’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk that Aurinia’s analyses, assessment and conclusions of the results of the AURA-LV clinical study set forth in this release may change based on further analyses of such data, and the risk that Aurinia’s clinical studies for voclosporin may not lead to regulatory approval. These and other risk factors are discussed under “Risk Factors” and elsewhere in Aurinia’s Annual Information Form for the year ended December 31, 2015 filed with Canadian securities authorities and available at www.sedar.com and on Form 40-F with the U.S. Securities Exchange Commission and available at www.sec.gov, each as updated by subsequent filings, including filings on Form 6-K. Aurinia expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Aurinia’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

 

Investor & Media Contact:
Aurinia Pharmaceuticals Inc.
Celia Economides
Head of IR & Communications
ceconomides@auriniapharma.com

Monday, December 19th, 2016 Uncategorized Comments Off on $AUPH Long-Term #Manufacturing Collaboration w/ #Lonza, #Voclosporin

$BCLI Reports on Successful End of #Phase2 Meeting with #FDA #NurOwn

Conference Call @ 8:30am Eastern Time Today to Provide Corporate Update and Discuss Plans for 2017

HACKENSACK, N.J. and PETACH TIKVAH, Israel, Dec. 19, 2016 — BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today provided a corporate update and announced its clinical development objectives for 2017.

2017 Goals and Objectives

  • Commence an international Phase 3 trial with NurOwn® in ALS
  • Submission of Application for Hospital Exemption for NurOwn® in Israel

Successful End of Phase 2 Meeting

Brainstorm recently completed a successful End-of-Phase 2 Meeting with the United States Food and Drug Administration (FDA). Brainstorm has reached general agreement with the FDA to proceed to a Phase 3 trial. Importantly, the FDA has accepted the key elements of the Phase 3 program to support a Biologic License Application (BLA) for NurOwn® in ALS. The planned Phase 3 clinical trial will be a randomized, double-blind, placebo-controlled multi-dose trial that will be conducted at multiple sites in the U.S. and in Israel. The trial is expected to begin enrolling patients in the second quarter of 2017.

“We are very pleased with the outcome of the End-of-Phase 2 meeting with the FDA, and we look forward to initiating our Phase 3 clinical trial for NurOwn® in ALS,” said Chaim Lebovits, BrainStorm’s President and Chief Executive Officer. “Together with our clinical investigators in the U.S. and Israel, we have worked diligently with the FDA to advance NurOwn® through to late-stage development.  Building off NurOwn’s safety and clinical efficacy observed to date, we are developing a Phase 3 program that, if successful, will position us to bring to the market an innovative, disease modifying treatment for patients suffering from ALS.”

BrainStorm to Apply for Hospital Exemption for NurOwn® in Israel

Brainstorm plans to submit an application in Israel that will allow patient access to NurOwn® as a treatment that has been granted Hospital Exemption. This recently approved pathway would permit Brainstorm to partner with a medical center in Israel and be allowed to treat patients with NurOwn® for a fee.

Hospital Exemption allows for advanced therapy medicinal products to be made available to a group of patients to be agreed upon by the Israeli Ministry of Health. It is intended to provide patients with the possibility to benefit from a custom-made, innovative, individual treatment where there is a critical unmet need and an absence of valid therapeutic alternatives. The treatment is usually a custom-made product, such as NurOwn®, manufactured using a patient’s own cells that are prepared on a non-routine basis. In order to qualify for a Hospital Exemption, a number of important criteria must be met including preparation according to specific quality standards (equivalent to those for a licensed product), use in a hospital and use under the exclusive responsibility of a medical practitioner.

“Our planned application for Hospital Exemption is our first step toward providing ALS patients with access to NurOwn,” said Mr. Lebovits. “Our decision to proceed with this application is based on a strong interest voiced by ALS patients via a questionnaire. We foresee possible treatments under this pathway as early as the second half of 2017.”

Conference Call and Webcast Details

Brainstorm will host a conference call and live webcast, today, Monday December 19th, at 8.30am Eastern Time. The call will be conducted in English.  Callers may participate in the conference call by dialing:

USA: 888-389-5987
Canada: 719-325-2425
Israel: 1 80 924 5905
Conference ID: 3566333
Webcast: http://public.viavid.com/index.php?id=122186

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. Brainstorm holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the Brainstorm’s website at
www.brainstorm-cell.com.

Safe Harbor Statement

Statements in this announcement other than historical data and information constitute “forward-looking statements” and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.’s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as “may”, “should”, “would”, “could”, “will”, “expect”, “likely”, “believe”, “plan”, “estimate”, “predict”, “potential”, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm’s limited operating history, history of losses; minimal working capital, dependence on its license to Ramot’s technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm’s forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Media:

Uri Yablonka, COO
Brainstorm Cell Therapeutics Inc.
Phone: (646) 666-3188
uri@brainstorm-cell.com

Investors:
Michael Rice
LifeSci Advisors, LLC
Phone: 646-597-6979
mrice@lifesciadvisors.com

Monday, December 19th, 2016 Uncategorized Comments Off on $BCLI Reports on Successful End of #Phase2 Meeting with #FDA #NurOwn

$CXRX Provides Business Update

OAKVILLE, ON, Dec. 19, 2016  – Concordia International Corp. (“Concordia” or the “Company”) (NASDAQ: CXRX) (TSX: CXR), an international specialty pharmaceutical company focused on generic and legacy pharmaceutical products and orphan drugs, today announced that the Company has paid the first installment of its earn-out to Cinven1 relating to Concordia’s October 2015 acquisition of Amdipharm Mercury Limited. All financial references below are in U.S. dollars unless otherwise noted.

Today’s payment of £72 million was paid with cash on hand generated by the Company’s cash flows. Following today’s payment, the Company has a cash balance of approximately $410 million2. The Company also has up to an additional $200 million available under its undrawn revolving credit facility, subject to compliance with certain debt incurrence covenants if drawn upon.

The Company believes that it has access to sufficient liquidity to meet all of its near term financial obligations, as it continues to focus on developing a new long term strategic plan.

“A few weeks into my new role as CEO, and having met the majority of our employees, key shareholders and debtholders, I am looking forward to working with our senior management team and board of directors to chart a path forward that will help us rebuild value for all stakeholders,” stated Mr. Oberman. “This plan will focus on management’s key priorities for the Company, which include operational excellence, portfolio expansion, financial management and stakeholder outreach.  We are working to execute on each of these priorities, and in furtherance of our focus on operational excellence, we have recently implemented the termination of the Company’s phase 3 trial for Photodynamic Therapy with Photofrin® and the elimination of the Company’s contract sales force in the first phase of this plan.  We look forward to providing a progress update during our regular year-end reporting, anticipated in March 2017.”

Termination of the Company’s Phase 3 Trial for Photodynamic Therapy with Photofrin®

The Company continues to market Photodynamic Therapy (PDT) with Photofrin® for its FDA-approved indications, which include esophageal cancer, high-grade dysplasia in Barrett’s esophagus and non-small cell lung cancer.

However, after careful consideration, Concordia has decided to terminate enrollment for its phase 3 trial, which is evaluating PDT with Photofrin® as a potential treatment for cholangiocarcinoma, a rare form of cancer.  Patients currently enrolled in the phase 3 trial will continue through to completion.

