Archive for August, 2017

$BLDP to Webcast Proceedings of September 14 “Investor & Analyst Day” Event

VANCOUVER and NEW YORK, Aug. 31, 2017 – Ballard Power Systems (NASDAQ: BLDP; TSX: BLDP) today announced that the Company’s Management Team will be hosting an invitation-only “Investor & Analyst Day” event on Thursday, September 14th in New York City, from 10:00 a.m. to 2:30 p.m. Eastern Time.

The Investor & Analyst Day event will provide a comprehensive review of the company’s strategic plan – including key market opportunities – as well as progress and outlook across a number of important commercial, technology and operational fronts. The event will also feature a presentation by Mr. Charles Lu, Founder and Chairman of Zhongshan Broad-Ocean Motor Co., Ltd., a key Ballard strategic partner in China and Ballard’s largest shareholder.

The Investor & Analyst Day event will be webcast for the benefit of interested investors, with the audio and presentation materials posted after the event to the Ballard corporate website at www.ballard.com/investors.

For a live link to the webcast, interested parties should register at http://bit.ly/2g3iP7e prior to the scheduled start time of 10:00 a.m. Eastern Time on Thursday, September 14th. The live link will provide access to both audio and presentation materials.

About Ballard Power Systems
Ballard Power Systems (NASDAQ: BLDP; TSX: BLDP) provides clean energy products that reduce customer costs and risks, and helps customers solve difficult technical and business challenges in their fuel cell programs. To learn more about Ballard, please visit www.ballard.com.

This release contains forward-looking statements concerning anticipated product performance, customer benefits and market demand for our products. These forward-looking statements reflect Ballard’s current expectations as contemplated under section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any such forward-looking statements are based on Ballard’s assumptions relating to its financial forecasts and expectations regarding its product development efforts, manufacturing capacity, and market demand.

These statements involve risks and uncertainties that may cause Ballard’s actual results to be materially different, including general economic and regulatory changes, detrimental reliance on third parties, successfully achieving our business plans and achieving and sustaining profitability. For a detailed discussion of these and other risk factors that could affect Ballard’s future performance, please refer to Ballard’s most recent Annual Information Form. Readers should not place undue reliance on Ballard’s forward-looking statements and Ballard assumes no obligation to update or release any revisions to these forward looking statements, other than as required under applicable legislation.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.  The Ballard Common Shares have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Thursday, August 31st, 2017 Uncategorized Comments Off on $BLDP to Webcast Proceedings of September 14 “Investor & Analyst Day” Event

$SGRY Completes Acquisition of National Surgical Healthcare

Combination creates leading independent surgery company with strong musculoskeletal programs

Bain Capital Private Equity completes acquisition of H.I.G. Capital’s stake in Surgery Partners with the NSH close

NASHVILLE, Tenn., Aug. 31, 2017 — Surgery Partners, Inc. (NASDAQ:SGRY) (“Surgery Partners”), a leading healthcare services company, today announced that it has successfully completed its previously announced acquisition of National Surgical Healthcare (“NSH”), an owner and operator of surgical facilities in partnership with local physicians.

On May 9, 2017, Surgery Partners announced a definitive merger agreement under which Surgery Partners would acquire NSH from Irving Place Capital for approximately $760 million.  The combination of Surgery Partners and NSH creates an enterprise with 125 surgical facilities across 32 states, with a strong presence in musculoskeletal programs, including orthopedics, pain and spine.  In addition, the combined company operates a network of over 5,000 physicians and ancillary services, resulting in a diversified surgical provider.

“With the addition of National Surgical Healthcare, Surgery Partners has strengthened its position as the nation’s largest independent provider of outpatient surgical services.  This transaction also enhances our focus on musculoskeletal specialties, where we anticipate significant growth as commercial payors and Medicare look to transition more procedures to the outpatient setting,” said Mike Doyle, Chief Executive Officer of Surgery Partners.  “I would like to welcome the NSH team and physicians and look forward to working together to further develop our network healthcare services.”

Financing for the deal consists of Surgery Partners’ recently completed offering of $370 million in 6.750% senior unsecured notes due 2025, a new $1.29 billion term loan and a new preferred security purchased by Bain Capital Private Equity.   At closing, the Company remains well capitalized with sufficient liquidity to fund both internal and acquisition driven growth initiatives, with cash on the balance sheet in excess of $180 million, in addition to a revolver entirely undrawn at close.   Simultaneously with the closing of this transaction, Bain Capital Private Equity, as previously announced, has completed its purchase of H.I.G. Capital’s 54% stake in Surgery Partners at $19 per share.

Jefferies LLC acted as the exclusive financial advisor to Surgery Partners and provided committed financing to the company for the transaction.  Ropes & Gray LLP served as legal counsel to Surgery Partners, and PwC LLP has acted as accounting advisor to Surgery Partners and Bain Capital Private Equity.  Kirkland & Ellis LLP acted as legal counsel to Bain Capital Private Equity.  J.P. Morgan Securities LLC acted as financial advisor to NSH, and Weil, Gotshal & Manges LLP as legal advisor to NSH and Irving Place Capital.

About Surgery Partners
Headquartered in Nashville, Tennessee, Surgery Partners is a leading healthcare services company with a differentiated outpatient delivery model focused on providing high quality, cost effective solutions for surgical and related ancillary care in support of both patients and physicians.  Founded in 2004, Surgery Partners is one of the largest and fastest growing surgical services businesses in the country.  With the addition of National Surgical Healthcare, the company now operates more than 180 locations in 32 states, including ambulatory surgical facilities, surgical hospitals, a diagnostic laboratory, multi-specialty physician practices and urgent care facilities.

About Bain Capital Private Equity
Bain Capital Private Equity (www.baincapitalprivateequity.com) has partnered closely with management teams to provide the strategic resources that build great companies and help them thrive since our founding in 1984.  Our team of more than 220 investment professionals creates value for our portfolio companies through our global platform and depth of expertise in key vertical industries, including industrials, consumer/retail, financial and business services, healthcare, and technology, media and telecommunications.  We have a history of successful investments across a broad range of healthcare sectors including service providers, facilities, life sciences, devices, and distribution.  Our experience owning industry leading facilities-based healthcare businesses includes HCA Healthcare, Acadia Healthcare Company, Air Medical Group Holdings, Grupo NotreDame Intermedica and Aveanna Healthcare, among others. In addition to private equity, Bain Capital invests across asset classes including credit, public equity and venture capital, and leverages the firm’s shared platform to capture opportunities in strategic areas of focus.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding certain growth and liquidity expectations. These forward-looking statements involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. These forward-looking statements speak only as of the date of this release. We expressly disclaim any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Contacts:
Surgery Partners, Inc.
Teresa Sparks, Chief Financial Officer
(615) 234-8940
IR@surgerypartners.com
Thursday, August 31st, 2017 Uncategorized Comments Off on $SGRY Completes Acquisition of National Surgical Healthcare

$CRIS Announces CA-170 Poster Presentation at ESMO 2017 Congress

LEXINGTON, Mass., Aug. 31, 2017 — Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, today announced the presentation of a trial-in-progress poster describing preliminary clinical data from the dose escalation stage of CA-170 Phase 1 clinical trial at the European Society for Medical Oncology (ESMO) 2017 Congress. The conference will take place September 8-12 in Madrid. CA-170, an oral small molecule targeting the immune checkpoints PDL1 and VISTA, is in development for the treatment of patients with advanced solid tumors or lymphomas.

Additional information on the presentation can be found below and can be accessed at www.esmo.org.

CA-170 Poster Presentation:

Date/Time: Monday, Sept. 11, 9:15 AM – 10:45 AM CEST
Abstract Number: 1141PD
CA-170, a first in class oral small molecule dual inhibitor of immune checkpoints PD-L1 and VISTA, demonstrates tumor growth inhibition in
Presentation Title: pre-clinical models and promotes T cell activation in Phase 1 study

About Curis

Curis is a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, including its lead development candidate, CUDC-907, which is being investigated in clinical studies in patients with lymphomas and solid tumors. Curis is also engaged in a broad collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of the PD1 and VISTA pathways, including PDL1/VISTA antagonist CA-170, and oral small molecule antagonists of the PD1 and TIM3 pathways, including PDL1/TIM3 antagonist CA-327, as well as to molecules designed to inhibit the IRAK4 kinase, including CA-4948. CA-170 is currently undergoing testing in a Phase 1 trial in patients with advanced solid tumors and lymphomas. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma, and are further developing Erivedge in myelofibrosis. For more information, visit Curis’s website at www.curis.com.

For More Information:
James E. Dentzer
Chief Financial Officer & Chief Administrative Officer
Curis, Inc. 
617-503-6500
jdentzer@curis.com

Media Contact
David Schull
Russo Partners
(212) 845-4271
david.schull@russopartnersllc.com
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$CARA to Participate in September Medical Meetings

  • Data from Phase 2 chronic osteoarthritis pain study of Oral CR845 to be presented in poster session at PAINWeek

STAMFORD, Conn., Aug. 31, 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 upcoming CR845 presentations at PAINWeek, to be held September 5-9, 2017 in Las Vegas, NV and the American Association of Nurse Anesthetists (AANA) Nurse Anesthesia Annual Congress, to be held September 8-12, 2017 in Seattle, WA.

Presentations will include clinical trial data for CR845, Cara’s first-in-class peripherally selective kappa opioid agonist being developed for the treatment of acute and chronic pain, as well as chronic kidney disease-associated pruritus.

PAINWeek
Details for the presentations are as follows:

CR845 Poster Presentation:

Poster Title:     A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Titration-to-Effect Study of Orally Administered CR845 in Patients with Osteoarthritis of the
Hip or Knee
Poster Number: 101
Date/ Time: Thursday, September 7, 2017; 6:30-8:30 p.m. PT

Satellite Symposium:

Presentation Title:     A Potential New Path of Pain Relief: Time for a Change with a Peripherally Acting Kappa Opioid Receptor Agonist (KORA)
Date/ Time: Friday, September 8, 2017; 12:30 – 1:30 p.m. PT
Moderator: Joseph Stauffer, D.O., M.B.A., Chief Medical Officer, Cara Therapeutics
Faculty: Michael J. Brennan, M.D., Medical Director, the Pain Center of Fairfield; Senior Attending Physician, Department of Medicine, Bridgeport Hospital;
Associate Director, Chronic Pain and Recovery Program, Silver Hill Hospital

For information about PAINWeek, visit http://www.painweek.org/.

AANA Nurse Anesthesia Annual Congress
Details for the satellite symposium are as follows:

Presentation Title:     A Potential New Path of Pain Relief
Date/ Time: Sunday, September 10, 2017; 4:00 – 5:00 p.m. PT
Speakers: Jackie Rowles, D.N.P., M.B.A., C.R.N.A., A.N.P.-B.C., D.A.A.P.M., F.A.A.N., Director, DNP Nurse Anesthesia Program, Marian University; Associate
Professor, Leighton School of Nursing; Clinical Instructor, College of Osteopathic Medicine; Adjunct Faculty, Nurse Anesthesia Pain Management Fellowship,
Texas Christian University
Joseph Stauffer, D.O., M.B.A., Chief Medical Officer, Cara Therapeutics

For information about AANA, visit http://aana2017.com/.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates, led by CR845, that target the body’s peripheral nervous system. CR845 has demonstrated initial efficacy in patients with moderate-to-severe pain, without inducing many of the undesirable side effects typically associated with currently available pain therapeutics. In patients with moderate-to-severe CKD-associated pruritus, CR845 has demonstrated its potential to reduce itch and improve quality of life.

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

MEDIA CONTACT: 
Annie Starr
6 Degrees
973-415-8838 
astarr@6degreespr.com
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$DMTX Begins Dosing Phase 1/2 Clinical Trial of DTX301 in OTC Deficiency

Twelve trial sites recruiting patients with OTC deficiency in the United States, United Kingdom, Spain, and Canada

Initial data from the company’s Phase 1/2 study anticipated by late 2017

CAMBRIDGE, Mass., Aug. 31, 2017 — Dimension Therapeutics, Inc. (NASDAQ:DMTX), a biopharmaceutical company advancing novel, adeno-associated virus (AAV) gene therapies targeting the liver, a key organ for human metabolism, today announced the initiation of patient dosing in the company’s global, multi-center Phase 1/2 clinical trial to evaluate DTX301, the only AAV gene therapy in clinical testing for the treatment of patients with Ornithine Transcarbamylase (OTC) Deficiency. DTX301 is designed to deliver stable expression and activity of OTC following a single intravenous infusion and has been shown in academic preclinical studies in relevant mouse models to normalize levels of urinary orotic acid, a marker of ammonia metabolism. In the late onset form of the disease, elevated ammonia can lead to significant medical issues for patients who are in need of better disease-modifying therapies.

“OTC deficiency is an inherited metabolic disease (IMD) for which approved therapies are unable to eliminate the risk of metabolic crises from elevated ammonia. We believe that DTX301, based on our differentiated AAV8 platform in IMD, holds great promise for addressing the unmet need among patients, and we look forward to the continued advancement of the trial,” said Annalisa Jenkins, MBBS, FRCP, Chief Executive Officer of Dimension. Based on the current progress, Dimension anticipates reporting initial clinical data from the Phase 1/2 DTX301 clinical trial by late this year.

Dimension’s phase 1/2 clinical trial is an open-label, dose-finding safety study of single ascending doses of DTX301 in adults with late-onset OTC Deficiency. To evaluate therapeutic response of DTX301, the trial plans to measure ammonia levels and other biomarkers, including 13C-acetate, which are established measures of OTC deficiency disease status and hepatocyte (liver) ureagenesis capacity, respectively. Additional information about Dimension’s Phase 1/2 study of DTX301 may be found at ClinicalTrials.gov, using Identifier NCT: NCT02991144.

“Inherited metabolic diseases can have severe effects on patient health and quality of life, and in many of these urea cycle diseases, including OTC deficiency, the only curative option is liver transplantation, which is often associated with significant morbidity and mortality,” stated Mark L. Batshaw, M.D., Executive Vice President, Physician-in-Chief & Chief Academic Officer of Children’s National Medical Center and head of Dimension’s Clinical Advisory Board (CAB) for urea cycle disorders.

About DTX301

Dimension is developing its AAV gene therapy product DTX301 for the treatment of individuals with OTC deficiency. DTX301 is designed to deliver ornithine transcarbamylase gene expression in a durable fashion, preventing or reducing the occurrence of complications associated with OTC deficiency. Preclinical studies completed to date indicate DTX301 has the potential to be a well-tolerated, effective therapy for OTC deficiency. DTX301 was granted Orphan Drug Designation in the United States and Europe in January and March 2016, respectively.

Background on OTC Deficiency

OTC deficiency, the most common urea cycle disorder, is caused by a genetic defect in a liver enzyme responsible for detoxification of ammonia. Individuals with OTC deficiency can build up excessive levels of ammonia in their blood, potentially resulting in neurological deficits and other toxicities. It is estimated that more than 10,000 patients are affected by OTC deficiency worldwide, of which approximately 80% are classified as late-onset, Dimension’s target population. The greatest percentage of patients, including males and females, experience late-onset disease, representing a clinical spectrum of disease severity. Neonatal onset disease occurs in males, presents as severe disease, and can be fatal at an early age. Approved therapies, which must be taken multiple times a day for the patient’s entire life, do not eliminate the risk of future metabolic crises. Currently, the only curative approach is liver transplantation.

About Dimension Therapeutics, Inc.

Dimension Therapeutics, Inc. (NASDAQ:DMTX) is a leader in discovering and developing new therapeutic products for people living with devastating rare and metabolic diseases associated with the liver, based on the most advanced mammalian adeno-associated virus (AAV) gene delivery technology. Dimension is actively progressing its broad pipeline, which features programs addressing unmet needs for patients suffering from inherited metabolic diseases, including OTC deficiency and GSDIa, and a collaboration with Bayer in hemophilia A. Dimension has initiated a phase 1/2 clinical trial with DTX301 for the treatment of OTC deficiency. The company targets diseases with readily identifiable patient populations, highly predictive preclinical models, and well-described, and often clinically validated, biomarkers. Founded in 2013, Dimension maintains headquarters in Cambridge, Massachusetts.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding timing and likelihood of achievement of our upcoming development milestones, including timing of disclosure of data, the expected progress of or portfolio and programs, and our ability to successfully complete, clinical studies. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks that Dimension’s product candidates, including its candidate, DTX301, will not achieve development milestones, including patient enrollment, dosing of patients, release of initial data, or regulatory filings; and the other risks described under the caption “Risk Factors” in Dimension Therapeutics’ Quarterly Report on Form 10-Q for the period ended June 30, 2017, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Dimension Therapeutics’ additional filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Dimension Therapeutics undertakes no duty to update this information unless required by law.

Additional Information about the Proposed Transaction and Where to Find It

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This document relates to a proposed transaction between Dimension Therapeutics, Inc. (the “Dimension”) and REGENXBIO Inc. (“REGENXBIO”), which will become the subject of a proxy statement/prospectus to be filed with the SEC by Dimension, and may be deemed to be solicitation material in respect of the proposed transaction. This document is not a substitute for the proxy statement/prospectus that Dimension will file with the SEC or any other documents that Dimension may file with the SEC or send to stockholders in connection with the proposed transaction. Before making any voting decision, investors and security holders are urged to carefully read the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about Dimension, REGENXBIO, the proposed transaction and related matters.

Investors and security holders will be able to obtain free copies of the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by Dimension through the website maintained by the SEC at www.sec.gov.

