Archive for February, 2017

$SPAR #Utilimaster Switches Gears on #USPS Next-Gen Delivery Vehicle Program

Partners with Prototype Award Participant to Upfit USPS Vehicles with Cargo Management Solutions

CHARLOTTE, Mich., Feb. 21, 2017  — Spartan Motors, Inc. (NASDAQ: SPAR) (“Spartan” or the “Company”), a global leader in specialty chassis and vehicle design, manufacturing and assembly, today announced that its Spartan Fleet Vehicles and Services (FVS) business unit — which encompasses the Utilimaster go-to-market brand — has stopped development on the United States Postal Service (USPS) Next Generation Delivery Vehicle (NGDV) Program as a prime contractor in the functional prototype development project and has sought withdrawal from the USPS. Spartan is continuing efforts to support this project and will partner with a leading USPS prototype award participant, to provide interior cargo solutions specific for the USPS’s needs.

“As a global leader in fleet vehicle design and production, we were honored to be among a select group of vehicle makers to win the USPS prototype award,” said Daryl Adams, President and Chief Executive Officer of Spartan Motors. “However, when we took a close look at the economics as a result of our inability to reach a satisfactory agreement with our commercial chassis supplier, further participation in the program as the primary body builder did not meet our baseline financial targets. Working closely with one of the USPS prototype award participants will enable us to participate in this significant NGDV program without the related upfront developmental capital requirement, while building what we’re best at for the fleet market – custom interior cargo management solutions.”

Utilimaster has produced route delivery and other vehicles for the USPS since 1999. As previously announced, Utilimaster was one of six vehicle manufacturers selected to receive the prototype award as part of a comprehensive USPS Request for Proposal (RFP) process. After a thorough evaluation, in-depth supplier consideration, and extensive financial modeling, Spartan has determined that remaining in the USPS NGDV project as a cargo management supplier provides a better return on capital, which better serves the Company and its shareholders.

“We would like to extend our most sincere thanks to the USPS for considering and selecting Spartan to take part in the evolution of their fleet,” continued Adams. “We look forward to assisting with development effort and providing the USPS with high quality cargo management solutions that best meet the needs of their business, while ensuring improved safety, productivity, and performance for their route delivery personnel.”

About Spartan Motors
Spartan Motors, Inc. is a leading designer, engineer, manufacturer and marketer of a broad range of specialty vehicles, specialty chassis, vehicle bodies and parts for the fleet and delivery, recreational vehicle (RV), emergency response, defense forces and contract assembly (light/medium duty truck) markets. The Company’s brand names— Spartan Motors, Spartan Specialty Vehicles, Spartan Emergency Response, Spartan Parts and Accessories, and Utilimaster®, a Spartan Motors Company— are known for quality, durability, performance, customer service and first-to-market innovation. The Company operates facilities in Michigan, Indiana, Pennsylvania, Kansas, Wisconsin, Nebraska, South Dakota, Saltillo, Mexico; and Lima, Peru. Spartan reported sales of $550 million in 2015. Visit Spartan Motors at www.spartanmotors.com.

This release contains several forward-looking statements that are not historical facts, including statements concerning our business, strategic position, financial projections, financial strength, future plans, objectives, and the performance of our products and operations.  These statements can be identified by words such as “believe,” “expect,” “intend,” “potential,” “future,” “may,” “will,” “should,” and similar expressions regarding future expectations.  These forward-looking statements involve various known and unknown risks, uncertainties, and assumptions that are difficult to predict with regard to timing, extent, and likelihood.  Therefore, actual performance and results may materially differ from what may be expressed or forecasted in such forward-looking statements. Factors that could contribute to these differences include operational and other complications that may arise affecting the implementation of our plans and business objectives; continued pressures caused by economic conditions and the pace and extent of the economic recovery; challenges that may arise in connection with the integration of new businesses or assets we acquire or the disposition of assets; restructuring of our operations, and/or our expansion into new geographic markets; issues unique to government contracting, such as competitive bidding processes, qualification requirements, and delays or changes in funding; disruptions within our dealer network; changes in our relationships with major customers, suppliers, or other business partners, including Isuzu; changes in the demand or supply of products within our markets or raw materials needed to manufacture those products; and changes in laws and regulations affecting our business.  Other factors that could affect outcomes are set forth in our Annual Report on Form 10-K and other filings we make with the Securities and Exchange Commission (SEC), which are available at www.sec.gov or our website.  All forward-looking statements in this release are qualified by this paragraph.  Investors should not place undue reliance on forward-looking statements as a prediction of actual results.  We undertake no obligation to publicly update or revise any forward-looking statements in this release, whether as a result of new information, future events, or otherwise.

Tuesday, February 21st, 2017 Uncategorized Comments Off on $SPAR #Utilimaster Switches Gears on #USPS Next-Gen Delivery Vehicle Program

$APOP Announces Positive #ClinicalTrial Results #ApoGraft

ApoGraft TM, Cellect’s flagship technology, validated as safe, robust and reproducible process for clinical use after a 104 donor test base

Cellect CEO: “In plain words, these positive results bring us one step closer to making stem cell therapies safe, effective and available”

TEL AVIV, Israel, Feb. 21, 2017 — Cellect Biotechnology Ltd. (Nasdaq:APOP) (TASE:APOP), a developer of stem cell selection technology, announced today positive final results from its clinical trial of ApoGraft™ in healthy donors. The study’s primary objective was to validate the Company’s propriety method of stem cell selection by going through the process of production and characterization with ApoGraft™, and was conducted on samples obtained in collaboration with two leading medical centers in Israel, The Schneider Children’s Medical Center and the Rambam Medical Center.