The decision to end the trial does not diminish management’s confidence in PDT with Photofrin®’s potential as a commercial product. Rather, it is reflective of some of the challenges the Company experienced enrolling the trial for a rare disease that affects a relatively small patient population. The Company intends to redirect its resources to other potential PDT with Photofrin® opportunities.

Elimination of Contract Sales Team

As part of the Company’s ongoing evaluation of its business, Concordia has decided to further reduce expenses by terminating its current contract sales team that was promoting Donnatal®. Donnatal® is a commercial therapy prescribed to treat irritable bowel syndrome.

The Company believes it has allocated the appropriate amount of time to assess the impact of its contract sales force on Donnatal® sales and concluded that the results were not in line with expectations.

Management expects Donnatal® to remain an important product for Concordia and intends to evaluate new cost-effective opportunities to market the product, including co-promotion arrangements.

Nasdaq Biotech Index

In addition, the Company announced it will be removed from the Nasdaq Biotech Index (NBI) effective prior to the market open today. On an annual basis, Nasdaq re-ranks the NBI based on market capitalization parameters that Concordia currently does not meet.

About Concordia

Concordia is a diverse, international specialty pharmaceutical company focused on generic and legacy pharmaceutical products and orphan drugs. The Company has an international footprint with sales in more than 100 countries, and has a diversified portfolio of more than 200 established, off-patent molecules that make up more than 1,300 SKUs. Concordia also markets orphan drugs through its Orphan Drugs Division, consisting of Photofrin® for the treatment of certain rare forms of cancer.

Concordia operates out of facilities in Oakville, Ontario and, through its subsidiaries, operates out of facilities in Bridgetown, Barbados; London, England and Mumbai, India.

Notice regarding forward-looking statements and information:

This press release includes forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of Canadian securities laws, regarding Concordia and its business, which may include, but are not limited to the Company’s cash balances, the availability of the revolving credit facility, the Company having sufficient liquidity to meet all of its near term financial obligations, the development of a new long term strategic plan, rebuilding value for all stakeholders, management’s key priorities and the execution of those priorities, the Company providing progress updates (including in March 2017), continuing to market PDT with Photofrin®, confidence in PDT with Photofrin® as a potential commercial product, the potential of PDT with Photofrin®, the availability of other opportunities for PDT with Photofrin®, Donnatal® remaining an important product for the Company, and the evaluation of new cost-effective opportunities for Donnatal® (including, co-promotion opportunities). Often, but not always, forward-looking statements and forward-looking information can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of Concordia’s management, and are based on assumptions and subject to risks and uncertainties. Although Concordia’s management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this press release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to the inability to develop a new strategic plan and/or implement the Company’s key priorities, the inability to manage the Company’s cash balances, the inability to access the Company’s revolving credit facility (including, the inability to comply with various covenants included in the Company’s debt agreements), the lack of access to capital to manage the Company’s liquidity (including, without limitation, to meet the Company’s near term financial obligations), the inability to create value for all stakeholders, the inability to commercialize PDT with Photofrin®, Photofrin® not growing in its respective markets or new markets, Donnatal® continuing to face competitive pressures, the inability to enter into cost-effective opportunities for Donnatal®, the inability to grow Donnatal®’s market share, the loss of sales of Donnatal due the inability to find an alternative to the terminated contract sales force, Concordia’s securities, risks associated with developing new product indications, increased indebtedness and leverage, the inability to generate cash flows, revenues and/or stable margins, the inability to grow organically, the inability to repay debt and/or satisfy future obligations (including, without limitation, earn out obligations), risks associated with Concordia’s outstanding debt, risks associated with the geographic markets in which Concordia operates and/or distributes its products, risks associated with fluctuations in exchange rates (including, without limitation, fluctuations in currencies), risks associated with the use of Concordia’s products to treat certain diseases, the pharmaceutical industry and the regulation thereof, regulatory investigations, the failure to comply with applicable laws, risks relating to distribution arrangements, possible failure to realize the anticipated benefits of acquisitions and/or product launches, risks associated with the integration of assets and businesses into Concordia’s business, product launches, the inability to launch products, the fact that historical and projected financial information may not be representative of Concordia’s future results, the failure to obtain regulatory approvals, economic factors, market conditions, acquisition opportunities, risks associated with the acquisition and/or launch of pharmaceutical products, risks regarding clinical trials and/or patient enrollment into clinical trials, the equity and debt markets generally, risks associated with growth and competition (including, without limitation, with respect to Concordia’s niche, hard-to-make products), general economic and stock market conditions, risks associated with the United Kingdom’s exit from the European Union (including, without limitation, risks associated with regulatory changes in the pharmaceutical industry, changes in cross-border tariff and cost structures and the loss of access to the European Union global trade markets), risks related to patent infringement actions, the loss of intellectual property rights, risks and uncertainties detailed from time to time in Concordia’s filings with the Securities and Exchange Commission and the Canadian Securities Administrators and many other factors beyond the control of Concordia.  Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and forward-looking information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or forward-looking information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and forward-looking information speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement or forward-looking information, whether as a result of new information, future events, or otherwise.

1 In this press release ‘Cinven’ means, depending on the context, any of or collectively, Cinven Group Limited, Cinven Partners LLP, Cinven (LuxCo1) S.A., Cinven Capital Management (V) General Partner Limited and their respective Associates (as defined in the Companies Act 2006) and/or funds managed or advised by the group.

2 Approximate figures.  Based on management’s current estimates.

Monday, December 19th, 2016 Uncategorized Comments Off on $CXRX Provides Business Update

$XGTI Definitive Purchase Agreement to #Acquire #Vislink

SARASOTA, Fla., Dec. 19, 2016  — xG Technology, Inc. (“xG”) (Nasdaq: XGTI, XGTIW), a leader in providing critical wireless communications for use in challenging operating environments, is pleased to announce that it has signed the final definitive business purchase agreement to acquire Vislink Communication Systems (“Vislink”) from Vislink, Plc. All substantive terms of the acquisition, which was originally announced on Oct. 20, 2016, have been agreed upon by the respective parties and due diligence has been completed. The agreement is subject to Vislink shareholder approval, and funding of the acquisition is expected to be finalized thereafter.

The Vislink acquisition gives xG a market-leading position in delivering end-to-end video capture/transmit/receive solutions to broadcast, sports and entertainment, and mission-critical public safety and defense sectors worldwide. The integration of Vislink will add significant revenue to xG’s overall operations and offer the opportunity to realize numerous synergies with its IMT business unit. At present, there is comparatively little overlap between IMT and Vislink in the areas of product offerings, sales channels, and market coverage, which increases the potential for new and expanded business wins for both companies.

George Schmitt, CEO and Board Chairman of xG Technology, said, “The Vislink acquisition represents a transformational step for xG Technology, and we believe it will help xG realize overall revenues of at least $60 million in 2017. There are impressive sales, technology, and manufacturing synergies between Vislink and IMT which will be realized as we integrate the operations in 2017. In addition to providing us a position of market prominence in delivering customized video technology systems, this acquisition offers new opportunities to incorporate xG’s patented interference mitigation and spectrum sharing technologies. Finally, we would like to welcome our new colleagues from Vislink into our company.”

Roger Branton, CFO of xG Technology, said, “The Vislink deal, which builds upon our prior purchase of IMT, underscores our plan to effect strategic acquisitions that further the Company’s long-term growth objectives. In the same way that we were successful in achieving efficiencies in all our business operating areas after acquiring IMT, we expect the Vislink acquisition to result in significant cost savings once it is fully integrated.”