In addition, investors and security holders will be able to obtain free copies of the proxy statement/prospectus, once it is filed, from Dimension by accessing Dimension’s website at www.dimensiontx.com or upon written request to Dimension Therapeutics, Inc., 840 Memorial Drive, Cambridge, Massachusetts 02139.

Participants in Solicitation

REGENXBIO, Dimension and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Dimension’s stockholders in connection with the proposed transaction. Information regarding Dimension’s directors and executive officers is contained in the proxy statement for Dimension’s 2017 Annual Meeting of Stockholders, which was filed with the SEC on April 14, 2017. You can obtain a free copy of this document at the SEC’s website at www.sec.gov or by accessing Dimension’s website at www.dimensiontx.com. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed transaction may be obtained by reading the proxy statement/prospectus regarding the proposed transaction when it becomes available. You may obtain free copies of this document as described in the preceding paragraph.

Contacts:

Mary Thistle
Chief Operating Officer
Dimension Therapeutics
617-714-0659
mary.thistle@dimensiontx.com

Burns McClellan, on behalf of Dimension Therapeutics
Media: Justin Jackson
212-213-0006, ext.327
jjackson@burnsmc.com
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$EXFO Acquires 33.1% Stake in Astellia Announces Plans to Launch Voluntary Takeover Bid

  • EXFO signed an agreement dated August 30, 2017, with the founding shareholders of Astellia to acquire the entirety of their shares, representing an equity stake of 25.4%, at a price of €10 per Astellia share. The transaction allows for a friendly industry combination with strong support from Astellia’s management and reference shareholders.
  • Concurrently, EXFO signed an agreement with Isatis Capital to acquire at the same price a majority of its shares, representing an equity stake of 7.7% and giving EXFO a total stake of 33.1% in Astellia’s equity.
  • The price of €10 per share proposed by EXFO represents a premium of 44.7% over Astellia’s closing share price on August 30, 2017, and of 56.1% based on the 12-month volume weighted average price.
  • Astellia’s Board of Directors has expressed its support for this transaction.
  • EXFO will initiate an all-cash voluntary public tender offer to acquire Astellia’s remaining shares.

RENNES, France and QUEBEC CITY, Aug. 31, 2017 – EXFO Inc. (NASDAQ: EXFO, TSX: EXF), the network test, monitoring and analytics experts, and Astellia (ISIN code: FR0004176535 – mnemonic: ALAST), a global leader in the performance analysis of mobile networks and subscriber experience, announced today the signing of agreements for EXFO to acquire a 33.1% equity stake in Astellia, with the intent to acquire the remaining equity.

Under terms of the agreements, EXFO will acquire from founders Christian Queffelec (President of Astellia), Frédéric Vergine (EVP, Strategic Customer Engagements), Julien Lecoeuvre (Chief Technology and Innovation Officer) and Emmanuel Audousset (EVP, International Accounts and Indirect Sales) the entirety of their shares in Astellia, and from Isatis Capital the majority of its shares in Astellia. Following these acquisitions, which contain no suspensive condition, EXFO will hold a 33.1% stake in Astellia’s equity, representing a total amount of €8.6 million at a price of €10 per Astellia share. The settlement of these acquisitions will take place in upcoming days.

Upon completion of these acquisitions and following the information and consultation process for Astellia’s workers councils, EXFO will launch an all-cash voluntary public tender offer to acquire Astellia’s remaining shares for the same price. The proposed public offer will remain subject to the approval of French foreign investment authorities and the supervision of Autorité des marchés financiers.

Astellia’s Board of Directors has expressed its support for EXFO’s firm offer and the agreements to be signed in order to complete a transaction that values the entirety of Astellia’s equity (on a fully diluted basis) at approximately €25.9 million. In accordance with the applicable regulation, Astellia’s Board of Directors will submit a reasoned opinion on the desirability of the public offering for the company, its employees and its shareholders after examining an independent expert’s report on the fairness of the offer and the opinion of Astellia’s workers councils, who will be consulted as soon as possible.

The closing of the public tender offer is subject to standard conditions and should take place around the end of calendar year 2017.

“This investment in Astellia is in line with our strategy to increase our critical mass and our client base, and to expand our addressable market in the global analytics and service assurance industry,” said Germain Lamonde, Executive Chairman of EXFO’s Board of Directors. “If our public tender offer is successful, we’ll be able to combine Astellia’s solutions and services with those of EXFO and become a world leader in the network monitoring and analytics sector and target growth opportunities such as network virtualization, 5G and the Internet of things.”

“We strongly support this strategic transaction with EXFO, whose values are shared by Astellia,” said Christian Queffelec, President of Astellia. “It will enable us to strengthen our ability to meet customer needs, widen our market coverage as well as foster our technological and commercial development.”

EXFO is advised by Société Générale and TD Securities (financial advisors) and Herbert Smith Freehills (legal advisor).

Astellia is advised by Drake Star Partners (financial advisor) and Aramis (legal advisor).

About Astellia
Astellia is a leading provider of network and subscriber intelligence enabling mobile operators to drive service quality, maximize operational efficiency, reduce churn and develop revenues. Its vendor-independent, real-time monitoring and troubleshooting solution optimizes networks end-to-end, from radio to core. Astellia’s unique blend of products and services provides automated optimization, actionable geolocated insights and big-data analytics to Network Operations, Service Operations Center, Customer Care and Marketing teams. Astellia has close partnerships with more than 120 telecom operators. Based in France, Astellia has significant operations in Spain and a strong presence in Canada, Lebanon, Morocco and South Africa.

About EXFO
EXFO develops smarter network test, monitoring and analytics solutions for the world’s leading communications service providers, network equipment manufacturers and webscale companies. Since 1985, we’ve worked side by side with our customers in the lab, field, data center, boardroom and beyond to pioneer essential technology and methods for each phase of the network lifecycle. Our portfolio of test orchestration and real-time 3D analytics solutions turn complex into simple and deliver business-critical insights from the network, service and subscriber dimensions. Most importantly, we help our customers flourish in a rapidly transforming industry where “good enough” testing, monitoring and analytics just aren’t good enough anymore—they never were for us, anyway. For more information, visit EXFO.com and follow us on the EXFO Blog.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and we intend that such forward-looking statements be subject to the safe harbors created thereby. Forward-looking statements are statements other than historical information or statements of current condition. Words such as may, expect, believe, plan, anticipate, intend, could, estimate, continue or similar expressions or the negative of such expressions are intended to identify forward-looking statements. In addition, any statement that refers to expectations, projections or other characterizations of future events and circumstances are considered forward-looking statements. They are not guarantees of future performance and involve risks and uncertainties. Actual results may differ materially from those in forward-looking statements due to various factors including, but not limited to, macroeconomic uncertainty as well as capital spending and network deployment levels in the telecommunications industry (including our ability to quickly adapt cost structures with anticipated levels of business and our ability to manage inventory levels with market demand); future economic, competitive, financial and market conditions; consolidation in the global telecommunications test and service assurance industry and increased competition among vendors; capacity to adapt our future product offering to future technological changes; limited visibility with regard to timing and nature of customer orders; longer sales cycles for complex systems involving customers’ acceptances delaying revenue recognition; fluctuating exchange rates; concentration of sales; timely release and market acceptance of our new products and other upcoming products; our ability to successfully expand international operations; our ability to successfully integrate businesses that we acquire; and the retention of key technical and management personnel. Assumptions relating to the foregoing involve judgments and risks, all of which are difficult or impossible to predict and many of which are beyond our control. Other risk factors that may affect our future performance and operations are detailed in our Annual Report, on Form 20-F, and our other filings with the U.S. Securities and Exchange Commission and the Canadian securities commissions. We believe that the expectations reflected in the forward-looking statements are reasonable based on information currently available to us, but we cannot assure that the expectations will prove to have been correct. Accordingly, you should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this document. Unless required by law or applicable regulations, we undertake no obligation to revise or update any of them to reflect events or circumstances that occur after the date of this document.

Thursday, August 31st, 2017 Uncategorized Comments Off on $EXFO Acquires 33.1% Stake in Astellia Announces Plans to Launch Voluntary Takeover Bid

$INCY to File Baricitinib Resubmission to U.S. FDA before end of January 2018

INDIANAPOLIS, Aug. 30, 2017 — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data. The companies anticipate the FDA will classify the application as a Class II resubmission, which will start a new six-month review cycle. Baricitinib is a once-daily oral investigational medication for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA).

“We are committed to making life better for people living with RA. There is a significant unmet need for Americans suffering from this debilitating disease in spite of available therapies,” said Christi Shaw, president of Lilly Bio-Medicines. “We are pleased with the opportunity to provide our resubmission package for baricitinib sooner than anticipated and look forward to continuing to work with the FDA as we seek to bring baricitinib to people with RA in the U.S.”

About Baricitinib
Baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016. Baricitinib was approved in the EU in February 2017 and in Japan in July 2017. In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib. Baricitinib remains under review in other markets. It is also being studied for the treatment of atopic dermatitis and systemic lupus erythematosus. The Phase 3 program for psoriatic arthritis is expected to begin in 2018.

About Rheumatoid Arthritis
Rheumatoid arthritis is a systemic autoimmune disease characterized by inflammation and progressive destruction of joints.[i,ii] More than 23 million people worldwide suffer from RA.[iii] Approximately three times as many women as men have the disease. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), such as methotrexate – the current standard of care – and injectable, biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.[iv] Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.[v,vi] There remains an important need to provide additional treatments to improve overall patient care.

About Baricitinib Phase 3 Trials
Lilly and Incyte conducted four successful pivotal Phase 3 clinical trials of baricitinib in patients with moderate-to-severe active rheumatoid arthritis to support regulatory submission in most countries. Two of the four studies included pre-specified comparisons to approved DMARDs: one to methotrexate (RA-BEGIN) and one to adalimumab (RA-BEAM). An additional phase 3 study recently concluded to support clinical development in China. The clinical trial program includes a wide range of patients including those who are methotrexate-naïve, inadequate responders to methotrexate, inadequate responders to conventional synthetic disease modifying antirheumatic drugs, or inadequate responders to bDMARDs including TNF inhibitors. Patients completing any of the Phase 3 studies were able to enroll in a long-term extension study. For additional information on this clinical trial program, please visit www.clinicaltrials.gov.

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

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

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.

P-LLY
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for patients with rheumatoid arthritis and reflects Lilly’s and Incyte’s current beliefs.  However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that baricitinib will receive regulatory approval or be commercially successful.  For further discussion of these and other risks and uncertainties, see Lilly’s and Incyte’s most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

i American College of Rheumatology, Rheumatoid Arthritis, http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp. Accessed July 21, 2017.
ii Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf. Accessed July 21, 2017.
iii WHO Global Burden of Disease Report, (table 7, page 32) 2004, http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed July 21, 2017.
iv Arthritis Foundation, Medications for Rheumatoid Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php. Accessed July 21, 2017.
v Rheumatoid arthritis, Lancet, https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed July 21, 2017.
vi Sustained rheumatoid arthritis remission is uncommon in clinical practice, Arthritis Research & Therapy, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed July 21, 2017.

Refer to: Danielle Neveles; danielle.neveles@lilly.com; +1-317-796-4564 (Lilly media)
Phil Johnson; johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly investors)
Catalina Loveman; cloveman@incyte.com; +1-302-498-6171 (Incyte media)
Michael Booth, DPhil; mbooth@incyte.com; +1-302-498-5914 (Incyte investors)
Wednesday, August 30th, 2017 Uncategorized Comments Off on $INCY to File Baricitinib Resubmission to U.S. FDA before end of January 2018

$ICAD Approval of Xoft® Axxent® Balloon Applicators by China’s FDA in Breast Cancer

Availability of full suite of Xoft System products in China represents significant milestone in expanding global access to advanced technology to treat range of cancers

NASHUA, N.H., Aug. 30, 2017 — iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the company’s Xoft Axxent balloon applicators have received approval from the China Food & Drug Administration (CFDA) for the treatment of early-stage breast cancer. The Xoft Axxent balloon applicators are a key component of the Xoft® Axxent® Electronic Brachytherapy (eBx®) System®, which is used to perform intraoperative radiation therapy (IORT) in early-stage breast cancer patients who meet specific selection criteria. With this CFDA approval, the complete suite of Xoft System products is now available to clinicians and patients in China.

“A growing number of countries recognize the unique benefits the Xoft System offers to both patients and clinicians in treating a range of cancers,” said Ken Ferry, CEO of iCAD. “In 2015, more than 268,000 women in China were diagnosed with breast cancer, more than 69,000 women died of the disease, and the incidence has been rising rapidly in recent years.1 Regulatory approval of Xoft Axxent balloon applicators in China represents a significant milestone in our continued efforts to bring this innovative, safe and clinically-proven treatment option to women worldwide with early-stage breast cancer.”

IORT with the Xoft System allows radiation oncologists and breast surgeons to work together to deliver a full course of radiation to the tumor site at the time of lumpectomy. The balloon applicator is used to deliver a single, precise dose of radiation to the lumpectomy cavity, directly targeting cancer cells while minimizing exposure to healthy surrounding tissue. In the procedure, the Xoft System’s miniaturized x-ray source is inserted into the balloon applicator, providing a channel to deliver high-dose rate, low energy radiation treatment. The balloon applicator is available in multiple sizes and shapes, can be filled with different volumes of saline to best fit the contour of the surgical cavity, and allows delivery of a more conformal radiation dose.

“The Xoft Axxent balloon applicators offer an attractive option for physicians and patients who desire improved flexibility, precision and personalization in the targeted treatment of early-stage breast cancer,” said Liu Yu, COO of Chindex Medical Limited, the distributor of iCAD’s Xoft System in China. “We are pleased to continue working with iCAD in offering our customers access to the most advanced cancer treatments, including the complete portfolio of Xoft System products, in the years ahead.”

The Xoft System is FDA-cleared for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer and gynecological cancers.

About Xoft Axxent Electronic Brachytherapy System

The Xoft System is an isotope-free radiation treatment that is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. It utilizes a proprietary miniaturized x-ray as the radiation source that delivers precise treatment directly to cancerous areas while sparing healthy tissue and organs. The Xoft System requires only minimal shielding and therefore does not require room redesign or construction investment. Minimal shielding also allows medical personnel to remain in the room with the patient during treatment. The mobility of the Xoft System makes it easy to treat patients at multiple locations and to easily store the system when not in use. The Axxent Hub is a cloud-based oncology collaboration software solution that enables centers to monitor treatment workflow and enhance communication between clinical specialists. Xoft is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com, like us on Facebook or follow us on Twitter at @xofticad.

About Chindex Medical Limited

Chindex Medical Limited (CML) is a prominent supplier of leading edge healthcare technologies to Greater China. With over 1,500 employees worldwide, headquarters located in China, and operations in North America, Europe, and Asia, CML offers a unique full-service distribution platform to manufacturers of medical devices, including product registration, marketing and sales (both direct and through a closely-managed network of carefully-selected sub dealers), warehousing and sales in local currency, clinical support, and installation and after-sales service provided by factory-trained engineers. Additionally, CML owns and manufactures several patented technologies, including proprietary blood banking and transfusion equipment, wound closure products, and general surgery theater instruments. The R&D and manufacturing processes utilized in the Chinese factories are at international levels, and the products are sold in more than 70 countries in Europe and the Americas. For more information, visit www.chindex.com.

About iCAD, Inc.

iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit or www.icadmed.com or www.xoftinc.com.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of 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 factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”, “demonstrate”, “intend”, “expect”, “would”, “could”, “consider”, “project”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, including the 10-K for the year ended December 31, 2016, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

1 http://onlinelibrary.wiley.com/doi/10.3322/caac.21338/full

Contact:

For iCAD investor relations:

LifeSci Advisors
Bob Yedid, (646)-597-6989
Bob@lifesciadvisors.com

or

For iCAD media inquiries:

Berry & Company Public Relations, LLC
Lynn Granito, 212-253-8881
lgranito@berrypr.com
Wednesday, August 30th, 2017 Uncategorized Comments Off on $ICAD Approval of Xoft® Axxent® Balloon Applicators by China’s FDA in Breast Cancer

$NBEV Expands Organic Marley Mate With Major Distributors Across US

Long-Term business partners Hensley, Palmentere, Haralambos, Folsom, Lenore and others expanding in their respective regions Organic Marley yerba Mate™ rolling out this week to major accounts including 7 Eleven and others nationally

DENVER, CO–(Aug 30, 2017) – New Age Beverages Corporation (NASDAQ: NBEV) the Colorado-based leading all-natural and organic healthy functional beverage company whose brands include XingTea®, XingEnergy®, Aspen Pure®, Búcha® Live Kombucha, Marley One Drop®, Marley Mellow Mood®, Marley Mate™, and Coco-Libre® today announced the expansion of Marley yerba Mate™ with some of its major distribution partners throughout the United States.

Terry Sperstad, Senior Vice President of Key Accounts for New Age commented, “We knew we had a winner with the Marley Mate™ brand and taste preference over competition, but the response from retailers and our distribution partners has been unlike anything we have seen before. We have had to triple our initial production plans already, have additional commitments from other retailers already rolling out in 2018, and know we are just getting started.”

Marley Mate™ which earlier in the month gained commitment for launch from 7 Eleven, has been ramping up production and began initial shipments this week. Haralambos Beverage Company is the largest beverage distributor in Southern California, and has historically distributed a competitive Yerba Mate product until their decision to switch to the New Age Organic Marley yerba Mate™. Sales of the competitor across Southern California alone eclipsed more than $3 million per month. New Age’s other partners including Hensley, one of the largest distributors in the United States, Folsom, Palmentere and others have also made similar decisions to extend their one-stop-shop relationship with New Age and take on the new Marley Mate™ brand.

