Archive for May, 2017

$CAAS Announces Receipt of Preliminary Non-Binding “Going Private” Proposal

WUHAN, China, May 15, 2017  — China Automotive Systems, Inc. (NASDAQ:  CAAS) (“CAAS” or the “Company”), a leading power steering components and systems supplier in China, today announced that its Board of Directors (the “Board”) has received a preliminary non-binding proposal letter, dated May 14, 2017, from its Chairman, Mr. Hanlin Chen, to acquire all of the outstanding shares of common stock of the Company not already beneficially owned by Mr. Chen for US$5.45 per share of common stock in cash. Mr. Chen and his affiliates currently beneficially own approximately 56.4% of the issued and outstanding shares of common stock of the Company on a fully diluted and as-converted basis. The proposal is expressly conditioned on approval by a special committee of the Board comprised of independent directors and is subject to a non-waivable condition requiring approval by a majority vote of the Company’s unaffiliated stockholders.

The Board has established a special committee of the Board (the “Special Committee”), consisting of Mr. Arthur Wong, Mr. Robert Tung and Mr. Guangxun Xu, to consider the proposal. The Special Committee is empowered to, and will be responsible for, among other things, investigating, evaluating, negotiating and making a recommendation to the Board with respect to the proposal. The Special Committee is also empowered to retain its own independent advisors to assist in the evaluation of the proposal and any alternative proposals.

The Company cautions that no decisions have been made by the Special Committee or the Board with respect to the Company’s response to the proposal. There can be no assurance that any definitive offer will be made by Mr. Chen or any other person, that any definitive agreement will be executed relating to the proposal or any other transaction, or that this or any other transaction will be approved or consummated.

About China Automotive Systems, Inc.

Based in Hubei Province, the People’s Republic of China, China Automotive Systems, Inc. is a leading supplier of power steering components and systems to the Chinese automotive industry, operating through eight Sino-foreign joint ventures. The Company offers a full range of steering system parts for passenger automobiles and commercial vehicles. The Company currently offers four separate series of power steering with an annual production capacity of over 5.5 million sets of steering gears, columns and steering hoses. Its customer base is comprised of leading auto manufacturers, such as China FAW Group, Corp., Dongfeng Auto Group Co., Ltd., BYD Auto Company Limited, Beiqi Foton Motor Co., Ltd. and Chery Automobile Co., Ltd. in China, and Chrysler Group LLC in North America. For more information, please visit: http://www.caasauto.com.

Forward Looking Statements

This press release contains statements that are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our estimates and assumptions only as of the date of this press release. These forward-looking statements include statements regarding the qualitative and quantitative effects of the accounting errors, the periods involved, the nature of the Company’s review and any anticipated conclusions of the Company or its management and other statements that are not historical facts. Our actual results may differ materially from the results described in or anticipated by our forward-looking statements due to certain risks and uncertainties. As a result, the Company’s actual results could differ materially from those contained in these forward-looking statements due to a number of factors, including those described under the heading “Risk Factors” in the Company’s Form 10-K annual report filed with the Securities and Exchange Commission on March 30, 2017, and in documents subsequently filed by the Company from time to time with the Securities and Exchange Commission. We expressly disclaim any duty to provide updates to any forward-looking statements made in this press release, whether as a result of new information, future events or otherwise.

For further information, please contact:

Jie Li
Chief Financial Officer
China Automotive Systems, Inc.
Email: jieli@chl.com.cn

Kevin Theiss
Investor Relations
+1-646-726-6511
Email: Kevin.Theiss@awakenlab.com

Monday, May 15th, 2017 Uncategorized Comments Off on $CAAS Announces Receipt of Preliminary Non-Binding “Going Private” Proposal

$EKSO CEO Update on Magnitude of Stroke Rehab Market, CNBC’s “On the Money”

RICHMOND, Calif., May 15, 2017 — Thomas Looby, President and Chief Executive Officer of Ekso Bionics Holdings, Inc. (NASDAQ:EKSO), a robotic exoskeleton company delivering solutions for medical and industrial markets, provided an update on the stroke rehabilitation market. Addressing the stroke market is a unique opportunity for Ekso Bionics to create a new standard of care focusing on issues such as cost of care, safety of care-workers, and length of stay, while simultaneously building a long-term sustainable business model.

The interview, which aired on CNBC’s “On the Money” with Becky Quick, can be viewed here: Ekso on CNBC Becky Quick

“To meet global demands for quality, efficiency and performance, companies around the world continue to integrate robotic technologies into their processes.   Healthcare is no exception as robot-assisted surgery has become the standard of care for some procedures. In the area of stroke rehabilitation, there is a need to ignite patient neuroplasticity through repetitive motion and the Ekso GT technology is ideally positioned to meet that demand,” said Thomas Looby, President and Chief Executive Officer of Ekso Bionics.

“Being the first in a new category means charting new territory with limited visibility on the pace of adoption and the ideal mix of sales versus rentals.  We believe that we have the best and smartest medical device on the market for our clinical customers with the broadest FDA approval in the industry.  We remain confident in our ability to deliver on the promise of expanding the use of robotic exoskeletons across industries. We have clear objectives for our businesses, are closely monitoring key metrics and will aggressively act to course correct as needed,” added Looby.

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

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

 

Media Contact:
Carrie Yamond
212-867-1788
cyamond@lazarpartners.com

Investor Contact:
Debbie Kaster
415-937-5403
investors@eksobionics.com
Monday, May 15th, 2017 Uncategorized Comments Off on $EKSO CEO Update on Magnitude of Stroke Rehab Market, CNBC’s “On the Money”

$CYRN Detects, Blocks WannaCry Ransomware Worm Attack

Cyren also discovers file sharing services delivering WannaCry 2.0 ransomware

MCLEAN, Va., May 15, 2017  — Cyren (NASDAQ: CYRN), a leading internet Security as a Service provider, has issued a Customer Update for all of the company’s customers and partners regarding the recent massive ransomware outbreak known as WannaCry (aka WannaCryptor, Wcrypt, and WannaCrypt). Cyren’s cloud security products fully protect customers and partners from all known variants of the WannaCry ransomware delivered over email or the web.

  1. Cyren customers are protected from all WannaCry variants and were protected from the initial malware outbreak by Cyren’s SaaS email security gateway, web security gateway, and cloud sandboxing services.
  2. Cyren Threat Intelligence Services partners are protected from all WannaCry variants and were protected from the initial malware outbreak by our OEM threat intelligence services for anti-spam, anti-malware, anti-phishing, IP reputation, and URL filtering.
  3. Cyren’s cloud-based platform identified and protected customers from the first early stages of the WannaCry attack. This included detection of the initial vulnerability exploit payload and classification of all related evidence of the attack in email and web, including “kill switch” IP addresses and command & control (C&C) server callbacks.
  4. Cyren’s cloud has identified over 300 variants of the WannaCry attack to date. Cyren’s cloud automatically classifies any related indicators of the attack, and protects customers from compromised URLs that are used as droppers.
  5. Cyren’s cloud continues to identify infected URLs as well as malicious IP addresses and the C&C server with which the WannaCry attack communicates.
  6. Cyren has identified that WannaCry is still being delivered through several file sharing services over HTTPS.
  7. More details can be viewed on the Cyren blog at: https://blog.cyren.com/articles/wannacrypt-ransomware-spreads-via-nsa-exploit.html

How WannaCry Works
On Friday, May 12, a massive ransomware attack called “WannaCry” hit a broad set of organizations in Europe, including the UK National Health Service (NHS) and Spanish telecom firm Telefonica. Cyren’s blog article (https://blog.cyren.com/articles/wannacrypt-ransomware-spreads-via-nsa-exploit.html) provides further detail about the attack and how it works. One of the important things to note is how the attack spreads. Traditionally, ransomware is delivered via email, but this attack appears to have added Worm capabilities to the ransomware, giving it the ability to self-propagate once inside an organisation by spreading from machine to machine using unpatched vulnerabilities in the Windows operating system. Note that, while the initial attack was stopped by a security researcher who was able to shut down a “kill switch” in the malware, new strains of the ransomware are emerging that have removed this functionality. Organizations need to take steps to make sure they protect themselves against both the initial exploit and lateral propation. See Cyren’s guidance on this below.

How Customers Can Protect Themselves

About Cyren
Cyren (NASDAQ and TASE: CYRN) protects more than 600 million users against cyber attacks and data breaches through its cloud-based web security, email security, DNS security and cloud sandboxing solutions. Relied upon by many of the world’s largest technology companies such as Dell, Google, McAfee and Microsoft, Cyren offers enterprise-focused security-as-a-service solutions as well as embedded solutions for software and security providers. Cyren’s global cloud security platform processes more than 17 billion daily transactions and uses innovative zero-day protection technology to proactively block over 130 million threats each day. Learn more at www.cyren.com.

Blog: blog.cyren.com
Facebook: www.facebook.com/CyrenWeb
LinkedIn: www.linkedin.com/company/cyren
Twitter: www.twitter.com/CyrenInc or twitter.com/cyren_ir

Media Contact:
Matthew Zintel
Zintel Public Relations
281.444.1590
matthew.zintel@zintelpr.com

Monday, May 15th, 2017 Uncategorized Comments Off on $CYRN Detects, Blocks WannaCry Ransomware Worm Attack

$CBMG Second Clinical Site, Expansion of CAR-T Phase I Clinical

SHANGHAI, China and CUPERTINO, Calif., May 15, 2017  — Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the “Company”), a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, today announced the addition of a new independent Phase I clinical trial of the Company’s ongoing CARD-1 study in patients with chemorefractory and aggressive DLBCL. The Company and Shanghai Tongji Hospital (Tongji) are conducting a single arm, non-randomized study to evaluate the safety and efficacy of C-CAR011 (Anti-CD19 single-chain variable fragment (scFv) (41BB-CD3ζ)) therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL). The trial will enroll 15 patients comprised of DLBCL, Primary Mediastinal Large B-Cell Lymphoma (PMBCL) and Follicular Lymphoma (FL).

“Driven by Shanghai’s regional demand, Tongji’s CAR-T expertise, the requirement to confirm site to site consistency and our need to prepare for the next phase of a confirmatory clinical trial, the new trial will benefit patients in Shanghai and provide CBMG with incremental data in safety and tolerability of C-CAR011 in more chemorefractory and aggressive DLBCL patients comprised of unique histogenesis and those with the most common indolent form of non-Hodgkin lymphoma (NHL),” said Mr. Tony Liu, Chief Executive Officer for CBMG.

Mr. Tony Liu added, “Due to our robust clinical pipeline, we believe the Company’s stock is currently undervalued. The management and our scientific team are committed to delivering long-term clinical benefits to patients that have the potential to address very large cancer and knee osteoarthritis markets and create long-term value for shareholders. We believe that CBMG has one of the very few leading integrated chemistry, manufacturing, and controls (CMC) facilities in the world for a cell therapy company, which when fully built out in China, will have the manufacturing capacity to support the treatment of 10,000 cancer and 10,000 knee osteoarthritis patients per year.  With a healthy balance sheet and an efficient deployment of capital that will enable CBMG to execute on its clinical developments over the next twelve months, we are well equipped to further our clinical trials including the addition of new cancer indications by adding more top cancer centers in China for DLBCL and ALL trials using our C-CAR011 product. As a reminder, each year China has approximately five million new cancer patients, which far surpasses the U.S.  We are pleased with our CAR-T patient screening and trial enrollment progress thus far and are on track to share our topline clinical data in the fourth quarter of this year as it becomes available.  We look forward to evaluating new interests in expanding our clinical development and CAR-T partnerships with leading hospitals in major cities in China.”

2017 Business & Technology Highlights

  • In 2016, commenced patient enrollment in China for its CARD-1 (“CAR-T Against DLBCL”) Phase I clinical trial utilizing CBMG’s optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with refractory Diffuse Large B-cell Lymphoma (DLBCL);
  • Announced addition of second clinical trial site for its Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for its CARD-1 Trial in patients with refractory Diffuse Large B-cell Lymphoma (DLBCL) in Shanghai with Tongji Hospital;
  • Commenced CALL-1 (“CAR-T against Acute Lymphoblastic Leukemia”) Phase I clinical trial in China utilizing its optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL);
  • Received the first disbursement of $1.2 million in the $2.29 million grant by California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support pre-clinical studies of AlloJoinTM, CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States;
  • Completed expansion of its 30,000 square foot facility in Huishan High Tech Park in Wuxi, China, with 20,000 square feet of the Wuxi GMP facility dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents;
  • Began construction of a new GMP facility in “Pharma Valley” in Shanghai Zhangjiang High-Tech Park, which will consist of 40,000 square feet dedicated to advanced cell manufacturing;
  • Established a strategic research collaboration with GE Healthcare Life Sciences China to co-develop certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing, and form a joint laboratory within CBMG’s new Shanghai Zhangjiang GMP-facility dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system.

About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. We conduct immuno-oncology and stem cell clinical trials in China using products from our integrated GMP laboratory. Our GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards.  CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoinTM (CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis (KOA). CBMG was recently awarded $2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoinTM for Knee Osteoarthritis in the United States. The Company also recently announced a strategic partnership with GE Healthcare Life Sciences China to establish a joint technology laboratory to develop control processes for the manufacture of CAR-T and stem cell therapies. To learn more about CBMG, please visit www.cellbiomedgroup.com.

About Shanghai Tongji Hospital
Established in 1900, Shanghai Tongji Hospital, a AAA General Hospital in Shanghai, China, is affiliated with Tongji University, one of the oldest and most prestigious universities in China. The hospital comprises 52 clinical and paramedical departments with a total of 4,000 beds and over 4,500 employees. The Department of Rehabilitation is designated as a training and research center of World Health Organization (WHO). The hospital maintains cooperative relationships with other research hospitals and laboratories in many countries including Germany, USA, Japan and France. It has published more research papers than any other medical institution in China.

About PMBCL & FL
Primary mediastinal B-cell lymphoma (PMBCL) belongs to the group of aggressive diffuse large B-cell lymphomas. Its molecular signature and clinical features resemble classical Hodgkin lymphoma. It constitutes approximately 2 % to 4 % of all non-Hodgkin lymphomas (around 6 % of diffuse large B-cell lymphomas (DLBCL)).
Follicular lymphoma (FL) is the most common indolent (slow- growing) form of NHL, accounting for approximately 12 percent of all B-cell NHLs.

Forward-Looking Statements
Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include risks inherent in doing business, trends affecting the global economy, including the devaluation of the RMB by China in August 2015 and other risks detailed from time to time in CBMG’s reports filed with the Securities and Exchange Commission, quarterly reports on form 10-Q, current reports on form 8-K and annual reports on form 10-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” or “continue,” or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

Contacts:
Sarah Kelly 
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com

Vivian Chen
Managing Director Investor Relations, Citigate Dewe Rogerson
+1 347 481-3711
vivian.chen@citigatedr.com
Monday, May 15th, 2017 Uncategorized Comments Off on $CBMG Second Clinical Site, Expansion of CAR-T Phase I Clinical

$STKL to Present at the BMO Capital Markets 12th Annual, May 17

SunOpta Inc. (“SunOpta”) (Nasdaq:STKL) (TSX:SOY), a leading global company focused on organic, non-genetically modified and specialty foods, today announced that David Colo, Chief Executive Officer and Robert McKeracher, Chief Financial Officer, are scheduled to present at the BMO Capital Markets 12th Annual Farm to Market Conference in New York, NY on Wednesday, May 17, 2017 at 8:50 a.m. ET.

The presentation will be available to interested parties via a live audio webcast. The webcast will be available via the “Investors” tab on SunOpta’s website at http://investor.sunopta.com/events.cfm. A replay of the webcast will be archived online for 30 days.

About SunOpta Inc.