Cellect’s technology enables the use of stem cells for regenerative therapies by eliminating mature cells while leaving the stem cells unharmed using a natural process occurring in the human body, apoptosis (programed cell death), which “orders” cells to commit suicide. Cellect’s validated scientific platform, and the focus of its 7 families of patents, is that the apoptosis command destroys primarily mature cells, while stem cells remain alive and flourishing. This process allows for natural enrichment of stem cells, thus enabling stem cell-based therapies or transplantation to possess an abundance of quality stem cells with little to no risk of rejection or other complications, such as Graft versus Host Disease (GvHD).

The study included 104 healthy donors of blood stem cells. The samples (collected under approval of Helsinki committees) represented 5% of a graft used for transplantation into patients. The grafts were processed allowing stem cell production for transplantation with Cellect’s ApoGraft™. The use of the ApoGraft™ resulted in a significant increase in the death of mature immune cells, primarily T Lymphocytes, without compromising the quantity and quality of stem cells. The process takes only a few hours as compared to days of complex and expansive lab work with traditional methods, is anticipated to be extremely cost effective in comparison to current approaches, and has the potential to significantly reduce the risk of GvHD.

Dr. Yaron Pereg, Cellect’s Chief Development Officer, commented: “These results from processing human stem cells for bone marrow transplantation using ApoGraft™ clearly demonstrated that Cellect’s proprietary platform could improve the outcome of stem cell transplantations in patients suffering from hematological malignancies.”

About Cellect Biotechnology Ltd.

Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP) (NASDAQ:APOPW) (TASE:APOP). The Company has developed a breakthrough technology for the isolation of stem cells from any given tissue that aims to improve a variety of stem cells applications.

The Company’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells for in quantity and quality that will allow stems cell related treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of bone marrow transplantations.

Forward-Looking Statements          
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss that the positive results reported in this press release bring us one step closer to making stem cell therapies safe, effective and available, that Cellect’s proprietary platform could improve the outcome of stem cell transplantations in patients suffering from hematological malignancies and that our technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells for in quantity and quality that will allow stems cell related treatments and procedures. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.’s final prospectus dated July 29, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. and in the Company’s period filings with the SEC and the Tel-Aviv Stock Exchange.

Contact
Cellect Biotechnology Ltd. 
Eyal Leibovitz, Chief Financial Officer
www.cellectbio.com
+ 972-9-974-1444

LifeSci Advisors
Bob Yedid, Managing Director
646-597-6989
bob@lifesciadvisors.com
Tuesday, February 21st, 2017 Uncategorized Comments Off on $APOP Announces Positive #ClinicalTrial Results #ApoGraft

$AETI $6M of #IntelliSafe Program for #Permian Terminals, Pipelines

HOUSTON, Feb. 21, 2017 — American Electric Technologies, Inc. (NASDAQ:AETI), a leading provider of power delivery solutions for the global energy industry, announced today that its M&I Electric business has been awarded multiple contracts to provide turnkey power delivery solutions for a leading North American provider of midstream energy services to producers and consumers of natural gas, NGLs, crude oil, refined products and petrochemicals.

M&I received orders for IntelliSafe™ arc-resistant switchgear and M&I turnkey solutions to power a new pipeline designed to transport Permian Basin crude oil and condensate from the customer’s Midland, Texas terminal to its storage facility west of Houston. M&I received a separate order for the IntelliSafe to provide safe power distribution for the expansion of the customer’s Houston-based terminal that provides crude storage capacity and a pipeline that links the terminal with refining facilities in the southeast Texas refinery market.

“Although arc-resistant switchgear has been used to enhance operator safety for many years in the refining and chemical markets, the midstream industry has traditionally been resistant to deploy arc-resistant switchgear due to perceptions of increased cost,” said Troy Coker, Vice President, North America Power Distribution at M&I.  “We are very pleased that our customer is leading the midstream industry by deploying M&I’s IntelliSafe arc-resistant technology to meet the growth requirements of their Permian crude project, while setting a new standard for increased electrical personnel protection for their pipeline and other midstream projects.

M&I Electric’s IntelliSafe™ arc-resistant medium voltage switchgear incorporates patent pending safety features, 100% PIP (Process Industry Practices) specification compliance, and industrial internet of things capabilities enabling a new level of safety for oil and gas, power generation, and other critical power projects. IntelliSafe is part of the M&I’s turnkey power delivery solutions portfolio which includes custom-designed medium and low voltage conventional switchgear, Power Distribution Centers (PDCs), power conversion systems, power management and SCADA systems, construction and E&I services.

About AETI:

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

Contact: 
Bill Brod
Chief Financial Officer
713-644-8182
Tuesday, February 21st, 2017 Uncategorized Comments Off on $AETI $6M of #IntelliSafe Program for #Permian Terminals, Pipelines

$NVDQ #Dermacell Receives Coverage from $CI #Cigna

VIRGINIA BEACH, Va., Feb. 21, 2017  — Global health services company Cigna (NYSE:CI) now covers Dermacell® for breast reconstruction surgery and Dermacell AWM® for diabetic foot ulcers. Dermacell is an advanced acellular dermal matrix developed by LifeNet Health and distributed exclusively by Novadaq Technologies, Inc. (NASDAQ: NVDQ)

“We are proud that Cigna, the first of the four major commercial health-care payers to review the growing base of evidentiary support, now covers Dermacell and Dermacell AWM when deemed medically necessary by physicians,” said Bud Brame, Vice President of Strategic Product Planning and Reimbursement Services at LifeNet Health. “We believe the positive results from recent Dermacell publications, including our randomized clinical trial, as well as growing surgeon demand for the graft contributed to this favorable outcome.”