Zach Ross, Marketing Manager for the Marley Brand mentioned, “The launch of the Marley Mate™ brand is the first of a number of initiatives behind the Marley platform since we acquired the business in the end of June. We know what we gained with the Marley acquisition, the positive core brand on which to build, but also the historical execution issues before New Age took the business over. Since then, we have completely rearchitected the brand leveraging all the Marley iconography that Marley fans resonate with. The new Live. Love. Marley. campaign, coupled with the new brand launches of Marley Mate™ and others in the pipeline, are excellent examples of New Age’s marketing capabilities to capture the potential of its newly acquired companies and brand platforms. Initial consumer feedback on the Organic Marley Yerba Mate has been unprecedented, and the next Marley brand launching in Q4 has already been approved for distribution in major accounts as well.”

New Age has exclusively partnered with the world’s 5th largest water charity, WATERisLIFE, to end the world water crisis with the most innovative technologies available. Donate at WATERisLIFE.com to help us #EnditToday.

About New Age Beverages Corporation (NASDAQ: NBEV)
New Age Beverages Corporation is a Colorado-based, leading all-natural and organic healthy functional beverage company that was founded in 2003. The Company competes in the fast growing healthy functional beverage segments including Ready to Drink (RTD) Tea, RTD Coffee, Kombucha, Energy Drinks, Relaxation Drinks, Coconut Waters and Functional Waters with the brands XingTea®, Marley One Drop®, Búcha® Live Kombucha, XingEnergy®, Marley Mellow Mood®, Marley Mate™, Coco-Libre®, and Aspen Pure® PH and Aspen Pure® Probiotic Water. The Company’s brands are sold across all 50 states within the US and in more than 10 countries internationally across all channels via direct and store door distribution systems. The company operates the websites http://newagebev.us, http://newagehealth.us, www.mybucha.com, www.xingtea.com, www.aspenpure.com, www.drinkmarley.com, and www.cocolibre.com.

Safe Harbor Disclosure
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statement reflecting management’s current expectations regarding future results of operations, economic performance, financial condition and achievements of the Company including statements regarding New Age Beverage’s expectation to see continued growth. The forward-looking statements are based on the assumption that operating performance and results will continue in line with historical results. Management believes these assumptions to be reasonable but there is no assurance that they will prove to be accurate. Forward-looking statements, specifically those concerning future performance are subject to certain risks and uncertainties, and actual results may differ materially. New Age Beverages competes in a rapidly growing and transforming industry, and other factors disclosed in the Company’s filings with the Securities and Exchange Commission might affect the Company’s operations. Unless required by applicable law, nBev undertakes no obligation to update or revise any forward-looking statements.

Websites: www.newagebev.us
http://newagehealth.us
www.mybucha.com
www.xingtea.com
www.drinkmarley.com
www.cocolibre.com

 

For investor inquiries about New Age Beverages Corporation please contact:
Amato and Partners, LLC
Investor Relations Counsel
admin@amatoandpartners.com

Wednesday, August 30th, 2017 Uncategorized Comments Off on $NBEV Expands Organic Marley Mate With Major Distributors Across US

$MZOR and Medtronic Enter Next Phase of Strategic Partnership

CAESAREA, Israel

Conference Call Today at 8:30 AM EDT (3:30PM IDT)

Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical guidance systems, today announced that it has entered the next phase of its strategic partnership with Medtronic earlier than planned and their existing agreements have been amended accordingly. The agreements provide for the conversion of the commercial relationship between the parties, with Medtronic assuming exclusive worldwide distribution of the Mazor X system, and Medtronic making a $40 million third tranche investment in Mazor. These developments are a result of the early achievement of certain sales and marketing milestones by both companies, as well as higher than expected global market acceptance and demand for the Mazor X system. Medtronic and Mazor originally entered into a strategic agreement in May 2016.

Key Highlights Include:

  • Medtronic assumes exclusive global spine market commercial responsibility for the Mazor X Surgical Assurance Platform and its accessories.
  • The implementation of annual minimums for purchase of Mazor X systems by Medtronic with a cumulative potential of hundreds of Mazor X systems over a four and a half-year period.
  • Approximately 30 members of the current Mazor sales organization are expected to join Medtronic to assure continuation of the current momentum.
  • Co-development of future products for the spine market that combine Mazor Robotics’ core expertise in surgical planning and precision-guided surgical systems with Medtronic’s navigation capabilities and implant systems. The first results of this combined and synergistic effort are expected to be demonstrated this fall.
  • Mazor will continue to provide service to the global installed base of the Mazor X.
  • A shared economic incentive to continue developing products and services that maintain innovation leadership and utilization of Mazor Robotics clinical solutions.
  • Medtronic will invest $40 million in Mazor Robotics’ American Depository Shares (ADS) at a price of $38.46 per ADS, which represents the weighted average of the closing price of Mazor’s ADS on Nasdaq over the past 20 trading days. This third tranche of investment in Mazor by Medtronic will bring Medtronic’s total investment in Mazor to $72 million, representing approximately 11.9% of the outstanding shares post investment and 10.6% of the fully diluted shares outstanding post investment. Mazor will also issue to Medtronic warrants to purchase an additional 1.21 million Mazor ADSs at an exercise price of $44.23 per ADS. The exercise price represents a 15% premium over the per share price for the $40 million equity investment. Medtronic has the right to exercise the warrants immediately in whole or in part, for cash, and they expire after 18 months. Assuming the full exercise of the warrants, Medtronic’s investment in Mazor will reach $125 million and its ownership could increase to 4.2 million ADSs, or 14.2%, based on the current number of ADSs outstanding on a fully diluted basis. Closing of the $40 million equity investment is expected to take place on or around September 12, 2017.

“Medtronic is our valued strategic partner and together we have achieved the desired outcome for Phase I well ahead of our original plan,” commented Ori Hadomi, Chief Executive Officer. “I believe that the move to this next phase reinforces our significant leadership position in the growing market for surgical guidance systems for spine procedures. Our strategic partnership will allow hospitals in new markets around the world to have access to the Mazor X and gain the clinical benefits that this technology offers.

“The strategic partnership between Mazor and Medtronic has already resulted in 59 Mazor X system orders since the October 2016 launch and reflects an accelerated sales cycle due to customers’ eagerness to adopt our solutions for the spine market,” added Mr. Hadomi. “Now, as commercial responsibility for the Mazor X in the spine market shifts to Medtronic, the annual minimums for sale of Mazor X systems agreed to by the two companies are expected to drive substantial improvement in Mazor’s financial results during the next several years. Together we will be able to further advance our robust jointly-developed product pipeline for the spine market, to make a difference for patients while Mazor also pursues new opportunities to apply our innovative technologies to other medical needs.”

“Moving to the next phase of our strategic partnership demonstrates our shared passion for transforming how spine surgery is done,” said Doug King, senior vice president & president of the Medtronic Spine division, which is part of Medtronic’s Restorative Therapies Group. “Mazor Robotics’ technology and Medtronic’s navigation capabilities and implant systems provide spine surgeons with complete procedural solutions that advance the standard of care and will help surgeons maximize predictability and efficiency.”

Mazor will continue to manufacture and recognize revenues for Mazor X system sales, disposable kits and service fees all of which will be sold at contractual pricing agreed with Medtronic. The contracted pricing is at a lower rate than Mazor realized through its direct sales channel. In addition, Mazor will be entitled to certain synergy fees associated with the use of Medtronic implants in Mazor Robotics’ installed base. Moving from direct sales to a strategic distribution model is expected to immediately reduce Mazor’s annual operating expenses by approximately $13 million. Trailing 12-month operating expenses for Mazor totaled $52.7 million.

The proceeds from the investment will further strengthen Mazor’s balance sheet and provide the resources to continue to collaborate with Medtronic to develop innovative solutions for the spine market, as well as develop innovative solutions for other potential markets.

Mazor will continue to independently develop and market globally the Renaissance Surgical Guidance System, which was first launched in 2011. Efforts for Renaissance will be focused on certain market segments for which the Renaissance provides significant customer added value.

CONFERENCE CALL INFORMATION

The Company will host a conference call to discuss today’s announcement at 8:30 AM EDT (3:30 PM IDT). Investors within the United States interested in participating are invited to call 1-800-289-0498. Participants in Israel can use the toll-free dial-in number 1-80-925-8350. All other international participants can use the dial-in number 1-719-325-4818. For all callers, refer to Conference ID 1217133.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-866-375-1919 and reference the Replay Access Code: 1217133. All international callers can dial 1-719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance System enables surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. For example, Mazor is using forward-looking statements in this press release when it discusses the outcome of the Phase II agreements with Medtronic, when it states that the results of combined development efforts are expected to be launched this fall, when it states that sales minimums are expected to drive substantial improvement in Mazor’s financial results during the next several years, when it discusses that the strategic partnership will allow hospitals in new markets around the world to have access to the Mazor X and gain the clinical benefits that this technology offers, when benefits spine surgeons will get from the combination of Mazor’s technology and Medtronic’s navigation capabilities and implant systems are discussed, when it discusses advancing its robust, jointly-developed product pipeline for the spine market while pursuing exclusive efforts to apply its innovation to other medical needs, when it discusses that moving from direct sales to a strategic distribution model is expected to immediately reduce its annual operating expenses, when it discusses continuing to independently develop and market globally the Renaissance Surgical Guidance System and where it will focus its efforts with regard to this system, and when it discusses the timing of the closing of the Medtronic purchase of ADSs and the potential exercise of warrants as well as the use of proceeds from the sale of such securities. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 1, 2017 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

 

EVC Group
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
or
Doug Sherk, 646-445-4800
dsherk@evcgroup.com

Wednesday, August 30th, 2017 Uncategorized Comments Off on $MZOR and Medtronic Enter Next Phase of Strategic Partnership

$REED Chairman John Bello Purchases 147,047 Shares of Common Stock

LOS ANGELES, Aug. 29, 2017 — Reed’s, Inc. (NYSE American:REED), owner of America’s #1 selling Ginger Beer and the nation’s leading portfolio of handcrafted, all-natural beverages, today announced that on August 24, 2017, Chairman John Bello purchased 117,647 shares of Reed’s, Inc. common stock at the market price of $1.70 per share. Chairman Bello purchased an additional 29,400 shares on August 25, 2017 at $1.70 per share.

Chairman Bello commented, “We are getting things done at Reed’s.  The recent additions of Val Stalowir as CEO and Stefan Freeman leading operations as COO join our proven sales veteran Neal Cohane.  This cohesive team of seasoned professionals are already adding value and delivering on their initiatives.  My recent stock purchases, that were delayed due to blackout period trading restrictions, reinforces my belief that we are doing all the right things to turn around Reed’s and get the Company back into growth mode.   We are simplifying the business and remain focused on driving growth through our core Reed’s and Virgil’s product offerings.  There are many exciting things on the horizon at Reed’s including the introduction of our new all natural no sugar beverage line that we believe will be revolutionary in the industry.”

Additional details regarding Mr. Bello’s purchases are reflected in a Form 4 Statement of Change in Beneficial Ownership of Securities filed with the Securities and Exchange Commission on August 28, 2017.

About Reed’s, Inc.
Established in 1989, Reed’s has sold over 500 million bottles of its category leading hand-brewed craft beverages. Reed’s is America’s #1 selling Ginger Beer brand and has been the leader and innovator in the ginger beer category for decades. The company is the maker of some of the best-selling all natural, handcrafted beverages in the natural and specialty foods channel. Reed’s portfolio is sold in well over 20,000 natural, specialty, mainstream and independent supermarkets nationwide. Additionally, Reed’s products are sold through accounts within the drug, club, mass, and convenience store channels as well as on-premise accounts that include bars and restaurants nationwide. The Reed’s and Virgil’s brands can also be found in a growing number of international markets. Its seven award-winning non-alcoholic Ginger Brews are unique in the beverage industry. Reed’s Ginger Brews are hand brewed, not formulated and use more than a million pounds of fresh ginger combined with spices and fruit juices every year. Reed’s Ginger Brews deliver a delicious and intense ginger bite and burn that can only come from fresh ginger root. The Company applied this same handcrafted brewed approach and focus on high quality ingredients to its award-winning Virgil’s Root Beer. The Virgil’s line of all natural, handcrafted beverages is the top-selling craft soda in the natural food channel and is one of the leading brands within the fast-growing craft soda category.

For more information about Reed’s, please visit the Company’s website at: http://www.reedsinc.com or call 800-99-REEDS.
Follow Reed’s on Twitter at http://twitter.com/reedsgingerbrew
Reed’s Facebook Fan Page at https://www.facebook.com/ReedsGingerBrew

SAFE HARBOR STATEMENT
Some portions of this press release, particularly those describing Reed’s goals and strategies, contain “forward-looking statements.” These forward-looking statements can generally be identified as such because the context of the statement will include words, such as “expects,” “should,” “believes,” “anticipates” or words of similar import. Similarly, statements that describe future plans, objectives or goals are also forward-looking statements. While Reed’s is working to achieve those goals and strategies, actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. These risks and uncertainties include difficulty in marketing its products and services, maintaining and protecting brand recognition, the need for significant capital, dependence on third party distributors, dependence on third party brewers, increasing costs of fuel and freight, protection of intellectual property, competition and other factors, any of which could have an adverse effect on the business plans of Reed’s, its reputation in the industry or its expected financial return from operations and results of operations. In light of significant risks and uncertainties inherent in forward-looking statements included herein, the inclusion of such statements should not be regarded as a representation by Reed’s that they will achieve such forward-looking statements. For further details and a discussion of these and other risks and uncertainties, please see our most recent reports on Form 10-K and Form 10-Q, as filed with the Securities and Exchange Commission, as they may be amended from time to time. Reed’s undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Reed's, Inc.
Investor Relations
(310) 217-9400 ext. 6
Email: ir@reedsinc.com
www.reedsinc.com
Tuesday, August 29th, 2017 Uncategorized Comments Off on $REED Chairman John Bello Purchases 147,047 Shares of Common Stock

$VERI Begins Shipping Xcellis Workflow Storage w/ Veritone aiWARE Platform

Integrated Solution From Quantum and Veritone Provides On-Premise Cognitive Analytics, Empowering Users to Unlock Unrealized Value of Media Content

SAN JOSE, Calif., Aug. 29, 2017 — Quantum Corp. (NYSE: QTM) today announced aiWARE™ for Xcellis®, an on-premise and cloud version of the artificial intelligence (AI) platform from Veritone (NASDAQ: VERI). Bringing Veritone’s multi-engine AI capabilities into a Quantum StorNext®-managed environment, aiWARE for Xcellis enables users to leverage the power of Veritone’s cognitive services and applications ― beginning with optical character recognition (OCR), object detection and speech-to-text transcription as the first network-isolated engines ― to extract new value from their on-premise video and audio content. Situating powerful AI processing behind corporate firewalls, the integrated solution is ideal for companies with significant investments in on-premise storage and/or latency, cost or security concerns about cloud storage.

Maximizing Media Value With AI
Using cognitive engines to delve deeper and faster into their content, media companies can gain greater insights and drive increased business and organizational success. For example, aiWARE for Xcellis enables users to:

  • create more customized video-on-demand offerings through robust metadata tagging of existing content.
  • provide better ROI data to sponsors by identifying where and how often logos, as well as spoken and text brand integrations, appear in broadcast media and redistributed clips.
  • accelerate postproduction work through enhanced context-based search and discovery.

Optimizing Cognitive Analytics With Quantum and Veritone
Cognitive engines can deliver greater value when they have more data to analyze. The combination of Quantum’s StorNext-powered Xcellis with Veritone aiWARE enables users to apply AI to on-premise content that previously could not be leveraged for this purpose and to add new content for analysis as that content is captured. The integrated solution also provides the option to leverage Veritone’s continuously evolving array of best-of-breed cognitive engines in the cloud, either exclusively or in concert with on-premise engines, when desired or appropriate.

Availability and Deployment Options
aiWARE for Xcellis is available now from Quantum and its reseller partners, with three initial deployment options: “Embedded” for containerized deployment on an existing Xcellis workflow storage system, “Standard” delivered on an Xcellis Application Director for more processing performance, and “High Performance” based on an enhanced Xcellis Application Director with additional processing cores and expanded memory. The integrated solution can easily scale with additional appliances as the environment grows.

Quantum will highlight the new solution at IBC2017, Sept. 15-19, in Amsterdam (Stand 7.B27), showcasing the three initial on-premise cognitive engines and integrated access to cloud-based engines. The company will add support for additional on-premise engines over the course of the year and beyond.

Supporting Quotes
Nick Gold, Chief Revenue Officer, Chesapeake Systems
“Our customers are extremely excited about the prospect of using cognitive engines to mine their content repositories. Up until the availability of aiWARE for Xcellis, they haven’t seen a way to smoothly integrate AI processing with their on-premise content. Quantum’s approach solves the on-premise challenges while maintaining access to cloud-based engines and orchestration of everything for fantastic flexibility and options.”

Keith Lissak, Senior Director, Media and Entertainment Solutions Marketing, Quantum
“The integration of AI with on-premise storage enables organizations to apply cognitive analytics to video and audio content and generate much more robust metadata without the cost and hassle of moving their extensive media libraries to the cloud. This will be a game-changing capability for many media companies, as it opens up new realms of possibility for monetizing these libraries.”