SunOpta Inc. is a leading global company focused on organic, non-genetically modified (“non-GMO”) and specialty foods. SunOpta specializes in the sourcing, processing and packaging of organic and non-GMO food products, integrated from seed through packaged products; with a focus on strategic vertically integrated business models. SunOpta’s organic and non-GMO food operations revolve around value-added grain, seed, fruit and vegetable based product offerings, supported by a global sourcing and supply infrastructure.

 

SunOpta Inc. Contact:
ICR
Scott Van Winkle, 617-956-6736
scott.vanwinkle@icrinc.com

Friday, May 12th, 2017 Uncategorized Comments Off on $STKL to Present at the BMO Capital Markets 12th Annual, May 17

$ZIOP Announces Pricing of $50 Million Follow-On Offering of Common Stock

BOSTON, May 12, 2017 — ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, today announced that it has priced an underwritten follow-on offering of 9,708,738 shares of its common stock at an offering price of $5.15 per share to a single institutional investor, before underwriting discounts and commissions. All of the shares are being offered by ZIOPHARM.

Proceeds to ZIOPHARM from this offering are expected to be $50 million, before deducting underwriting discounts and commissions and estimated offering expenses. ZIOPHARM intends to use the net proceeds from the offering for general corporate and working capital purposes, including the advancement of its clinical programs. Given ZIOPHARM’s current development plans and assuming that the offering closes as expected, ZIOPHARM anticipates that its current cash resources, after giving effect to the proceeds of the proposed offering, will be sufficient to fund its operations into the fourth quarter of 2018. The offering is expected to close on May 16, 2017, subject to customary closing conditions.

Guggenheim Securities, LLC is acting as the sole book-running manager for the offering.

These securities being offered are registered pursuant to an automatic shelf registration statement filed with the U.S. Securities and Exchange Commission on February 2, 2015 and the offering is being made only by means of a written prospectus. A copy of the final prospectus relating to these securities, when available, may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, via telephone at (212) 518-9658 or by email to GSEquityProspectusDelivery@guggenheimpartners.com.

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

About ZIOPHARM Oncology, Inc.

ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology company employing novel gene expression, control and cell technologies to deliver safe, effective and scalable cell- and viral-based therapies for the treatment of cancer and graft-versus-host-disease. The Company’s immuno-oncology programs, in collaboration with Intrexon Corporation (NYSE:XON) and the MD Anderson Cancer Center, include chimeric antigen receptor T cell (CAR-T) and other adoptive cell-based approaches that use non-viral gene transfer methods for broad scalability. The Company is advancing programs in multiple stages of development together with Intrexon Corporation’s RheoSwitch Therapeutic System® technology, a switch to turn on and off, and precisely modulate, gene expression in order to improve therapeutic index. The Company’s pipeline includes a number of cell-based therapeutics in both clinical and preclinical testing which are focused on hematologic and solid tumor malignancies.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ZIOPHARM Oncology, Inc., including statements about the anticipated closing of the offering, the amount and use of the anticipated proceeds the Company expects to receive from the offering, clinical development of the Company’s product candidates, expectations regarding the Company’s cash resources to fund its future operations and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the risks and uncertainties related to the satisfaction of customary closing conditions related to the offering and such other factors as are discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and the Company’s other filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Contact:
Amy Trevvett
Vice President, Corporate Communications and Investor Relations
617-502-1881
atrevvett@ziopharm.com
Friday, May 12th, 2017 Uncategorized Comments Off on $ZIOP Announces Pricing of $50 Million Follow-On Offering of Common Stock

$MNTX Pricing for Sale of Half ASV Shares in Underwritten Public Offering

BRIDGEVIEW, Ill., May 12, 2017 — Manitex International, Inc. (NASDAQ:MNTX), a leading international provider of cranes and lifting equipment, today announced that it has priced its sale of 2 million shares of ASV Holdings, Inc., (formerly A.S.V., LLC, “ASV”) in an underwritten public offering.

Manitex will receive net proceeds of approximately $13 million, and after the sale, will retain a minority ownership interest in ASV of 2.1 million shares.

Manitex will use the proceeds of the sale to repay debt.  In addition, and as previously reported, as a result of this transaction, ASV will no longer be included in Manitex’s consolidated financial statements.  This deconsolidation, together with Manitex’s debt repayment will result in a total reduction in Manitex debt of approximately $56 million.

About Manitex International, Inc.

Manitex International, Inc. is a leading worldwide provider of highly engineered specialized equipment including boom trucks, cranes, and other related industrial equipment. Our products, which are manufactured in facilities located in the USA and Europe, 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, PM, Badger, Sabre, and Valla.  Manitex owns a minority interest in ASV which manufactures and sells a line of high quality compact track and skid steer loaders.

Forward-Looking Statement

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
djlangevin@manitex.com 

Darrow Associates, Inc.
Peter Seltzberg, Managing Director
Investor Relations
(516) 419-9915
pseltzberg@darrowir.com
Friday, May 12th, 2017 Uncategorized Comments Off on $MNTX Pricing for Sale of Half ASV Shares in Underwritten Public Offering

$CARA to Host KOL Meeting on Chronic Kidney Disease-Associated Pruritus May 16

STAMFORD, Conn., May 12, 2017 — Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors, today announced that the Company will host a key opinion leader (KOL) breakfast meeting focused on CR845’s potential to treat patients with chronic kidney disease (CKD)-associated pruritus on Tuesday, May 16, 2017 from 8:30 to 10:30 a.m. ET in New York.

The meeting will feature keynote presentations from Steven Zeig, M.D., Nephrologist and Principal Investigator, Pines Clinical Research Inc., and Shayan Shirazian, M.D., Nephrologist and Clinical Researcher, Winthrop-University Hospital and Stony Brook University School of Medicine. Additionally, executives from Cara will review the data from Part A of the Phase 2/3 trial in patients with CKD-associated pruritus and provide an overview of the CR845 program.

A live audio webcast of the event and accompanying slides can be accessed under “Events and Presentations” in the News & Investors section of the Company’s website at www.CaraTherapeutics.com.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors. Cara Therapeutics is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated initial efficacy in patients with moderate-to-severe pain and pruritus without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

INVESTOR CONTACT:
Michael Schaffzin
Stern Investor Relations
212-362-1200
michael@sternir.com

MEDIA CONTACT:
Annie Starr
6 Degrees
973-415-8838 
astarr@6degreespr.com
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$PME Takes Second Step to Enter Consumer Food Market

FUZHOU, China, May 12, 2017 — Pingtan Marine Enterprise Ltd. (Nasdaq: PME) (“Pingtan” or the “Company”), a global fishing company based in the People’s Republic of China (PRC), today announced that the Company has signed a tripartite Framework Agreement (“the Agreement”) with Shanghai City Supermarket Co., Ltd (“City Shop”) and Shenzhen Honglicun Restaurant Co., Ltd (“Honglicun”) to provide its fish products.

Pursuant to the Agreement, Pingtan will provide its deep ocean fish products directly to City Shop and Honglicun as a primer supplier. City Shop, established in 1999, is one of the largest chain stores in Shanghai dealing in an extensive range of gourmet foods from around the globe. Honglicun’s restaurants are located in Shenzhen, Guangzhou, Dongguan, Huizhou and Honglicun also provides catering to airlines, shipping companies, and trains and other mainstream transportation dining platforms.

The three parties will form a broad strategic cooperation in production, processing and supply management of Pingtan’s fishing products. The Company expects to complete the preparations and begin recognizing sales in the fourth quarter of 2017.

Management Commentary

Mr. Xinrong Zhuo, Chairman and CEO of the Company, commented, “We are very pleased to be partnering with two major competent companies to enter directly the e-commerce and restaurant chain. It is important that we continue to rapid expand our presence in China as the domestic demand for deep ocean fish products continues to grow. We believe this partnership with City Shop and Honglincun will establish a win-win cooperation and a direct sales and procurement channel to bypass the intermediaries, and will accelerate our progress to becoming a comprehensive seafood provider.”

About Pingtan

Pingtan is a global fishing company engaging in ocean fishing through its subsidiary, Fujian Provincial Pingtan County Ocean Fishing Group Co., Ltd., or Pingtan Fishing.

Business Risks and Forward-Looking Statements

This press release may contain forward-looking statements that are subject to the safe harbors created under the Securities Act of 1933 and the Securities Exchange Act of 1934.   These statements can be identified by the use of forward-looking terminology such as “believe,” “expect,” “may,” “will,” “should,” “project,” “plan,” “seek,” “intend,” or “anticipate” or the negative thereof or comparable terminology, and includes statements about expected sales and entry into consumer food chain. Although forward-looking statements reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements.  Risks include failure to start sales of product in the fourth quarter of 2017 due to economic conditions, unforeseen delays in the delivery of products, adverse weather or oceanic conditions or mechanical or other operational failure of fishing vessels, an unexpected dramatic decrease in production, operational, mechanical, climatic or other unanticipated issues that adversely affect the production capacity of the Company’s vessels,   applicable regulatory, environmental, political, legal and economic risks, and other risk factors contained in Pingtan’s SEC filings available at www.sec.gov, including Pingtan’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. Pingtan undertakes no obligation to update or revise any forward-looking statements for any reason.

CONTACT:

Roy Yu
Chief Financial Officer
Pingtan Marine Enterprise Ltd.
Tel: +86 591 87271753
ryu@ptmarine.net

INVESTOR RELATIONS
The Equity Group Inc.
Adam Prior, Senior Vice President
Tel: (212) 836-9606
aprior@equityny.com

In China
Katherine Yao, Senior Associate
Tel: +86 10 6587 6435
kyao@equityny.com

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$COUP Executive Advisory Board Welcomes Additional Industry Experts

EAB members will meet to provide thought leadership at Coupa’s Inspire ‘17

SAN MATEO, Calif., May 11, 2017 — Coupa Software (NASDAQ:COUP), a leader in cloud-based spend management, announced today that additional top industry leaders have joined its Executive Advisory Board (EAB) to help companies rethink how they can improve profit margins and increase global compliance with cloud-based spend management solutions.

Established in 2016, the EAB has expanded to 21 industry leaders whose mission is to transform how enterprises manage their spend. Over the past year, the EAB has focused on thought leadership – webinars, speaking engagements, blogs – around spend management as the new business imperative and how IT, finance, and procurement can work together to optimize business value.

“I am eager to join the EAB and leverage my 30 years of business experience as we work to help companies identify new and better methods of streamlining procurement processes,” said Chris Chadwick, director of procurement at Caterpillar.

On May 18, Chadwick will join Deloitte in discussing The Digital Supply Network mainstage at the fifth annual Coupa Inspire ‘17 event located at The Westin St. Francis San Francisco on Union Square.

“The EAB’s inaugural year has been quite productive and focused on evangelizing an expert point-of-view on the state of our industry,” said Todd Dooley, former vice president of finance at H&R Block. “I look forward to moving the needle even more in our second year with the addition of more experts on board.”

At Coupa Inspire ‘17, EAB members will also discuss their industry point-of-view by participating on a mainstage panel on May 17th entitled “Transforming your Business via Digitization”. Over the event’s two days, EAB members will also lead conversations in various CIO, CFO, and CPO focused breakout sessions on what’s top of mind for executives in today’s world of digital transformation. The EAB members will share thoughts on topics including maximizing profit margins, reducing costs, business agility, compliance, risk, and globalization.

The EAB is led by Coupa’s Executive Strategic Advisor Kendra Von Esh and includes current and former business executives. Of the 21 members on the board, 19 are external members and two are from the Coupa corporate team.

External members of the Coupa EAB, listed below, cover the financial services, healthcare, manufacturing, banking, technology, non-profit, retail and hospitality industries.

The Coupa corporate members of the EAB are:

  • Kendra Von Esh, Executive Strategic Advisor, Coupa Software
  • Donna Wilczek, Vice President Strategy and Product Marketing, Coupa Software

“We have a phenomenal group of industry thought leaders that are working collaboratively to strategize about the future of spend management,” Von Esh said. “The EAB goal is to increase knowledge on how strategic spend management can fund growth initiatives and deliver bottom-line measurable results – making it the new business financial imperative. Our inaugural year has set a strong foundation for continued EAB success in 2017 and beyond.”

To learn more about EAB members, click on the following link: http://www.coupa.com/leadership/advisory-board/.

About Coupa Software
Coupa Software (NASDAQ:COUP) is the cloud platform for business spend. We deliver “Value as a Service” by helping our customers maximize their spend under management, achieve significant cost savings and drive profitability.  Coupa provides a unified, cloud-based spend management platform that connects hundreds of organizations representing the Americas, EMEA, and APAC with millions of suppliers globally.  The Coupa platform provides greater visibility into and control over how companies spend money. Customers – small, medium and large – have used the Coupa platform to bring billions of dollars in cumulative spend under management.  Learn more at www.coupa.com. Read more on the Coupa Blog or follow @Coupa on Twitter.

 

Media inquiries:
Orlando De Bruce
Coupa Software
Global Public Relations
orlando.debruce@coupa.com
O (650) 485-8629
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$PEGA Recognized as a Leader in Gartner’s Magic Quadrant for CRM

Leading analyst firm names Pega a CRM leader for eighth straight year

CAMBRIDGE, Mass., May 11, 2017  — Pegasystems Inc. (NASDAQ:PEGA), the software company empowering customer engagement at the world’s leading enterprises, today announced it has been named a leader in Gartner’s Magic Quadrant for CRM Customer Engagement Center (1) report. This marks the eighth consecutive year Gartner has named Pega a leader in this report.

Gartner evaluated CRM solutions from 15 vendors – five of which were named leaders. In the report, Gartner describes what it takes to be positioned as a Leader: “Leaders demonstrate market-defining Completeness of Vision and the Ability to Execute that vision through products, services, sales figures and solid new references for multiple geographies and industries. Clients report that these vendors deliver high levels of value and return on their investment. These vendors’ development teams have a clear vision for the emerging area of customer engagement, the growing influence of AI and the ‘mobile first’ future. They engineer flexible products that have easily changeable business rules. They factor the impact on customer service requirements of advanced analytics, social media engagement and the IoT (including wearable devices).”

Pega’s end-to-end suite of customer engagement applications for marketing, sales, and customer service are powered by Pega® Customer Decision Hub, its market-leading real-time artificial intelligence (AI) engine. Built on Pega® Platform, Pega’s CRM solution enables clients to constantly anticipate customers’ changing needs and provide personalized AI-driven recommendations throughout the customer journey. By engaging customers with the right message, at the right time, on any channel, Pega clients increase customer satisfaction while enhance customer lifetime value.

The unified Pega Platform is the only solution in Gartner’s Magic Quadrant for CRM Customer Engagement Center to also be named by Gartner in both its newly released Magic Quadrant for Multichannel Campaign Management 2017 (2) and its most recent Magic Quadrant for Sales Force Automation 2016 (3). Taken together, Pega believes this uniquely positions it as a unified business transformation platform that drives intelligent customer engagement across marketing, sales, and service.

Pega has also recently been recognized by other influential analyst firms for its CRM solutions. Forrester named Pega a leader in The Forrester Wave™: CRM Suites For Enterprise Organizations, Q4 2016 (4), while Ovum positioned Pega as a Market Leader in the Ovum Decision Matrix: Selecting a Customer Relationship Management Solution, 2016-17 (5).

In addition, Pega was named a leader by top analyst firms in real-time interaction management, case management, and business process management – three essential elements the company believes are critical to providing the most complete and effective CRM solution. These reports are: Forrester’s The Forrester Wave™: Real-Time Interaction Management, Q3 2015 (6), Gartner’s Magic Quadrant for BPM-Platform-Based Case Management Frameworks 2016 (7), and Gartner’s Magic Quadrant for Intelligent Business Process Management Suites 2016 (8).