With this decision, more than 15 million Cigna members throughout Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Maryland, Missouri, North and South Carolina, Tennessee, Texas and Virginia will have coverage for Dermacell and Dermacell AWM. Cigna’s new coverage policy applies to Dermacell and Dermacell AWM grafts provided for patients on and after Feb. 15, 2017.

“We are optimistic that other large commercial payers like Anthem, Aetna, and Humana will view the safety, efficacy and performance of Dermacell just as favorably and also expand their policies to include Dermacell,” Brame said.

Dermacell is decellularized using Matracell®, a proprietary and patented technology that removes more than 97 percent of the donor’s DNA without compromising the desired biomechanical or biochemical properties, and allows for rapid cellular infiltration and re-vascularization. LifeNet Health Preservon® technology allows the graft to be stored fully hydrated at ambient temperature, eliminating the need for refrigeration and rehydrating processes. Dermacell also is terminally sterilized, rendering the graft sterile to medical device-grade standards, with a sterility assurance level of 10-6.

About LifeNet Health
LifeNet Health helps save lives, restore health, and give hope to thousands each year. It is the world’s most trusted provider of transplant solutions — from organ procurement to bio-implants and cellular therapies — and a leader in regenerative medicine, while always honoring the donors and healthcare professionals who enable healing. For more information about LifeNet Health, go to www.LifeNetHealth.org.

Tuesday, February 21st, 2017 Uncategorized Comments Off on $NVDQ #Dermacell Receives Coverage from $CI #Cigna

$EYEG & $VRX #LicensingAgreement #EyeGate #EGP437 Combo

Novel Approach Offers Eye Care Practitioners Delivery Alternative for Post-Operative Therapeutic Regimens

LAVAL, Quebec and WALTHAM, Mass., Feb. 21, 2017  — Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) (“Valeant”) and EyeGate Pharmaceuticals, Inc. (Nasdaq: EYEG) (“EyeGate”), a specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today announced that they have entered into an exclusive, worldwide licensing agreement through which EyeGate has granted a subsidiary of Valeant exclusive, worldwide commercial and manufacturing rights to the EyeGate® II Delivery System and EGP-437 combination product candidate for the treatment of post-operative pain and inflammation in ocular surgery patients.

This partnership follows a 2015 agreement in which Valeant secured an exclusive worldwide license for its subsidiary to this product for uveitis. Valeant has maintained its right of last negotiation to license the product for other indications.

“We are pleased to extend our relationship with EyeGate, and to obtain the global commercial and manufacturing rights to the EyeGate II Delivery System for the indication of post-operative inflammation and pain in ocular surgery patients. We believe that the product has significant potential in the market as part of our Bausch + Lomb business and applaud EyeGate for a remarkable job in advancing the product’s development in both uveitis and cataract surgery,” said Joseph C. Papa, Chairman and CEO of Valeant. “We look forward to further supporting EyeGate as they continue their progress in bringing this product to market to meet the needs of our customers and their patients.”

“This second licensing agreement with Valeant provides an important validation of both the clinical and commercial potential of iontophoretic EGP-437. We believe that Bausch + Lomb’s sales, marketing and commercial capabilities in ophthalmology are unrivalled, making them the optimal partner to bring this unique product to market,” said Stephen From, President and Chief Executive Officer of EyeGate. “For the approximately 3 million cataract surgery patients in the U.S. each year, adherence to the post-operative therapeutic regimen is imperative. As many of these patients are older and may struggle with self-administration of corticosteroid eye drops, we believe that iontophoretic EGP-437 administered by the eye care practitioner will provide a promising new treatment in addressing the needs of this large patient population.”

Under the license agreement, EyeGate received an upfront cash payment and has the potential to receive certain development-based milestone payments, as well as additional milestone payments based on the achievement of certain cumulative and annual sales milestones. Additionally, EyeGate will receive royalties on Valeant’s net sales of the product.

EyeGate will be responsible for the continued development of the EyeGate II delivery system in the U.S. for the treatment of post-operative pain and inflammation in ocular surgery patients, and all associated costs. Valeant has the right to further develop the product outside of the U.S., at its cost. In December 2016, EyeGate reported positive top-line data from a Phase 1b/2a trial assessing iontophoretic EGP-437 in the treatment of ocular inflammation and pain in post-surgical cataract patients.

About Valeant

Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.

About EyeGate

EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing products for treating diseases and disorders of the eye. EGP-437, EyeGate’s first product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System.  In addition, EyeGate is developing, through its wholly-owned Jade subsidiary, products using cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (HA), which possesses unique physical and chemical properties such as hydration and healing properties. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries. For more information, please visit www.EyeGatePharma.com.

Forward-looking Statements

This press release may contain forward-looking statements which may generally be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the most recent annual or quarterly reports of Valeant and Eyegate and detailed from time to time in Valeant’s and Eyegate’s other filings with the Securities and Exchange Commission and Valeant’s other filings with the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Neither Valeant nor Eyegate undertakes any obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.