Photo Link: www.quantum.com/pr/aiWARE-for-Xcellis.jpg
Photo Caption: aiWARE for Xcellis: AI Analytics for Media Content

Additional Resources

About Quantum
Quantum is a leading expert in scale-out tiered storage, archive and data protection. The company’s StorNext platform powers modern high-performance workflows, enabling seamless, real-time collaboration and keeping content readily accessible for future use and re-monetization. More than 100,000 customers have trusted Quantum to address their most demanding content workflow needs, including top studios, major broadcasters and cutting-edge content creators. With Quantum, customers have the end-to-end storage platform they need to manage assets from ingest through finishing and into delivery and long-term preservation. See how at www.quantum.com/customerstories-mediaent.

Quantum, the Quantum logo, StorNext and Xcellis are registered trademarks of Quantum Corporation and its affiliates in the United States and/or other countries. All other trademarks are the property of their respective owners.

“Safe Harbor” Statement: This press release contains “forward-looking” statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Quantum advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, 1) benefits and value to customers from the combination of Quantum’s StorNext-powered Xcellis with Veritone aiWARE, 2) customer demand for and Quantum’s future revenue from such integrated solutions and 3) Quantum’s plans to add support for additional on-premise engines over the course of the year and beyond. All forward-looking statements are based on information available to Quantum on the date hereof. These statements involve known and unknown risks, uncertainties and other factors that may cause Quantum’s actual results to differ materially from those implied by the forward-looking statement, including unexpected changes in the Company’s business. More detailed information about these risk factors, and additional risk factors, are set forth in Quantum’s periodic filings with the Securities and Exchange Commission, including, but not limited to, those risks and uncertainties listed in the section entitled “Risk Factors,” in Quantum’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2017, especially those risks listed in this section under the headings “Our results of operations depend on a limited number of products and on new product introductions, which may not be successful, in which case our business, financial condition and results of operations may be materially and adversely affected.” Quantum expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Public Relations Contact:
Elisabetta Fernandez
Wall Street Communications
503-577-3125
elisabetta@wallstcom.com

Tuesday, August 29th, 2017 Uncategorized Comments Off on $VERI Begins Shipping Xcellis Workflow Storage w/ Veritone aiWARE Platform

$IMGN & $JAZZ Antibody-Drug Conjugate Strategic Collaboration and Option Agreement

DUBLIN & WALTHAM, Mass.

Strengthens Jazz hematology/oncology portfolio with options for innovative development candidates IMGN779 and IMGN632

ImmunoGen to receive a $75 million upfront payment, up to $100 million in research support, a co-commercialization option, and potential future opt-in fees, milestones and royalties

ImmunoGen conference call to be held today at 8:00 AM EDT; Jazz conference call to be held today at 4:30 PM EDT

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and ImmunoGen, Inc. (Nasdaq: IMGN) today announced that the companies have entered into a collaboration and option agreement granting Jazz Pharmaceuticals exclusive, worldwide rights to opt into development and commercialization of two early-stage, hematology-related antibody-drug conjugate (ADC) programs, as well as an additional program to be designated during the term of the agreement. The programs covered under the agreement include IMGN779, a CD33-targeted ADC for the treatment of acute myeloid leukemia (AML) in Phase 1 testing, and IMGN632, a CD123-targeted ADC for hematological malignancies expected to enter clinical testing before the end of the year.

Under the terms of the agreement, ImmunoGen will be responsible for the development of the three ADC programs prior to any potential opt-in by Jazz. Following any opt-in, Jazz would be responsible for any further development as well as for potential regulatory submissions and commercialization.

As part of the agreement, Jazz will pay ImmunoGen an upfront payment of $75 million. Additionally, Jazz will pay ImmunoGen up to $100 million in development funding over seven years to support the three ADC programs. For each program, Jazz may exercise its opt-in right at any time prior to a pivotal study or any time prior to a biologics license application (BLA) upon payment of an option exercise fee of mid-double digit millions or low triple digit millions, respectively. For each program to which Jazz elects to opt-in, ImmunoGen would be eligible to receive milestone payments based on receiving regulatory approval of the applicable product, plus tiered royalties as a percentage of commercial sales by Jazz, which depending upon sales levels and the stage of development at the time of opt-in, range from mid- to high single digits in the lowest tier to low 10’s to low 20’s in the highest tier. After opt-in, Jazz and ImmunoGen would share costs associated with developing and obtaining regulatory approvals of the applicable product in the United States (U.S.) and the European Union. ImmunoGen has the right to co-commercialize in the U.S. one product (or two products, under certain limited circumstances) with U.S. profit sharing in lieu of Jazz’s payment of the U.S. milestone and royalties to ImmunoGen.

“We are pleased to enter into this collaboration with ImmunoGen, a well-known leader in the field of ADC technology, with demonstrated success in creating ADC molecules, including the only FDA-approved ADC product to treat metastatic breast cancer. This investment supports our long-term commitment to expand our hematology/oncology portfolio with the potential addition of multiple innovative antibody drug conjugates,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “We look forward to the advancement of these ADC programs and the potential synergy of these compounds with our current products and pipeline, as new therapeutic options for cancer patients are urgently needed.”

“This strategic partnership with Jazz significantly advances our goal of accelerating the development of our early-stage novel ADC assets. This deal joins us with a global partner, provides us with substantial funding to support these programs, and preserves the right to co-commercialize one of these assets,” said Mark Enyedy, president and chief executive officer of ImmunoGen. “Jazz has demonstrated the ability to bring innovative compounds to patients and will make an ideal partner to help develop and commercialize our novel ADC assets targeting AML, and more broadly, in the area of hematology/oncology. In addition, this partnership significantly strengthens our financial position and moves us closer to delivering upon our mission of bringing ADC therapies to patients.”

IMGN779 is a novel ADC that combines a high-affinity, humanized anti-CD33 antibody, a cleavable disulfide linker, and one of ImmunoGen’s novel indolino-benzodiazepine payloads, called IGNs, which alkylate DNA without crosslinking, resulting in potent preclinical anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells1,2. IMGN779 is in Phase 1 clinical testing for the treatment of AML. IMGN632 is a preclinical stage humanized anti-CD123 antibody-based ADC that is a potential treatment for AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN), myelodysplastic syndrome, B-cell acute lymphocytic leukemia, and other CD123-positive malignancies. IMGN632 uses a novel payload, linker, and antibody technology and in AML xenograft models has demonstrated a large therapeutic index3. ImmunoGen expects to file an investigational new drug application (IND) for IMGN632 this quarter and enroll the first patient in a Phase 1 study before the end of the year.

Jazz Pharmaceuticals Conference Call Details
Jazz Pharmaceuticals will host a conference call and live audio webcast today at 4:30 p.m. EDT/9:30 p.m. IST to discuss this transaction. Interested parties may access the live audio webcast and slide presentation via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for one week.

Jazz audio webcast/conference call:
U.S. Dial-In Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 76457218

A replay of the conference call will be available through September 5, 2017 and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 76457218

ImmunoGen Conference Call Details
ImmunoGen will host a conference call and live audio webcast today at 8am EDT to discuss this transaction. Interested parties may access the live audio webcast via the Investors section of the ImmunoGen website at www.immunogen.com. A replay of the webcast will be archived on the website for approximately one week.

ImmunoGen audio webcast/conference call:
Dial-In Number: +1 719-457-2607
Passcode: 8332814

About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and Vyxeos™ (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For more information, please visit www.jazzpharmaceuticals.com.

About ImmunoGen
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology. ImmunoGen’s lead product candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen’s ADC technology is used in Roche’s marketed product, Kadcyla®, in other clinical-stage ImmunoGen product candidates, and in programs in development by Amgen, Bayer, Biotest, CytomX, Debiopharm, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.

Jazz Pharmaceuticals “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the potential exercise by Jazz Pharmaceuticals of its opt-in rights with respect to certain early-stage product candidates covered by the collaboration and option agreement, the potential benefits of such product candidates and related development and regulatory activities, potential future payments to ImmunoGen by Jazz Pharmaceuticals, the potential exercise by ImmunoGen of its co-commercialization rights with respect to such product candidates, Jazz Pharmaceuticals’ commitment to expand its hematology/oncology portfolio with the potential addition of multiple innovative antibody drug conjugates, the advancement of the ADC program covered by the collaboration and option agreement and the potential synergy of these compounds with Jazz Pharmaceuticals’ current products and pipeline, the timing of such events and activities, and other statements that are not historical facts. These forward-looking statements are based on the company’s current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: whether Jazz Pharmaceuticals will exercise its opt-in rights with respect to certain early-stage product candidates covered by the collaboration and option agreement, and, if exercised, Jazz Pharmaceuticals’ ability to achieve the expected benefits (commercial or otherwise) from the acquisition of rights to such product candidates; whether ImmunoGen will exercise its co-commercialization rights with respect to such product candidates; pharmaceutical product development and clinical success thereof; the regulatory approval process; and effectively commercializing any product candidates acquired by Jazz Pharmaceuticals under the collaboration and option agreement; and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals plc’s Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and future filings and reports by the company. Other risks and uncertainties of which the company is not currently aware may also affect the company’s forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise. The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

ImmunoGen “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including IMGN779 and IMGN632, including risks relating related to preclinical and clinical studies, their timing and results. A review of these risks can be found in ImmunoGen’s Transition Report on Form 10-K for the six-month period ended December 31, 2016 and other reports filed with the Securities and Exchange Commission.

References:
1 S. Adams et al, Abstract P526, Presented at the 22nd Congress of the European Hematology Association, June 22-25, 2017.
2 Y. Kotvun et al. (2016) Blood 128:768.
3 S. Adams et al, Abstract 2832, Presented at the American Society of Hematology, December 3-6, 2016.

 

Jazz Pharmaceuticals Contacts:
Investors:
Kathee Littrell
Ireland, +353 1 634 7887
U.S., +1-650-496-2717
Vice President, Investor Relations
or
Media:
Jacqueline Kirby
Ireland, +353 1 697 2141
U.S., +1-215-867-4910
Vice President, Corporate Affairs & Government Relations
or
ImmunoGen Contacts:
Investors:
Sarah Kiely, 781-895-0600
Director, Investor Relations
sarah.kiely@immunogen.com
or
Media:
Courtney O’Konek, 781-895-0158
Director, Corporate Communications
courtney.okonek@immunogen.com
or
FTI Consulting, Inc.
Robert Stanislaro, 212-850-5657
robert.stanislaro@fticonsulting.com

Tuesday, August 29th, 2017 Uncategorized Comments Off on $IMGN & $JAZZ Antibody-Drug Conjugate Strategic Collaboration and Option Agreement

$ABEO FDA Breakthrough Therapy Designation for EB-101 in RDEB

  • FDA recently guided Company to accelerate Phase 3 trial for EB-101 autologous cell therapy
  • Breakthrough Therapy designation enables priority review and expedites approval process
  • EB-101 has demonstrated significant efficacy in treated patients for over 2 years
  • Accelerates Phase 3 clinical trial for EB-101, the leading gene therapy for patients with Recessive Dystrophic Epidermolysis Bullosa

NEW YORK and CLEVELAND, Aug. 29, 2017 – Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced today that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation status to the Company’s EB-101 gene therapy program for patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB).  The designation from the FDA enables collaborative discussions with senior FDA personnel, priority review and an expedited approval process to drug candidates where preliminary clinical trials indicate that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.

“EB-101 is an autologous gene-corrected cell therapeutic approach that utilizes a patient’s own cells and genetically engineering them to produce the correct version of collagen, which helps hold skin on to the body, thereby reducing the number of painful blisters caused by injury and improving wound healing,” stated Timothy J. Miller, Ph.D., Abeona’s President and CEO. “We are grateful that the FDA has recognized the promising clinical data from the EB-101 program with Breakthrough Therapy designation and look forward to initiating our pivotal Phase 3 trial as we advance EB-101 for patients with this debilitating disease.”

The Breakthrough Therapy designation is based on data from the Phase 1/2 EB-101 clinical trial, which demonstrated significant wound healing (greater than 50% healed) in treated wounds for over two years. Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for this particular designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.  A Breakthrough Therapy designation conveys all fast track program features with more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review. This is the first Breakthrough Therapy designation for Abeona since the FDA initiated the program in 2013, highlighting the necessity to develop innovative therapies in diseases where there is a significantly unmet clinical need like RDEB.

The Company continues to engage the FDA on the final Phase 3 clinical trial design, planned to commence early 2018, and will provide an update on the program in the coming months.  Abeona’s EB-101 product is an autologous, ex-vivo gene-corrected cell therapy in which the COL7A1 gene is inserted into a patient’s own skin cells (keratinocytes) for the treatment of the underlying disease in Recessive Dystrophic Epidermolysis Bullosa. The EB-101 program has been granted Orphan Drug and Rare Pediatric Disease Designations from the US Food and Drug Administration (FDA) and Orphan Drug Designation from the European Medicines Agency (EMA).

About EB-101 Phase 1/2 Clinical Trial:
In the recent Phase 1/2 clinical trial, EB-101 was administered to non-healing chronic wounds on each subject and assessed for wound healing at predefined time points. The trial met the primary endpoints safety and efficacy, where wound healing after EB-101 administration was compared to control untreated wounds from a supporting natural history study that evaluated 128 patients. Secondary endpoints included expression of collagen C7 and restoration of anchoring fibrils at three and six-months post-administration. Clinical data were presented at the Society of Investigative Dermatology (SID) conference by Stanford collaborators, and demonstrated that EB-101 treated wounds were significantly healed >50% for more than two years post-administration. The data included:

Wound healing, defined as >50% closure after EB-101 administration, was observed in:
—   100% (36/36 treated wounds, n=6 subjects) at 3 months;
—   89% (32/36 treated wounds, n=6 subjects) at 6 months;
—   83% (20/24 treated wounds, n=4 subjects) at 12 months;
—   88% (21/24 treated wounds, n=4 subjects) at 24 months;
—   100% (6/6 treated wounds, n=1 subject) at 36 months post-administration.

Collagen VII (C7) expression: C7 and morphologically normal NC2 reactive anchoring fibrils were observed in EB-101 treated wounds up to two years post-administration.

Importantly, data from a supportive natural history study of 1,436 wounds from 128 patients with RDEB, established by Stanford and EBCare Registry, were also presented at the conference and to the FDA. Notably, 13 RDEB patients with a total of 15 chronic wounds were treated with an allograft product, including Apligraf® and Dermagraft®. Of these wounds treated with allografts, only 7% (1/15 treated wounds) remained healed after 12 weeks, and 0% (0/15 treated wounds) remained healed after 24 weeks. This is a meaningful finding of the natural history study, as there are no approved therapies for RDEB patients that demonstrate significant wound closure after two months post-application.

About Abeona: Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene therapies for life-threatening rare genetic diseases. Abeona’s lead programs include ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA) and EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB).  Abeona is also developing ABO-101 (AAV-NAGLU) for Sanfilippo syndrome type B (MPS IIIB), ABO-201 (AAV-CLN3) gene therapy for juvenile Batten disease (JNCL), ABO-202 (AAV-CLN1) for treatment of infantile Batten disease (INCL), EB-201 for epidermolysis bullosa (EB), ABO-301 (AAV-FANCC) for Fanconi anemia (FA) disorder and ABO-302 using a novel CRISPR/Cas9-based gene editing approach to gene therapy for rare blood diseases. In addition, Abeona has a proprietary vector platform, AIM™, for next generation product candidates. For more information, visit www.abeonatherapeutics.com.

Investor Contact:
Christine Silverstein
Vice President, Investor Relations
Abeona Therapeutics Inc.
+1 (212) 786-6212
csilverstein@abeonatherapeutics.com

Media Contact: 
Lynn Granito
Berry & Company Public Relations
+1 (212) 253-8881
lgranito@berrypr.com

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include, without limitation, our plans for continued development and internationalization of our clinical programs, that patients will continue to be identified, enrolled, treated and monitored in the EB-101 clinical trial, and that studies will continue to indicate that EB-101 is well-tolerated and may offer significant improvements in wound healing. These statements are subject to numerous risks and uncertainties, including but not limited to continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the impact of competition; the ability to develop our products and technologies; the ability to achieve or obtain necessary regulatory approvals; the ability to secure licenses for any technology that may be necessary to commercialize our products; the impact of changes in the financial markets and global economic conditions; and other risks as may be detailed from time to time in the Company’s Annual Reports on Form 10-K and other reports filed by the Company with the Securities and Exchange Commission. The Company undertakes no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Tuesday, August 29th, 2017 Uncategorized Comments Off on $ABEO FDA Breakthrough Therapy Designation for EB-101 in RDEB

$LINU Strategic Cooperation Agreement with Shou Guang Agriculture Logistic Park

LiNiu Technology Group (f/k/a Iao Kun Group Holding Company Limited) (“LINU” or the “Company”) (NASDAQ:LINU), which launched its electronic trading platform focused on the Chinese agricultural industry in April 2017 through Guangzhou LiNiu Network Technology Co., Ltd. (“Guangzhou LiNiu”), today announced that it has signed a strategic cooperation agreement with Shou Guang Agriculture Logistic Park (“SGALP”), one of the largest vegetable distribution, pricing, information exchanges and logistic centers in China and throughout Asia.

SGALP is a company approved by the China National Development and Reform Commission. The park has a total area of 3,000 acres with vegetable, fruit and agriculture material trading areas, as well as agriculture products processing, storage, logistic and services areas. SGALP had annual trading volume of vegetables, fruits and agricultural and sideline products of approximately 10 billion kg and valued at approximately RMB80 billion in 2016, and projects trading volume in excess of 10 billion kg and valued at over RMB80 billion in 2017.