“The xG Technology brand and business unit IMT are leaders in communication and digital microwave systems serving the Broadcast, Sports & Entertainment and MAG (Military, Aerospace & Government) markets. We are very excited to become part of the xG Technology family,” said James Walton, CEO of Vislink Communication Systems. “The product and technology synergies between Vislink and IMT will create a formidable alliance and further strengthen and expand our solutions for secure, high-quality video capture and delivery. I am confident that this transaction will significantly increase the global foothold of our market leading wireless camera and satellite communications systems. Collaboratively, Vislink Communication Systems and IMT will develop new marketing channels, strengthen innovative technology integration, and enrichen our global depth of innovative solutions within broadcast and law enforcement markets.”

About xG Technology, Inc.

Founded in 2002, xG Technology has developed technologies that enable always-available, always-connected and always-secure voice, broadband data and video communications. The company’s brand portfolio includes xMax and Integrated Microwave Technologies (IMT).

xMax is a patented all-IP, software-defined cognitive radio network that delivers mission-assured wireless connectivity in any RF environment. It provides a solution to the challenges of interoperability, survivability and flexibility in expeditionary and critical communications networks. xMax incorporates advanced optimizing technologies that include spectrum sharing, interference mitigation, multiple-input multiple-output (MIMO) and software defined radio (SDR), making it ideal for wide area, as well as rapid emergency communication deployment in unpredictable environments and during fluid situations. xMax offers solutions for numerous industries worldwide, including military, emergency response and public safety, telemedicine and critical infrastructure.

IMT is a leading provider of mission-critical video solutions, advanced digital microwave systems and engineering, integration, installation and commissioning services serving the Broadcast, Sports & Entertainment and MAG (Military, Aerospace & Government) markets. Since its inception, IMT has focused on building a product portfolio that incorporates a high level of performance, reliability and build quality, extended operating ranges and compact form factors. IMT’s product lines include digital broadcast microwave video systems, compact microwave video equipment for licensed and license-free sports and entertainment applications, and wireless video solutions designed for use by state, local and federal police departments. More information on IMT can be found at www.imt-solutions.com.

Based in Sarasota, Florida, xG has over 100 patents and pending patent applications. xG is a publicly traded company listed on the NASDAQ Capital Market (symbol: XGTI) For more information, please visit www.xgtechnology.com

Cautionary Statement Regarding Forward Looking Statements

Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to xG Technology, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.

For More Information:

Daniel Carpini
xG Technology
daniel.carpini@xgtechnology.com
(941) 953-9035

Monday, December 19th, 2016 Uncategorized Comments Off on $XGTI Definitive Purchase Agreement to #Acquire #Vislink

$EGLT #Egalet002 Positive Top-Line Results

WAYNE, Pa., Dec. 16, 2016  — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today announced positive top-line results from a Category 3 intranasal human abuse potential (HAP) study of Egalet-002, an abuse-deterrent, extended-release oxycodone product candidate which uses Egalet’s Guardian™ Technology. Egalet-002 is in late-stage development 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.

“Given that intranasal abuse is the most common form of non-oral oxycodone abuse, these results, having hit the primary endpoint of reduced maximum drug liking, are promising,” said Bob Radie, president and chief executive officer. “We will look to submit the full data for presentation at a medical meeting in 2017.”

Egalet-002 was designed using a version of Egalet’s proprietary Guardian Technology that contains an inner matrix and an exterior shell. This results in tablets with controlled-release properties as well as physical and chemical features that have been demonstrated to resist both common and rigorous methods of manipulation, in order to deter common routes of abuse. The physical hardness of the tablet and the gelling effect of the matrix are designed to give Egalet-002 its physical and chemical abuse-deterrent characteristics.

The study was a randomized, double-blind, active and placebo-controlled 6-period crossover study. The study evaluated the abuse potential of manipulated Egalet-002 compared to crushed immediate-release (IR) oxycodone through the nasal route in 46 non-dependent recreational opioid users experienced in nasal insufflation. A comparison to manipulated OxyContin® (oxycodone hydrochloride) was also included as an exploratory arm. The study was conducted in accordance with the FDA’s Guidance for Industry, Abuse-Deterrent Opioids — Evaluation and Labeling (April, 2015), and used more aggressive methods of manipulation for Egalet-002 identified from the Category 1 in vitro laboratory studies which were needed to get Egalet-002 into a snortable form.

The treatment periods included: Egalet-002 40 mg (manipulated with shell on), Egalet-002 40 mg (manipulated with shell taken off through an additional manipulation step), crushed IR oxycodone 40 mg, manipulated OxyContin 40 mg, manipulated Egalet-002 placebo tablet, and placebo powder.  The primary study endpoint was Drug Liking measured on a bipolar 100-point scale, where 50 is neutral, 100 is maximum liking and 0 is maximum disliking.

Top-line results from the study include:

  • For the primary comparison, the difference in maximum Drug Liking (Emax) between manipulated Egalet-002 (with shell on; 79.5) was significantly lower compared to crushed IR oxycodone (86.6); p = 0.0004
    • This outcome was also significant for the comparison between manipulated Egalet-002 (with shell off; 77.4) and crushed IR oxycodone (86.6); p < 0.0001
  • For the secondary outcome of Take Drug Again (measured on a bipolar 100-point scale), the results were 69.9 for manipulated Egalet-002 (shell on), 72.4 for manipulated Egalet-002 (shell off), and 75.5 for crushed IR oxycodone; not statistically significant for either comparison
  • In the exploratory analysis with OxyContin, Emax Drug Liking was similar in all treatment arms: manipulated Egalet-002 (with shell on; 79.5), manipulated Egalet-002 (with shell off; 77.4), and manipulated OxyContin (76.2)
    • Ease of Snorting and Pleasantness of Snorting were also assessed using unipolar 100-point scales where 100 represented ‘very easy’/’very pleasant’ and 0 meant ‘very hard’/’very unpleasant’; results were as follows:
      • Ease of Snorting was significantly harder for manipulated Egalet-002 (with shell on; 42.0) and manipulated Egalet-002 (with shell off; 49.5) compared to manipulated OxyContin (65.1); p < 0.0001 and p = 0.0050, respectively
      • Pleasantness of Snorting was significantly lower for manipulated Egalet-002 (with shell on; 40.7) and manipulated Egalet-002 (with shell off; 44.7) compared to manipulated OxyContin (55.3); p = 0.0003 and p = 0.0081, respectively

Guardian™ Technology
Egalet’s Guardian Technology has many applications and has been used to develop abuse-deterrent forms of commonly abused prescription medications. Egalet’s proprietary Guardian Technology is a polymer matrix tablet technology that utilizes a novel application of the well characterized manufacturing process of injection molding, which results in tablets that are more difficult to manipulate for misuse and abuse. This approach offers the ability to design tablets with controlled-release profiles as well as physical and chemical properties that have been demonstrated to resist both common and rigorous methods of manipulation. Tablets manufactured with Guardian Technology have been shown to have increased resistance to physical methods of manipulation, such as cutting, crushing, grinding or breaking using a variety of tools. They are also resistant to chemical manipulation and extraction and turn into a viscous hydrogel on contact with liquid, making syringeability very difficult. Egalet-002 was designed using a version of Egalet’s proprietary Guardian Technology that contains an inner matrix and an exterior shell while ARYMO ER uses a different version of the Guardian Technology.