Contact Information:
Valeant EyeGate Pharmaceuticals
Elif McDonald Lee Roth / Janhavi Mohite
514-856-3855 646-536-7012 / 7026
877-281-6642 (toll free) lroth@theruthgroup.com / jmohite@theruthgroup.com
elif.mcdonald@valeant.com
Media:
Renée Soto
or
Chris Kittredge/Jared Levy
Sard Verbinnen & Co.
212-687-8080
Tuesday, February 21st, 2017 Uncategorized Comments Off on $EYEG & $VRX #LicensingAgreement #EyeGate #EGP437 Combo

$TPHS Announces Record Date for Proposed Rights Offering

Trinity Place Holdings Inc. (the “Company”) (NYSE:TPHS) announced today that a record date of March 1, 2017 has been set for a proposed rights offering of its shares of common stock. Upon commencement of the proposed rights offering, the Company will distribute to its existing stockholders as of the record date non-transferable subscription rights to purchase their pro rata portion of newly issued shares of its common stock. Each whole subscription right will entitle the holder to purchase one share of common stock at a subscription price equal to $7.50 per share. Holders as of the record date will also have oversubscription rights, pursuant to which they may be able to purchase additional shares at the subscription price to the extent that not all subscription rights are exercised, subject to certain limitations.

The rights offering will be made pursuant to the Company’s effective shelf registration statement on file with the Securities and Exchange Commission (Reg. No. 333-214482). The information herein is not complete and is subject to change. This press release does not constitute an offer to sell or the solicitation of an offer to buy nor will there be any sale of any securities referred to in this press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. The rights offering will be made only by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

About Trinity Place Holdings Inc.

Trinity Place Holdings Inc. is a real estate holding, investment and asset management company. The Company’s business is primarily to own, invest in, manage, develop and/or redevelop real estate assets and/or real estate related securities. As of December 31, 2016, the Company owned a property located at 77 Greenwich Street (aka 28-42 Trinity Place) in Lower Manhattan, sometimes referred to as the Trinity Place Property, and one of Lower Manhattan’s premier development sites. As of December 31, 2016, the Company also owned a retail strip center located in West Palm Beach, Florida and former retail properties in Westbury, New York and Paramus, New Jersey and a 50% joint venture interest in a multi-family property located in Brooklyn, New York, called The Berkley. The Company’s intellectual property includes rights related to the Filene’s Basement trademarks. In addition, as of September 30, 2016, the Company also had approximately $225.3 million of Federal net operating losses. More information on the Company can be found at www.trinityplaceholdings.com.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, expectations and intentions that are not historical facts, and other statements identified by words such as “may,” “will,” “expects,” “believes,” “plans,” “anticipates,” “opportunity,” “current,” “seeks,” “estimates,” or “potential,” or the negative thereof or other and similar expressions. These forward-looking statements are based on current expectations and projections about future events. Investors are cautioned that forward-looking statements are not guarantees of future performance or results and involve risks and uncertainties that cannot be predicted or quantified, and, consequently, the actual performance of the Company may differ materially from those expressed or implied by such forward-looking statements.

 

Trinity Place Holdings Inc.
Linda Flynn, 212-235-2191
Linda.Flynn@tphs.com

Friday, February 17th, 2017 Uncategorized Comments Off on $TPHS Announces Record Date for Proposed Rights Offering

$MYGN #Prolaris Test, Great Results, #ProstateCancer Risk Classification

New Data from 16,000 Patient Study to Be Presented at 2017 ASCO GU

SALT LAKE CITY, Feb. 17, 2017  — Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in personalized medicine, today announced new data demonstrating the utility of the Prolaris® test to more accurately classify mortality risk and guide the management of newly diagnosed men with prostate cancer. The data are being presented at the 2017 Genitourinary Cancers Symposium (ASCO GU) meeting in Orlando, Fla.

“Myriad is pioneering personalized medicine for prostate cancer and is committed to helping men achieve their treatment goals,” said Michael Brawer, M.D., vice president of Medical Affairs, Myriad Genetic Laboratories.  “We are excited about the new data on prostate cancer reclassification being presented at ASCO GU, which adds to the growing body of evidence supporting the Prolaris test and will help urologists to match treatment options with patients’ risk profiles.”

Poster Presentation
Title: Patient NCCN Risk Classification Based on Combined Clinical Cell Cycle Risk (CCR) Score.
Presenter: Steve Stone, Ph.D.
Date: Friday, Feb. 17, 2017: 12:15-1:45 and 6:00-7:00 p.m. ET.
Location: C-17.

This study evaluated the prognostic information provided by the Prolaris test plus CAPRA (i.e., clinical features) to generate an estimate of prostate cancer mortality within 10 years of diagnosis versus NCCN risk category as determined by clinical features alone.  The analysis included data from 16,442 men who received the Prolaris test.  Based on clinical features alone, men were classified according to NCCN guidelines as low (n=8,695), favorable intermediate (n=3,347), intermediate (n=3,086) or high risk (n=1,224).

After recalculating the risk of prostate cancer mortality using the Prolaris test plus CAPRA, approximately one third of patients were reassigned to a different 10-year mortality risk category.  The specific reclassifications by NCCN category were as follows:

  1. Low Risk: 25 percent reclassified to favorable intermediate or intermediate risk.
  2. Favorable Intermediate Risk: 24 percent reclassified to lower and 23 percent to higher risk.
  3. Intermediate Risk: 24 percent reclassified to lower and 25 percent to higher risk.
  4. High Risk: 25 percent reclassified to favorable intermediate or intermediate risk.

“Clinical features alone are useful, but as this study illustrates, and was demonstrated by our numerous prior clinical validation studies, the Prolaris test is a powerful and independent predictor of clinical outcome that can substantially improve the risk classification of newly diagnosed men with prostate cancer,” said Brawer.

Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #GU17.

About Prolaris®
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in patients with prostate cancer. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth.  Low gene expression is associated with a low risk of disease-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy.  For more information visit: www.prolaris.com.