Through the agreement, the companies will cooperate in connection with, among other things, product offerings, information resources, consumers and management of the logistic park. Guangzhou LiNiu will provide advanced technology to consolidate the Electronic Data Interchange (“EDI”), Radio Frequency (“RF”), Geographic Information System (“GIS”), Global Positioning System (“GPS”), and Intelligent Transportation Systems (“ITS”) in order to grow the information management center of the logistic park. Both parties intend to create an integrated production, transportation, warehousing, deployment, sales and marketing ecosystem for vegetables. In addition, Guangzhou LiNiu will provide SGALP with access to Internet sales channels through its LiNiuYang trading platform, while SGALP allows Guangzhou LiNiu to access its production, sales, distribution and logistics big data.

Overall, LINU expects, through the cooperative agreement, that SGALP will increase its annual trading amount, while Guangzhou LiNiu will earn additional commission income though the increase in daily traffic on its platform.

“We are pleased to embark on our new relationship with SGALP, which we believe will be a key strategic alliance that should provide a significant boost to our LiNiuYang platform, while allowing us to further utilize our technological capabilities to the benefit of SGALP,” said Mr. Wang Shun Yang, co-Chief Executive Officer of LiNiu Technology Group.

About LiNiu Technology Group

LiNiu Technology Group (NASDAQ: LINU) recently launched the LiNiu Network, a Business to Customer (“B2C”), Customer to Customer (“C2C”) and Online to Offline (“O2O”) electronic trading platform focused on the Chinese agricultural industry. The Company also currently participates in the promotion of VIP gaming at the Altira Macau. For more information on the LiNiu Network, please visit www.liniuyang.com.

Forward-Looking Statements

This press release includes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of the Company’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Factors that could cause actual results to differ materially from management’s current expectations include but not limited to those risks and uncertainties relating to future business development; ability to maintain the reputation and brand; privacy and regulatory concerns; competition; security breaches; the continued growth of the e-commerce market in China; and fluctuations in general economic and business conditions in China and assumptions underlying or related to any of the foregoing. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investors and potential investors should consult all of the information set forth herein and should also refer to the risk factors set forth in the Company’s Annual Report on Form 20-F filed in April 2017, and other reports filed or to be filed from time-to-time with the Securities and Exchange Commission.

 

LiNiu Technology Group
Ryan Yip, +852 2111 9220
ryany@liniuyang.com

Tuesday, August 29th, 2017 Uncategorized Comments Off on $LINU Strategic Cooperation Agreement with Shou Guang Agriculture Logistic Park

$PERF Norell Blushing Debuts, Third Addition to Norell Luxury Fragrance Collection

NEW YORK

Parlux Fragrances, Ltd. announces the launch of Norell Blushing, the latest addition to the Norman Norell fragrance portfolio in celebration of the American designer’s iconic style.


Norell Blushing (Photo: Business Wire)

A luxury fragrance of the highest standard with a distinctly modern olfactive composition, the coy and coquettish floral evokes a sense of nostalgia with a uniquely timeless appeal. The scent enchants with an exquisite sensuality of the finest ingredients with each bottle possessing over 500 luxuriant petals of the coveted Damask Rose.

THE FRAGRANCE
Created by International Flavors & Fragrances Perfumer, Yves Cassar, the fragrance features fresh top notes of Juicy Nectarine, Sparkling Mandarin, and Watery Pear that sparkle with a youthful radiance. A flourish of florals represent the heart of the fragrance with Orange Flower and Syringa that flirt with the fruity top notes to highlight the luminous femininity of Damask Rose and Jasmine. The base notes of Creamy Birchwood, Vanilla, and Sandalwood blend with the sensuality of Skin Musks to impart a sparkling allure.

“Norell Blushing captures the sparkle and light of elegant femininity with a wink of playful mischief and a luminous love of life,” said Cassar.

Designed with sophisticated, discerning women in mind, Norell Blushing is a fragrance for a new generation of contemporary women seeking to express their unique and individual style.

THE PACKAGING
Remaining true to the signature styling of the Norell fragrance collection, the deluxe yet charming presentation is an ode to the craftsmanship and art of perfumery. Housed in an exquisite flacon, the elegant glass stopper is encrusted with sparkling diamante detailing, echoing the understated glamour of Norell’s legendary aesthetic.

THE COLLECTION
Norell Blushing Eau de Parfum      3.4 fl. oz. / 100 mL      $150

AVAILABILITY
Norell Blushing will launch exclusively at Neiman Marcus beginning August 2017.

ABOUT PARLUX FRAGRANCES, LTD:

Parlux Fragrances, Ltd., a leading global beauty company designs, manufactures, markets and distributes prestige designer fragrances and related products since 1987. Parlux Fragrances, ltd. is a wholly owned subsidiary of Perfumania Holdings Inc., an independent, national, vertically integrated wholesale distributor and specialty retailer of fragrances and related products. It is traded on the NASDAQ exchange (PERF).

 

Parlux Fragrances Ltd:
Emma Garner, 212-878-3738
emmag@parlux.com
or
Paul Wilmot Communications:
Betty Mui, 212-206-7447
bmui@paulwilmot.com

Monday, August 28th, 2017 Uncategorized Comments Off on $PERF Norell Blushing Debuts, Third Addition to Norell Luxury Fragrance Collection

$TNDM FDA Approval, Launch of G5 Integrated t:slim X2 Insulin Pump

‒ Software Update Available for Current t:slim X2 Pump Users Via Personal Computer ‒

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration, the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger1. The software featured on this pump will also be available to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing pumps from home using a personal computer. Individual emails are being sent directly to t:slim X2 Pump customers with instructions on how to perform the update. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration is approved for ages 6 and older.

This approval marks the Company’s fifth new insulin pump launch in only 5 years and the second featuring Dexcom technology. It is the only available pump that conveniently displays a user’s insulin delivery activity and Dexcom G5 Mobile CGM data together on a single device. The t:slim X2 Pump is also the only insulin pump capable of remote software updates2, allowing existing users to add features like CGM integration from home. It is up to 38% smaller than other pumps3, but includes advanced features like a large color touchscreen, Bluetooth® radio, rechargeable battery, USB connectivity, 300-unit insulin capacity and watertight construction (IPX7)4.

“We are setting a new standard in our industry by simultaneously offering our existing and future customers the benefits of best-in-class CGM integration on our simple-to-use touchscreen insulin pump,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “The t:slim X2 Pump is designed to accelerate the pace in which we can bring new innovations to people with diabetes, which is of particular importance as we develop software updates to add automated insulin delivery algorithms to our platform.”

“Dexcom has been moving its technology forward at a rapid pace, and Tandem’s ability to roll out remote software updates like this opens up exciting possibilities for faster integrations of our future products,” said Steve Pacelli, Executive Vice President of Strategy and Corporate Development at Dexcom. “We are excited to have our latest CGM technology integrated with their t:slim X2 Insulin Pump, and to see it offered not only to new customers but also to existing t:slim X2 Pump users.”

The t:slim X2 Pump can operate as a stand-alone insulin pump without CGM, or be paired with the Dexcom G5 Mobile CGM to track glucose continuously and display that information directly on the pump’s home screen. Dexcom G5 Mobile is the only CGM system FDA approved to let users make treatment decisions without pricking their finger. Dexcom is also consistently rated the #1 CGM brand in independent patient surveys5. In addition to integration with the t:slim X2 Pump, dynamic glucose data from the Dexcom G5 Mobile CGM can be easily accessed and shared using a compatible mobile device.

For additional t:slim X2 Pump product and safety information, or to begin the order process, visit
www.tandemdiabetes.com/tslimX2
or call 877-801-6901, Monday – Friday between 6am and 5pm Pacific Time

Download Tandem’s free t:simulator™ App to experience the touchscreen interface of the t:slim X2 Pump with Dexcom G5 Mobile CGM integration directly on your mobile device. For more information and to download the app, visit http://www.tandemdiabetes.com/tsimulator.

Information for Current t:slim X2 Pump Users

All eligible t:slim X2 Pump users have the option to add Dexcom G5 Mobile CGM integration via a software update using a personal computer. Individual emails are being sent directly to t:slim X2 Pump customers with instructions on how to perform the update. The software update is Mac® and PC compatible. For more information on system requirements, visit www.tandemdiabetes.com/updater.

Remote Software Updates for Insulin Pumps

Tandem is the only company with a tool for providing remote software updates for its insulin pumps using a personal computer. The power of the t:slim X2 Pump’s touchscreen allows for buttons to be moved and data like the interactive CGM screen to be added via software updates without getting a new device. With innovations in diabetes technology consistently moving faster than the typical insurance pump replacement cycle, remote software updates make it easier to make a purchasing decision today without worrying that the device will soon be outdated. Future Tandem products are being developed with software updates in mind, with the goal of delivering new technologies to both new and current customers at the same time.2

The Benefits of Insulin Pump Therapy with CGM

Published studies have shown that insulin pump therapy, when paired with proper training and support, can result in better blood sugar control and lower total daily insulin use compared to multiple daily injections.6,7,8 CGM has demonstrated improved blood sugar control, increased confidence related to the risk of low blood sugar, and decreased diabetes stress.9,10 Combining insulin pump therapy and CGM has demonstrated the best overall glucose control compared to multiple daily injections or pump therapy alone, in addition to the quality of life improvements associated with each individual therapy.9

Insulin Pump Use and Diabetes

Diabetes is a chronic, life-threatening disease that affects more than 29 million people in the United States, or nearly 1 in 10 Americans. Tandem estimates that more than 3 million people in the United States require daily administration of insulin and are candidates for pump therapy. More than 425,000 Americans with type 1 diabetes use an insulin pump, or approximately 27% of the type 1 diabetes population. In addition, approximately 125,000 Americans with type 2 diabetes use an insulin pump, a small fraction of the type 2 diabetes population.

The t:slim X2 Pump with Dexcom G5 Mobile CGM integration will replace the Company’s previous-generation t:slim G4™ Pump. The Company will continue to service all current t:slim G4 Pumps for the duration of their warranty. An upgrade program is available through September 30, 2017, for t:slim and t:slim G4 Pump users interested in accessing the t:slim X2 Pump. For more information, visit www.tandemdiabetes.com/upgrade.

About Tandem Diabetes Care, Inc.

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

Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2, #tslimG4, #tflex, #tconnect, and $TNDM.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.

Tandem Diabetes Care is a registered trademarks, and t:slim X2 and t:slim G4 are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G5 are registered trademarks of Dexcom, Inc. Bluetooth® is a registered trademark of Bluetooth SIG, Inc. All other trademarks are the property of their respective owners.

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements include statements regarding the Company’s ability to develop software updates that add automated insulin delivery algorithms to the t:slim X2 and the potential for faster integration with Dexcom products in the future. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including the Company’s ability to complete the development of automated insulin delivery algorithms for the t:slim X2, the Company’s ability to successfully complete clinical trials for new products when anticipated (or at all), the potential that the results of any such clinical trials may not be sufficient to support regulatory approvals for new products as anticipated and the Company’s ability to obtain regulatory approvals for future products and product features generally. Other risks and uncertainties are identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other documents that the Company files with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.

1 CGM-based treatment requires fingersticks for calibration; may result in hypoglycemia if calibration not performed, when taking acetaminophen, or if symptoms/expectations do not match CGM readings.
2 Additional feature updates are not currently available for the t:slim X2 Pump with Dexcom G5 Mobile CGM integration and are subject to future FDA approvals. Charges may apply.
3 38% smaller than MiniMed 630G and 670G and at least 28% smaller than MiniMed 530G, Animas Vibe and Omnipod System. Data on file, Tandem Diabetes Care.
4 Tested to 3 feet for 30 minutes (IPX7 rating).
5 dQ&A USA Diabetes Connections Surveys, 2009-2016.
6 Reznik Y, Cohen O, Aronson R, et al. Lancet. 2014;384(9950):1265-1272.
7 Hoogma RPLM, Hammond PJ, Gomis R, et al. Diabet Med. 2005;23:141-147.
8 Bode BW, Sabbah HT, Gross TM. Diabet Metab Res Rev. 2002;18(suppl 1):S14-S20.
9 Foster N, Miller K, Tamborlane W, Bergenstal R, Beck R, & T1D Exchange Clinical Network (2016). Diabetes Care 2016 Jun; 39(6): e81-e82.
10 Polonsky B, Hessler D, Ruedy K, Beck R. & DIAMOND Study Group. Diabetes Care. 2017. doi:10.2337/dc17-0133. [Epub ahead of print]

 

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

Monday, August 28th, 2017 Uncategorized Comments Off on $TNDM FDA Approval, Launch of G5 Integrated t:slim X2 Insulin Pump

$FSNN Definitive Agreement to Acquire Birch Com’s Cloud and Business Services Segment

Transaction expected to create one of the largest North American cloud services providers, with total pro forma annual revenue of approximately $575 million; Combination expected to significantly enhance Fusion’s innovative strategy as the single source for the cloud

NEW YORK, NY–(August 28, 2017) – Fusion (NASDAQ: FSNN)

  • Fusion to acquire Birch’s Cloud and Business Services business, including its customers, operations and infrastructure
  • Combined company is expected to have total pro forma annual revenue of approximately $575 million and more than $150 million in pro forma annual adjusted EBITDA, including anticipated cost synergies
  • Transaction is expected to be significantly accretive to Fusion’s adjusted EBITDA immediately upon closing, generating positive free cash flow while dramatically reducing the company’s overall leverage ratio, with net debt expected to be less than 4.0x pro forma adjusted EBITDA
  • Birch shareholders will exchange their equity position in Birch’s Cloud and Business Services business, valued at approximately $280 million, for common equity of the combined company
  • All-stock transaction in which Birch shareholders will receive approximately 73 million common shares of Fusion valued at $3.85 per share, a premium of more than 200% versus the prior trading day’s closing price, representing approximately 5x the pro forma adjusted EBITDA of Birch’s Cloud and Business Services business including anticipated synergies
  • Combined company will serve more than 150,000 business customers throughout the United States and Canada, and will have strong distribution through direct sales, inside sales and more than 800 distribution partners
  • Significant opportunities for growth through cross-selling and upselling new services into the combined customer base

Fusion (NASDAQ: FSNN), a leading cloud services provider, announced today that it has entered into a definitive agreement to acquire the Cloud and Business Services customers, operations and infrastructure of privately-held Birch Communications, which represents the majority of Birch’s current revenues. The transaction is expected to close by the end of 2017, subject to customary approvals and closing conditions.

The combination is expected to create one of the largest cloud services providers in North America, with more than 150,000 business customers and a 100% Internet Protocol-based network, including 30 data centers, 31,000 fiber route-miles of network, and metro fiber assets in 11 major markets. The combined customer base is expected to demonstrate strong fundamentals, with monthly recurring revenue comprising approximately 87% of total revenue. In addition, the combined company will have significant opportunities for growth by cross-selling and upselling to existing customers with a comprehensive suite of cloud and business services.

The acquisition will not include Birch’s legacy consumer and single-line business customers, which have lower profitability and Average Revenue Per Customer (ARPU) as well as higher churn rates.

The scale that this acquisition will bring to Fusion further accelerates the company’s single-source cloud strategy. By delivering its fully integrated cloud solutions over a single platform, Fusion is able to solve the increasingly complex challenges of migrating to the cloud. Fusion offers customers a more efficient integration of cloud services and provides greater control over the end-to-end user experience, thereby avoiding the “finger pointing” often encountered when using multiple service providers.

“This acquisition is a major milestone in Fusion’s targeted and disruptive strategy of becoming the leading single-source cloud services provider to business and enterprise customers,” said Matthew Rosen, Fusion’s Chief Executive Officer. “Customers increasingly demand an end-to-end experience that is reliable as well as efficient and innovative. Fusion is well positioned to provide these services having been first-to-market to pursue this strategy, and can now do so with increased scale and resources.”

Mr. Rosen continued, “This combination will immediately move Fusion into the top tier of cloud services providers and establishes a robust platform from which to pursue aggressive value enhancing initiatives through both organic growth and strategic acquisitions. By leveraging the significantly larger scale of Fusion following the acquisition, the company will gain new efficiencies and greater cash flows, which we believe will drive shareholder value. We also expect that the new Fusion will gain broader awareness among investors and analysts, along with expanded access to the capital markets, which will further support our compelling growth strategy.”

Vincent Oddo, Chief Executive Officer of Birch Equity Partners, said, “Matthew Rosen and his team have a unique and compelling strategy for addressing the challenges that so many businesses face when migrating to the cloud. Time and again, Fusion has demonstrated its ability to deliver innovative and integrated customer solutions, firmly establishing the company as the ideal partner for Birch. We are confident that the combination of our two companies will create significant value for our customers and all stakeholders.”

Mr. Oddo continued, “Our common vision for the future, commitment to service excellence and culture of innovation provide a great foundation for the integration of our teams and our ability to attract customers with compelling cloud-based solutions. We are excited to participate in Fusion’s ongoing success as shareholders in the combined company.”

Additional Transaction Details

  • Under the terms of the merger agreement, which has been approved by the boards of directors of both companies, Birch shareholders will receive, for all issued and outstanding shares of Birch common stock, the right to receive, in the aggregate, shares of Fusion common stock equal to three times the total number of issued and outstanding shares of Fusion common stock immediately prior to the merger (assuming conversion of all Fusion preferred stock into common stock and in-the-money warrants, but excluding current outstanding options), resulting in 25% pro forma ownership by Fusion shareholders and 75% pro forma ownership by Birch shareholders
  • It is currently estimated that approximately 73 million common shares of Fusion will be issued in connection with this transaction, valued at $3.85 per share
  • Fusion will assume Birch’s existing debt of approximately $458 million, which is expected to be refinanced along with Fusion’s existing debt
  • Matthew Rosen, Chief Executive Officer of Fusion, will serve as CEO of the combined company and will assume the role of Chairman of the Board upon the close of the transaction
  • Fusion and Birch shareholders will each appoint four directors to the combined company’s Board, with a ninth director to be nominated by Birch shareholders with Fusion’s prior approval
  • The transaction contemplates over $20 million of cost synergies which are expected to be achieved within 12 months of closing
  • The combined company expects that it will continue to be listed on the Nasdaq Capital Market and trade under the Fusion name and symbol (FSNN)
  • All members of Fusion’s Board of Directors have signed a support agreement to vote their aggregate 10.5% interest in favor of the transaction

The transaction is subject to shareholder approvals and the satisfaction of certain closing conditions including the receipt of required regulatory and antitrust approvals and financing for the transaction, as well as other customary closing conditions.