Pega’s latest CRM innovations will be showcased at PegaWorld, Pega’s annual conference to be held June 4-7, 2017 at the MGM Grand in Las Vegas. For more information, visit www.pegaworld.com.

Quotes & Commentary
“The CRM market has evolved significantly over the last eight years that Pega has been recognized as a Leader in the Gartner Magic Quadrant for Customer Engagement Centers,” said Kerim Akgonul, senior vice president, products, Pegasystems. “We believe this demonstrates our dedication and track record of success in empowering our clients to lead their markets with the latest customer engagement innovations. From robotic automation and AI to chatbots and virtual assistants, Pega’s end-to-end engagement suite helps our clients not just survive but thrive in today’s fast changing digital reality.”

Supporting Resources:

Analyst report: Gartner’s Magic Quadrant for CRM Customer Engagement Center

Product background: Pega CRM applications

Video: Pega CRM Build for Change

About Pegasystems
Pegasystems Inc. is a leader in software that streamlines business and enhances customer engagement in Global 3000 organizations. With more than 30 years of proven innovation, Pega seamlessly connects organizations with their customers across multiple channels in real time using market-leading CRM, advanced artificial intelligence, and powerful automation. Pega’s adaptive, cloud-architected applications – built on its unified Pega® Platform – empower people with comprehensive visual tools to easily extend and change applications to meet strategic business needs. For more information on Pegasystems (NASDAQ:PEGA) visit http://www.pega.com.

Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

  1. Gartner, Inc., “Magic Quadrant for the CRM Customer Engagement Center,” Michael Maoz, Brian Manusama, May 8, 2017
  2. Gartner, Inc., “Magic Quadrant for Multichannel Campaign Management,” Adam Sarner, Mike McGuire, Jennifer Polk, Noah Elkin, April 11, 2017
  3. Gartner, Inc., Magic Quadrant for Sales Force Automation, by Tad Travis, Ilona Hansen, Joanne Correia, Julian Poulter, August 10, 2016
  4. Forrester Research:  The Forrester Wave™: CRM Suites for Enterprise Organizations, Q4 2016,”  Kate Leggett, Stephen Powers, Mark Grannan, Sara Sjoblom, Chad Rafferty, and Peter Harrison, November 21, 2017
  5. Ovum Decision Matrix: Selecting a Customer Relationship Management Solution, 2016-17
  6. Forrester Research: The Forrester Wave™: “Real-Time Interaction Management, Q3 2015,” Rusty Warner with Srividya Sridharan, Olivia French and Matthew Izzi, July 29, 2015
  7. Gartner, Inc., “Magic Quadrant for BPM-Platform-Based Case Management Frameworks,” by Rob Dunie, Janelle B. Hill, October 24, 2016
  8. Gartner, Inc., “Magic Quadrant for Intelligent Business Process Management Suites,” by Rob Dunie, W. Roy Schulte, Marc Kerremans, Michele Cantara, August 19, 2016 (previously Magic Quadrant for Business Process Management Suites)

All trademarks are the property of their respective owners.

 

Press Contact:
Sean Audet
Pegasystems Inc.       
sean.audet@pega.com
(617) 528-5230                       
Twitter: @pega
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$CORI Reports Positive Preliminary Results in Alzheimer’s Clinical Study

Once-Weekly Corplex™ Donepezil Patch Achieves Bioequivalence to Aricept®

MENLO PARK, Calif., May 11, 2017 — Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today reported preliminary positive results from its recently completed pilot bioequivalence (BE) study demonstrating that its Corplex™ Donepezil product candidate successfully met the criteria for bioequivalence to oral Aricept® (donepezil hydrochloride) using primary pharmacokinetic (PK) endpoints previously established with the US Food and Drug Administration (FDA).  Corplex Donepezil is a proprietary once-weekly transdermal patch for delivery of the most commonly prescribed treatment for all stages of Alzheimer’s disease.

The pilot BE study was a six-month, three-period, randomized crossover study comparing the steady-state pharmacokinetic profiles of once-daily oral Aricept with two Corplex Donepezil transdermal patches that differed only in size.  Corium reported that the steady-state PK profiles of the transdermal dosage forms exhibited a close similarity with the oral dosage form PK results, and that the smaller of the two patches met the statistical criteria for bioequivalence at steady-state, based on the primary PK parameters of Cmax (maximum plasma concentration) and AUC (area under the curve).

Both Corplex transdermal treatments were well tolerated, with favorable adhesion, skin safety and gastrointestinal side effect profiles after application of over 500 patches in the course of the study.  For example, the incidence of nausea in subjects on the smaller patch was more than four-fold lower than the incidence of nausea with oral Aricept.

Corium is pursuing the bioequivalence-based development and regulatory pathway for Corplex Donepezil after receiving positive written feedback on this approach from the FDA in April 2016.  The pilot study was designed with the objective of enabling the company to finalize patch size and other key parameters to successfully demonstrate bioequivalence in a pivotal BE study.  Corium is planning to start its pivotal BE study later this year and remains on track to file a Section 505(b)(2) New Drug Application (NDA) for the product candidate in 2018.  The pivotal study will be a simpler, two-way crossover design compared to the three-way crossover pilot study.

“We are extremely pleased that our Corplex Donepezil patches performed as well as we had projected, and that one of the tested patches actually met the regulatory bioequivalence criteria at the pilot stage.  Based on these results, we can now move forward knowing that we have a product candidate that can meet the bioequivalence-based registration criteria,” said Parminder “Bobby” Singh, Ph.D., Chief Technology Officer and Vice President of Research and Development of Corium.  “With this exciting clinical progress, we are finalizing the scale up and related activities to support the start of our pivotal study this fall, with the objective of filing our NDA in 2018.”

“I am encouraged by the rapid clinical development of Corium’s once-weekly transdermal donepezil product,” added Pierre N. Tariot, M.D., a leading authority on Alzheimer’s disease research who is Director of the Banner Alzheimer’s Institute in Phoenix, Arizona, co-director of the NIH-funded Alzheimer’s Prevention Initiative, and a clinical advisor to Corium.  “Given the inherent challenges we face treating persons with Alzheimer’s, as well as limitations of currently available medications, I am hopeful that the transdermal approach can afford improved compliance and potential clinical benefits that could truly matter to both our patients and their families.”

Study Design

The pilot BE study was performed at a single trial site and enrolled 60 healthy male and female volunteers aged 20 to 78, with over 80% of the subjects over the age of 40.

The study, conducted over a period of six months, was a three-period, randomized crossover study comparing the steady-state PK profiles of once-daily oral Aricept with two Corplex Donepezil transdermal patches that differed only in size.

During each period, study participants received one week of 5mg per day of donepezil, followed by 4 weeks of 10mg per day of donepezil.  PK measurements were evaluated during the fifth week of each treatment period, when plasma concentrations had achieved steady state levels.  PK samples for subjects receiving the transdermal treatments were taken on a daily basis throughout this fifth week; subjects receiving oral Aricept had PK samples taken on the last day of the fifth week.  There was a three-week washout period between treatment periods.

The primary objective was to enable the company to finalize key parameters for the pivotal BE study, including determination of the final patch size and the required number of subjects.  The secondary objectives were assessment of safety and tolerability.

About Alzheimer’s Disease and Donepezil

Alzheimer’s disease is a progressive brain disorder in which the brain cells degenerate and die, causing a steady decline in memory and mental function.  An estimated 5.5 million Americans are living with Alzheimer’s disease in 2017; by 2025, this number is expected to exceed 7 million.  Alzheimer’s disease is the most common cause of dementia among older adults.  Dementia ranges in severity from mild, when it is just beginning to affect a person’s functioning, to moderate, and severe, when the person must depend on others for the basic activities of day-to-day life.

Donepezil (the active ingredient in Aricept) is the most widely prescribed medication in a class of Alzheimer’s drugs known as cholinesterase inhibitors, and is approved for the treatment of mild, moderate and severe disease.  Donepezil is currently only available in tablet or orally disintegrating tablet form, each administered once daily, presenting compliance challenges for family members and caregivers who cannot rely on patients to consistently take their daily tablets, and is known to cause gastrointestinal side effects, including nausea, vomiting and loss of appetite.

About Corplex

Corium’s Corplex system is a novel commercial-stage platform technology designed to broadly enable the transdermal delivery of small molecules, many of which have not previously been amenable to transdermal delivery.  Corplex advanced transdermal and transmucosal systems are broadly adaptable for use in multiple drug categories and indications, and have the potential to reduce quantities of active ingredient utilized in transdermal products.  Additionally, Corplex transdermal patches can enable efficient drug delivery, and adhere to either wet or dry surfaces for an extended period of time.  Corium’s Corplex technology has been successfully commercialized in Procter & Gamble’s Crest® Whitestrips products, and is being utilized in several proprietary therapeutic products under development.

Conference Call and Webcast Details

Corium will host a conference call today at 8:30 a.m. ET (5:30 a.m. PT) to discuss the financial results for the second fiscal quarter ended March 31, 2017 and the preliminary results of the Corplex Donepezil pilot bioequivalence study.  Investors and analysts can access the call toll-free by dialing (844) 831-3024 (United States) or +1 (315) 625-6887 (international).  The conference ID# is 20268962.  The conference call will also be available via a live audio webcast which may be accessed here, or by visiting the Investors section of Corium’s website at http://ir.coriumgroup.com/events.cfm where an accompanying slide presentation will be available.  The webcast will be archived on the Corium website for two weeks following the presentation.

About Corium

Corium International, Inc. is a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products that leverage the company’s broad experience with advanced transdermal and transmucosal delivery systems.  Corium has multiple proprietary programs in preclinical and clinical development, focusing primarily on the treatment of neurological disorders, with lead programs in Alzheimer’s disease.  Corium has developed and is the sole commercial manufacturer of seven prescription drug and consumer products with partners Mayne Pharma and Procter & Gamble.  The company has two proprietary transdermal platforms: Corplex™ for small molecules and MicroCor®, a biodegradable microstructure technology for small molecules and biologics, including vaccines, peptides and proteins.  The company’s late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics and additional transdermal products that are being developed with other partners.  For further information, please visit www.coriumgroup.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, including statements regarding our clinical trial and regulatory timing and plans, the achievement of clinical and commercial milestones, and the advancement of our technologies as well as our proprietary, co-developed and partnered products and product candidates.  Forward-looking statements are based on management’s current expectations and projections and are subject to risks and uncertainties, which may cause Corium’s actual results to differ materially from the statements contained herein.  Further information on potential risk factors that could affect Corium’s business and its results are detailed in Corium’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2016, filed with the Securities and Exchange Commission (SEC) on February 14, 2017, and other reports as filed from time to time with the SEC.  Undue reliance should not be placed on forward-looking statements, especially guidance on future financial or operating performance, which speaks only as of the date they are made.  Corium undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.

Corplex™ and MicroCor® are trademarks of Corium International Inc.
Aricept® is a registered trademark of Eisai R&D Management Co, Ltd.
Crest® Whitestrips is a registered trademark of The Procter & Gamble Company.

Source: Corium

Investor and Media Contact:
SMP Communications
Susan M. Pietropaolo
susan@smpcommunications.com
(201) 923-2049
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$LPSN to Participate in Upcoming Investor Conferences

NEW YORK, May 11, 2017 — LivePerson, Inc. (Nasdaq: LPSN), a leading provider of cloud-based mobile and online business messaging solutions, today announces that the Company will participate in the following upcoming investor events:

2017 Needham Emerging Technology Conference
Tuesday, May 16th
Westin Grand Central Hotel in New York, New York

Attendees:
Daryl Carlough, Global Controller
Matthew Kempler, Head of FP&A and Investor Relations

18th Annual B. Riley Co. Investor Conference
Wednesday, May 24th
Loews, Santa Monica Beach Hotel, California

Attendees:
Dan Murphy, CFO
Matthew Kempler, Head of FP&A and Investor Relations

14th Annual Craig-Hallum Institutional Investor Conference
Wednesday, May 31st
The Depot Renaissance Minneapolis Hotel, Minneapolis

Attendees:
Dan Murphy, CFO
Matthew Kempler, Head of FP&A and Investor Relations

Benchmark One-on-One Conference
Thursday, June 1st
Palmer House Hilton, Chicago

Attendees:
Daryl Carlough, Global Controller
Matthew Kempler, Head of FP&A and Investor Relations

Presentation materials will be available on the investor relations section of the Company’s web site at www.liveperson.com.

About LivePerson, Inc.

LivePerson, Inc. (NASDAQ: LPSN) is a leading provider of cloud-based mobile and online business messaging solutions, enabling a meaningful connection between brands and consumers. LiveEngage, the Company’s enterprise-class platform, empowers consumers to stop wasting time on hold with 1-800 numbers, and instead message their favorite brands, just as they do with friends and family. More than 18,000 businesses, including Adobe, Citibank, HSBC, EE, IBM, L’Oreal, Orange, PNC and The Home Depot rely on the unparalleled intelligence, security and scalability of LiveEngage to reduce costs, increase lifetime value and create meaningful connection with consumers.

For more information, please visit www.liveperson.com. To view other global press releases about LivePerson, please visit pr.liveperson.com.

Twitter: @LivePerson
Facebook: http://www.facebook.com/LivePersonInc

Investor Relations Contact
Matthew Kempler
mkempler@liveperson.com
212-609-4214

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$MSLI and Norgine Enter into a Definitive Arrangement Agreement

TORONTO and AMSTERDAM, May 11, 2017

  • Norgine to acquire all outstanding shares of Merus for $1.65 per share in cash

TORONTO and AMSTERDAM, May 11, 2017  – Merus Labs International Inc. (“Merus” or the “Company“) TSX: MSL, NASDAQ: MSLI and Norgine B.V. (“Norgine“) announced today that they have entered into a definitive agreement (the “Arrangement Agreement“) under which Norgine will acquire all of the issued and outstanding common shares of Merus for $1.65 per share in cash including the assumption of all debt obligations, for a total enterprise value of approximately $342 million (the “Arrangement“). The transaction will be financed through a combination of available cash and new credit facilities that Norgine has secured prior to executing the Arrangement. The transaction price of $1.65 per share represents a premium of 63.4% to the closing price of $1.01 on the TSX on May 10, 2017 and a premium of 55.1% over the 30-day volume weighted average price of $1.06 on the TSX.

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2016, Norgine’s total sales revenue was €295 million. It employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sales and supply.

Michael Cloutier, Chairman of Merus, commented:

“After a comprehensive review of strategic alternatives, and consultation with the Company’s financial and legal advisors and the Special Committee of Independent Directors, our Board has unanimously concluded that this transaction is in the best interests of the Company and our stakeholders. We are pleased that this transaction appropriately recognizes the value of Merus’ stable legacy product portfolio and strong cash flow.”

Peter Stein, Chairman and Chief Executive Officer of Norgine, commented:

“Our acquisition of Merus will strengthen our position as the ‘go-to’ European specialist pharma company. The Merus team has built a strong platform of established products. We look forward to working closely with the Merus team to efficiently complete this transaction and welcoming them to Norgine.”

Transaction Details

The transaction is subject to court approval, and the approval of the holders of at least 66⅔% of Merus’ common shares present in person or represented by proxy at a special meeting of Merus shareholders to be called to consider the Arrangement. Directors and senior executive officers of Merus, who together hold an aggregate of approximately 5.7% of the issued and outstanding Merus common shares (calculated on a non-diluted basis), have entered into voting support agreements with Norgine in favour of the Arrangement. The Company intends to mail a proxy circular in the upcoming weeks to shareholders for a meeting expected to be held in July 2017.

In addition to shareholder and court approvals, the transaction is subject to customary closing conditions, including receipt of all regulatory approvals, and is expected to close by September 30, 2017.