About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement       
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to data being presented at the at the 2017 Genitourinary Cancers Symposium;  the ability of the Prolaris test to more accurately classify mortality risk and guide the management of newly diagnosed men with prostate cancer; the ability to help urologists to match treatment options with patients’ risk profiles; and the Company’s strategic directives under the caption “About Myriad Genetics.”  These “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 described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements;  the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our Annual report on Form 10-K for the fiscal year ended June 30, 2016, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.

Media Contact:     
Ron Rogers
(801) 584-3065	
rrogers@myriad.com                                  

Investor Contact:     
Scott Gleason 
(801) 584-1143
sgleason@myriad.com
Friday, February 17th, 2017 Uncategorized Comments Off on $MYGN #Prolaris Test, Great Results, #ProstateCancer Risk Classification

$GST Capital Transaction w/ Ares, Updated #STACK Play Results, FY16 Recap

Gastar to host a conference call to discuss the announcement at 9:00 am CST today

HOUSTON, Feb. 17, 2017  — Gastar Exploration Inc. (“Gastar” or the “Company”) (NYSE MKT: GST) announced today that it has entered into a definitive securities purchase agreement with funds managed by affiliates of Ares Management, L.P. (NYSE: ARES) (“Ares”) that provides for $425 million in new financing to the Company in the form of a $250 million secured term loan, $125 million secured convertible notes and a $50 million common stock issuance (collectively, the “Ares Investment”).  Proceeds from the Ares Investment will be used to fully repay Gastar’s existing $70.4 million revolving credit facility and redeem its $325 million senior secured notes due May 2018.  The closing and funding of the Ares Investment, which is expected this month, is subject to the finalization of security and collateral documentation and the satisfaction of customary conditions precedent to funding.

The Ares Investment key terms are as follows:

  • $250 million first lien secured term loan, 8.5% interest, maturing March 2022;
  • $125 million second lien secured convertible notes, 6.0% interest, convertible, upon receipt of stockholder approval, at an initial conversion price of $2.21 per share at the option of the holder, maturing March 2022; and
  • 29,408,305 common shares issued at $1.7002 per share representing the 30-day volume weighted average sales price as of February 15, 2017.

If the conversion rights of the convertible notes are not approved by Gastar’s stockholders within four months, the convertible notes will not become convertible and will begin bearing interest at 15.0% as a straight high-yield debt obligation.  In connection with the closing of the Ares Investment, Gastar expects to call for redemption of all of its outstanding $325 million principal of its 8.625% senior secured notes due May 15, 2018 in accordance with their terms.

Ares will be granted the right to nominate, following closing, up to two directors to an expanded board of eight directors subject to certain minimum stock ownership requirements.

Commenting on the transaction, J. Russell Porter, Gastar’s President and Chief Executive Officer, said, “We are extremely pleased to welcome Ares as a financing partner and as an equity sponsor.  This transaction will allow Gastar to fully delineate our STACK position across multiple productive formations, as well as to pursue strategic M&A opportunities in the Mid-Continent.  While this new capital structure does not provide an immediate, comprehensive resolution to our leverage position, we believe it establishes a very achievable path toward further de‑levering our balance sheet through a combination of increasing cash flow from drilling operations as well as the potential conversion of the $125 million secured convertible notes, which were priced at an attractive premium to our current share price.”

Mr. Porter continued, “The fact that a firm with Ares’ experience and successful track record is choosing to invest $425 million in Gastar is a testament to the quality of our assets and our entire team.  We are pleased to welcome Nate Walton and Ronnie Scott to Gastar’s Board of Directors in the near future and look forward to working with them.”

Mr. Walton, a partner at Ares, also commented on the transaction, “Through this investment in Gastar, we look forward to working together to unlock the value in its attractive STACK assets.  We believe that access to capital, combined with Gastar’s outstanding assets, management and staff, provides an opportunity to create substantial value for all of Gastar’s stakeholders.”

Seaport Global Securities LLC served as financial advisor and placement agent and Vinson & Elkins L.L.P. served as legal advisor to the Company. Tudor, Pickering, Holt & Co. served as financial advisor and Latham & Watkins LLP served as legal advisor to Ares.

Operations Update

Gastar also announced additional well results from recent STACK drilling activities.  Under its previously announced drilling joint venture, Gastar has now drilled and completed eight Meramec wells and has drilled, but not yet completed, seven Meramec wells and one Osage well.  Of the eight wells, six wells are in various stages of initial flow back prior to reaching their initial peak production rates.

Two of the Meramec wells, the Ingle 29-1H and the Geis 31-1H, have achieved initial peak production (“IP”) rates of 1,037 (81% oil) and 877 (69% oil) barrels of oil equivalent (“BOE”) per day, respectively.  Gastar is currently drilling the 15th and 16th wells in the initial 20‑well tranche of the drilling joint venture and expects to release additional results concurrent with its future quarterly earnings announcements.

Outside Gastar’s drilling joint venture, the Company has recently drilled and completed one Osage well and one Oswego well.  Gastar’s initial Osage well, the McGee 29-1H located in southern Garfield County, Oklahoma, had an IP rate of 414 BOE per day (80% oil) and a post-peak IP 30-day rate of 353 BOE per day (74% oil).  The McGee 29-1H well was drilled in the lower Osage with its production rate impacted by approximately 30% of the wellbore being completed outside of the primary target zone.  The McGee 29-1H well was cored through the Osage and Woodford formations and that information was used to re-target the remaining 70% of the lateral into the primary target zone.  The core information also confirmed the presence of an upper Osage target that will be tested in future wells.