Fusion is subject to customary restrictions on its ability to solicit alternative acquisition proposals from third parties and to provide information to, and participate in discussions and engage in negotiations with, third parties regarding alternative acquisition proposals. However, prior to the receipt of the necessary stockholder approval, such solicitation restrictions are subject to a customary “fiduciary out” provision that allows Fusion, under certain specified circumstances, to provide information to, and participate in discussions and engage in negotiations with, third parties with respect to alternative acquisition proposals if its Board of Directors determines in good faith (after consultation with its financial advisor and outside legal counsel) that such alternative acquisition proposal either constitutes a superior proposal or is reasonably likely to result in a superior proposal and the failure to explore the alternative acquisition proposal would be inconsistent with the directors’ fiduciary duties pursuant to applicable law.

Advisors

Greenberg Traurig LLP is serving as M&A legal advisor and Kelley Drye & Warren LLP is serving as special regulatory counsel to Fusion. FTI Consulting is serving as financial advisor to Fusion and has rendered a fairness opinion to Fusion’s Board of Directors and its shareholders. Moelis & Co. is serving as financial advisor to Birch. Jones Day is serving as M&A legal advisor and Cahill Gordon & Reindell LLP is serving as special regulatory counsel to Birch.

Investor Call and Presentation Information

An investor presentation and pre-recorded comments from Fusion’s management regarding the transaction will be made available on August 28, 2017 at approximately 8:00 a.m. Eastern time. To access the pre-recorded comments and presentation, please use the following information:

By Phone:

Participant Toll-Free Dial-In Number: (833) 652-5913

Participant International Dial-In Number: (270) 823-1182

Confirmation code: 77161636

Via Webcast:

http://edge.media-server.com/m/p/qctk7z5i

Or visit Fusion’s Investor Relations website at ir.fusionconnect.com under “Events”

In addition, the investor presentation will be filed with the Securities and Exchange Commission (the “SEC”) on or before September 1, 2017, which can be viewed on the SEC’s website at www.sec.gov.

Forward Looking Statements

Statements in this press release that are not purely historical facts, including statements regarding Fusion’s beliefs, expectations, intentions or strategies for the future, may be “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, both as amended by the under the Private Securities Litigation Reform Act of 1996. Such statements consist of any statement other than a recitation of historical fact and may sometimes be identified by the use of forward-looking terminology such as “may”, “might,” “will,” “should,” “could,” “predict,” “project,” “future,” “potential,” “seek to,” “plan,” “assume,” “believe,” “target,” “forecast,” “goal,” “objective,” “expect”, “anticipate”, “intend”, “estimate” or “continue” or the negative thereof or other variations thereof or comparable terminology. The reader is cautioned that all forward-looking statements are speculative, and there are certain risks and uncertainties that could cause actual events or results to differ from those referred to in such forward-looking statements. These forward-looking statements, include, but are not limited to, statements regarding benefits of the proposed merger, integration plans and expected synergies, anticipated future financial and operating performance and results, including estimates for growth. Important risks regarding the Company’s business include the Company’s ability to raise additional capital to execute its comprehensive business strategy; the integration of businesses and assets following an acquisition; the Company’s ability to comply with covenants included in its senior debt agreements; competitors with broader product lines and greater resources; emergence into new markets; natural disasters, acts of war, terrorism or other events beyond the Company’s control; and other factors identified by Fusion from time to time in its filings with the Securities and Exchange Commission (“SEC”), which are available through www.sec.gov. However, the reader is cautioned that Fusion’s future performance could also be affected by risks and uncertainties not enumerated above. There are a number of risks and uncertainties that could cause actual results to differ materially from the forward-looking statements included in this communication. For example, the expected timing and likelihood of completion of the pending merger, including the timing, receipt and terms and conditions of any required governmental and regulatory approvals of the pending merger that could reduce anticipated benefits or cause the parties to abandon the transaction, the ability to successfully integrate the businesses, the occurrence of any event, change or other circumstance that could give rise to the termination of the agreement, the possibility that Fusion shareholders may not provide the required shareholder approvals, the risk that the parties may not be able to satisfy the conditions to the proposed transaction in a timely manner or at all, risks related to disruption of management time from ongoing business operations due to the proposed transaction, the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of Fusion’s common stock, the risk that the proposed transaction and its announcement could have an adverse effect on the ability of Fusion and Birch to retain customers and retain and hire key personnel and maintain relationships with their suppliers and customers and on their operating results and businesses generally, problems may raise in integrating the businesses of the companies which may result in the combined company operating less effectively and efficiently than anticipated, the combined company may not be able to achieve cost-cutting synergies or it may take longer than anticipated to achieve those synergies, there is no guarantee as to the trading price of the stock of the combined company and other factors. All such factors are difficult to predict and are beyond Fusion’s control. The Company disclaims and does not undertake any obligation to update or revise any forward-looking statement in this report, except as required by applicable law or regulation.

Additional Information and Where to Find It

This communication relates to the proposed merger involving Fusion Telecommunications International, Inc. (“Fusion”), Fusion BCHI Acquisition LLC and Birch Communications Holdings, Inc. (“Birch”). In connection with the proposed merger, Fusion intends to file relevant materials with the SEC, including Fusion’s proxy statement on Schedule 14A (the “Proxy Statement”). This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, and is not a substitute for the Proxy Statement or any other document that Fusion may file with the SEC or send to its stockholders in connection with the proposed merger. STOCKHOLDERS OF FUSION ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE PROXY STATEMENT, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain the documents free of charge at the SEC’s web site, www.sec.gov and Fusion stockholders will receive information at an appropriate time on how to obtain transaction-related documents for free from Fusion.

Participants in the Solicitation

This communication is not a solicitation of a proxy from any security holder of Fusion. However, Fusion and Birch and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Fusion in connection with the proposed merger. Information about the persons who are, under the rules of the SEC, participants in the solicitation of the stockholders of Fusion in connection with the proposed transactions, including a description of their direct or indirect interest, by security holdings or otherwise, will be set forth in the proxy statement when it is filed by Fusion with the SEC. Information about the officers and directors of Fusion may be found in its proxy statement for Fusion’s 2016 Annual Meeting of stockholders, which was filed with the SEC on September 2, 2016, and in Fusion’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which was originally filed with the SEC on March 21, 2017 and Amendment on April 11, 2017 and April 28, 2017.

About Fusion

Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry’s single source for the cloud. Fusion’s advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including cloud communications, contact center, cloud connectivity, and cloud computing. Fusion’s innovative, yet proven cloud solutions lower our customers’ cost of ownership, and deliver new levels of security, flexibility, scalability, and speed of deployment. For more information, please visit www.fusionconnect.com.

About Birch

Birch Communications is a leading North American Cloud and Business Solutions Provider. For more than 20 years, Birch has been recognized as a provider that delivers cost-effective solutions for small and mid-sized businesses as well as an exceptional customer experience. Birch’s industry-leading IP-network and product portfolio are available across North America, and include: cloud communications, cloud connectivity and cloud computing. For more information, visit www.birch.com.

Investor Contacts:
Brian Coyne
212-201-2404
Email contact

Chris Tyson
MZ North America
(949) 491-8235
Email contact

www.mzgroup.us

Media Contacts:
For Fusion
Daniel Yunger / Daniel Del Re
KEKST
212.521.4800

For Birch
Michelle Ansley
770.874.4939
Email contact

Monday, August 28th, 2017 Uncategorized Comments Off on $FSNN Definitive Agreement to Acquire Birch Com’s Cloud and Business Services Segment

$MXPT Acquisition by Harland Clarke Holdings’ Valassis

Acquisition Enhances Valassis Digital’s Targeting, Personalization and Measurement Capabilities

LIVONIA, Mich. and RALEIGH, N.C., Aug. 28, 2017  — Valassis, a leader in intelligent media delivery, today announced that it has reached a definitive agreement, through its parent company Harland Clarke Holdings, to acquire MaxPoint Interactive (NASDAQ:MXPT), a leading digital marketing technology company. MaxPoint provides an industry-leading data management platform that fuels superior display advertising and in-store campaign solutions for advertising clients.

The acquisition of MaxPoint reflects Valassis’ continued commitment to enhance its portfolio of multi-channel delivery solutions. Valassis drives measurable media solutions for clients to engage and influence consumers wherever they plan, shop, buy or share. Valassis’ wholly owned subsidiary, Valassis Digital, offers industry proven digital solutions including mobile and desktop display, video, social, digital coupons, retailer offers, search, and email marketing solutions to drive online engagement.

MaxPoint has provided its industry-leading solutions to a strong and diverse client base, including each of the top 20 leading national advertisers and each of the top 10 advertising agencies in the United States. MaxPoint’s client base is a perfect complement to Valassis’ more than 58,000 advertiser clients while adding penetration into industry verticals such as financial services, healthcare and automotive. In addition, MaxPoint’s innovative location-powered technology will assist in delivering both print and digital advertising campaigns across multiple devices with precise relevance to the same customer.

“The acquisition of MaxPoint, following on the recent acquisition of RetailMeNot, is another key transaction that will significantly increase our digital presence. It will create greater strength in managing integrated media delivery campaigns for the world’s largest consumer products companies, retailers and agencies,” said Victor Nichols, CEO of Harland Clarke Holdings. “This will result in operating efficiencies and deeper digital expertise that will provide more effective solutions for our global clients as well as the tens of thousands of small and medium-sized businesses we serve.”

“MaxPoint’s exceptional entrepreneurial team and digital advertising solutions will be a strong complement to our team and industry leading solutions. Combining MaxPoint’s rich consumer intelligence with Valassis’ robust data and analytics capabilities will help deliver more personalization, targeting and measurement at unmatched scale,” said Cali Tran, President, Valassis Digital. “Together, we will have a world class research and development team to create leading technology solutions that will help advertisers drive higher performance with their media strategies.”

“This marks a great milestone for MaxPoint, our clients and our stockholders,” said Joe Epperson CEO, MaxPoint. “The combined team with our strong technical capabilities and client focused expertise will be second to none in the industry. As one team we’ll bring proven digital media solutions along with a simplified buying process to our clients.”

Under the agreement, Harland Clarke Holdings, a wholly owned subsidiary of MacAndrews & Forbes Incorporated and owner of Valassis, will acquire all of the outstanding shares of MaxPoint for $13.86 per share in cash. The transaction, which has been unanimously approved by MaxPoint’s Board of Directors, has an equity value of approximately $95 million. MaxPoint’s top 3 stockholders have signed support agreements reflecting their commitment to this transaction and intent to tender their shares in the tender offer.

The transaction will be effected through a tender offer for all of the outstanding shares of MaxPoint followed by a merger at the same price per share. The transaction is expected to close in the fourth quarter of 2017. Upon completion of the transaction, MaxPoint will become a privately held company and MaxPoint’s outstanding shares will no longer be listed on any public market. In light of the transaction, MaxPoint will not provide earnings guidance going forward.

Kirkland & Ellis LLP is serving as legal advisor to Harland Clarke Holdings. Cleary Gottlieb Steen & Hamilton LLP is serving as legal advisor to Harland Clarke Holdings for financing matters.

Goldman Sachs is serving as financial advisor and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP is serving as legal advisor to MaxPoint in connection with the transaction.

About Valassis

Valassis is a leader in intelligent media delivery, providing over 58,000 clients with innovative media solutions to influence consumers wherever they plan, shop, buy and share. By integrating online and offline data combined with powerful insights, Valassis precisely targets its clients’ most valuable shoppers, offering unparalleled reach and scale. The Valassis Digital Division offers a powerful and industry proven suite of digital solutions including, but not limited to, mobile and desktop display, video, social, digital coupons, retailer offers, search, and email marketing solutions to drive online engagement to acquire and influence consumers on their path to purchase. NCH Marketing Services, Inc. and Clipper Magazine are Valassis subsidiaries, and RedPlum® is its consumer brand. Its signature Have You Seen Me?® program delivers hope to missing children and their families. As wholly owned subsidiaries of Harland Clarke Holdings, Valassis and RetailMeNot, a leading destination for digital savings, are partnering to connect retailers and consumers through meaningful digital, mobile and print promotions.

About Harland Clarke Holdings

Harland Clarke Holdings is comprised of companies focused on optimizing client relationships through multiple channels by enabling them to acquire, retain and grow their customer base. Its major business units, Valassis, RetailMeNot, Harland Clarke and Scantron are recognized as leading providers of marketing services, transaction solutions, education services and intelligent media delivery that create millions of customer touch points annually for their clients. Harland Clarke Holdings is a wholly owned subsidiary of MacAndrews & Forbes Incorporated.

About MaxPoint

MaxPoint is a marketing technology company that generates hyperlocal intelligence to optimize brand and retail performance. We provide a platform for brands to connect the digital world with the physical world through hyperlocal execution, measurement, and consumer insights.

The company’s proprietary Digital Zip® technology and the MaxPoint Intelligence Platform™ predict the most likely buyers of a specific product at a particular retail location and then execute cross-channel digital marketing programs to reach these buyers. For more information, visit maxpoint.com.

Forward-looking Statements

Statements in this document that are not strictly historical, including statements regarding the proposed acquisition, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined businesses and any other statements regarding events or developments that we believe or anticipate will or may occur in the future, may be “forward-looking” statements within the meaning of the federal securities laws, and involve a number of risks and uncertainties. There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: general economic conditions and conditions affecting the industries in which Harland Clarke, Valassis and MaxPoint operate; the uncertainty of regulatory approvals; the parties’ ability to satisfy the tender offer conditions and conditions to the merger agreement and consummate the transaction and the timing thereof; the availability of financing on attractive terms or at all; the ability to realize anticipated growth; MaxPoint’s performance and maintenance of employee, customer and other important business relationships; and the risk that stockholder litigation in connection with the transaction may result in significant costs of defense, indemnification and liability. Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in MaxPoint’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. The forward-looking statements made herein speak only as of the date hereof and none of Harland Clarke, Valassis or MaxPoint, or any of their respective affiliates, assumes any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

Additional Information and Notice to Investors

This announcement is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the outstanding shares of MaxPoint common stock described in this press release has not yet commenced. At the time the planned offer is commenced an indirect wholly-owned subsidiary of Harland Clarke Holdings will file a tender offer statement on Schedule TO with the SEC and MaxPoint will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the planned offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Those materials will be made available to MaxPoint security holders for free. In addition, all of those materials (and all other offer documents filed with the SEC) will be available at no charge on the SEC’s website: www.sec.gov.

Contact Information

For MaxPoint:

Media Contact:
Patrick Foarde
Ketchum for MaxPoint
patrick.foarde@ketchum.com
(404) 879-9254

Investor Relations Contact:
Denise Garcia
ir@maxpoint.com
(800) 916-9960

For Harland Clarke Holdings:

Media Contact:
Debbie Serot
Debbie.serot@harlandclarke.com
(210) 697-6239

For MacAndrews & Forbes Incorporated:

Media Contact:
Josh Vlasto
jvlasto@mafgrp.com
(212) 572-5969
Monday, August 28th, 2017 Uncategorized Comments Off on $MXPT Acquisition by Harland Clarke Holdings’ Valassis

$SYBX Completes Merger with Mirna Therapeutics

CAMBRIDGE, Mass. & AUSTIN, Texas

– Synlogic Commences Trading on NASDAQ Capital Market under Ticker Symbol “SYBX”

– Combined Company has Approximately $100 Million in Cash and Cash Equivalents Following Transaction Close

– Company Strengthens Board of Directors with addition of Michael Powell, Ph.D., and Richard Shea

Synlogic, Inc. and Mirna Therapeutics, Inc. today announced that the proposed merger of the two companies has closed following the approval of Mirna’s stockholders received on August 24, 2017. The merged company will operate as Synlogic, Inc. and will focus on advancing Synlogic’s platform for development of Synthetic Biotic™ medicines, which are designed using synthetic biology to genetically reprogram probiotic bacteria to treat metabolic and inflammatory diseases and cancer. Synlogic will commence trading on the NASDAQ Capital Market today, August 28, 2017, under the ticker symbol “SYBX”.

“The close of this merger, in combination with our recent financing, provides Synlogic with significant resources to move forward as a public company and realize our goal of developing a new class of living medicines that have the unique potential to compensate for dysfunctional pathways in serious diseases,” said Jose Carlos Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive officer. “Earlier this year we initiated the first human clinical trial of our lead Synthetic Biotic investigational medicine for hyperammonemia, and in the first half of 2018 we expect to initiate clinical trials of a second Synthetic Biotic medicine candidate for the treatment of phenylketonuria (PKU). Our solid financial position enables us to continue to execute on advancing our novel development programs through the clinic to demonstrate the therapeutic potential of our Synthetic Biotic platform.”