The Arrangement Agreement includes a non-solicitation covenant on the part of Merus, subject to customary “fiduciary out” provisions that entitle Merus to consider and accept unsolicited superior proposals and a right in favour of Norgine to match any superior proposal. If the Arrangement Agreement is terminated in certain circumstances, including if Merus enters into an agreement with respect to a superior proposal or if the Board of Directors of Merus (the “Board“) withdraws or modifies its recommendation with respect to the Arrangement, Norgine will be entitled to a termination fee of $7.5 million. Full details of the Arrangement will be included in an information circular to be mailed to Merus shareholders in accordance with applicable securities laws.

The Board, after consultation with its financial and legal advisors unanimously recommends that Merus shareholders vote in favour of the Arrangement. The Board has also received fairness opinions from both Rothschild & Co. and Clarus Securities Inc. in connection with the Arrangement Agreement to the effect that, as of the date of such opinions, and subject to the assumptions, limitations and qualifications set forth therein, the consideration to be received by Merus’ common shareholders pursuant to the Arrangement is fair from a financial point of view.

The transaction is structured as a plan of arrangement under the Business Corporations Act (British Columbia). Further details regarding the terms of the transaction are set out in the Arrangement Agreement which will be publicly filed by Merus under its profile at www.sedar.com.

Advisors

Rothschild & Co. is acting as financial advisor and Torys LLP is acting as legal counsel to Merus. RBC Capital Markets is acting as financial advisor and Stikeman Elliott LLP is acting as legal counsel to Norgine.

About Merus

Merus is a specialty pharmaceutical company focused on acquiring and optimizing legacy and growth products. The Company leverages its expertise and scalable platform across Europe, Canada and select other markets to deliver value.

About Norgine

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2016, Norgine’s total revenue was €368 million, including product sales, partnering milestones and other income. Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply. Norgine specialises in gastroenterology, hepatology, cancer and supportive care. Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France. For more information, please visit www.norgine.com

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and applicable Canadian securities legislation. Forward-looking statements include statements relating to the proposed acquisition of Merus by Norgine, the expected timing, impact and sources of funding the transaction, the anticipated benefits of the transaction, effects on footprint, expected synergies, and certain combined operational, financial and other information and projections, and other statements that are not historical facts. Such statements involve assumptions relating to the receipt, in a timely manner of regulatory, shareholder and Canadian court approvals in respect of the transaction and may also involve assumptions relating to the Company’s business, including government regulation of the pricing of the Company’s products, the competitive environment of the Company’s products, the stability of foreign exchange rates and the availability of prospective acquisition targets.

Although the Company’s management believes that the assumptions underlying these forward-looking statements are reasonable, as of the date of this news release, they are subject to change after such date. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results expressed or implied by these statements. There are also risks that are inherent in the nature of the transaction, including: risks regarding the integration of the two entities; incorrect assessments of the values of the other entity; and failure to obtain any required regulatory or other approval (or to do so in a timely manner). There is no assurance that the transaction will occur, or that it will occur on the terms and conditions contemplated in this news release. The anticipated timeline for completion of the transaction may change for a number of reasons, including the inability to secure necessary regulatory, Canadian court or other approvals in the time assumed or the need for additional time to satisfy the conditions to completion of the transaction. Investors should refer to the Company’s MD&A, Annual Information Form and Annual Report on 40-F for the year ended September 30, 2016 for a more comprehensive discussion of the risks that are material to the Company and its business. In light of these and other uncertainties, the forward-looking statements included in this press release should not be regarded as a representation by Merus that Merus’ plans, objectives and guidance will be achieved. These forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements except as required by applicable securities laws.

For Further Information on Merus Labs: Dr. Michael Bumby, CFO, T: +1.905.726.0995, info@meruslabs.com, www.meruslabs.com; For Further Information on Norgine: Finance: Christopher Bath, CFO, T: +44(0)1895 453723; Media: Isabelle Jouin, T: +44 (0)1895 453643; Follow us @norgine; www.norgine.comCopyright CNW Group 2017

Thursday, May 11th, 2017 Uncategorized Comments Off on $MSLI and Norgine Enter into a Definitive Arrangement Agreement

$CALA & $BMY Expand Oncology Collaboration, Opdivo & CB-839

  • Study to evaluate potential of CB-839 plus Opdivo to target immunosuppressive cancer metabolism in the tumor microenvironment
  • Companies have ongoing collaboration evaluating clear cell renal cell carcinoma

Bristol-Myers Squibb Company (NYSE:BMY) and Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced the companies have expanded their existing collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with Calithera’s CB-839 in patients with non-small cell lung cancer (NSCLC) and melanoma. CB-839 is an investigational orally administered glutaminase inhibitor currently in Phase 1/2 clinical studies.

Preclinical data suggest that CB-839, which is designed to target a pathway to starve tumor cells of the key nutrient glutamine, may enhance the effects of checkpoint inhibitors and may also reverse tumor resistance to checkpoint inhibitors by altering the immune-suppressive microenvironment and promoting an anti-tumor immune response. Opdivo is designed to overcome immune suppression. The companies will evaluate the potential clinical value of combining these two agents to treat NSCLC and melanoma.

“We are pleased to expand our collaboration with Calithera into NSCLC and melanoma, building upon our existing clinical study evaluating Opdivo and CB-839 in clear cell renal cell carcinoma,” said Fouad Namouni, M.D., senior vice president, Head of Oncology Development, Bristol-Myers Squibb.

“The expansion of this clinical collaboration with Bristol-Myers Squibb into NSCLC and melanoma is an important addition to our immunotherapy clinical strategy for CB-839,” said Susan Molineaux, CEO of Calithera Biosciences. “This represents one of several strategies to develop CB-839, a glutaminase inhibitor, in combination with approved therapies with the hope of improving the treatment of patients with solid tumors.”

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

INDICATIONS

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.

Immune-Mediated Neuropathies

In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients.

Immune-Mediated Skin Adverse Reactions and Dermatitis

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome.

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients.

Complications of Allogeneic HSCT after OPDIVO

Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.

Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.

Embryo-Fetal Toxicity

Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO . The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO. The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥ 20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%).

In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, for YERVOY.

Please see U.S. Full Prescribing Information for OPDIVO.

About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedInTwitter, YouTube and Facebook.

About Calithera Biosciences

Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera’s lead product candidate, CB-839, is an inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents. CB-1158 is an investigational immuno-oncology metabolic checkpoint inhibitor designed to target arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells (MDSCs). Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells. CB-1158 is being developed in collaboration with Incyte Corporation and is currently in a Phase I clinical trial. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit http://www.calithera.com/.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that CB-839 in combination with Opdivo, will be successfully developed or approved for any of the indications described in this release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Calithera Biosciences Forward-Looking Statement

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “poised” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of CB-839, Calithera’s plans to continue development of CB-839 in combination therapy for clear cell renal cell carcinoma, the potential for combining Opdivo with CB-839 to drive improved and sustained efficacy in ccRCC and other cancers, including NSCLC and melanoma, and the advancement of CB-839 in clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

 

Bristol-Myers Squibb
Media:
Ken Dominski, 609-252-5251, ken.dominski@bms.com
Lisa McCormick Lavery, 609-252-7602, lisa.mccormicklavery@bms.com
or
Investors:
Tim Power, 609-252-7509, timothy.power@bms.com
Bill Szablewski, 609-252-5894, william.szablewski@bms.com
or
Calithera Biosciences
Jennifer McNealey, 650-870-1071, ir@Calithera.com

Wednesday, May 10th, 2017 Uncategorized Comments Off on $CALA & $BMY Expand Oncology Collaboration, Opdivo & CB-839

$INCR and inVentiv Health to Merge

Creates a Leading Global Biopharmaceutical Solutions Organization with Combined Net Revenue of More Than $3.2 Billion

Combined Company Will Be Second Largest Biopharmaceutical Outsourcing Provider, One of the Top 3 Contract Research Organizations and the Largest Contract Commercial Organization by Net Revenue

Comprehensive Suite of End-To-End Solutions to Support Development and Commercialization of Biopharmaceutical Compounds and Biologics

Complementary and Diversified Customer Base with Leadership in Large, Mid-Sized and Small Biopharma

Transaction Estimated to Realize Approximately $100 Million in Annual Run-Rate Cost Synergies and Projected to be Accretive to Adjusted EPS

INC Research Announces First Quarter 2017 Results in a Separate Release

INC Research and inVentiv Health to Host Conference Call at 8:00 a.m. ET Today

RALEIGH, N.C. and BOSTON, May 10, 2017 — INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I–IV Contract Research Organization (“CRO”), and inVentiv Health, Inc., a leading, privately held, global CRO and Contract Commercial Organization (“CCO”), today announced that their Boards of Directors have unanimously approved a definitive merger agreement pursuant to which their businesses would combine in an all-stock transaction, creating a leading global biopharmaceutical solutions organization. Based upon the closing price of INC Research common stock on Tuesday, May 9, 2017, the transaction values inVentiv at an enterprise value of approximately $4.6 billion, and the combined company at an enterprise value of approximately $7.4 billion.

Upon closing of the transaction, INC Research shareholders are expected to own approximately 53 percent and inVentiv shareholders are expected to own approximately 47 percent of the combined company on a fully diluted basis. Advent International and Thomas H. Lee Partners, two preeminent private equity firms, are currently equal equity owners of inVentiv and will remain investors in the combined company upon closing of the merger.

Today’s announcement creates:

  • The second largest biopharmaceutical outsourcing provider focused on creating value for customers, patients, physicians, payers and employees.
  • A Top 3 CRO globally and the leading CCO provider focused on improving customer performance and accelerating new products to market. The combined company will have more than 22,000 employees spanning more than 60 countries, and will serve customers in more than 110 countries.
  • Leadership positions in the growing CRO and CCO markets. The Commercial market represents an underpenetrated opportunity with only 16% penetration and outsourcing potential of $150 billion, providing substantial growth potential.

Upon completion of the transaction the combined company will leverage commercial insights to inform the clinical trial process, designing studies to be more efficient and effective to address evolving patient and payer needs. Commercial solutions informing accelerated clinical trial design include market access, data-driven Real World Evidence (“RWE”), advocacy relations and medical affairs. The new organization’s combined clinical scale, therapeutic depth and expertise will allow it to partner with biopharmaceutical companies of all sizes to navigate an increasingly complex biopharmaceutical development and commercialization environment.

Alistair Macdonald, Chief Executive Officer of INC Research, said, “Today marks a significant milestone for INC Research. Customers are increasingly seeking simultaneous approvals and product launches in multiple markets worldwide. Through this strategic combination we are bringing together two of the most innovative and respected players in the field to create a leading global biopharma solutions organization with a full suite of clinical and commercial solutions to address the needs of biopharmaceutical companies, patients, physicians and payers. The combination of INC Research and inVentiv will expand our global scale and add capabilities to grow our addressable market.” He continued, “Both companies have a history of successfully integrating acquisitions, and I am confident that we will capitalize on the many opportunities this combination creates for all stakeholders. We look forward to working closely with the talented inVentiv employees, who share our dedication to making the world a better place by bringing new therapies to patients, while building significant value for our shareholders.”

Michael Bell, Chief Executive Officer of inVentiv Health, said, “As biopharmaceutical companies of all sizes face increasingly complex challenges to bring products to market, they are seeking comprehensive outsourced solutions across the clinical and commercial spectrum. The new company is purpose-built to address market realities where clinical and commercial must work together, sharing expertise, data and insights, to improve client performance.” He continued, “We believe this merger has significant client advantages as it deepens our scale, scope and therapeutic expertise. The combination also provides the opportunity to leverage INC Research’s Trusted Process® – a proven methodology to accelerate success – which can improve the overall cost of development and time to market for our customers. We have long-admired INC Research, and this is an exciting opportunity to bring together two best-in-class, industry-leading teams who share the commitment to shorten the distance from lab to life.”

Benefits of the Merger

  • Offers customers a comprehensive suite of outsourced services across the drug development and commercialization continuum: INC Research’s strong therapeutic focus and proven Trusted Process, combined with inVentiv’s differentiated CRO/functional service provider (“FSP”) and CCO capabilities, including selling solutions, communications, consulting and medication adherence, delivers a leading portfolio of services designed to address the evolving challenges of the biopharmaceutical industry.
  • Competes in two highly attractive markets: The clinical development market served by CROs is expected to reach $36 billion by 2020, growing at an approximate 6 percent CAGR, while the CCO market is expected to reach $34 billion by 2020, growing at an approximate 8 percent CAGR, providing substantial growth potential.
  • Creates a global leader in Phase I–IV clinical development: The combined company will become one of the Top 3 CROs globally. Scale is increasingly becoming a key consideration for CRO customers and the combined company will be well-positioned to capitalize on this dynamic. The transaction will expand the combined company’s global presence in important strategic geographies such as Asia/Pacific and specifically Japan, where there is significant opportunity for growth. The combined company’s global reach will enable it to continue to serve as a leading outsourcing partner on a full service, functional and hybrid basis to biopharmaceutical customers.
  • Capitalizes on growing commercial outsourcing trend: The demand for outsourced commercialization services is growing, with specialized knowledge and expertise increasingly required for the successful launch and commercialization of products. inVentiv is well-positioned to capitalize on this trend and enhance the clinical development process with commercial capabilities, including selling solutions, communications, consulting and medication adherence. inVentiv also has access to subject matter experts such as medical science liaisons (“MSL”), nurse educators, patient advocates and strategic consultants.
  • Deepens therapeutic expertise: Both inVentiv and INC Research have significant therapeutic expertise in core areas, including oncology and central nervous system (“CNS”), which together represent a combined 2016 net revenue of over $1.2 billion. The merger will deepen the combined company’s therapeutic experience in these complex disease areas and enhance expertise in areas such as cardiovascular, metabolic and respiratory diseases. Having therapeutic breadth and depth is an increasingly important factor in customers’ outsourcing selection decisions. 
  • Improves access to data assets informing clinical and commercialization design and execution: The combination of inVentiv’s pharmacy data through its Adheris pharmacy network, RWE programs and other data sets, along with INC Research’s Real World & Late Phase business, site relationships, and predictive clinical data sets, increases the combined company’s access to physicians, investigators and patients, generating actionable insights. These are all key factors to inform the design and execution of clinical development and commercialization programs.
  • Serves a diversified and highly complementary customer base: INC Research’s strong relationships and expertise providing services to small and mid-sized biopharmaceutical companies, combined with inVentiv’s relationships with large biopharma, including all of the top 20 biopharma, will create a complementary and diversified customer base with leadership across large, mid-sized and small biopharma. INC Research and inVentiv have limited client overlap, and foresee no revenue dis-synergies. The companies see this merger as an opportunity to deepen client relationships and expand the combined company’s share of outsourced clinical development and commercialization spend. 
  • Provides significant cost synergy potential: The transaction is estimated to achieve approximately $100 million in annual run-rate cost synergies, which the companies expect will be fully realized within three years.
  • Creates cross-selling opportunities: INC Research and inVentiv can cross-sell their complementary services to their respective clients. INC Research’s small to mid-sized biopharmaceutical clients will now be able to access inVentiv’s comprehensive commercialization services, including selling solutions, communications, consulting and medication adherence. This capitalizes on the growing trend for small to mid-sized companies to bring their own products to market. INC Research and inVentiv will be able to cross-sell their complementary clinical capabilities, including enhanced therapeutic expertise and service delivery models (full service, hybrid, and FSP).
  • Provides accretion: The transaction is projected to be accretive to INC Research’s adjusted earnings per share in the first 12 months following close, mid to high single-digit accretive in 2018 and  accretive by more than 20 percent in 2019 and beyond.
  • Maintains strong balance sheet with robust free cash flow generation: With over $600 million of pro forma EBITDA for the Trailing Twelve Months ended March 31, 2017, and the expectation of approximately $100 million in annual run-rate cost synergies, plus the ability to realize nearly $850 million in NOLs, net leverage is expected to be reduced from approximately four times at closing to under three times within 18 months to two years of closing.