About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions. Egalet has two approved products: OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using its proprietary Guardian™ Technology, Egalet is developing a pipeline of clinical-stage, product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO™ ER, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are being developed 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. Egalet’s Guardian Technology can be applied broadly across different classes of pharmaceutical products and can be used to develop combination products that include multiple active pharmaceutical ingredients with similar or different release profiles. For additional information on Egalet, please visit egalet.com. For full prescribing information on SPRIX, including the boxed warning, please visit sprix.com. For full prescribing information on OXAYDO, please visit oxaydo.com.

Safe Harbor
Statements included in this press release that are not historical in nature and contain the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “look forward to” and other similar expressions are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, and are subject to known and unknown uncertainties and risks. Actual results could differ materially from those discussed due to a number of factors, including, but not limited to: the success of Egalet’s clinical trials, including the timely recruitment of trial subjects and meeting the timelines therefor; Egalet’s ability to obtain regulatory approval of its product candidates; Egalet’s ability to maintain the intellectual property position of its products and product candidates; Egalet’s ability to identify and reliance upon qualified third parties to manufacture its products; Egalet’s ability to service its debt obligations; Egalet’s ability to raise additional funds to execute its business plan and growth strategy on terms acceptable to Egalet, if at all; Egalet’s ability to find and hire qualified sales professionals; the receptivity in the marketplace and among physicians to Egalet’s products; the success of products which compete with Egalet’s that are or become available; general market conditions; and the Risk Factors set forth in Egalet’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in other filings Egalet makes with the SEC from time to time.  In addition, the forward-looking statements included in this press release represent Egalet’s views only as of the date hereof. Egalet anticipates that subsequent events and developments may cause its views to change. While Egalet may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by law.

OXYCONTIN is a registered trademark of Purdue Pharma L.P.

Investor and Media Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: bcs@egalet.com
Tel: 917-432-9275

Friday, December 16th, 2016 Uncategorized Comments Off on $EGLT #Egalet002 Positive Top-Line Results

$DGICB & Mountain States Mutual Casualty Company

MARIETTA, Pa. and ALBUQUERQUE, N.M., Dec. 16, 2016  — Donegal Mutual Insurance Company (“Donegal Mutual”) and Mountain States Mutual Casualty Company (“Mountain States”) announced today that they have signed an agreement whereby, subject to applicable regulatory approvals and the approval of the policyholders of Mountain States, Mountain States will merge with and into Donegal Mutual.  Donegal Mutual will be the surviving company in the merger, and Mountain States’ insurance subsidiaries, Mountain States Indemnity Company and Mountain States Commercial Insurance Company, will become insurance subsidiaries of Donegal Mutual.  Mountain States and its insurance subsidiaries currently conduct business together as the Mountain States Insurance Group in the states of Colorado, New Mexico, Texas and Utah.

Upon consummation of the merger, Donegal Mutual will enter into quota share reinsurance, services and technology license agreements with Mountain States’ insurance subsidiaries with the intent of making those subsidiaries eligible for A.M. Best Company’s assignment of Donegal Mutual’s group rating of A (Excellent) to those subsidiaries and reducing operating costs of those subsidiaries through economies of scale.  Donegal Mutual and those insurance subsidiaries will market their products together as the Mountain States Insurance Group in the Southwestern region of the United States as they seek profitable growth in the region.

William F. Davis, President of Mountain States, stated that the merger and the related transactions will enable the Mountain States Insurance Group to enhance its competitive position within its property and casualty insurance markets.  Donegal Mutual will bring management assistance, as well as significant operational and technology resources, to provide the Mountain States Insurance Group enhanced opportunities to improve its underwriting profitability and grow its business.  Mr. Davis further noted that the merger, which the board of directors of Mountain States Mutual has unanimously approved, will provide significant benefits and opportunities for the policyholders, agents and employees of the Mountain States Insurance Group.  The executive officers of Mountain States will become officers of Donegal Mutual and will retain their current responsibilities in the current Albuquerque, New Mexico headquarters of the Mountain States Insurance Group.

The proposed affiliation affords Donegal Mutual an opportunity to expand its business into the Southwestern region, where it currently has no operations.  Donald H. Nikolaus, President of Donegal Mutual, remarked, “We look forward to our affiliation with Mountain States, which has longstanding excellent relationships with its independent agents throughout its marketing region.  We will bring our 127-year history of financial strength and profitable growth to the Mountain States Insurance Group as we work with its management team and provide strategic resources to enable the Mountain States Insurance Group to deliver enhanced products and services to its agents and policyholders.”

Mountain States was formed in 1937 and writes commercial lines of insurance in Colorado, New Mexico, Texas and Utah.  The Mountain States Insurance Group had net premiums written of $42.3 million in 2015.

Donegal Mutual, which was incorporated in 1889, is a mutual insurance company located in Marietta, Pennsylvania.  Donegal Mutual underwrites a broad line of personal and commercial insurance coverages.  Donegal Mutual owns approximately 73% of the voting control of Donegal Group Inc., an insurance holding company.  Donegal Mutual and the insurance subsidiaries of Donegal Group Inc. conduct property and casualty insurance business together as the Donegal Insurance Group in 21 Mid-Atlantic, Midwestern, New England and Southern states and had net premiums written of $738.7 million in 2015.  The Class A common stock and the Class B common stock of Donegal Group Inc. are traded on the NASDAQ Global Select Market (NASDAQ:DGICA) (NASDAQ:DGICB).

For an indefinite period of time following the consummation of the affiliation, Donegal Mutual will exclude the business of the Mountain States Insurance Group from its pooling agreement with Atlantic States Insurance Company.

Donegal Mutual and Donegal Group Inc. have completed numerous acquisitions of property and casualty insurance companies since 1986 and expect to continue to acquire other insurance companies over time to expand their business.

Jeffrey D. Miller, Executive Vice President & Chief Financial Officer
Donegal Mutual Insurance Company
Phone: (717) 426-3529 ext. 7357
Fax: (717) 426-7009
E-mail: jeffmiller@donegalgroup.com

William F. Davis, President & Chief Executive Officer
Mountain States Insurance Group
Phone: (505) 764-1414
Fax: (505) 764-3600
E-mail: wdavis@msig-nm.com
Friday, December 16th, 2016 Uncategorized Comments Off on $DGICB & Mountain States Mutual Casualty Company

$OPGN Provides #ATM Program Update

GAITHERSBURG, Md., Dec. 16, 2016  — OpGen, Inc. (NASDAQ:OPGN) announces that during the fourth quarter of 2016 it has issued approximately 3.6 million shares of its common stock under its previously announced “at the market offering” program, resulting in aggregate net proceeds to the Company of approximately $4.6 million.  The proceeds will be used to support the company’s research, development and manufacturing of product candidates, and for other general corporate purposes.

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

About OpGen
OpGen, Inc. is harnessing the power of informatics and genomic analysis to provide complete solutions for patient, hospital and network-wide infection prevention and treatment. Learn more at www.opgen.com and follow OpGen on Twitter and LinkedIn.