Gastar’s preliminary 2017 capital budget includes the drilling of 14 additional Osage wells in Kingfisher and Garfield Counties, Oklahoma outside of the drilling joint venture area.

Gastar’s initial Oswego well, the Tomahawk 7-1H, located in Kingfisher County, Oklahoma, realized an IP rate of 418 BOE per day (100% oil) and a post-peak IP 30-day rate of 262 BOE per day (98% oil).  Gastar’s 2017 preliminary drilling budget currently does not include additional operated Oswego wells, however, Gastar is participating in one Oswego well being drilled by another operator in the area.

Additional details regarding Gastar’s well results are available on its website.

Year-End Reserves

Gastar’s year-end 2016 Securities and Exchange Commission (“SEC”) proved reserves totaled 25.6 million BOE comprised of 54% oil and condensate, 25% natural gas and 21% natural gas liquids.  Total proved reserves declined from year-end 2015 by 30.3 million BOE, of which 14.8 million BOE was related to the sale of the Company’s assets in the Appalachian Basin.  The remainder of the reserve decline was primarily the result of the removal of Hunton proved undeveloped locations as the Company now focuses its current and future capital activity on drilling Meramec and Osage wells to hold acreage by production and delineate its STACK position.  Proved developed reserves represented 51% of total proved reserves and declined from 2015 by approximately 594,000 BOE, excluding the impact of the sale of the Company’s assets in the Appalachian Basin.

The SEC-priced pre-tax PV-10 (a non-GAAP financial measure defined at the end of this news release) was $141.3 million. The calculation of the PV-10 value of Gastar’s proved reserves for year-end 2016 used the SEC benchmark average 12-month pricing of $42.75 per barrel of oil and $2.48 per MMBtu of natural gas.

2017 Capital Plan and Liquidity

Gastar’s 2017 capital budget is approximately $84.0 million comprised of $46.0 million of drilling and completion costs, $30.8 million in leasing costs and $7.2 million for capitalized interest and administration costs.  The Company currently operates approximately 92% of its drilling and completions budget.  Additional details regarding Gastar’s capital budget are available on its website.

Gastar ended 2016 with approximately $71.5 million of cash and $84.6 million of debt outstanding under the revolving credit facility. To date, the Company has issued approximately 24.0 million common shares under its at-the-market (“ATM”) program for net proceeds of $32.8 million.  The ATM proceeds were used primarily to catch-up preferred dividend payments and associated pay down of the revolving credit facility.  There are no current plans to issue any additional common shares under the ATM program.  Gastar expects to fund its 2017 capital program through existing cash balances, recent financing activities and internally generated cash flow from operating activities.

Additional details regarding the Ares Investment, year-end 2016 reserves, 2017 capital plan and recent well results are available for download from the Events & Presentations section of Gastar’s website at www.gastar.com.

Gastar has scheduled a conference call for 10:00 a.m. Eastern Time (9:00 a.m. Central Time) today, Friday, February 17, 2017.  Investors may participate in the call either by phone or audio webcast.

By Phone: Dial 1-412-902-0030 at least 10 minutes before the call. A telephone replay will be available through February 23 by dialing 1-201-612-7415 and using the conference ID: 13655655.
By Webcast: Visit the Investor Relations page of Gastar’s website at www.gastar.com under “Events & Presentations.” Please log on a few minutes in advance to register and download any necessary software. A replay will be available shortly after the call.

For more information, please contact Donna Washburn at Dennard-Lascar Associates at 713-529-6600 or e-mail dwashburn@dennardlascar.com.

About Gastar Exploration

Gastar Exploration Inc. is a pure play Mid-Continent independent energy company engaged in the exploration, development and production of oil, condensate, natural gas and natural gas liquids. Gastar’s principal business activities include the identification, acquisition, and subsequent exploration and development of oil and natural gas properties with an emphasis on unconventional reserves, such as shale resource plays. Gastar holds a concentrated acreage position in what is believed to be the core of the STACK Play, an area of central Oklahoma which is home to multiple oil and natural gas-rich reservoirs including the Meramec, Oswego, Osage, Woodford and Hunton formations. For more information, visit Gastar’s website at www.gastar.com.

Information on Reserves and PV-10 Value  

For the year ended December 31, 2016, future cash inflows were computed using the 12-month un-weighted arithmetic average of the first-day-of-the-month prices for natural gas and oil (the “benchmark base prices”) adjusted by lease in accordance with sales contracts and for energy content, quality, transportation, compression and gathering fees and regional price differentials, relating to the Company’s proved reserves.  Benchmark base prices are held constant in accordance with SEC guidelines for the life of the wells but are adjusted by lease in accordance with sales contracts and for energy content, quality, transportation, compression, and gathering fees and regional price differentials.

PV-10 represents the present value, discounted at 10% per annum, of estimated future net revenue before income tax of our estimated proved reserves. PV-10 is a non-GAAP financial measure as defined by the SEC.  We believe that the presentation of PV-10 is relevant and useful to our investors because it presents the discounted future net cash flows attributable to our reserves prior to taking into account corporate future income taxes and our current tax structure.  We further believe investors and creditors use PV-10 as a basis for comparison of the relative size of our reserves as compared with other companies.

The financial measure most directly comparable to PV-10 is the standardized measure of future net cash flows (“Standardized Measure”).  We are not yet able to provide a reconciliation of PV-10 to Standardized Measure because the discounted future income taxes associated with our reserves is not yet calculable.  We expect to report, however, that our PV-10 will be equal to our Standardized Measure as of December 31, 2016 due to the absence of projected income tax expense estimated in future net cash flows.