Management and Headquarters

Following the close of the transaction, Alistair Macdonald will serve as Chief Executive Officer of the combined company, with Greg Rush serving as Chief Financial Officer and Michael Bell serving as Executive Chairman. The Board of Directors of the combined company will consist of 10 directors, with five directors designated by INC Research, including Alistair Macdonald, and with five directors designated by inVentiv, including two directors designated by Advent International, two directors designated by Thomas H. Lee Partners, and Michael Bell serving as Executive Chairman of the Board. The global organization will be headquartered in Raleigh, North Carolina, with a significant presence in the Northeast corridor of the United States, and operations worldwide, including in Asia and Europe.

Additional Transaction Details

The companies intend to refinance certain debt in connection with the merger. Credit Suisse has provided committed financing for the transaction.

The transaction, which is expected to be completed in the second half of 2017, is subject to, among other things, approval by INC Research shareholders, the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the satisfaction of other regulatory requirements and other customary closing conditions.

INC Research First Quarter 2017 Results
In a separate press release issued earlier today, INC Research also announced financial results for the first quarter ended March 31, 2017. To access the release, please visit the INC Research Newsroom.

Advisors
Centerview Partners LLC is acting as INC Research’s financial advisor and Sullivan & Cromwell LLP is serving as its legal counsel.

Credit Suisse is acting as inVentiv’s financial advisor and Weil, Gotshal & Manges LLP is serving as its legal counsel.

Webcast and Conference Call Details
A joint conference call to discuss the transaction is scheduled for today, May 10, 2017, at 8:00 a.m. EDT. To participate by telephone, dial +1 (877) 930-8058 within the United States or +1 (253) 336-7551 outside the United States, approximately 15 minutes before the scheduled start of the call. The conference ID for the call is 11961964.

The conference call will also be available in listen-only mode via live webcast on the companies’ websites at www.incresearch.com and www.inVentivHealth.com.

A presentation will accompany the conference call and will be posted prior to the start of the call. These slides may be accessed on the INC Research and inVentiv websites.

An archived replay of the conference call will be available online on the companies’ websites at www. INCResearch.com and www.inVentivHealth.com after 1:00 p.m. EDT on May 10, 2017. In addition, an audio replay will be available for one week following the call and will be accessible by dialing +1 (855) 859-2056 within the United States or +1 (404) 537-3406 outside the United States. The audio replay ID is 11961964.

About INC Research
INC Research (Nasdaq:INCR) is a leading global contract research organization (“CRO”) providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industries.  Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market.  The Company was ranked “Top CRO to Work With” among the top 10 global CROs in the 2017 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 110 countries. For more information, please visit www.incresearch.com and connect with us on LinkedIn and Twitter @inc_research.

About inVentiv Health
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in more than 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment. For more information, visit www.inVentivHealth.com.

Forward-Looking Statements
This communication includes contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such forward-looking statements reflect, among other things, our current expectations and anticipated results of operations, all of which are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements, market trends, or industry results to differ materially from those expressed or implied by such forward-looking statements. Therefore, any statements contained herein that are not statements of historical fact may be forward-looking statements and should be evaluated as such. Without limiting the foregoing, the words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “projects,” “should,” “would,” “targets,” “will” and the negative thereof and similar words and expressions are intended to identify forward-looking statements. Forward-looking statements by their nature address matters that are, to different degrees, uncertain, such as statements about the potential timing or consummation of the proposed transaction or the anticipated benefits thereof, including, without limitation, future financial and operating results. INC Research cautions readers that these and other forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed in any forward-looking statements. Important risk factors that may cause such a difference include, but are not limited to risks and uncertainties related to (i) the ability to obtain shareholder and regulatory approvals, or the possibility that they may delay the transaction or that such regulatory approval may result in the imposition of conditions that could cause the parties to abandon the transaction, (ii) the risk that a condition to closing of the merger may not be satisfied; (iii) the ability of INC Research and inVentiv to integrate their businesses successfully and to achieve anticipated synergies, (iv) the possibility that other anticipated benefits of the proposed transaction will not be realized, including without limitation, anticipated revenues, expenses, earnings and other financial results, and growth and expansion of the new combined company’s operations, and the anticipated tax treatment, (v) potential litigation relating to the proposed transaction that could be instituted against INC Research, inVentiv or their respective directors, (vi) possible disruptions from the proposed transaction that could harm INC Research’s and/or inVentiv’s business, including current plans and operations, (vii) the ability of INC Research or inVentiv to retain, attract and hire key personnel, (viii) potential adverse reactions or changes to relationships with clients, employees, suppliers or other parties resulting from the announcement or completion of the merger, (ix) potential business uncertainty, including changes to existing business relationships, during the pendency of the merger that could affect INC Research’s or inVentiv’s financial performance, (x) certain restrictions during the pendency of the merger that may impact INC Research’s or inVentiv’s ability to pursue certain business opportunities or strategic transactions, (xi) continued availability of capital and financing and rating agency actions, (xii) legislative, regulatory and economic developments and (xiii) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism or outbreak of war or hostilities, as well as management’s response to any of the aforementioned factors. These risks, as well as other risks associated with the proposed transaction, will be more fully discussed in the proxy statement that will be filed with the Securities and Exchange Commission in connection with the proposed transaction. While the list of factors presented here is, and the list of factors to be presented in the proxy statement are, considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward looking statements. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, business disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material adverse effect on INC Research’s or inVentiv’s consolidated financial condition, results of operations, credit rating or liquidity. Unless legally required, INC Research does not assume any obligation to update any such forward-looking information to reflect actual results or changes in the factors affecting such forward-looking information.

Additional Information and Where to Find It
This communication is being made in respect of the proposed merger transaction involving the INC Research and inVentiv. In connection with the proposed transaction, INC Research will file with the Securities and Exchange Commission a proxy statement and will mail the proxy statement to its shareholders. Shareholders are encouraged to read the proxy statement regarding the proposed transaction in its entirety when it becomes available and before making any voting decision as it will contain important information about the transaction. Shareholders will be able to obtain a free copy of the proxy statement (when available), as well as other filings made by INC Research regarding INC Research, inVentiv, and the proposed transaction, without charge, at the Securities and Exchange Commission’s website (http://www.sec.gov) or at INC Research’s website (investor.incresearch.com).

Participants in the Solicitation
INC Research and its respective executive officers, directors and other persons may be deemed to be participants in the solicitation of proxies from INC Research’s shareholders with respect to the special meeting of shareholders that will be held to consider and vote upon the approval of the share issuance and the proposed transaction. Information regarding the officers and directors of INC Research is included in its Annual Report on Form 10-K for the year ended Dec. 31, 2016, and INC Research’s notice of Annual Meeting of Shareholders and Proxy Statement, which were filed with the Securities and Exchange Commission on April 13, 2017. Other information regarding the participants in the solicitation and a description of their direct and indirect interests, by security holdings or otherwise, which may be different than those of INC Research’s shareholders generally, will be contained in the proxy statement (when filed) and other relevant materials to be filed with the Securities and Exchange Commission in connection with the proposed transaction. This communication is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote of approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

INC Research Contacts

Investor Relations Contact:
Ronnie Speight
Vice President, Investor Relations
+1 919-745-2745
Investor.Relations@incresearch.com

Press/Media Contacts:
Lori Dorer
Senior Director, Corporate Communications
+1 919-745-2890
Corporate.Communications@incresearch.com

Matthew Sherman / Kelly Sullivan / Viveca Tress
Joele Frank, Wilkinson Brimmer Katcher
+1 212-355-4449

inVentiv Health Contacts

Press/Media Contacts:
Danielle DeForge
Senior Director, Corporate Communications
+1 202-210-5992
Email: Danielle.DeForge@inVentivHealth.com

Kaitlin Bilby
Sard Verbinnen & Co
+1 212-687-8080
Wednesday, May 10th, 2017 Uncategorized Comments Off on $INCR and inVentiv Health to Merge

$PRTO Receives FDA Breakthrough Therapy Designation for Vonapanitase

WALTHAM, Mass., May 10, 2017  — Proteon Therapeutics, Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced that its investigational treatment, vonapanitase, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for increasing arteriovenous fistula secondary patency (i.e., survival of the fistula without abandonment) and use for hemodialysis in patients on or expected to initiate hemodialysis.

Secondary patency and fistula use for hemodialysis are the co-primary endpoints of Proteon’s ongoing pivotal Phase 3 clinical trial, PATENCY-2. As previously announced, the FDA has confirmed that the PATENCY-2 trial together with data from previously completed studies would provide the basis for a Biologics License Application (BLA) submission as a single pivotal study if PATENCY-2 is successful in showing statistical significance (p≤0.05) on each of the co-primary endpoints.

The FDA awards Breakthrough Therapy designations to expedite the development and review of drugs that are intended to address a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may offer a substantial improvement over available therapies on one or more clinically significant endpoints.  Proteon’s Breakthrough Therapy designation is supported by data from PATENCY-1, the Company’s first Phase 3 clinical trial evaluating vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula. In that study, vonapanitase demonstrated clinically meaningful improvements in secondary patency and use for hemodialysis, although it did not meet the primary endpoint of improving primary patency.

“We believe the decision by the FDA to grant vonapanitase a Breakthrough Therapy designation speaks to the clinical importance of fistula survival and use for hemodialysis to patients with chronic kidney disease,” said Timothy Noyes, President and Chief Executive Officer of Proteon Therapeutics. “Our productive ongoing dialogue with the FDA has helped to create a clear path forward for vonapanitase, and we look forward to continuing to work closely with the FDA to expedite our development efforts for this important program.”

Enrollment in the PATENCY-2 trial is expected to complete in the first quarter of 2018 and Proteon expects to report top-line data in the first quarter of 2019.  Proteon also expects to submit a BLA to the FDA in 2019.

About Chronic Kidney Disease, Hemodialysis and Vascular Access

In the most severe stage of chronic kidney disease (CKD), also known as kidney failure, the kidneys can no longer function to sustain life. The majority of patients with kidney failure undergo chronic hemodialysis, which requires a high-flow vascular access to repeatedly connect the patient’s bloodstream to a hemodialysis machine for this life-saving treatment. The preferred form of vascular access for hemodialysis is a radiocephalic arteriovenous fistula, created when a surgeon connects a vein to an artery in the forearm, resulting in a substantial increase in blood flow and vein dilation.

About Vonapanitase

Vonapanitase is an investigational drug intended to improve hemodialysis vascular access outcomes. Vonapanitase is applied in a single administration and is currently being studied in a Phase 3 program in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Vonapanitase has received Breakthrough Therapy, Fast Track and Orphan Drug designations from the FDA, and Orphan Medicinal Product Designation from the European Commission, for hemodialysis vascular access indications. In addition, vonapanitase may have other surgical and endovascular applications in diseases or conditions in which vessel injury leads to blockages in blood vessels and reduced blood flow. Proteon is currently conducting a Phase 1 clinical trial of vonapanitase in patients with peripheral artery disease (PAD).

About Proteon Therapeutics

Proteon Therapeutics is committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics. Proteon’s lead product candidate, vonapanitase, is an investigational drug intended to improve hemodialysis vascular access outcomes. Proteon is currently enrolling patients in PATENCY-2, a Phase 3 clinical trial evaluating vonapanitase in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Proteon is also evaluating vonapanitase in a Phase 1 clinical trial of vonapanitase in patients with PAD. For more information, please visit www.proteontx.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are, or may be deemed to be, “forward-looking statements.” In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” or “will,” in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including the timing of enrollment in the PATENCY-2 trial, when the Company expects to report top-line data from the PATENCY-2 trial, whether and when we may submit a BLA, whether additional studies will be necessary to support a BLA submission as a single pivotal trial, the potential treatment of renal and vascular diseases with vonapanitase, the effect or benefit of vonapanitase in patients with CKD, whether vonapanitase improves secondary patency or fistula use for hemodialysis and the clinical importance of these endpoints, the potential surgical and endovascular applications for vonapanitase, including PAD, and those relating to future events or our future financial performance or condition, involve substantial known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors, including whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements for the period anticipated; whether data from early nonclinical or clinical studies will be indicative of the data that will be obtained from future clinical trials; whether vonapanitase will advance through the clinical trial process on the anticipated timeline and warrant submission for regulatory approval; whether such a submission would receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies on a timely basis or at all; and whether we can successfully commercialize and market our product candidates, are described more fully in our Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission (“SEC”) on March 16, 2017, and our subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, as filed with the SEC, particularly in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” In light of the significant uncertainties in our forward-looking statements, you should not place undue reliance on these statements or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements contained in this press release represent our estimates and assumptions only as of the date of this press release and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Investor Relations Contact
George Eldridge, Proteon Therapeutics, Senior Vice President and Chief Financial Officer
781-890-0102
geldridge@proteontherapeutics.com

Media Contact
Ann Stanesa, Ten Bridge Communications
617-230-0347
proteon@tenbridgecommunications.com

Wednesday, May 10th, 2017 Uncategorized Comments Off on $PRTO Receives FDA Breakthrough Therapy Designation for Vonapanitase

$MKGI Fiscal 2017 Year-in-Review; Novel, Proprietary Booking Engine Highlighted

WESTON, FL–(May 10, 2017) – Monaker Group (OTCQB: MKGI), a travel and technology company focused on the alternative lodging rental (ALR) market, reported results for its full fiscal year ended February 28, 2017.

Fiscal 2017 Operational Highlights

  • Introduced the Monaker Booking Engine (MBE), the first customizable, alternative lodging booking engine with instant booking of vacation homes, villas, chalets, apartments, condos and castles. As a cloud-based platform driven by proprietary technology and contracted properties, MBE dynamically controls ALR inventory, allowing users to search and instantly book their reservation, versus the traditional industry method of waiting with uncertainty for the property owner to respond to a booking request.
  • Added hundreds of property managers and homeowners to the Monaker travel network, resulting in 1.2 million ALR properties across Europe, and Asia North America, South America and the Caribbean, available for instant booking via the Monaker platform. Monaker is in the process of onboarding additional properties that are expected to increase its total global inventory to more than 2 million.
  • Completed development and released the application programming interface for MBE, which provides a B2B solution for other travel companies to access Monaker’s ALR properties for display and instantaneous booking via their website or internal booking system. The API allows extensive customization, including types of properties, rental rates, commissions, user fees, geographic regions and other settings. This unique real-time access to a wholesale source of ALR properties has attracted several major travel distributors looking to integrate with the MBE platform.
  • Signed the first major industry partner to integrate MBE into its travel booking platform. As the nation’s leading-edge travel technology provider that propels some of the biggest brands in travel, the partner serves leading airlines, hotels and resorts, tour operators, travel agencies, tourist bureaus, theme parks and other suppliers worldwide. With more than $1 billion in bookings made annually through its platform, it is the premier source for leisure travel agents to expertly research, market and sell vacations to their clients. Monaker’s ALR inventory gives its network of more than 70,000 agents an easy, commissionable option for selling vacation rentals to their clients.
  • Launched Phase 1 of NextTrip.com, the company’s consumer facing website and mobile app where consumers can instantly book and confirm ALR properties simultaneously with airlines, car rentals, hotels, tours and activities. The site features more than 1.2 million instantly bookable ALR properties and 200,000 hotels, 400+ airlines, all major car rental companies, 10,000 tours and activities, as well as unique social media features.
  • Developed and launched the preview version of the NextTrip mobile app for iOS and Android. The apps will become fully functional with enhancements and upgrades at time of the NextTrip Phase II launch.
  • Travel Rewards Club, a new travel service and loyalty program, was launched in partnership with Recruiter.com, a leading global recruiting service and job market technology platform. The program provides Recuiter.com members a variety of special benefits, including discounted travel and vacation packages offering a “best price” promise, customizable options to build trips with friends and associates, complimentary flight insurance, access to fast pass visa and passport services, and exclusive savings on luxury travel and experiences.
  • Strengthened Monaker’s corporate governance though the appointment of additional, highly-accomplished independent directors to the board, Simon Orange and Bob Post. The appointments and the subsequent creation of new governance committees advanced the company toward meeting the requirements for up-listing to a major stock exchange.