 

OpGen Contact:
Michael Farmer
Director, Marketing
240-813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com

OpGen Investor and Media Contact:
MacDougall Biomedical Communications
Cammy Duong
781-591-3443
cduong@macbiocom.com
Friday, December 16th, 2016 Uncategorized Comments Off on $OPGN Provides #ATM Program Update

$APVO Amends Collaboration w/ #MorphoSys #MOR209 #ES414 #Immunotherapeutic

SEATTLE, Dec. 15, 2016  — Aptevo Therapeutics Inc. (Nasdaq:APVO) a biotechnology company focused on developing novel oncology and hematology therapeutics, today announced that it has amended the terms of its collaboration agreement with MorphoSys AG, originally executed in August 2014, for the joint worldwide development and commercialization of MOR209/ES414, a novel bispecific immuno-oncology therapeutic currently being evaluated in a Phase 1 clinical study for the treatment of metastatic castration-resistant prostate cancer (mCRPC.)

Aptevo and MorphoSys agreed to modify their collaboration agreement to, among other things, adjust the allocation of certain manufacturing and development costs and extend MorphoSys’ convenience termination rights.  Under the amendment, the timeframe for a one-time right to terminate the collaboration agreement by MorphoSys has been extended from December 31, 2016 to June 30, 2017, or after review of clinical data from the first 6 patients enrolled and dosed in the MOR209/ES414 Phase I clinical trial.  In addition, the companies have agreed that Aptevo will be responsible for 75% of the development costs of the program through June 30, 2017 with MorphoSys responsible for the remaining 25%, after which time the cost-sharing ratio shifts to 49% for Aptevo and 51% for MorphoSys through 2018, and subsequently 36% for Aptevo and 64% for MorphoSys in 2019 and thereafter.

“Bispecific antibodies represent an emerging new class of protein therapeutics that holds promise as an important new immunotherapeutic approach to cancer treatment,” commented Marvin L. White, President and Chief Executive Officer of Aptevo.  “We are pleased to have the opportunity to collaborate with MorphoSys on the development of MOR209/ES414 and look forward to the results of the ongoing Phase I dose escalation study.”

About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Our core technology is the ADAPTIR™ (modular protein technology) platform. Aptevo has four commercial products in the areas of hematology and infectious diseases, as well as various investigational stage product candidates in immuno-oncology.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding the potential opportunities, our technology and related pipeline, collaboration and partnership opportunities and their financial implications and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including possible negative effects on our business operations, assets or financial results as a result of the separation; a deterioration in our business or prospects; adverse developments in our customer-base or markets; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in our filings with the Securities and Exchange Commission, including Aptevo’s most recent Quarterly Report on Form 10-Q, as filed on November 14, 2016. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement.

Contact: 
Stacey Jurchison
Senior Director, Investor Relations and Corporate Communications
206-859-6628
JurchisonS@apvo.com
Friday, December 16th, 2016 Uncategorized Comments Off on $APVO Amends Collaboration w/ #MorphoSys #MOR209 #ES414 #Immunotherapeutic

$QUIK #CEO to Participate in Panel Discussion at #CES

SUNNYVALE, CA–(Dec 16, 2016) – QuickLogic Corporation (NASDAQ: QUIK), a developer of ultra-low power programmable sensor processing SoCs, display bridges, FPGAs, and embedded FPGA IP, today announced that its president and CEO, Brian Faith, will be participating in a MEMS & Sensors Industry Group panel discussion at the 2017 Consumer Electronics Show (CES) in Las Vegas. The company will also host a private hospitality suite demonstrating its latest SoC solutions that enable more immersive user experiences in smartphone, wearable device and IoT applications.

Panel Discussion
Thursday, January 5, 11:30 a.m. – 12:30 p.m., Venetian, Level 4, Marcello 4501

Mr. Faith will be participating in a panel discussion at the show entitled “Where are Consumer Electronics Taking the Sensors Industry?” He and other industry leaders will be covering topics such as the current trends in consumer electronics, the technology and consumer trends driving sensor investment, and the gaps that hinder achieving key technology and investment goals.

QuickLogic Hospitality Suite
Venetian Towers, Floor 31, suite 310 and 312

The company will host a hospitality suite, giving attendees the opportunity to collaborate directly with company executives and engineers. Attendees will also have the opportunity to learn more about the company’s new ArcticPro™ embedded FPGA IP initiative which enables SoC designers to add post-production design flexibility to their devices.

Some of the many solutions for smartphone, wearable and IoT applications at the suite include:

  • EOS™ S3 Sensor Processing Platform featuring:
    • Always-on voice processing (including Sensory “Truly Hands Free Voice demo”) with industry-leading ultra-low power consumption
    • CyWeeMotion’s Android-compliant sensor fusion optimized for low power consumption
    • Voice-enabled TV remote control with Peel’s SmartIR technology
  • Wide range of OEM products showcasing QuickLogic’s SoCs, display bridges, and FPGAs

Meetings are by appointment only. Please email info@quicklogic.com to set up a meeting.

MEMS & Sensor Industry Group – QuickLogic Booth
Booth 40736 (Smart Home), Sands Convention Center, Level 2

QuickLogic will be showcasing its EOS S3 Sensor Processing Platform at the MEMS & Sensors Industry Group Pavilion.

For more information, conference program schedules and exhibit hours, please visit the CES website at http://www.cesweb.org/

About QuickLogic
QuickLogic Corporation (NASDAQ: QUIK) enables OEMs to maximize battery life for highly differentiated, immersive user experiences with Smartphone, Wearable and IoT devices. QuickLogic delivers these benefits through industry leading ultra-low power customer programmable SoC semiconductor solutions, embedded software, and algorithms for always-on voice and sensor processing. The company’s embedded FPGA initiative also enables SoC designers to easily implement post production changes, and increase revenue by providing hardware programmability to their end customers. For more information about QuickLogic, visit www.quicklogic.com.

The QuickLogic logo, QuickLogic and ArcticLink are registered trademarks of QuickLogic Corporation. All other brands or trademarks are the property of their respective holders and should be treated as such.

Code: QUIK-G

Contact:
Andrea Vedanayagam
Veda Communications
(408) 656-4494
Email Contact

Friday, December 16th, 2016 Uncategorized Comments Off on $QUIK #CEO to Participate in Panel Discussion at #CES

$LTEA Expands Northeast Distribution through Partnership with #Bozzuto’s

– further consolidates Northeast positioning –

HICKSVILLE, NY–(Dec 15, 2016) – Long Island Iced Tea Corp. (NASDAQ: LTEA) (the “Company”), a growth-oriented company focused on the ready-to-drink (“RTD”) tea segment in the beverage industry, today announced a new partnership to distribute its beverages through Bozzuto’s Inc. (“Bozzuto’s”), one of New England’s largest wholesalers.

Philip Thomas, Chief Executive Officer of the Company, stated, “We are excited to build this new relationship and further enhance our Northeast distribution network through this partnership with Bozzuto’s, as they are one of the largest and premiere grocery wholesalers in the region. Our brand has its roots in the Northeast and this partnership will further strengthen our presence across this market.”

Long Island Iced Tea® is a RTD tea that will initially be available through Bozzuto’s in gallon bottles beginning in early 2017.

About Bozzuto’s Inc.

Bozzuto’s Inc. is a leading total service wholesale distributor of food and household products to over 800 grocery retailers in New England, New York, New Jersey and Pennsylvania. Established in 1945, the company is headed by Chairman, President and CEO Michael A. Bozzuto. Based in Cheshire, Connecticut, Bozzuto’s is a longtime active supporter of Special Olympics. For more information, visit Bozzuto’s website at www.bozzutos.com.

About Long Island Iced Tea Corp.