The Company’s 2016 year-end total proved reserves estimates were prepared by Wright & Company, Inc.

Forward Looking Statements

In this press release, Gastar provides estimated year-end 2016 proved reserves information, a well results update and its preliminary capital plan for 2017.  Gastar has prepared the summary preliminary data in this release based on the most current information available to management.  Gastar’s normal closing and financial reporting processes with respect to the preliminary data herein have not been fully completed and, as a result, its actual results could be different from this summary preliminary information presented herein, and any such differences could be material.

This news release also includes “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward looking statements give our current expectations, opinion, belief or forecasts of future events and performance.  A statement identified by the use of forward looking words including “may,” “expects,” “projects,” “anticipates,” “plans,” “believes,” “estimate,” “will,” “should,” and certain of the other foregoing statements may be deemed forward-looking statements.  Although Gastar believes that the expectations reflected in such forward-looking statements are reasonable, these statements involve risks and uncertainties that may cause actual future activities and results to be materially different from those suggested or described in this news release.  These include risks inherent in oil and natural gas drilling and production activities, including risks with respect to continued low or further declining prices for oil and natural gas that could result in further downward revisions to the value of proved reserves or otherwise cause Gastar to further delay or suspend planned drilling and completion operations or reduce production levels, which would adversely impact cash flow; risks relating to the availability of capital to fund drilling operations that can be adversely affected by adverse drilling results, production declines and continued low or further declining prices for oil and natural gas; risks regarding Gastar’s ability to meet financial covenants under its indenture or credit agreements or the ability to obtain amendments or waivers to effect such compliance; risks of fire, explosion, blowouts, pipe failure, casing collapse, unusual or unexpected formation pressures, environmental hazards, and other operating and production risks, which may temporarily or permanently reduce production or cause initial production or test results to not be indicative of future well performance or delay the timing of sales or completion of drilling operations; delays in receipt of drilling permits; risks relating to unexpected adverse developments in the status of properties; borrowing base redeterminations by Gastar’s banks; risks relating to the absence or delay in receipt of government approvals or third-party consents; risks relating to Gastar’s ability to realize the anticipated benefits from acquired assets; risks related to the completion of any refinancing; and other risks described in Gastar’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the SEC, available at the SEC’s website at www.sec.gov. Gastar’s actual sales production rates can vary considerably from tested initial production rates depending upon completion and production techniques and its primary areas of operations are subject to natural steep decline rates.  By issuing forward looking statements based on current expectations, opinions, views or beliefs, Gastar has no obligation and, except as required by law, is not undertaking any obligation, to update or revise these statements or provide any other information relating to such statements.

Contacts:
Gastar Exploration Inc.
J. Russell Porter, Chief Executive Officer
713-739-1800 / rporter@gastar.com

Investor Relations Counsel:
Lisa Elliott, Dennard▪Lascar Associates:
713-529-6600 / lelliott@DennardLascar.com

Friday, February 17th, 2017 Uncategorized Comments Off on $GST Capital Transaction w/ Ares, Updated #STACK Play Results, FY16 Recap

$DTRM Again Tops #Gartner #MagicQuadrant for Strategic Sourcing Application Suites

CARMEL, IN–(Feb 17, 2017) – Determine, Inc. (NASDAQ: DTRM), the pioneering leader in global Source-to-Pay and Enterprise Contract Lifecycle Management (ECLM) Cloud Platform solutions, maintains its position as a Visionary in the latest Magic Quadrant for Strategic Sourcing Application Suites, published by Gartner in February, 2017*. The Gartner Magic Quadrant evaluates vendors on both completeness of vision and the ability to execute on it.

In a competitive business environment where end users increasingly require integrated suites and consumer-like user experiences to support and automate their strategic sourcing processes, SmartSource® continues to stand out.

“We are immensely proud for being recognized as a Visionary again this year in the Gartner Magic Quadrant,” states Determine President and CEO Patrick Stakenas. We feel this recognition is a testament to the innovative spirit and dedication of our team, which is constantly pushing boundaries to empower our customers.”

Gartner’s Strategic Sourcing Application Suites review spans the complete upstream procurement continuum, including spend analysis, e-sourcing, contract management and supply base management. Determine believes our designation as a Visionary is an acknowledgement of our ability to provide one seamless source-to-pay and enterprise contract management solutions cloud platform.

As described in the Gartner Strategic Sourcing Magic Quadrant, “Strategic sourcing application suite vendors in the Visionaries quadrant are ahead of most of the competition in developing innovative products and services. They harness the power of the nexus of forces — mobile, social, cloud and big data — to create unique solutions, and they anticipate emerging/changing market needs. Visionaries in this report, however, have some challenges delivering those innovations to clients.”

“Maintaining our position as a Visionary is especially rewarding this year as we continue to set new standards with our Determine Cloud Platform,” said Rose Lee, Determine Chief Customer Officer. “Customer success is always focus #1, and with the Cloud Platform our goal is to push the satisfaction rating even higher.”

The Determine Cloud Platform is making an impact on the way customers achieve business results through what the company calls Platformance. Explains Mr. Stakenas, “By integrating best-of-breed solutions on one platform with a single source of data truth, we want to empower the decisions that help customers accelerate their success. Platformance isn’t just about technology, but what success looks like.”

*Gartner Magic Quadrant for Strategic Sourcing Application Suites, Magnus Bergfors, Deborah R Wilson, Desere Edwards, 8 February 2017.

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

For more information about Gartner, please email info@gartner.com or visit gartner.com.