Fiscal 2017 Financial Highlights

  • In fiscal 2017, the company transition from a holding company with various assets to focusing primary on developing and deploying the Monaker ALR platform. The transition resulted in write-offs and restructuring which generated $40 million in deferred tax credit against future earnings
  • Focused primarily on the launch of the new ALR booking engine and partner integrations, the company effectively operated as a development stage company during fiscal 2016 and reported nominal revenues.
  • To fund development, during fiscal 2017 the company raised $3.0 million from equity offerings and received $1.3 million from the exercise of warrants. Subsequent to the end of the fiscal year, the company raised an additional $1.6 million from an equity offering, of which $300,000 was represented by members of the company’s board of directors. Directors and insiders currently represent more than 65% of Monaker’s shareholder base.
  • Complete details of the company’s results for the fiscal year are available on the company’s Form 10-K filed with the Securities and Exchange Commission and in the financial information section of the company’s website.

Fiscal 2018 Outlook

  • In fiscal 2018, the company looks to take advantage of the growing demand for alternative lodging and the strong growth in digital travel sales. The ALR industry is expected to grow at more than 7% CAGR to $198 billion in 2021, according to Technavio, making it the fastest growing sector of the travel industry. Meanwhile, worldwide digital travel sales will to climb at a 9.7% CAGR to top $817 billion by 2020, says eMarketer.
  • NextTrip Phase II is targeted for release in late summer 2017, which will include comprehensive group planning in addition to booking for ALR, air, car, hotel, tours, restaurants and cruises. The NextTrip planner will allow users to import bookings from other websites, find nearby attractions, organize the details of a trip, and split costs among co-travelers. Users are also expected to benefit from the implementation of artificial intelligence that will assist with search and booking, and eliminate the typical hours involved in research and vacation planning. New social media capabilities will 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.
  • Monaker is in the process of uploading and certifying additional inventory from secured contracts, which is expected to increase its ALR inventory of properties from 1.2 million to more than 2 million.
  • In the second fiscal quarter, the company expects to launch its first partner integration of the MBE as the industry’s first B2B, customizable, real-time, alternative lodging booking engine. Upon launch, the company anticipates a ramp up in ALR booking activity to generate substantial revenue growth over the remainder of fiscal 2018 and beyond. Additional partner deployments are expected to follow, which will further drive revenue growth.

Management Commentary

“Of all the major developments in fiscal 2017, the most significant was our first industry partnership that will integrate the Monaker Booking Engine into a major travel platform,” noted Monaker chairman and CEO, Bill Kerby. “Second was the introduction of NextTrip, which will showcase the power of our MBE as a model for our partners, as well as incorporate advanced features that will make the site truly unique in our industry.

“The major challenge with ALR sites, even with Airbnb, is that many properties are not instantly bookable; that is, travelers must often wait indefinite periods of time for an owner to confirm their booking. For the same reason, online travel agencies, tour operators, and airline and cruise originators increasingly require ALR providers to offer instant bookings.

“The second major challenge for ALR platforms has been that no one has yet offered along with ALR the full spectrum of mainstream travel services, like flights, conventional lodging, timeshares, rental cars, cruises, and tour and land packages. Travelers where forced to cobble their trip together from various sources, and usually with unsatisfactory results. NextTrip and MBE solve both these issues, with MBE customization via our API providing Monaker a first-mover advantage in the B2B space.

“Given the rich features, we expect NextTrip and MBE will appeal to a far greater number of travelers and wholesale travel providers than any other ALR source, and thereby generate significant booking revenue for Monaker in fiscal 2018. We expect the majority of this revenue will be derived from our MBE and travel wholesale partners, as we see the market demand for such a wholesale ALR solution dwarfing that of our direct-to-consumer NextTrip offering.

“Our revenue outlook is further buoyed by data from independent experts who report that the ALR industry is one of the fastest growing segments in the travel sector, with digital travel sales also climbing at a phenomenal rate over the next several years.

“In all, we wrapped up fiscal 2017 and launched into the new fiscal year with a clean capitalization structure, nominal short-term debt, solid funding, and an ALR platform that can uniquely service the unmet demands of both B2B and B2C customers. Looking ahead, we believe our MBE and NextTrip will truly be travel industry game changers.”

About Monaker

Monaker Group is a technology-driven travel company focused on delivering innovation to alternative lodging rentals (ALR) market. The Monaker Booking Engine (MBE) delivers instant booking of more than 1.2 million vacation rental homes, villas, chalets, apartments, condos and castles. MBE offers travel distributors and agencies an industry-first: a customizable instant booking platform for ALR. Monaker’s NextTrip.com B2C website, also powered by MBE, is the first to offer significant instantly bookable ALR products along with mainstream travel products and services all on a single site. NextTrip also features rich content, imagery and high-quality video to enhance a traveler’s booking experience and assist in the search, decision and buying process for both individuals and groups. For more information, visit www.monakergroup.com or www.nexttrip.com.

Important Cautions Regarding Forward Looking Statements

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

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

Investor Relations Contact
Ronald Both or Grant Stude
CMA
Tel: (949) 432-7557
rb@cma.bz

Wednesday, May 10th, 2017 Uncategorized Comments Off on $MKGI Fiscal 2017 Year-in-Review; Novel, Proprietary Booking Engine Highlighted

Pivot Pharmaceuticals Inc. (PVOTF)

Pivot Pharmaceuticals Inc. (OTCQB: PVOTF), based in Vancouver, Canada, is an emerging biopharmaceutical company engaged in the development and commercialization of pharmaceuticals and nutraceuticals that provide novel treatments for unmet healthcare needs. Pivot’s recent acquisition of BiPhasix ™ Transdermal Drug Delivery technology for the delivery of cannabinoids (CBD) to patients provides the answer for an age-old problem associated with cannabinoid-based therapies: the lack of a robust smoke-less delivery mechanism.

Research into the bioavailability of cannabinoid-based therapeutics shows that rates of absorption vary greatly between smoking cannabis to an orally-consumed product, with a difference noted even between individuals. Cannabinoids are degraded in the stomach and smoking may not appeal to patients for health or lifestyle reasons. Topical delivery, while a better alternative, has suffered from weak formulation issues. Transdermal cannabinoid delivery, on the other hand, could provide a better alternative route since it reduces side effects and bypasses other absorption issues. In addition, transdermal delivery provides the benefit of enabling patients to access a steady stream of medication over a prolonged period with fewer side effects.

Pivot Pharmaceutical’s newly created subsidiary, Pivot Green Stream Health Solutions Inc. (“Pivot Green Stream”), will focus on improving the bioavailability of cannabinoid-based and pharmaceuticals. BiPhasix™ has been tested in FDA and EMA approved human clinical trials, which have shown the delivery system enhances the bioavailability of many drugs and improves clinical outcomes. Pivot Green Stream is tasked with developing several natural health products containing cannabinoids (CBD) that can receive a Health Canada Natural Health Product (NHP) designation. This marketing method ensures a shorter development cycle and faster revenue generation opportunities.

Pivot Pharmaceuticals Inc., which has positioned itself as a growing and crucial vertical in the cannabis industry, represents a compelling opportunity in the biotechnology field. The company’s plans include working with Licensed Producers (LP) and Licensed Dealers (LD) to bring newer therapies to patients. The company has also applied to list on the Canadian Stock Exchange (CSE).

The global medical marijuana market is expected to reach a value of $55.8 billion by 2025, according to a new report by Grand View Research, Inc. The growing number of states and countries gaining approval for using cannabis in therapeutic applications is expected to continue driving the market forward.

Pivot Pharmaceuticals has assembled a highly experienced management team, bringing together a wealth of clinical, commercial, product development and financial experience. Among the many healthcare targets in Pivot’s pipeline are cancer supportive care, pain and inflammation, women’s sexual dysfunction, dermatology and eye disease.

Investment Considerations

  • Transdermal cannabis-based therapy promises greater absorption, less side effects
  • Global medical marijuana market projected to reach $55.8 billion U.S. by 2025
  • Novel CBD delivery method targets array of unmet healthcare needs

Tuesday, May 9th, 2017 Uncategorized Comments Off on Pivot Pharmaceuticals Inc. (PVOTF)

$SMSI Licenses Smith Micro’s Firmware Update Technology

FOTA technology adds comprehensive functionality and robust update capabilities to the Kona S platform

Smith Micro Software, Inc. (NASDAQ:SMSI) today announced that Kona S, an embedded solutions and services provider based in the Republic of Korea (South Korea), has selected Smith Micro’s FOTA (firmware over-the-air) software for integration into its device management (DM) platform. Part of Smith Micro’s comprehensive QuickLink® IoT Services Platform, Smith Micro’s FOTA solution supports the entire firmware update process from update package creation to device installation and update verification.

Leveraging advanced differencing algorithms, Smith Micro’s FOTA solution creates delta firmware update packages that are significantly smaller in size than the original firmware updates. This technology enables Kona S to greatly reduce the amount of Internet traffic associated with updating a large network of IoT devices. Once created and delivered, the FOTA technology unpacks the delta versions of the firmware update packages and applies them to the device in a very robust manner by active handling of bad memory blocks, recovery due to power loss, and detection of corrupted update packages.

A leading DM solution provider for the telecom industry, Kona S is expanding its footprint into the surging connected car market with AVN (Audio, Visual, Navigation) solutions. Due to recent market consolidation, Kona S needed a proven, independent FOTA solution for integration into this new DM offering for the AVN use case.

“Smith Micro’s FOTA technology adds comprehensive capabilities for updating device firmware over-the-air to our DM platform,” said Thomas Choi, IoT planning/Manager for Kona S. “The solution is extensible with well-documented APIs that can be easily adapted by OEMs to almost any hardware platform running Linux.”

“We are pleased that Kona S is licensing our FOTA technology as part of their device management offering for the automotive sector in the APAC region,” said William W. Smith, Jr., President and CEO of Smith Micro Software. “The market consolidation in this segment has enabled Smith Micro to address the growing demand for proven device management solutions in the rapidly expanding IoT market. With the need to update millions of mobile devices already in the field, and with millions more to come, our carrier-grade, QuickLink IoT Services Platform provides comprehensive, in-field support for connected devices throughout their entire lifecycle.”

Integrated into the Kona S offering, Smith Micro’s FOTA technology will be deployed in South Korea, China, and Japan in the second quarter of 2017. Learn more about Smith Micro’s FOTA technology here.

About Kona S

Kona S Co., Ltd., a subsidiary of Seoul-based Kona I, is a trusted provider of device management, data synchronization, and remote FOTA update solutions. Since its establishment in 1999, Kona S has provided embedded software solutions and services to telecom services providers and leading device manufactures, such as Samsung Electronics, LG Electronics, and Pantech.

About QuickLink IoT Services Platform

The QuickLink IoT Services Platform provides end-to-end device management functionality for connected devices in the Internet of Things. Features include secure firmware updates, device monitoring, remote configuration, data collection, and much more. Original Equipment Manufacturers (OEMs) and Original Device Manufactures (ODMs) can leverage the extensibility and flexibility of the QuickLink IoT Services Platform to address a wide array of use cases. Built on industry standards defined by the Open Mobile Alliance, such as OMA-DM and LwM2M, QuickLink IoT adds robust and secure device management functionality into both legacy connected devices and next-generation smart devices that comprise the growing Internet of Things. Learn more about the QuickLink IoT Services Platform here.

About Smith Micro Software, Inc.

Smith Micro develops software to simplify and enhance the mobile experience, providing solutions to some of the leading wireless service providers, device manufacturers, and enterprise businesses around the world. From optimizing wireless networks to uncovering customer experience insights, and from streamlining Wi-Fi access to ensuring family safety, our solutions enrich today’s connected lifestyles while creating new opportunities to engage consumers via smartphones. Our portfolio also includes a wide range of products for creating, sharing, and monetizing rich content, such as visual messaging, video streaming, and 2D/3D graphics applications. For more information, visit smithmicro.com. (NASDAQ:SMSI)

Safe Harbor Statement:

This release contains forward-looking statements that involve risks and uncertainties, including without limitation, forward-looking statements relating to the company’s financial prospects and other projections of its performance, the existence of new sales opportunities and interest in the company’s products and solutions, the company’s ability to increase its revenue by capitalizing on new opportunities, and customer concentration given that the majority of our sales depend on a few large client relationships, including Sprint. Among the important factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements are changes in demand for the company’s products from its customers and their end-users, new and changing technologies, customer acceptance and timing of deployment of those technologies, and the company’s ability to compete effectively with other software and technology companies. These and other factors discussed in the company’s filings with the Securities and Exchange Commission, including our filings on Forms 10-K and 10-Q, could cause actual results to differ materially from those expressed or implied in any forward-looking statements. The forward-looking statements contained in this release are made on the basis of the views and assumptions of management regarding future events and business performance as of the date of this release, and the company does not undertake any obligation to update these statements to reflect events or circumstances occurring after the date of this release.

Smith Micro and the Smith Micro logo are registered trademarks or trademarks of Smith Micro Software, Inc. All other trademarks and product names are the property of their respective companies.

Smith Micro Software, Inc.
Charles Messman, +1 949-362-5800
PR@smithmicro.com

Tuesday, May 9th, 2017 Uncategorized Comments Off on $SMSI Licenses Smith Micro’s Firmware Update Technology

$UEC Strengthens Leading ISR Portfolio with Acquisition of Fully Licensed Reno Creek Project

Canada NewsWire

CORPUS CHRISTI, TX, May 9, 2017

NYSE MKT Symbol – UEC

CORPUS CHRISTI, TX, May 9, 2017 – Uranium Energy Corp (NYSE MKT: UEC, the “Company” or “UEC”) is pleased to announce that the Company has entered into a definitive Share Purchase Agreement (the “Agreement”) with Pacific Road Resources Funds (“PRRF”) to acquire all of the issued and outstanding shares of Reno Creek Holdings Inc. (“RCHI”) and, indirectly thereby, 100% of its fully permitted Reno Creek in-situ recovery (“ISR”) project located in the Powder River Basin, Wyoming (“Reno Creek” or the “Project”).

Transaction Highlights

  • Strengthens UEC’s pipeline of low-cost ISR uranium projects with the addition of Reno Creek, located in the prolific Powder River Basin in Wyoming.
  • Reno Creek hosts an NI 43-101 Measured and Indicated resource of 27.47 million tons grading 0.041% U3O8 yielding 21.98 million lbs U3O8 at a grade-thickness (GT) cutoff of 0.20*.
  • The NI 43-101 resource report also indicates potential to expand the resource with additional drilling.
  • A Source and By Product Materials License for Reno Creek was issued in February 2017 from the U.S Nuclear Regulatory Commission (“NRC”), supported by a Final Environmental Impact Statement and Record of Decision, to permit production of up to 2 million lbs. U3O8 per year.
  • Strategically located within the Powder River Basin in Wyoming, a uranium mining-friendly state with excellent infrastructure and an experienced labor force.
  • A Pre-Feasibility Study (“PFS”)** on Reno Creek completed in 2014 demonstrated strong project economics with low capital and operating costs consistent with ISR projects in Wyoming. A new and optimized PFS is in progress and will be completed by UEC.
  • Cumulative expenditures to date of approximately $60 million.
  • A new partnership with respected mining private equity firm Pacific Road Resources Funds, who will own approximately 9% of UEC’s common shares at closing.