Headquartered in Long Island, New York, Long Island Iced Tea Corp. operates in the ready-to-drink segment of the beverage industry. The Company has developed non-alcoholic, premium iced tea bottled beverages made with quality ingredients that are offered at an affordable price. The Company is currently organized around its flagship brand Long Island Iced Tea®, a premium, ready-to-drink iced tea sold primarily on the East Coast of the United States through a network of regional chains and distributors. The Company’s website is www.longislandicedtea.com.

Forward Looking Statements

This press release includes statements of the Company’s expectations, intentions, plans and beliefs that constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to come within the safe harbor protection provided by those sections. These statements, which involve risks and uncertainties, relate to the discussion of the Company’s business strategies and its expectations concerning future operations, margins, sales, new products and brands, potential joint ventures, potential acquisitions, expenses, profitability, liquidity and capital resources and to analyses and other information that are based on forecasts of future results and estimates of amounts not yet determinable. These statements include any statement that does not directly relate to a historical or current fact. You can also identify these and other forward-looking statements by the use of such words as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “thinks,” “estimates,” “seeks,” “predicts,” “could,” “projects,” “potential” and other similar terms and phrases, including references to assumptions. These forward looking statements are made based on expectations and beliefs concerning future events affecting the Company and are subject to uncertainties, risks and factors relating to its operations and business environments, all of which are difficult to predict and many of which are beyond its control, that could cause its actual results to differ materially from those matters expressed or implied by these forward looking statements. These risks include its history of losses and expectation of further losses, its ability to expand its operations in both new and existing markets, its ability to develop or acquire new brands, its relationships with distributors, the success of its marketing activities, the effect of competition in its industry and economic and political conditions generally, including the current economic environment and markets. More information about these and other factors are described in the reports the Company files with the Securities and Exchange Commission, including but not limited to the discussions contained under the caption “Risk Factors.” When considering these forward looking statements, you should keep in mind the cautionary statements in this press release and the reports the Company files with the Securities and Exchange Commission. New risks and uncertainties arise from time to time, and the Company cannot predict those events or how they may affect it. The Company assumes no obligation to update any forward looking statements after the date of this press release as a result of new information, future events or developments, except as required by the federal securities laws.

Contacts:

For Investors
Phil Thomas
Long Island Iced Tea Corp.
1-855-542-2832
info@longislandteas.com

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$VBTX to #Merge with #SovereignBancshares

DALLAS, Dec. 14, 2016  — Veritex Holdings, Inc. (NASDAQ:VBTX) (“Veritex”), the parent holding company for Veritex Community Bank, today announced that it has entered into a definitive agreement to merge with Dallas-based Sovereign Bancshares, Inc. and its wholly-owned subsidiary Sovereign Bank.

Sovereign Bancshares, through Sovereign Bank, operates ten full service banking locations in Texas. As of September 30, 2016, Sovereign Bancshares, on a consolidated basis, reported total assets of $1.1 billion, total deposits of $858.6 million, and total equity capital of $118.4 million. As of September 30, 2016, the combined company would have combined assets of $2.4 billion, combined loans of $1.8 billion and combined deposits of $1.9 billion.

Veritex Holdings Chairman and Chief Executive Officer C. Malcolm Holland stated, “The merger with Sovereign Bank is a transformative event in the growth of Veritex Community Bank. Upon completion of the transaction, Veritex Community Bank will be one of the ten largest banks headquartered in Dallas-Fort Worth.”

Thomas J. Mastor, the Chief Executive Officer of Sovereign Bancshares, said, “We are excited to combine with an organization that shares our dedication to customer service and quality community banking and, when combined, we will complement each other tremendously. We believe our team’s experience and expertise will meaningfully contribute to serving the shareholders, customers, employees and communities of both institutions.”

“This merger will double our asset size as well as our number of locations. It significantly expands our presence in the Dallas metropolitan area and marks our entry into the Austin, Fort Worth and Houston communities,” Holland continued. “We are not just getting bigger, we’re getting better. Sovereign Bank is a great bank; they have a quality management team as well as talented and dedicated employees. Most importantly they, like Veritex, are community focused. We look forward to Sovereign’s clients, shareholders, and employees becoming part of the Veritex family.”

Under the terms of the merger agreement, Veritex will issue 5,117,647 shares of its common stock and pay approximately $58.0 million in cash to existing shareholders of Sovereign Bancshares, subject to certain conditions and potential adjustments as described in the merger agreement. In connection with the transaction, two representatives of Sovereign Bancshares’ board of directors will join the Veritex board of directors. The merger agreement contains customary representations and warranties and covenants by Veritex and Sovereign Bancshares. The transaction is subject to customary closing conditions, including the receipt of regulatory approvals and approval of the merger agreement by the shareholders of Sovereign Bancshares and the issuance of shares by the shareholders of Veritex Holdings.  The transaction is expected to close during the second quarter of 2017.

Veritex was advised in this transaction by Stephens Inc., as financial advisor, and Norton Rose Fulbright US LP as legal counsel. Sovereign Bancshares was advised by Sandler + O’Neill Partners, L.P., as financial advisor, and Fenimore, Kay, Harrison & Ford, LLP as legal counsel.

In addition to the information contained within this announcement, an Investor Presentation has been posted on Veritex Community Bank’s website (www.veritexbank.com) containing additional information regarding this transaction.

About Veritex Holdings, Inc.
Headquartered in Dallas, Texas, Veritex Holdings is a bank holding company that conducts banking activities through its wholly-owned subsidiary, Veritex Community Bank, with locations throughout the Dallas metropolitan area. Veritex Community Bank is a Texas state chartered bank regulated by the Texas Department of Banking and the Board of Governors of the Federal Reserve System. For more information, visit www.veritexbank.com.

About Sovereign Bancshares, Inc.
Founded in 2004, Sovereign Bancshares is a bank holding company that provides financial services including a wide range of depository services, commercial and industrial lending, SBA loans, specialized lending for the energy industry, private banking, real estate lending and treasury management services through its wholly-owned subsidiary Sovereign Bank. Sovereign Bank currently serves its customers through seven branch locations in the Dallas – Fort Worth Metroplex, two Austin branches and one Houston location.

Additional Information for Investors and Shareholders
The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy any securities or a solicitation of any vote or approval. In connection with the proposed merger of Veritex Holdings and Sovereign Bancshares, Veritex Holdings will file a registration statement on Form S-4 with the Securities and Exchange Commission (the “SEC”). The registration statement will include a joint proxy statement of Veritex and Sovereign Bancshares, which also will constitute a prospectus of Veritex Holdings, which Veritex Holdings and Sovereign Bancshares will send to their respective shareholders. Investors and shareholders are advised to read the joint proxy statement/prospectus when it becomes available because it will contain important information about Veritex Holdings, Sovereign Bancshares and the proposed transaction. These documents will contain important information relating to the proposed transaction. When filed, this document and other documents relating to the merger filed by Veritex Holdings can be obtained free of charge from the SEC’s website at www.sec.gov.