The combined company’s cash and cash equivalents, as of immediately following the closing of the merger, is approximately $100 million. This includes proceeds from a Series C financing that closed immediately prior to the signing of the merger agreement in which Synlogic raised approximately $42 million from leading biotechnology investors, including Aju IB Investment, Ally Bridge Group, Arctic Aurora LifeScience, CLI Ventures, Perceptive Advisors, Rock Springs Capital, and other undisclosed new investors. Existing investors, Atlas Venture, Deerfield, New Enterprise Associates (NEA), and OrbiMed also participated in the financing. As a result of the closing of the merger, Synlogic stockholders and option holders own, or have rights to acquire, approximately 82 percent of the combined company, and former Mirna stockholders own approximately 18 percent of the combined company.

Appointment of New Members to Synlogic’s Board of Directors

The company also announced today that Michael Powell, Ph.D., and Richard Shea will join the Synlogic Board of Directors.

“We are delighted to welcome Mike and Rick to Synlogic’s Board,” said Dr. Gutiérrez-Ramos. “Both bring a wealth of both operational and public company board experience in the pharmaceutical and biotechnology industries that will be invaluable as we advance our novel platform of Synthetic Biotic medicines through clinical studies.”

Dr. Powell, who has been a General Partner of Sofinnova Ventures since 1997, served as the Chairman of the Mirna board of directors. Before joining Sofinnova, he was Group Leader of Drug Delivery at Genentech where his focus was developing new formulations for protein and peptide therapeutics. In 1987, he was part of the founding team of Cytel, serving as Director of Product Development, and before that was a scientist and project team leader at Syntex Research (Roche).

Dr. Powell received his Ph.D. in physical chemistry from the University of Toronto and completed post-doctoral work in bioorganic chemistry at the University of California, where he was subsequently a faculty member. He currently serves on the Board of Trustees of Washington University in St. Louis and as an adjunct professor of pharmaceutical chemistry at the University of Kansas. Dr. Powell will serve as Chairman of Synlogic’s nominating and corporate governance committee and as a member of the audit committee.

Mr. Shea currently serves as Chief Financial Officer and Treasurer of Syndax Pharmaceuticals, Inc., and previously served as a member of its board of directors from January 2014 to February 2017. Prior to joining Syndax, he served in several key roles in publicly traded companies. This includes Senior Vice President and Chief Financial Officer of Momenta Pharmaceuticals Inc., and Chief Operating Officer and Chief Financial Officer of Variagenics Inc., a pharmacogenomics company. He was Vice President of Finance of Genetics Institute, Inc., which was acquired by Wyeth Pharmaceuticals, Inc. Mr. Shea received an A.B. from Princeton University and an M.B.A. from the Public Management Program at Boston University. Mr. Shea will serve as Chairman of Synlogic’s audit committee.

About Synlogic’s Lead Programs

In June 2017, Synlogic initiated a Phase 1 clinical trial in healthy volunteers to evaluate the safety and tolerability of SYNB1020, which is being developed for the potential treatment of Urea Cycle Disorders (UCD) and hepatic encephalopathy (HE), both diseases where patients experience elevated ammonia levels that can have life-threatening consequences. Following potential success in the Phase 1 trial, the company plans to initiate additional clinical trials in patients by mid-2018.

Synlogic’s second development candidate, SYNB1618, is being developed for the treatment of Phenylketonuria (PKU), which is caused by defective metabolism of the amino acid phenylalanine. The company’s goal is to initiate a Phase 1 clinical trial of SYNB1618 in the first half of 2018.

About Synthetic Biotic™ Medicines:

Synlogic’s innovative new class of Synthetic Biotic medicines leverages the tools and principles of synthetic biology to genetically reengineer probiotic microbes to perform or deliver critical functions missing or damaged due to disease. The company’s two lead programs target diseases known as inborn errors of metabolism. Patients with these rare metabolic diseases are born with a faulty gene, which inhibits the body’s ability to break down commonly occurring by-products of digestion that then accumulate to toxic levels with serious health consequences. Delivered orally, Synthetic Biotic medicines are designed to act from the gut to compensate for the dysfunctional metabolic pathway and have a systemic effect, clearing toxic metabolites associated with specific metabolic diseases. Synthetic Biotic medicines have the potential to significantly improve the quality of life for affected patients.

About Synlogic™

Synlogic is pioneering the development of a novel class of living treatments, Synthetic medicines, based on its proprietary drug development platform. Synlogic’s initial pipeline includes Synthetic Biotic medicines for the treatment of rare genetic diseases, such as Urea Cycle Disorder (UCD) and Phenylketonuria (PKU). In addition, the company is leveraging the broad potential of its platform to create Synthetic Biotic medicines for the treatment of more common diseases, including liver disease, inflammatory and immune disorders, and cancer. Synlogic is collaborating with AbbVie to develop Synthetic Biotic-based treatments for inflammatory bowel disease (IBD). For more information, please visit www.synlogictx.com.

Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Mirna, Synlogic or the management of either company, before or after the aforementioned merger, may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements relating to expectations regarding the capitalization, resources and ownership structure of Synlogic; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; the adequacy of Synlogic’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of Synlogic; the difficulty in predicting the time and cost of development of Synlogic’s product candidates and Synlogic’s executive and board structure. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Synlogic’s Registration Statement on Form S-4 (File No. 333-218885) and Synlogic’s periodic reports filed with the SEC. Except as required by applicable law, Mirna and Synlogic undertake no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

 

MEDIA:
Synlogic
Courtney Heath, 617-872-2462
courtney@scientpr.com
or
Mirna Therapeutics
Alan Fuhrman, 512-901-0950
afuhrman@mirnarx.com
or
INVESTORS:
Synlogic
Elizabeth Wolffe, Ph.D., 617-207-5509
liz@synlogictx.com
or
Mirna Therapeutics
Alan Fuhrman, 512-901-0950
afuhrman@mirnarx.com

Monday, August 28th, 2017 Uncategorized Comments Off on $SYBX Completes Merger with Mirna Therapeutics

$CIIX Launching 1st Chinese Daily Video News Broadcast at NYSE on Cryptocurrency, Blockchain

SAN GABRIEL, California, August 28, 2017 —

ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, today announces its plans to launch the first Chinese daily video news broadcast from the NYSE covering digital currency and blockchain technology. The videos will be produced by Wall Street Multimedia (“WSM”), an independent news agency located in the NYSE. The broadcasts, anticipated to begin airing in October, will provide timely information and exclusive analysis regarding all aspects of the emerging digital currency world, including specific cryptocurrencies, such as ‘bitcoin’ and ‘ethereum’, industry trends, price movement, blockchain technology, sector-related stocks and ETFs, etc.

“I have been following the progression of the cryptocurrency market closely since 2014,” says Warren Wang, Founder and CEO of CIIX. “Since January 2015, the price of bitcoin has increased 500% from $200 to $1,000 in January 2017, and recently spiked to a record high over $4,800. For example, during the Cyprus bank crisis, the government imposed tax on savings accounts to make up for losses on bank books. During this crisis, bitcoin reached nearly $1,000. Recently, with bitcoin being recognized as an accepted payment method in Japan, coupled with the limited quantities of bitcoin being issued in the market, the price of bitcoin exceeded $4,000. As the cryptocurrency market continues to grow, we believe this is the optimal time to launch our daily Chinese digital currency news broadcast in conjunction with WSM from the NYSE.”

Wall Street Multimedia, Inc. is a professional financial media company that delivers information on the global financial markets to Chinese audiences globally. As one of the first Chinese media companies to cover trends and developments in the U.S. securities market, WSM has established relationships with the major U.S. stock exchanges dating back many years. As a result, WSM is the only Chinese media outlet that can instantly access information from several major U.S. stock exchanges simultaneously and has the ability to conduct on-site interviews in those stock exchanges, including the NYSE, the NASDAQ, the American Stock Exchange, the Chicago Mercantile Exchange and the New York Mercantile Exchange.

“After the recent launch of our Cryptocurrency Education and Trading Subscription Service, the Company decided to further expand its presence in the digital currency market,” says Wang. “Similar to U.S. stocks, as the price of digital currency, such as bitcoin, continues to increase, Chinese people all over the world will take notice and will want access to timely information regarding market trends, news, and analysis. We look forward to being the premier source for this information.”

About ChineseInvestors.com (OTCQB: CIIX)

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

For more information visit ChineseInvestors.com

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

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

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

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

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

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776

Investor Relations:
Alan Klitenic
+1-214-636-2548

Corporate Communications:
NetworkNewsWire (NNW)
New York, New York
http://www.NetworkNewsWire.com
+1-212-418-1217 Office
Editor@NetworkNewsWire.com

Monday, August 28th, 2017 Uncategorized Comments Off on $CIIX Launching 1st Chinese Daily Video News Broadcast at NYSE on Cryptocurrency, Blockchain

$SGLB to Present at the Third Joint FAA – USAF AM Parts Workshop

SANTA FE, N.M., Aug. 25, 2017 – Sigma Labs, Inc. (NASDAQ:SGLB) (“Sigma Labs” or the “Company”), a provider of quality assurance software under the PrintRite3D® brand, today announced that the Company has received an invitation to speak at the Third Joint FAA – USAF Workshop on Qualification and Certification of Additively Manufactured Parts. Mark Cola, Sigma Labs’ President and CTO, will present, “In-situ Monitoring for Additive Manufacturing:  Implications for the Digital Manufacturing Age,” at 2:30 p.m. Eastern Time, on Thursday, August 31, 2017 at the University of Dayton River Campus.

This is the third workshop jointly organized by the FAA and Air Force Research Laboratory (AFRL) on Qualification and Certification of Additively Manufactured Parts, building upon the objectives met in the second workshop held from August 30-September 1, 2016, which included providing additional training and reference material on additive manufacturing processes to FAA employees, benchmark qualification and certification considerations across the regulatory agencies, and promoting collaboration both across government/academia/industry and within the FAA regarding qualification and certification of additively manufactured parts. Last year’s workshop consisted of 33 presentations addressing background, past and present programs, and qualification/certification challenges regarding additively manufactured metal parts. The sustained, high interest in additive manufacturing and the importance of safe and robust qualification and certification procedures for aerospace parts were illustrated by the filled agenda and enthusiastic participation.

“We are delighted to participate in this crucially important workshop, which serves to reinforce the importance of qualification and certification of additive manufactured parts,” said Mark Cola, President and CTO of Sigma Labs. “Sigma is honored to be invited to participate and we look forward to contributing to the successful achievement of the workshop’s auspicious objectives.”

About Sigma Labs, Inc.
Sigma Labs, Inc. is a provider of quality assurance software under the PrintRite3D® brand and a developer of advanced, in-process, non-destructive quality assurance software for commercial firms worldwide seeking productive solutions for advanced manufacturing. For more information please visit us at www.sigmalabsinc.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (which Sections were adopted as part of the Private Securities Litigation Reform Act of 1995). Statements preceded by, followed by or that otherwise include the words “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “project,” “prospects,” “outlook,” and similar words or expressions, or future or conditional verbs such as “will,” “should,” “would,” “may,” and “could” are generally forward-looking in nature and not historical facts. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any anticipated results, performance or achievements. The Company disclaims any intention to, and undertakes no obligation to, revise any forward-looking statements, whether as a result of new information, a future event, or otherwise. For additional risks and uncertainties that could impact the Company’s forward-looking statements, please see the Company’s Annual Report on Form 10-K (including but not limited to the discussion under “Risk Factors” therein) filed with the SEC on March 31, 2017 and which may be viewed at http://www.sec.gov.

Investor Relations Contact:
Bret Shapiro
Managing Director
CORE IR
561-479-8566 
brets@coreir.com
Friday, August 25th, 2017 Uncategorized Comments Off on $SGLB to Present at the Third Joint FAA – USAF AM Parts Workshop

$CHEF Acquires Fells Point Wholesale Meats

Acquisition Accelerates Protein Expansion on East Coast

RIDGEFIELD, Conn., Aug. 25, 2017  — The Chefs’ Warehouse, Inc. (NASDAQ:CHEF), a premier distributor of specialty food products in North America, today announced that it has acquired substantially all of the assets of Fells Point Wholesale Meats (“Fells Point”), based in Baltimore, MD. Founded in 1993, Fells Point is a specialty protein manufacturer and distributor in the metro Baltimore, Washington DC area.

“I would like to welcome Erik, Leo and the entire Fells Point organization into our growing family of companies,” said Christopher Pappas, Chairman and Chief Executive Officer of The Chefs’ Warehouse, Inc.  “We believe that this acquisition adds the processing facility needed to grow protein in the North East and even more importantly the expertise to support our nearly 150 sales professionals with over 5,000 customers in the region.  Erik and Leo mastered the art of butchering in Europe and honed their craft in the United States.  Experts in specialty meat with a focus on quality and service to fine dining establishments, we feel that Fells Point is built on principles that parallel our own.”

The Chefs’ Warehouse initially entered the Mid-Atlantic market in 1999 through greenfield expansion. In May of 2008 the Company acquired specialty food distribution company, American Gourmet Foods.  It’s currently the Company’s third largest market.

“I grew up in a butcher shop with my dad, at 12 years old I knew that this is what I was meant to do,” said Erik Oosterwijk, an owner and co-founder of Fells Point.  “Leo and I were both educated in butcher schools in Europe and ultimately brought those skills and passions to Baltimore, MD.  Nearly 25 years ago we bought a small place in Little Italy and eventually became one of the leading manufacturers and distributors of high-end meat in the Baltimore area. We look forward to joining Chris, an entrepreneur himself, and the rest of the Chefs’ Warehouse team as we all focus on providing our customers the highest quality specialty products and outstanding service.”

Fells Point is expected to generate approximately $55.0 million in annualized net sales and be accretive to earnings next year. Other terms of the transaction were not disclosed.

About The Chefs’ Warehouse
The Chefs’ Warehouse, Inc. (http://www.chefswarehouse.com) is a premier distributor of specialty food products in the United States and Canada focused on serving the specific needs of chefs who own and/or operate some of the nation’s leading menu-driven independent restaurants, fine dining establishments, country clubs, hotels, caterers, culinary schools, bakeries, patisseries, chocolatiers, cruise lines, casinos and specialty food stores. The Chefs’ Warehouse, Inc. carries and distributes more than 34,000 products to more than 26,000 customer locations throughout the United States and Canada.

Forward-Looking Statements
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding the Company’s business that are not historical facts are “forward-looking statements” that involve risks and uncertainties and are based on current expectations and management estimates; actual results may differ materially. The risks and uncertainties which could impact these statements include, but are not limited to, the Company’s sensitivity to general economic conditions, including the current economic environment, changes in disposable income levels and consumer discretionary spending on food-away-from-home purchases; the Company’s vulnerability to economic and other developments in the geographic markets in which it operates; the risks of supply chain interruptions due to a lack of long-term contracts, severe weather or more prolonged climate change, work stoppages or otherwise; the risk of loss of customers due to the fact that the Company does not customarily have long-term contracts with its customers; the risks of loss of revenue or reductions in operating margins in the Company’s protein business as a result of competitive pressures within this segment of the Company’s business; changes in the availability or cost of the Company’s specialty food products; the ability to effectively price the Company’s specialty food products and reduce the Company’s expenses; the relatively low margins of the foodservice distribution industry and the Company’s and its customers’ sensitivity to inflationary and deflationary pressures; the Company’s ability to successfully identify, obtain financing for and complete acquisitions of other foodservice distributors and to integrate and realize expected synergies from those acquisitions; the Company’s ability to service customers from its new Chicago, San Francisco and Las Vegas distribution centers and the expenses associated therewith; increased fuel cost volatility and expectations regarding the use of fuel surcharges; fluctuations in the wholesale prices of beef, poultry and seafood, including increases in these prices as a result of increases in the cost of feeding and caring for livestock; the loss of key members of the Company’s management team and the Company’s ability to replace such personnel; and the strain on the Company’s infrastructure and resources caused by its growth. Any forward-looking statements are made pursuant to the Private Securities Litigation Reform Act of 1995 and, as such, speak only as of the date made. A more detailed description of these and other risk factors is contained in the Company’s most recent annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 10, 2017 and other reports filed by the Company with the SEC since that date. The Company is not undertaking to update any information in the foregoing report until the effective date of its future reports required by applicable laws. Any projections of future results of operations are based on a number of assumptions, many of which are outside the Company’s control and should not be construed in any manner as a guarantee that such results will in fact occur. These projections are subject to change and could differ materially from final reported results. The Company may from time to time update these publicly announced projections, but it is not obligated to do so.

Contact: 
Investor Relations
John Austin, (718) 684-8415
Friday, August 25th, 2017 Uncategorized Comments Off on $CHEF Acquires Fells Point Wholesale Meats

$KMDA FDA Approval of KEDRAB™ for Post-Exposure Prophylaxis Against Rabies

FORT LEE, N.J. & REHOVOT, Israel

  • KEDRAB™ [rabies immune globulin (Human)], a plasma-derived human rabies immune globulin (HRIG), represents new entry into $100 million-plus U.S. rabies prevention market where only two other products exist.
  • Rabies, a serious public health concern, is one of world’s oldest and most deadly diseases.
  • Approval of KEDRAB is based on positive data from a prospective, randomized, double-blind, non-inferiority Phase 2/3 study of 118 healthy subjects, conducted in the U.S.
  • Approval of KEDRAB is the second product of Kamada approved by the FDA.
  • Kedrion Biopharma is a world leading supplier of high-titer rabies plasma, the raw material used in the manufacture of human rabies immune globulin (HRIG).