Amir Adnani, President & CEO, stated: “The acquisition of Reno Creek creates an industry-leading diversified pipeline of low-cost ISR uranium projects when combined with our production-ready South Texas hub-and-spoke operations and exploration/development portfolio in Paraguay.  The Reno Creek Project presents a rare opportunity to acquire a large, fully permitted, construction ready, and strategic low-cost ISR asset located in the United States – a complete set of attributes for any potential UEC acquisition.  The Powder River Basin of Wyoming has produced over 85 million lbs U3O8 historically, and is currently home to two of the largest uranium producers in the world: Cameco and Uranium One (Rosatom). We commend Pacific Road for their outstanding work to advance the Reno Creek project over the past seven years, and we welcome them as our newest shareholder.”

“We are very excited about combining Reno Creek with UEC”, said Dan Wilton, Partner at Pacific Road. “The UEC team has an outstanding track record of consolidating, developing and operating ISR uranium projects. We believe they have the right technical, operating and financing capabilities to deliver the true value of Reno Creek, continuing the excellent work done by Jim Viellenave’s team, who took the property from an initial resource through to a fully permitted project. The combination of UEC and Reno Creek creates one of the most attractive portfolios of U.S.-based low cost ISR uranium assets and is an important step in the consolidation of the U.S. ISR uranium sector.”

Transaction Details

Under the terms of the Agreement, the Company will issue to PRRF, in return for PRRF’s 97.27% ownership in RCHI (the “Transaction”), the following:

(i) 14.0 million shares of the Company (the “Share Consideration”);
(ii) 11.0 million warrants of the Company (the “Warrant Consideration”), with each warrant entitling the holder to acquire one share of the Company at an exercise price of $2.30 per share for a period of five years from closing. The warrants will have an accelerator clause which provides that, in the event that the closing price of UEC’s common shares on its principally traded exchange is equal to or greater than $4.00 per share for a period of 20 consecutive trading days, UEC may accelerate the expiry date of the warrants to within 30 days by providing written notice to the holders; and
(iii) a 0.5% net profits interest royalty, capped at $2.5 million (the “NPI Consideration”, and together with the Share Consideration and the Warrant Consideration, the “Consideration”);

Upon completion of the Transaction, PRRF will own approximately 9% of UEC’s shares outstanding.  PRRF has agreed to certain voting and resale conditions pursuant to the terms of the Agreement.

By way of certain ‘drag along’ rights, the Company will acquire the remaining 2.73% of RCHI from Bayswater Uranium Corporation for pro-rated consideration identical to the Consideration being issued to PRRF. The Transaction is subject to NRC approval and is expected to close on or about July 31, 2017.

Reno Creek ISR Project Overview

The Reno Creek ISR Project is located in the Powder River Basin, Campbell County, Wyoming, approximately 80 miles northeast of Casper. PRRF undertook significant project advancement since 2010 when they acquired the project, including expenditures targeting land acquisition, resource development, a pre-feasibility study, and permitting, which culminated in the NRC issuing a source and byproduct materials license to construct and operate an ISR uranium facility in February 2017.

The source materials license was the last major permit required to proceed with the development of the Project. The permits allow Reno Creek to process up to 2 million pounds of uranium a year from five resource units: North Reno Creek, Southwest Reno Creek, Moore, Bing, and Pine Tree. Within the five resource units are 16 proposed production units and associated wellfields, header houses, and a central processing plant.

History of the Project

Substantial historical exploration, development, and project permitting work has been completed on the Reno Creek property, beginning in the late 1960s and continuing to present.  Approximately 10,000 exploration drill holes have been completed by various operators over time, who continued to advance the project by drilling and growing land and mineral interests to nearly 16,000 acres by 2007. Since PRRF took control of the Project, mineral and surface land holdings have grown to approximately 22,000 acres, including a 40-acre company-owned central processing plant site.

Summary of Mineral Resources

In July 2016, PRRF commissioned an updated Technical Report completed by Behre Dolbear & Company (USA), Inc. on Reno Creek titled “Technical Report and Audit of Resources of the Reno Creek ISR Project, Campbell County, Wyoming, USA” (the “Current Technical Report”). Over $60 million has been expended on the Project to date, including completion of more than 10,000 drill holes. Data from drilling, including survey coordinates, collar elevations, depths, and grade of uranium intercepts, have been incorporated into the database that forms the current resource estimate at Reno Creek (Table 1).

Table 1(1)

Class Tons (millions) Weighted Average Thickness (feet) Weighted Average Grade (% U3O8) Pounds U3O8 (millions)
Measured & Indicated 27.47 12.3 0.041 21.98
Inferred 1.36 10.6 0.034 0.93
1 Cut-off of greater or equal to 0.20 grade x thickness per intercept

The inferred resources are found principally in underexplored portions of the Reno Creek property, along extensive identified redox fronts.  The authors of the July 2016 Reno Creek resource estimate recommend continuing exploration along these trends, with the expectation of further contributions to the reported resource base; given the known mineralization occurs in a continuous sandstone present across all of the Reno Creek, Moore, and Bing resource units.

The technical information in this news release has been prepared in accordance with the Canadian regulatory requirements set out in NI 43-101 and was reviewed by Clyde L. Yancey, P.G., Vice President-Exploration for the Company, a Qualified Person under NI 43-101.

Advisors and Counsel

Haywood Securities Inc. is acting as financial advisor to the Company. McMillan LLP and Holland & Hart LLP are acting as legal advisors to the Company. Osler, Hoskin & Harcourt LLP is acting as legal advisor to PRRF.

About Uranium Energy Corp

Uranium Energy Corp is a U.S.-based uranium mining and exploration company.  The Company’s fully-licensed Hobson Processing Facility is central to all of its projects in South Texas, including the Palangana ISR mine, the permitted Goliad ISR project and the development-stage Burke Hollow ISR project.  Additionally, the Company controls a pipeline of advanced-stage projects in Arizona, Colorado and Paraguay.  The Company’s operations are managed by professionals with a recognized profile for excellence in their industry, a profile based on many decades of hands-on experience in the key facets of uranium exploration, development and mining.

About Pacific Road Resources Funds

The Pacific Road Resources Funds are private equity funds investing in the global mining industry. They provide expansion and buyout capital for mining projects, mining related infrastructure and mining services businesses located throughout the world. The team is located in Sydney, Australia and Vancouver, Canada.

PRRF’s position in RCHI is held by Pacific Road Capital A Pty Ltd., as trustee for Pacific Road Resources Fund A, Pacific Road Capital B Pty Ltd., as trustee for Pacific Road Resources Fund B, and Pacific Road Holdings S.à.r.l., a Luxembourg corporation.

Stock Exchange Information:

NYSE MKT: UEC
Frankfurt Stock Exchange Symbol: U6Z
WKN: AØJDRR
ISN: US916896103

*Notice to U.S. Investors

The mineral resources referred to herein have been estimated in accordance with the definition standards on mineral resources of the Canadian Institute of Mining, Metallurgy and Petroleum referred to in NI 43-101 and are not compliant with U.S. Securities and Exchange Commission (the “SEC”) Industry Guide 7 guidelines. In addition, measured mineral resources, indicated mineral resources and inferred mineral resources, while recognized and required by Canadian regulations, are not defined terms under SEC Industry Guide 7 and are normally not permitted to be used in reports and registration statements filed with the SEC. Accordingly, we have not reported them in the United States. Investors are cautioned not to assume that any part or all of the mineral resources in these categories will ever be converted into mineral reserves. These terms have a great amount of uncertainty as to their existence, and great uncertainty as to their economic and legal feasibility. In particular, it should be noted that mineral resources which are not mineral reserves do not have demonstrated economic viability. It cannot be assumed that all or any part of measured mineral resources, indicated mineral resources or inferred mineral resources will ever be upgraded to a higher category. In accordance with Canadian rules, estimates of inferred mineral resources cannot form the basis of feasibility or other economic studies. Investors are cautioned not to assume that any part of the reported measured mineral resources, indicated mineral resources or inferred mineral resources referred to herein are economically or legally mineable.

**PFS

Upon the closing of the Transaction the Company plans to complete a new and optimized PFS based substantially on the information provided in the Current Technical Report.  Accordingly, the current PFS cannot be relied upon and should not be construed to reflect a current PFS in accordance with NI 43-101.

Safe Harbor Statement

Except for the statements of historical fact contained herein, the information presented in this news release constitutes “forward-looking statements” as such term is used in applicable United States and Canadian laws. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management. Any other statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects” or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans, “estimates” or “intends”, or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved) are not statements of historical fact and should be viewed as “forward-looking statements”. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such risks and other factors include, among others, the actual results of exploration activities, variations in the underlying assumptions associated with the estimation or realization of mineral resources, the availability of capital to fund programs and the resulting dilution caused by the raising of capital through the sale of shares, accidents, labor disputes and other risks of the mining industry including, without limitation, those associated with the environment, delays in obtaining governmental approvals, permits or financing or in the completion of development or construction activities, title disputes or claims limitations on insurance coverage. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements contained in this news release and in any document referred to in this news release.

Certain matters discussed in this news release and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause actual results to differ materially and that could impact the Company and the statements contained in this news release can be found in the Company’s filings with the Securities and Exchange Commission. For forward-looking statements in this news release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise. This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities.

Tuesday, May 9th, 2017 Uncategorized Comments Off on $UEC Strengthens Leading ISR Portfolio with Acquisition of Fully Licensed Reno Creek Project

$AETI M&I Electric announces $5M project with major EPC firm for new chemical plant

  • Break-in win at top 5 largest Engineering, Procurement and Construction firms
  • First award with $40B global chemical company owner

HOUSTON, May 09, 2017 —  American Electric Technologies, Inc. (NASDAQ:AETI), a leading provider of power delivery solutions for the global energy industry, announced today that its M&I Electric business has been awarded a $5M contract  to provide a turnkey power delivery solution for a new chemical plant under construction on the Texas Gulf Coast

This is M&I’s first turnkey solution project award with this large Engineering, Procurement and Construction (EPC) firm, who ranked in the top five largest Engineering News Record (ENR) Top 500 Design Firms with revenues of $10B.

The M&I turnkey power delivery system will supply safe, reliable power distribution for a new chemical plant under construction near Alvin, TX for a $40B global chemical company owner.

M&I’s turnkey power delivery solutions includes custom-designed medium and low voltage conventional switchgear, low voltage and medium voltage motor control centers, and communications equipment all integrated into  multiple M&I Power Distribution Centers (PDCs).

“This is a very important order award for the company as it represents a break-in win for our company into another top 5 EPC firm,” said Charles Dauber, President and CEO, AETI.  “We look forward to working with our new customer and the project owner to deliver our turnkey power delivery solution for this chemical plant project.”

M&I expects delivery of this project to occur in the late 2017. Additional details were not disclosed.

About AETI:

American Electric Technologies, Inc. (NASDAQ:AETI) is a leading supplier of power delivery solutions for the global energy industry. AETI offers M&I Electric™ power distribution and control products, electrical services, and E&I construction services. AETI is headquartered in Houston and has global operations in Beaumont, Texas; and Rio de Janeiro, Macae and Belo Horizonte Brazil. In addition, AETI has minority interests in two joint ventures, which have facilities located in Xian, China and Singapore. AETI’s SEC filings, news and product/service information are available at www.aeti.com.

Contact:
Bill Brod
Chief Financial Officer
713-644-8182
Tuesday, May 9th, 2017 Uncategorized Comments Off on $AETI M&I Electric announces $5M project with major EPC firm for new chemical plant

$CLNT YSK1860 Acquires Ownership Interest in Cleantech Solutions International

HONG KONG, CHINA–(May 9, 2017) – YSK1860, an investment holding company with investments in different countries covering a wide range of sectors from traditional construction, real estate, trading to environmental and the Internet, today announced that on April 27, 2017, it acquired all of the shares of Cleantech Solutions International, Inc. (“Cleantech Solutions”) (NASDAQ: CLNT) previously held by Cleantech Solutions’ Chairman and CEO, Mr. Jinhua Wu, and his affiliates.

Pursuant to the terms of the agreement, YSK1860 purchased 416,249 shares of Cleantech Solutions stock from Mr. Wu and his affiliates for $970,000, or $2.33 per share. Mr. Wu and his affiliates decision to sell their shares was based on personal reasons, and Mr. Wu will retain his positions as Chairman and CEO of Cleantech Solutions going forward.

Commenting on the transaction Mr. Wu said, “The decision to sell these shares was personal, and I am pleased to have found an investor with the patience, vision and expertise to support Cleantech Solutions now and in the future. I look forward to staying on as CEO as we work on improving existing operations and exploring other areas with growth potential.”

Dr. Thomas Chan, director of YSK1860, said “This investment in Cleantech Solutions demonstrates our trust and confidence in the US stock market and the Company for its long-term growth potential and opportunity to participate in the growing Chinese energy market. We also expect to leverage our investment expertise and connections in the technology, media and telecommunications sectors to support Cleantech Solutions in identifying new business opportunities in the future. We are confident in the current management’s ability to put this year of transition behind us and focus on improving the long-term business outlook.”

About Cleantech Solutions International
Cleantech Solutions, through its affiliated companies, designs, manufactures and distributes a line of proprietary high and low temperature dyeing and finishing machinery to the textile industry.

About YSK1860
YSK1860 is a privately held company with investments in different countries and categories. YSK1860’s investment portfolio has covered a wide range of sectors from traditional construction, real estate, trading to environmental, internet etc. As the world evolves, we face different challenges and opportunities during different periods. YSK1860 capitalizes on trends and opportunities of our time with the aim to not only achieve capital growth but also provide a positive influence on society and the world. YSK1860 is a partner/client of Rothschild, UBS, Credit Suisse, and LGT on investment management. For more information visit http://ysk1860.com/

Media Contact:
Cleantech Solutions International, Inc.
May Liu
Investor Relationship
E-mail: ir@cleantechsolutionsinternational.com
+852-31060372
Web: www.cleantechsolutionsinternational.com

Compass Investor Relations
Elaine Ketchmere
CFA
Email: eketchmere@compass-ir.com
+1-310-528-3031
Web: www.compassinvestorrelations.com

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$MKGI to Attend the Oppenheimer Emerging Growth Conference, May 16

WESTON, FL–(May 9, 2017) –  Monaker Group (OTCQB: MKGI), a leader in online travel reservations technology, will participate at the Oppenheimer & Co. Emerging Growth Conference to be held at the InterContinental New York Barclay hotel in New York City, on Tuesday, May 16, 2017.

Bill Kerby, Monaker Group CEO, and Richard Marshall, the company’s director of corporate development, will be available for one-on-one meetings with investors throughout the day. Management will discuss the company’s launch of Monaker Booking Engine (MBE), the first customizable, alternative lodging reservation system with instant booking of vacation homes, villas, chalets, apartments, condos and castles.

Conference participation is by invitation only and registration is mandatory. For more information on the conference or to schedule a one-on-one meeting, please contact your Oppenheimer representative.

About Oppenheimer

Oppenheimer & Co. Inc. (Oppenheimer) is a leading investment bank and full-service investment firm that provides financial services and advice to high net worth investors, individuals, businesses and institutions. For over 130 years, the company has provided investors with the necessary expertise and insight to meet the challenge of achieving their financial goals. The company’s commitment to its clients’ investment needs, its experienced and dedicated professionals, and its proud tradition empower it to deliver effective and innovative solutions to its clients. For more information, visit www.opco.com.