Participants in the Transaction
Veritex Holdings, Sovereign Bancshares and certain of their respective directors and executive officers may be deemed under the rules of the SEC to be participants in the solicitation of proxies from the respective shareholders of Veritex Holdings and Sovereign Bancshares in connection with the proposed transaction. Certain information regarding the interests of these participants and a description of their direct and indirect interests, by security holdings or otherwise, will be included in the joint proxy statement/prospectus regarding the proposed transaction when it becomes available. Additional information about Veritex Holdings and its directors and officers may be found in the definitive proxy statement of Veritex Holdings relating to its 2016 Annual Meeting of Stockholders filed with the SEC on April 7, 2016 and Veritex Holdings annual report on Form 10-K for the year ended December 31, 2015 filed with the SEC on March 15, 2016. The definitive proxy statement and annual report can be obtained free of charge from the SEC’s website at www.sec.gov or from Veritex Holdings’ at its website, www.veritexbank.com. Documents filed with the SEC by Veritex Holdings will be available free of charge by directing a request by telephone or mail to Veritex, 8214 Westchester Drive, Suite 400, Dallas, TX 75225 Attn: Investor Relations. Veritex Holdings’ telephone number is (972) 349-6200.

No Offer or Solicitation
This press release shall not constitute an offer to sell, a solicitation of an offer to sell, or the solicitation or an offer to buy any securities. There will be no sale of securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirement of Section 10 of the Securities Act of 1933, as amended.

Special Note Concerning Forward-Looking Statements
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. These forward-looking statements reflect the current views of Veritex Holdings’ management with respect to, among other things, future events and Veritex Holdings’ financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “project,” “forecast,” “goal,” “target,” “would” and “outlook,” or the negative variations of those words or other comparable words of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about Veritex Holdings’ industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond Veritex Holdings’ control. Accordingly, Veritex Holdings cautions you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although Veritex believes that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements. Factors that could cause actual results to differ materially from Veritex Holdings’ expectations include successfully implementing its growth strategy, including identifying acquisition targets and consummating suitable acquisitions;  continuing to sustain internal growth rate; providing competitive products and services that appeal to its customers and target market; continuing to have access to debt and equity capital markets and achieving its performance goals. The foregoing list of factors is not exhaustive.

For discussion of these and other risks that may cause actual results to differ from expectations, please refer to “Special Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” in Veritex Holdings’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2016 and any updates to those risk factors set forth in Veritex Holdings’ subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. If one or more events related to these or other risks or uncertainties materialize, or if Veritex Holdings’ underlying assumptions prove to be incorrect, actual results may differ materially from what Veritex Holdings anticipates. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and Veritex does not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise. New risks and uncertainties arise from time to time, and it is not possible for Veritex Holdings to predict those events or how they may affect it. In addition, Veritex cannot assess the impact of each factor on Veritex Holdings’ business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. All forward-looking statements, expressed or implied, included in this press release are expressly qualified in their entirety by this cautionary statement. This cautionary statement should also be considered in connection with any subsequent written or oral forward-looking statements that Veritex Holdings or persons acting on Veritex Holdings’ behalf may issue.

Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and may not reflect actual results.

For more information contact:
Susan Caudle
Veritex Community Bank
scaudle@veritexbank.com
972-349-6132
Thursday, December 15th, 2016 Uncategorized Comments Off on $VBTX to #Merge with #SovereignBancshares

$DRYS Comprehensive #Refinancing, #DeLeveraging & #StrategicRepositioning

ATHENS, GREECE–(Dec 15, 2016) –  DryShips Inc. (NASDAQ: DRYS) (the “Company”), an international owner of drybulk carriers and offshore support vessels, announced today that, subject to definitive documentation, it has reached an agreement with Sifnos Shareholders Inc. (“Sifnos”), an entity controlled by our Founder and Chairman Mr. Economou, for the refinancing of the majority of its outstanding debt under a virtue of a new senior secured revolving facility (“New Revolver”).

Under the terms of the New Revolver, Sifnos will extend a new loan of up to $200.0 million secured by all of the Company’s present and future assets except the MV Raraka which will continue to be financed by its existing commercial lender. The new loan will carry an interest rate of Libor plus 5.5%, is non-amortizing, has a tenor of 3 years, has no financial covenants and will be arranged at a cost of 2.0%. In addition, Sifnos will have the ability to participate in realized asset value increases of the collateral base in a fixed percentage of 30%.

The transaction was approved by the Company’s independent members of the board and a fairness opinion was obtained in connection with this transaction.

Following the repayment of $33.5 million under the previous Sifnos facility and the write-off of approximately $1.6 million of overdue interest under the ex-HSH Syndicated Facilities, we expect the following year-end approximate balances:

  • Total debt: between $135.0 million – 140.0 million
  • Total cash: between $40.0 million – 50.0 million
  • Available undrawn liquidity under New Revolver: $79.0 million

The Company also expects to enter into new agreements with TMS Bulkers Ltd. and TMS Offshore Services Ltd. entities (“TMS”) controlled by our Chairman Mr. Economou, to streamline the services offered by its managers as of January 1, 2017. In connection with the new agreements that entail an increased scope of services to be provided by TMS, including executive management services, the Company will terminate the consulting agreements with Fabiana Services S.A., Vivid Finance Limited and Basset Holdings Inc., entities controlled by our Founder and Chairman Mr. George Economou and our President Mr. Anthony Kandylidis. The all-in base cost for providing the increased scope of services will be reduced to $1,644/day per vessel, that is a 33% reduction from current levels, basis a minimum of 20 vessels, decreasing thereafter to $1,500/day per vessel.

Lastly, the Board of Directors has appointed Mr. Anthony Kandylidis as President and Chief Financial Officer and Mr. Dimitris Dreliozis as Vice President, Finance.

Mr. Anthony Kandylidis, President and Chief Financial Officer commented:

“We are delighted to announce a series of positive developments for the Company. We appreciate the support shown by our Founder to restore our balance sheet. Following the closing of our successful equity offering and putting the New Revolver in place, we will have total available liquidity of between $119.0 million and 129.0 million that will not only give us comfort to fund operations but also gives us the opportunity to evaluate the possible acquisition of assets at distressed values. We believe that given where we are in the cycle in both the tanker and drybulk markets, we are faced with a unique entry point to acquire vessels in these sectors at historic low prices. Together with the support of our manager TMS and the revised agreements that provide for full scalability, we will make DryShips great again.”

About DryShips Inc.

The Company is an owner of drybulk carriers and offshore support vessels that operate worldwide. The Company owns a fleet of 13 Panamax drybulk carriers with a combined deadweight tonnage of approximately 1.0 million tons, and 6 offshore supply vessels, comprising 2 platform supply and 4 oil spill recovery vessels.

The Company’s common stock is listed on the NASDAQ Capital Market where it trades under the symbol “DRYS.”

Forward-Looking Statements
Matters discussed in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with such safe harbor legislation.

Forward-looking statements reflect the Company’s current views with respect to future events, including the registered direct offering, and financial performance and may include statements concerning plans, objectives, goals, strategies and other statements.

The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in the Company’s records and other data available from third parties. Although the Company believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond the Company’s control, the Company cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.

Important factors that, in the Company’s view, could cause actual results to differ materially from those discussed in the forward-looking statements include the failure to consummate the registered direct offering, the strength of world economies and currencies, general market conditions, including changes in charter rates and vessel values, failure of a seller to deliver one or more vessels, failure of a buyer to accept delivery of a vessel, inability to procure acquisition financing, default by one or more charterers of our ships, changes in demand for drybulk commodities, changes in demand that may affect attitudes of time charterers, scheduled and unscheduled drydocking, changes in our voyage and operating expenses, including bunker prices, dry-docking and insurance costs, changes in governmental rules and regulations, changes in our relationships with the lenders under our debt agreements, potential liability from pending or future litigation, domestic and international political conditions, potential disruption of shipping routes due to accidents, international hostilities and political events or acts by terrorists.