Kedrion Biopharma and Kamada Ltd. (NASDAQ and TASE:KMDA), two leading human-derived protein therapeutics companies, today announced that KEDRAB™ [rabies immune globulin (Human)] has received U.S. Food and Drug Administration (FDA) approval for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine. Rabies is a life-threatening condition that impacts approximately 40,000 people in the U.S. each year, representing an annual market opportunity of $100 million-plus. KEDRAB will launch in the U.S. in early 2018.

Prior to FDA approval of KEDRAB, U.S. healthcare professionals had only two human rabies immune globulin (HRIG) therapy options from which to choose to prevent the onset of rabies in someone who may have been exposed to the deadly virus. KEDRAB, a human plasma-derived immunoglobulin, is entering a rabies market that has experienced inconsistent supply in recent years.

“The approval of KEDRAB by the FDA marks an exciting and important milestone in the evolution of Kedrion Biopharma as we continue to grow our U.S. business,” said Paolo Marcucci, President and Chief Executive Officer of Kedrion. “The approval of KEDRAB represents the first product that Kedrion Biopharma has had a role in developing throughout its clinical development and through to commercialization in the U.S. Rabies is a deadly, but entirely preventable disease, and we are pleased to offer physicians another safe and effective option. As Kedrion Biopharma is one of the world’s leading suppliers of high-titer rabies plasma, we are well-positioned to maximize the potential of this product, and we look forward to working with Kamada to launch KEDRAB in the U.S.”

“This significant achievement for Kamada represents the second FDA approval for the Company,” said Amir London, Kamada’s Chief Executive Officer. “We are proud that our unique and advanced immune globulin purification technology was used in the development of KEDRAB, and look forward to a successful launch of the product with Kedrion Biopharma. The BLA approval may also serve as basis for registration in other countries. This treatment represents an annual market opportunity of over $100 million in the U.S., of which we expect to take a significant market share. Moreover, this has the potential to be a highly profitable product for our companies. Meaningful sales from KEDRAB are expected to ramp up in 2018, during its first full year of launch. Revenues from this product are not included in our guidance of reaching $100 million in total revenue in 2017.”

Kamada has been selling the HRIG product since 2006 in numerous territories outside of the U.S. under the brand name KamRAB™. Kamada has sold more than 1.4 million vials of KamRAB to date, demonstrating significant clinical experience with the product. Under the clinical development and marketing agreement between Kedrion Biopharma and Kamada, upon receipt of FDA marketing approval, Kamada holds the license for KEDRAB, and Kedrion Biopharma has exclusive rights to commercialize the product in the U.S.

With the approval of KEDRAB, Kedrion Biopharma expands its portfolio of immune globulin products, which includes RhoGAM® and GAMMAKED™.

About KEDRAB™

KEDRAB [Rabies Immune Globulin (Human)] is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given promptly after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine.

Important Safety Information

  • Patients who can document previous complete rabies pre-exposure prophylaxis or complete post-exposure prophylaxis should only receive a booster rabies vaccine without KEDRAB, because KEDRAB may interfere with the anamnestic response to the vaccine.
  • KEDRAB should not be injected into a blood vessel because of the risk of severe allergic or hypersensitivity reactions, including anaphylactic shock.
  • Patients with a history of prior systemic allergic reactions following administration of human immune globulin preparations should be monitored for hypersensitivity.
  • KEDRAB contains a small quantity of IgA. Patients who are deficient in IgA have the potential to develop IgA antibodies and may have anaphylactic reactions following administration of blood components containing IgA.
  • Patients at increased risk of thrombosis or thrombotic complications should be monitored for at least 24 hours after KEDRAB administration.
  • Hemolysis may occur in patients receiving immune globulin products, particularly those who are determined to be at increased risk.
  • KEDRAB administration may interfere with the development of an immune response to live attenuated virus vaccines.
  • A transient rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results of serologic tests after KEDRAB administration.
  • KEDRAB is derived from human plasma; therefore, the potential exists that KEDRAB administration may transmit infectious agents.
  • In clinical trials, the most common adverse reactions in subjects treated with KEDRAB were injection site pain, headache, muscle pain, and upper respiratory tract infection.
  • Please see KEDRAB Full Prescribing Information for complete prescribing details. Full Prescribing Information

About the Phase II/III KEDRAB™ Clinical Study

The efficacy of KEDRAB administered concurrently with rabies vaccine was studied in a single-center, randomized, comparator HRIG-controlled clinical study. Study subjects were healthy adults 18 to 72 years of age who were without significant acute or chronic illness. A total of 118 subjects (59 per treatment group) received KEDRAB or comparator HRIG at a dose of 20 IU/kg intramuscularly on Day 0, and rabies vaccine on Days 0, 3, 7, 14 and 28. The mean age of study subjects was 45 years. The efficacy variable was rabies virus neutralizing antibody (RVNA) titer, as assessed by rapid fluorescent focus inhibition test (RFFIT), on Day 14. Efficacy analyses were performed on the As-Treated Population, which comprised the 116 study subjects who received KEDRAB or comparator HRIG and at least 3 of the 5 doses of rabies vaccine before Day 14.

About Rabies

Rabies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal. It is a serious, and nearly always fatal, infection. In the U.S., rabies in wild animals, especially raccoons, skunks, foxes and bats, accounts for most cases of rabies passed on to humans, pets, and other domestic animals. An acute, progressive viral encephalomyelitis, rabies carries the highest case fatality rate of any conventional etiological agent. Rabies is one of the oldest described infectious diseases, known for over 5,000 years.

About Kedrion Biopharma

Kedrion Biopharma is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as hemophilia, primary immune system deficiencies and Rh-sensitization. Kedrion Biopharma Inc., the U.S. subsidiary of Kedrion Biopharma, is headquartered in Fort Lee, New Jersey. Kedrion Biopharma launched U.S. operations in 2011, but the company’s international roots stretch back several decades in the production of blood and plasma-derived products. Kedrion Biopharma places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at www.kedrion.com and www.kedrion.us.

About Kamada

Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a robust late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived Immune globulins. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company’s flagship product is Glassia®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets Glassia® in the U.S. through a strategic partnership with Baxalta (formerly Baxter International Inc.’s BioScience business and now part of Shire plc) and in other counties through local distributors. In addition to Glassia®, Kamada has a product line of seven other pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. Kamada has five late-stage plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency for which Kamada completed a pivotal Phase 2/3 clinical trial in Europe. Kamada has also completed its Phase 2 clinical trial in the U.S. for the treatment of AAT deficiency with Inhaled AAT. In addition, Kamada’s intravenous AAT is in development for other indications such as type-1 diabetes, GvHD and prevention of lung transplant rejection. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 10 complementary products in Israel that are manufactured by third parties.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, sales volume, timing and results of clinical trials and EMA and U.S. FDA authorizations. Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in the U.S. FDA or the EMA approval process, additional competition in the AATD and Rabies markets or other markets in which Kamada operates or intends to operate, or further regulatory delays. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

References on file.

 

Media:
Kedrion Biopharma Inc.
Forrest McCaleb, 201-582-8143
Director, Global Communications – U.S. Kedrion Biopharma
f.mccaleb@kedrion.com
or
Method Health Communications
d/b/a Health Biz Write Now, LLC
Sheila A. Burke, 484-667-6330
HealthBizWriteNow@gmail.com
or
Kamada
Gil Efron
Chief Financial Officer
ir@kamada.com
or
LifeSci Advisors
Bob Yedid, 646-597-6989
bob@lifesciadvisors.com

Friday, August 25th, 2017 Uncategorized Comments Off on $KMDA FDA Approval of KEDRAB™ for Post-Exposure Prophylaxis Against Rabies

$USAU Provides 2017 Keystone Scout Drilling Results and Update

ELKO, Nev., Aug. 25, 2017 — U.S. Gold Corp. (the “Company”) (NASDAQ: USAU), a gold exploration and development company, recently completed the last four holes as part of its scout drilling program on the Keystone Project, Cortez Gold Trend, Nevada, and is pleased to report the following summary of results.

U.S. Gold Corp.’s Vice President and Head of Nevada Exploration, Dave Mathewson stated, “Our intent was to complete a scout drill-hole campaign at Keystone to investigate the stratigraphy and extent of alteration within 6 unique areas of the project. Early winter conditions in 2016 forced us to complete the last 4 holes of this program this summer. Keystone has never been systematically explored using modern exploration techniques with a model driven approach in its history, as such these holes were vital to gain an understanding of the rock formations and alteration characteristics in the district. We chose these locations through our first phase geophysics and geochemistry surveys. The results of this drill program have been encouraging. The extent and severity of the alteration encountered and the thickness of permissive rock packages combined with the shallow depths they were encountered and Keystone’s structural complexity highlight the potential of this district scale mineral system. The drilled intercepts bare many similarities to world-class gold deposits located on the north Carlin Trend and neighboring Cortez Trend deposits.

Hole Key17-03rc for example (summary below) is indicative of the size of the system. It encountered extraordinarily thick sections of permissive host rock and ultimately gave us a strong vectoring direction to what we anticipate to be much better mineralization.  There was an upper 705 foot thick gold anomalous zone in Horse Canyon, and perhaps more importantly a 190 foot thick zone of strongly anomalous gold in the lower Wenban, along with very indicative associated Carlin-type alteration. This zone remains completely open in essentially all directions, and we are now going to intensify our surface geochemistry and geophysics in this area.

We are currently designing a fall drilling program that will include the first vectoring drilling phase in the Key17-01rc through 03rc target area.  This target location is one of several that we have identified within the Keystone project as we continue the hunt for large Carlin-type gold deposits.”

Hole Key17-1c was a core hole drilled to 1605 feet (489 meters) to complete the scout drilling program that was started but not completed late in 2016 because of winter conditions.  The hole was drilled to provide an initial test at a location within the largely undrilled eastern flank of the Keystone project.  This locality is comprised of anomalous surface geochemistry at the margin of a major structural zone indicated from gravity interpretation.  No subsurface geologic information from any historic drilling existed within a mile of this hole.   Key17-1c encountered granodiorite intrusive, of probable early Tertiary age, at collar to 92 feet, then locally hornfelsed upper plate argillite, sandstone and siltstone to 359 feet interpreted to be upper-plate rock.  Scattered weak gold anomalies up to 0.079ppm were encountered in this interval.   From 359 to 971 feet moderate to strongly silicified lower-plate Devonian Horse Canyon was encountered containing scattered anomalous gold up to 0.031ppm to 971 feet.  From 971 to 1403 feet variable pyrrhotite-pyrite-magnetite skarn and hornfelsed Devonian Wenban was encountered.  Hornfelsed limestone of either Wenban or Roberts Mountain Formation limestone protolith was encountered near the bottom of the hole to 1605 feet.  Scattered, weakly anomalous zones of copper, lead and zinc were present within the skarn and hornfelsed zones.

Approximately one mile to the southwest, three vertical reverse circulation holes were drilled in June and July, 2017 to provide a first-pass assessment of another large anomalous area of surface gold, arsenic and other metals in rock and soil samples.  Non-permissive, but locally altered, upper-plate rock is exposed over most of the surface in this area.  Depth to the highly permissive lower-plate carbonate stratigraphy was essentially unknown in this area because of a lack of previous drilling.  However, U.S. Gold Corp. did have some information from 2016 vertical core hole, Key16-03c, drilled to 753 feet, and terminated because of difficult drilling.  Key16-03c contained anomalous gold up to 0.217ppm, with moderately strong pathfinder metals in strongly oxidized and broken, silicified upper and lower-plate rock units. This hole, and nearby historic hole 89-2/90-1, provided sufficient gold system indications to be followed-up with three recently completed holes, described below.  Non-permissive upper-plate rock units tend to obscure and provide a cap to hydrothermal system effects and metallization within the underlying lower-plate rock units.

Vertical Hole Key17-01rc drilled to 1810 feet (552 meters) was a reverse circulation offset 400 feet southeast of Key16-03c.  This drill hole encountered variable, but generally strong, silicified Devonian Horse Canyon calcareous siltstone to 700 feet.   Approximately 75% of this Horse Canyon siltstone unit is anomalous (>10ppb) in gold up to 0.181ppm with associated commensurate, uniformly weakly to moderately anomalous pathfinder metals of arsenic, antimony, mercury and zinc.

Vertical Hole Key17-02rc drilled to 1820 feet (555 meters) was a 500 foot offset to the south-southwest of Key17-01rc.  This hole intersected very altered, permissive Devonian Horse Canyon Formation from 40 to 580 feet that included two thin dacite dikes or sills from 270 to 285 feet.   Approximately 60% of the Horse Canyon was anomalous (>10ppb) in gold in multiple zones up to 0.080ppm with associated moderately anomalous arsenic, antimony, mercury and zinc.  Multiple thick zones of anomalous gold, up to 1.05ppm, were encountered within the underlying variably altered Wenban Formation limestone.  Roberts Mountain Formation limestone appears to have been intersected in the last 20, or so, feet of the hole.

Vertical reverse circulation Hole Key17-03rc drilled to 1940 feet (591 meters) was a 700 foot, south-southeast offset to hole Key 17-01rc.  Altered Horse Canyon calcareous siltstone was encountered to 950 feet.  A 705 foot thick zone of anomalous gold (>10ppb) up to 0.731ppm, with locally very anomalous arsenic up to >10,000ppm, antimony up to 196ppm, and mercury up to 61ppm is present within the Horse Canyon unit.  Several dacite intrusives, probably intruded as sills into collapse breccia, were encountered between 160 and 340 feet and again 805 and 830 feet.  Geochem values, including gold, tend to significantly spike in proximity to these sills.  Local abundant visible realgar had been observed in cuttings.  A 190 foot thick strongly anomalous gold, up 0.320ppm, and pathfinder mineralized zone is present within a 200 foot thick breccia in the lower Wenban limestones within this hole.

The above described, initial three-hole reverse circulation program provided a partial test of an open-ended, large zone of anomalous surface geochemistry coinciding with a gravity-data-interpreted north-northwest structural-intrusive zone referred to as the Sophia target area.   Very thick zones of Carlin-style, epithermal mineralization and alteration comprised of decalcification, silicification, and brecciation were encountered in all three holes.  Open-ended, southeastward-most hole Key 17-03rc is significantly more encouraging than Key 17-01 and 17-02, and it is probable that this mineralization characteristic is providing a direction to vector toward more significant gold mineralization.

The Devonian Horse Canyon calcareous siltstone and Wenban limestone units are two of the three primary host rock units that includes Roberts Mountain Formation in the Pipeline and Cortez mining area, controlled by Barrick Mining Co., on the same structural trend, 10 to 20 miles to the north-northwest of Keystone.  Detailed geological studies, including age-dating, conducted by the U.S. Gold Corp. geological team at Keystone have recognized very close similarities to the prospective host rocks of the Cortez area with those at Keystone.  Further, it appears evident that the Keystone project is comprised of a very expansive gold-bearing hydrothermal system within a complex lower-plate dome cored by a very complex early Tertiary intrusive system of fine-grained to coarse-grained felsic to mafic intrusives as stocks, dikes and sills.  Of primary importance at Keystone are the now evident very thick altered and drill-indicated gold mineralized zones and very permissive host characteristics of the prospective Horse Canyon (Carlin Trend Rodeo Creek Formation equivalent) and Wenban limestone host units.  Both these units are being encountered in our drill holes at the surface and, or at shallow exploration depths.  In addition, large zones of epithermal-type alteration and mineralization, including gold, are being encountered within dike and sill intruded collapse-style breccia bodies at Keystone.  Additional surface work is currently in progress in preparation for more precise targeting and conducting a follow-up drilling program beginning this Fall.

About U.S. Gold Corp.
U.S. Gold Corp. is a publicly traded, U.S. focused gold exploration and development company.  U.S. Gold Corp. has a portfolio of development and exploration properties.  Copper King is located in South East Wyoming and has an historical Preliminary Economic Assessment (PEA) done by Mine Development Associates in 2012 for Strathmore Minerals Corporation.  Keystone and Gold Bar North are exploration properties located on the Cortez trend in Nevada, identified and consolidated by Dave Mathewson.  For more information about U.S. Gold Corp., please visit www.usgoldcorp.gold

About Dataram Memory (“Dataram”)
Backed by more than 50 years of technology leadership and innovation, Dataram provides technology solutions that help customers simplify, consolidate, automate and scale their enterprise computing and data center environments.  Dataram’s solutions include memory and storage solutions, and related technical products and services for desktops, laptops, workstations and servers. The Company sells worldwide to OEMs, distributors, value-added resellers, embedded manufacturers, enterprise customers and end users. To learn more about Dataram, please visit www.dataram.com.

Safe Harbor
The information provided in this press release may include forward-looking statements relating to future events, such as the exploration success of U.S. Gold Corp., development of new Dataram products, pricing and availability of raw materials or the future financial performance of the Company.  Actual results may differ from such projections and are subject to certain risks including, without limitation, risks arising from: changes in the price of gold and mining industry cost inputs, memory chips, changes in the demand for memory systems, increased competition in the memory systems industry, order cancellations, delays in developing and commercializing new products, risks with respect to U.S. Gold Corp. faced by junior companies generally engaged in exploration activities, and other factors described in the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the Securities and Exchange Commission, which can be reviewed at www.sec.gov.  The Company has based these forward-looking statements on its current expectations and assumptions about future events.  While management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory, and other risks, contingencies, and uncertainties, most of which are difficult to predict and many of which are beyond the Company’s control.  The Company does not assume any obligations to update any of these forward-looking statements.

For additional information, please contact:

U.S. Gold Corp. Investor Relations:
+1 800 557 4550

ir@usgoldcorp.gold

www.usgoldcorp.gold

Friday, August 25th, 2017 Uncategorized Comments Off on $USAU Provides 2017 Keystone Scout Drilling Results and Update