About Monaker Group

Monaker Group is a technology-driven travel company focused on delivering innovation to alternative lodging rentals (ALR) market. The Monaker Booking Engine (MBE) delivers instant booking of more than 1.2 million vacation rental homes, villas, chalets, apartments, condos and castles. MBE offers travel distributors and agencies an industry-first: a customizable instant booking platform for ALR. Monaker’s NextTrip.com B2C website, also powered by MBE, is the first to offer significant instantly bookable ALR products along with mainstream travel products and services all on a single site. NextTrip also features rich content, imagery and high-quality video to enhance a traveler’s booking experience and assist in the search, decision and buying process for both individuals and groups. For more information, visit www.monakergroup.com or www.nexttrip.com.

Important Cautions Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties concerning the plans and expectations of Monaker Group. These statements are only predictions and actual events or results may differ materially from those described in this press release due to a number of risks and uncertainties, some of which are out of our control. The potential risks and uncertainties include, among others, or the expectations of future growth may not be realized. 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 www.sec.gov.

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

Investor Relations Contact
Ronald Both or Grant Stude
CMA
Tel: (949) 432-7557
rb@cma.bz

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ProBility Media Corp. (PBYA)

ProBility Media Corp., based in Houston, TX, is an EdTech Company that is building the first full service training and career advancement brand for the skilled trades. Through both acquisitions and organic growth, ProBility is executing a disruptive strategy of defragmenting the market place of disparate companies servicing fifteen vertical categories in over sixty skilled trades. ProBility has positioned itself as a key industrial training resource for individuals, small- and medium-size businesses as well as enterprise customers offering consistent high-quality training services and materials for education, testing, and career advancement.

Through its Electrical Training Division, the company has become the biggest wholesaler of electrical codes and test preparation materials in the U.S., while its Construction Training Division is one of the largest certification providers in the country, with programs in 22 states, and continuing to grow. The company serves corporate accounts and government buyers, and also offers advisory services for companies of all sizes.

Companies currently under the ProBility Media conglomerate include:

  • Brown Technical Media Corp. – An online web business with multiple micro web sites featuring training materials and codes and standards sought by engineers, construction workers, scientists and other tradesmen in a wide variety of fields.
  • Brown Technical Publications – A proprietary publishing business generating copyrighted training materials for engineers, construction workers, scientists and other tradesman in a wide variety of fields.
  • 1ExamPrep – E-Learning, education and exam preparation for contractors via the cheapest, fastest and most effective exam prep school in the industry instituting our 4-point proven learning system.
  • National Electrical Wholesale Providers – In the business of distributing wholesale industrial, commercial and residential training materials including HVAC, plumbing and electrical.

ProBility’s technology platform features virtual reality training for the crane business to be expanded into other industries, online subscription services for enterprise level companies, and recurring revenue streams. In addition, the company is already beginning to explore international expansion options, supported by the fact that other countries have adopted U.S. based codes, and have used U.S. training services.

The company’s acquisition strategy targets operations that service engineering firms, electrical contractors, fabricators, plumbing contractors, pipe fitters, riggers, QC firms, and additional vocational industries.

Investment Considerations

  • Development of the first full service training and career advancement brand for technical vocations and trades.
  • The current political and economic climate is aligned with the success of ProBility.
  • There are no other similar public companies to invest and gain exposure to the space.
  • Creation of new and recurring revenue streams through subscription services and the launching of multiple micro websites.
  • Management team experienced in value-building acquisitions, restructuring, and executive management in a range of industries.
  • State of the art training technology via virtual reality crane training with plans to expand into other fields


Monday, May 8th, 2017 Uncategorized Comments Off on ProBility Media Corp. (PBYA)

National Waste Management Holdings (NWMH)

National Waste Management Holdings, Inc. is a solid waste management company offering comprehensive solutions for full waste diversion along Florida’s west coast and in upstate New York. With an established base of long-term partnerships with municipal, institutional, commercial and industrial customers, along with a successful acquisition strategy, National Waste has set its course to become a leading waste diversion company.

National Waste’s 54-acre landfill facility located in Hernando, Florida, handles annual average disposals of roughly 240,000 cubic yards of construction debris annually. The site also offers an array of ancillary services such as roll-off dumpster services, mulching services and recycling. While the landfill facility is already permitted for future expansion, National Waste’s growth strategy also calls for the opening of new satellite offices in counties and states that neighbor its existing operations.

In addition to increasing its geographic foothold, National Waste employs a strategic acquisition model to increase its overall market share. In 2015, the company acquired Gateway Rolloff Services LP and Waste Recovery Enterprises LLC, which are expected to generate a combined $3.8 million in annual revenue for National Waste moving forward. In the second quarter of 2016, National Waste added Sivart Services to its roster, creating an immediate source of additional revenue and expanding its foothold in the northeast area of New York.

Management has confirmed its interest in additional acquisition targets while demonstrating its ability to effectively integrate and organically grow the company’s existing acquisition companies and maintain efficient operations.


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Monaker Group, Inc. (MKGI)

Monaker Group, Inc. is a technology driven travel company focused on leveraging resources to become a significant presence in the fastest growing sector of the $1.3 trillion travel and tourism market. The company’s flagship brand, NextTrip.com, is the industry’s first and only real-time booking engine that features alternative lodging (vacation home rentals, resort residences and unused timeshare inventory), as well as a full selection of airlines, hotels, cruises, rental cars, tours and concierge services. These features are combined into a single, easy-to-use platform that gives travelers complete real-time control when planning and booking their vacations.

NextTrip.com takes an integrated approach to the needs of travelers by combining multiple booking solutions into a highly intuitive real-time booking platform. Since its launch in February 2016, NextTrip has already grown to more than 250,000 units of vacation rental inventory. Monaker currently has roughly 1 million additional alternative lodging units under contract that will soon be added to the platform. This will place NextTrip among the top three largest vacation rental inventories and rival industry peers, Airbnb and HomeAway, in the rapidly expanding alternative lodging market. Unlike the competition, which book by request which can take hours or days before a lodging owner confirms, NextTrip’s platform books in real-time, similar to online hotel bookings.

Most NextTrip listings are in desirable locations in the U.S., the EU and the Caribbean with about 20% exclusive listings. Monaker expects rapid exclusive listing growth because, unlike the competition, Monaker doesn’t charge a sign-up fee, just a commission upon booking. The competition charges both. Monaker even has a proprietary solution to unlock Timeshare and Fractional Share properties as rental inventory.

Through strategic partnerships and acquisitions Monaker is now positioned to be a major player in the travel and alternative lodging sector. In addition Monaker is also the parent to Maupintour and Voyage TV.

In business for 65 years, Maupintour still leads the tour industry in the creation of outstanding, unique itineraries and has the highest repeat rate in the tour industry. Maupintour’s upscale luxury services create a unique blend with the various product offerings of NextTrip. Voyage TV has thousands of hours of travel footage shot in over 30 countries worldwide. These 15,000 video clips of hotels, resorts, cruise, and destination activities are a treasure trove for vacation travel marketing.

With an established portfolio of travel brands, and a proven record acquiring, consolidating and integrating companies, Monaker is building a diverse and exciting foundation to drive the company’s future. According to data from the U.S. Travel Association, direct spending on leisure travel by domestic and international travelers topped $650 billion in 2015. When combined with the fact that roughly 64 percent of travel companies are still considered small businesses, Monaker’s all-inclusive approach to vacation booking through NextTrip and Maupintour strategically positions it for sustainable growth moving forward.

Monaker is headquartered in South Florida with offices in California. The company is led by a seasoned management team with decades of applicable industry experience. Monaker’s Chairman and Chief Executive Officer Bill Kerby has over 18 years of experience in the media and travel industries, as well as 10 years of experience in the financial industry.


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Kootenay Zinc Corp. (CSE:ZNK) (OTCQB:KTNNF)

Kootenay Zinc Corp. (KTNNF) is a mineral exploration and development company focused on discovering large-scale sedimentary-exhalative (“SEDEX”) zinc deposits. Based in Vancouver, British Columbia, the company is ideally positioned near its primary target, the Sully Property, located 18 miles east of the world-class Sullivan Mine.

Of the 22 raw materials tracked by the Bloomberg Commodity Index, zinc was the best-performing base metal in 2016. Based on a widening global supply deficit, outlook for the commodity remains strong. As the most closely tied base metal to the Chinese economy, zinc demand and prices are expected to rise well into the year 2020, putting increased pressure on zinc supply.

For 2017, Goldman Sachs has predicted a 360,000 ton shortage of zinc, along with a subsequent rise in zinc prices to $2,500 per metric ton in the first half of the year. Zinc continues to make history in the metals exchange, driving significant interest in the market amid supply constraints in concentrates and refined metal drive prices.

Ready to claim its share of the market, Kootenay Zinc is focused on its Sully Property. It comprises 1,375 hectares and overlies rocks of similar age and origin as those which host the legendary Sullivan deposit. The Sullivan mine was discovered in 1892, and is known to be one of the world’s largest SEDEX deposits. Over its 100-year lifetime, Sullivan produced approximately 150 million tonnes of ore, including approximately 300 million ounces of silver, 8 million tonnes of zinc and 8 million tonnes of lead.

Notably, geophysical data suggests that Kootenay Zinc’s Sully project and Sullivan share many geological features:

  • Strata at Sully are in the same sedimentary basin as the Sullivan mine
  • The exact stratigraphic time horizon at which Sullivan formed is present at Sully
  • Filtered AeroMag anomalies coincident with Sullivan Time at Sully appear similar to Sullivan
  • Gravity anomaly at Sully indicates excess mass of comparable magnitude to Sullivan
  • Pb-Zn is present as traces in outcrop, drill core and in a soil geochemical anomaly

The squeeze in zinc supplies particularly affects China, which is both the world’s largest zinc consumer and its largest producer, with 4.9 million tons of output in 2015. Chinese manufacturers are now being forced to import zinc for use in cars, household appliances, paints, rubber products and smartphones.

Zinc’s rally shows no sign of slowing down in the near future, and companies that currently occupy stake in a zinc deposit find themselves in an enviable position over miners rushing to find new reserves. With its Sully Project, Kootenay Zinc could be on track to capture its share of the market, guided by a management team of mining directors and executives that currently lead some of the world’s best mining companies and have been involved in world-class discoveries which sold for billions of dollars. The company’s technical team includes industry experts that have worked on mega-mining projects, including the Sullivan and Voisey Bay projects.

Investment Considerations

  • Zinc is the top performer of the 22 raw materials tracked by the Bloomberg Commodity Index
  • Global outlook for zinc remains strong as growing supply deficit drives increase in prices
  • Sully Project located in world-class Sullivan Mine with production valued at US$49 billion


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Grey Cloak Tech, Inc. (GRCK)

Grey Cloak Tech, Inc. (GRCK) is a developer of industry-leading click-fraud detection software designed to overcome the most expensive and devastating threats in the digital world. Through its recently acquired subsidiary, ShareRails, Grey Cloak now also provides sophisticated e-commerce tools that help retailers evolve beyond their brick-and-mortar business practices to increase both their digital engagement and their foot traffic.

ShareRails is an online-to-offline technology firm that provides vitally important services within the trillion-dollar retail sector, helping brick-and-mortar retailers compete directly for online awareness with e-commerce-only brands. Through the ShareRails O2O platform, offline retailers can use online channels to more effectively drive sales and attract new customers.

The innovative solutions offered by ShareRails enable local retailers to capture the millions of online shopping searches they are currently missing out on because their product inventories and other key information is not currently available online and, therefore, does not appear in relevant searches and cannot be viewed digitally.

Most of today’s retail sales are Web-influenced. By utilizing digital marketing channels, merchants can enhance the in-store shopping experience for customers and simultaneously boost sales. The ShareRails O2O platform enables retailers to put their product catalogs online, along with product location and availability, and make the information searchable. The platform also offers digital merchandising tools that include an outfit builder and wishlist app along with conversational shopping tools. Through ShareRails O2O, merchants can additionally tap into data that details shopper insights and behavioral trends. Add-on services include click-n-collect, reservations for in-store pickup, and local delivery.

ShareRails additionally offers Dress.li, which is a recommendation and reward platform that connects shoppers to stylists, bloggers and other fashion influencers who provide them with expert shopping advice and uniquely styled looks and, simultaneously, connects the consumers to fashion retailers. Through Dress.li, the challenge of creating a seamless social shopping experience has finally been mastered! This platform facilitates live shopping communications, curation and content creation and lets users join a global network of trendsetters. Through this network, users can inspire and be inspired, accessing and sharing product recommendations and unique looks and receiving rewards each time another user makes a purchase from their recommendations. This platform not only provides an enjoyable and exciting network for shoppers and fashionistas, but it simultaneously supplies retailers with a lucrative outlet for acquiring new customers through a built-in global sales force of fashion influencers. As these Dress.li stylists create and share looks, they also deliver pre-qualified sales leads and conversions and are rewarded for doing so.

Joined together, Grey Cloak Tech’s industry-leading click-fraud detection solutions and the exciting retail-boosting products delivered through ShareRails offer a broad package of services to both protect businesses in the digital world and help them utilize digital channels to bolster their sales and enhance customer engagement.

Grey Cloak Tech continues to serve as an industry leader in developing the most effective and comprehensive weapons to fight online security threats. The company is keenly focused on protecting its clients’ interests through the identification of fraud patterns at the very earliest stages. When businesses partner with Grey Cloak Tech, they can look forward to benefiting from industry-leading technology, a top-tier client services team, and an augmented bottom line.

Investment Considerations

  • Proprietary Fraudlytic platform is a leading PPC protection product
  • ShareRails subsidiary offers a game-changing online-to-offline technology to help solve brick-and-mortar retailer challenges
  • Virtually limitless growth potential, as digital advertising fraud is a constantly evolving threat


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ChineseInvestors.com (CIIX)

Founded in 1999, ChineseInvestors.com has become a leading financial information website for Chinese-speaking investors in the United States and China. Recognizing unprecedented opportunities in the U.S. cannabis industry, CIIX is also laying the groundwork to capitalize on growing demand for cannabidiol (CBD)-based nutrition and health products.

Through its primary website, www.ChineseInvestors.com, CIIX offers a variety of investor education products and services, including real-time market commentary, analysis and educational related services in Chinese language character sets; consultative services to smaller private companies considering becoming a public company; and advertising and public relations related support services.

At the center of this initiative is the ChineseInvestors Method, a unique integration of a disciplined investing process, web-based tools, personalized instructions and support. Using this strategy, CIIX provides reliable market information to help investors make informed investment decisions and meet their individualized financial goals.

CIIX is also leveraging its financial expertise to enter into the burgeoning CBD industry, which within a few years has grown from a relatively invisible sector to a billowing market expected to reach $2.1 billion in consumer sales by 2020.

The increasing demand for CBD-based products is a catalyst for innovative business endeavors. To this accord, CIIX has established a three-year development plan to capitalize on the convergence of CBD and the nutrition and health products market in mainland China, where the benefits of CBD oil have not been widely recognized.

Under a wholesale agreement with a reputable CBD health brand, CIIX is launching the world’s first online CBD health products store published in the Chinese language. The site, www.ChineseCBDoil.com, caters to a growing number of Chinese people awakening to the numerous health benefits of CBD oil for treatment of a variety of conditions such as anxiety, stress, poor sleep, Alzheimer’s disease, and more. CIIX expects to launch this website at the end of January 2017, and plans to sell CBD-infused products via online and in-store.

In conjunction, CIIX’s cannabis-focused “Yelp”-style mobile app is in development as a platform for Chinese people to review and discuss various cannabis products. The app will be the first marijuana social media mobile app designed for Chinese-speaking customers worldwide.

Investment Considerations

  • Premier financial information website for Chinese-speaking investors
  • Launching the first-of-its-kind online cannabidiol (CBD) health products store
  • Cannabis initiatives target China’s consumer base of nearly 2 billion people


Monday, May 8th, 2017 Uncategorized Comments Off on ChineseInvestors.com (CIIX)