Risks and uncertainties are further described in reports filed by DryShips Inc. with the SEC, including the Company’s most recently filed Annual Report on Form 20-F.

Investor Relations / Media:

Nicolas Bornozis
Capital Link, Inc. (New York)
Tel. 212-661-7566
E-mail: dryships@capitallink.com

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$ESEA #Acquisition of #FeederContainership & #PrivatePlacement

MAROUSSI, ATHENS, GREECE–(Dec 15, 2016) – Euroseas Ltd. (NASDAQ: ESEA), an owner and operator of drybulk and container carrier vessels and provider of seaborne transportation for drybulk and containerized cargoes, announced today that it signed a memorandum of agreement to purchase the M/V RT Dagr, a feeder containership vessel of 1,645 teu built in 1998 in Germany, for approximately 900,000 shares of the Company’s common stock. The vessel is expected to be delivered to the Company in December 2016. The vessel will be acquired from an entity controlled by Tennenbaum Capital Partners, a holder of the Company’s preferred stock.

The Company also announced that it reached an agreement with Friends Investment Co., an affiliate and its largest shareholder, to sell to Friends 719,425 shares of common stock at $1.39 per share, the closing price of the Company shares on December 14, 2016, for total proceeds of $1,000,000. The agreement is subject to customary legal documentation.

Aristides Pittas, Chairman and CEO of Euroseas commented: “We are very pleased to announce the acquisition of M/V RT Dagr for common stock. This acquisition not only further positions the Company to benefit from a potential increase in the containership market after a long period of depressed rates, but also underlines the Company’s strategy and ability to act as a consolidator of tonnage in the feeder containership sector. Furthermore, we are pleased to announce raising one million dollars in a private placement with our main shareholder and founder of our Company. This investment evidences our main shareholder’s support and confidence in the prospects and strategy of our Company and further strengthens our balance sheet, and will assist us in pursuing our fleet renewal plans.”

Including the acquisition of M/V RT Dagr and previously announced acquisition of M/V Capetan Tassos (to be delivered to the Company in January 2017), the Company’s fleet will consist of 14 vessels, including four Panamax drybulk carriers, one Handymax drybulk carrier, one Kamsarmax drybulk carrier, and eight feeder containerships.

About Euroseas Ltd.: Euroseas Ltd. was formed on May 5, 2005 under the laws of the Republic of the Marshall Islands to consolidate the ship owning interests of the Pittas family of Athens, Greece, which has been in the shipping business over the past 140 years. Euroseas trades on the NASDAQ Capital Market under the ticker ESEA since January 31, 2007.

Euroseas operates in the dry cargo, drybulk and container shipping markets. Euroseas’ operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company and Eurobulk (FE) Ltd. Inc., also an affiliated ship management company, which are responsible for the day-to-day commercial and technical management and operations of the vessels. Euroseas employs its vessels on spot and period charters and through pool arrangements.

Including M/V Capetan Tassos to be delivered in January 2017 and the M/V RT Dagr, the Company has a fleet of 14 vessels, including 4 Panamax drybulk carriers, 1 Handymax drybulk carrier, 1 Kamsarmax drybulk carrier, and 8 Feeder containerships. Euroseas 6 drybulk carriers have a total cargo capacity of 426,372 dwt, its 8 containerships have a cargo capacity of 13,170 teu. The Company has also signed contracts for the construction of one Kamsarmax (82,000 dwt) fuel efficient drybulk carrier. Including the new-building, the total cargo capacity of the Company’s drybulk vessels will be 508,372 dwt.

Forward Looking Statement: This press release contains forward-looking statements (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events and the Company’s growth strategy and measures to implement such strategy; including expected vessel acquisitions and entering into further time charters. Words such as “expects,” “intends,” “plans,” “believes,” “anticipates,” “hopes,” “estimates,” and variations of such words and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates that are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of the Company. Actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to changes in the demand for dry bulk vessels and container ships, competitive factors in the market in which the Company operates; risks associated with operations outside the United States; and other factors listed from time to time in the Company’s filings with the Securities and Exchange Commission. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Visit our website www.euroseas.gr

Company Contact
Tasos Aslidis
Chief Financial Officer
Euroseas Ltd.
11 Canterbury Lane,
Watchung, NJ 07069
Tel, (908) 301-9091
E-mail: aha@euroseas.gr

Investor Relations / Financial Media
Nicolas Bornozis
President
Capital Link, Inc.
230 Park Avenue, Suite 1536
New York, NY 10169
Tel, (212) 661-7566
E-mail: euroseas@capitallink.com

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$COOL Announces Clinical Advisory Board

SOUTH PLAINFIELD, NJ–(Dec 14, 2016) – Following Majesco Entertainment, Inc.’s (NASDAQ: COOL) (“Majesco”) announcement on 12/8/16 that it had signed a definitive merger agreement with PolarityTE, Inc. (“Polarity”) www.polarityte.com, Polarity has revealed the first wave of their World Class Clinical Advisory Board, as Drs. Michael Grant, Stephen Milner, and Anand Kumar. Chairman and CEO, Denver Lough MD, PhD elaborated, “Our goal is to build an entirely new type of regenerative medicine company with PolarityTE™. The PolarityTE™ Clinical Advisory Board will play a critical role in translating our regenerative technology into pragmatic clinical practice, helping us address the realities of the field on a real-time basis. It is this tangible feedback that allows PolarityTE™ technology to evolve quickly under the guidance of thought leaders in reconstructive surgery and regenerative medicine, while permitting our platform to break into new markets and develop new integrative technologies. We are extremely excited to announce the first tier of our world class clinical advisory board” as:

Michael P Grant MD, PhD, FACS
Paul N. Manson Distinguished Professor and Chief
Plastic, Reconstructive and Maxillofacial Surgery
R Adams Cowley Shock Trauma Center
University of Maryland Medical Center

Stephen Milner MD, DDS, DSc, FRCSE, FACS
Professor of Plastic and Reconstructive Surgery and Pediatrics at Johns Hopkins School of Medicine,
Director of the Johns Hopkins Burn Center,
Professor at the Bloomberg School of Public Health,
Director of the Michael D Hendrix Burn Research Center,
Adjunct Professor Uniformed Services University of the Health Sciences,
Honorary Civilian Consultant Advisor to the British Army in Plastic Surgery and Burns

Anand Kumar MD, FACS
Associate Professor of Plastic and Reconstructive Surgery
Director, Center for Pediatric Craniofacial Surgery
Johns Hopkins School of Medicine

About PolarityTE
PolarityTE, Inc. is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough MD, PhD. This radical and proprietary technology employs a patients’ own cells for the healing of full-thickness functionally-polarized tissues. If clinically successful, the PolarityTE platform will be able to provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient’s own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. It is because PolarityTE uses a natural and biologically sound platform technology, which is readily adaptable to a wide spectrum of organ and tissue systems, that the company and its world-renowned clinical advisory board, are poised to drastically change the field and future of translational regenerative medicine. More info can be found online at www.polarityte.com Welcome to the Shift™

Forward Looking Statements
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company’s ongoing compliance with the requirements of The NASDAQ Stock Market and the Company’s ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. 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 filed with the SEC (copies of which may be obtained at 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.

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