Supporting Resources

Determine blog

Determine on LinkedIn

Determine on Twitter

Determine Resources

About Determine, Inc.

Determine, Inc. (NASDAQ: DTRM) is a leading global provider of SaaS Source to Pay and Enterprise Contract Lifecycle Management (ECLM) solutions. Our visionary technologies allow our customers to effectively manage the full scope of Source to Pay and ECLM using our Determine Cloud Platform. Our Source to Pay software suite includes strategic sourcing, supplier management, contract management and procure-to-pay applications.

The Determine Cloud Platform gives procurement, finance and legal professionals the ability to deliver profound insights through analysis of their supplier relationships and contractual requirements. Our customers leverage the Determine Cloud Platform to discover previously unseen supplier and spend data; make more informed and smarter business decisions; drive new revenue; control costs; improve workflow efficiencies; and mitigate risk.

Our customers benefit from the Determine Cloud Platform’s robust suite of integrated applications. Whether they start with a full-suite implementation or choose to implement just one application and build over time, each additional application allows for the automatic sharing of data already in place on the Determine Cloud Platform.

For more information, please visit: www.determine.com.

Contact
Media Relations:
Rose Lee
Determine Inc.
+1.650.532.1590
pr@determine.com

Friday, February 17th, 2017 Uncategorized Comments Off on $DTRM Again Tops #Gartner #MagicQuadrant for Strategic Sourcing Application Suites

$GSIT to Present at the Energy Consequences of Information #ECI Workshop

SUNNYVALE, CA–(Feb 17, 2017) – GSI Technology, Inc. (NASDAQ: GSIT) today announced that Paul D. Armijo, Jr., Director of Aerospace & Defense Business Sector, will present at the Energy Consequences of Information (ECI) Workshop at the La Fonda on the Plaza Hotel in Santa Fe. The workshop will be held February 23-25, 2017 and is being hosted by the Air Force Research Laboratory (AFRL), the Air Force Office of Scientific Research (AFOSR), and the Department of Energy (DOE). The presentation is scheduled for Thursday, February 23, and will cover a patented Associative Processing Unit (APU) that changes the concept of computing from serial data processing — where data is moved back and forth between the processor and memory — to massive parallel data processing, compute, and search in-place directly in the memory array.

This in-place associative computing technology removes the bottleneck at the I/O between the processor and memory. Data is accessed by content and processed directly in place in the memory array without having to cross the I/O. The result is an orders of magnitude performance-over-power ratio improvement compared to conventional methods that use CPU and GPGPU (General Purpose GPU) along with DRAM.

Target applications include image detection, signal identification, speech recognition, convolutional neural networks, recommender systems, and data mining tasks such as prediction, clustering, and classification.

About GSI Technology

Founded in 1995, GSI Technology, Inc. is a provider of high performance semiconductor memory solutions to networking, industrial, medical, aerospace and military customers. The company is headquartered in Sunnyvale, California and has sales offices in the Americas, Europe and Asia. For more information, please visit http://www.gsitechnology.com.

Contacts
GSI Technology, Inc.
Bob Haig
512-346-7180

Hayden IR
David Fore or Brett Maas
206-395-2711

Friday, February 17th, 2017 Uncategorized Comments Off on $GSIT to Present at the Energy Consequences of Information #ECI Workshop

$LMIA to be #Acquired by #SonacaGroup

  • Transaction creates a combined global leader in design and manufacture of complex aerostructures
  • LMI will operate as a member of the Sonaca Group
  • LMI headquarters to remain in St. Louis

ST. LOUIS, Feb. 16, 2017 — LMI Aerospace Inc. (Nasdaq:LMIA) has entered into a merger agreement to be acquired by Sonaca Group, a global aerostructures company headquartered in Gosselies, Belgium. Under the agreement, LMI shareholders will receive $14 per share in an all-cash transaction. Sonaca’s offer represents a 52 percent premium over LMI’s closing share price on Feb. 16, 2017, of $9.19 per share, a 63 percent premium over LMI’s 3-month volume weighted average price up to and including Feb. 16, 2017, of $8.59 per share, and a 78 percent premium over LMI’s 6-month volume weighted average price up to and including Feb. 16, 2017, of $7.88 per share.

In connection with the merger agreement, Sonaca has obtained debt and equity financing commitments. The merger agreement, however, does not include, and the consummation of the merger is not conditioned upon satisfaction of, a financing condition.

“This deal brings our combined company to the forefront as a leader in the design and manufacture of complex aerostructures while working to diversify our global customer base,” said Dan Korte, LMI Aerospace chief executive officer. “In addition, LMI and Sonaca have complementary product portfolios while largely serving different aerospace primes and Tier 1 suppliers around the world, enabling us to better serve our customers.”

“The addition of LMI Aerospace to the Sonaca Group supports our vision to expand our capabilities in the United States,” said Bernard Delvaux, Sonaca chief executive officer. “Sonaca and LMI have both distinguished themselves in the industry through capabilities such as wing movables, wing panels, complex fuselage and structural assemblies, and together we will be able to strengthen our competitive advantage in the global aerospace market.”

LMI’s independent directors unanimously approved the transaction. The deal is expected to close mid-2017, subject to LMI shareholder approval as well as certain regulatory approvals and other customary closing conditions.

Upon transaction close, LMI will operate as LMI Aerospace – A Member of the Sonaca Group, with headquarters remaining in St. Louis. Korte will continue to serve as LMI Aerospace CEO and will report directly to Delvaux. Other members of the LMI senior leadership team also will remain in place and will continue their current reporting relationships. The company will continue investing in its current footprint, continuously improving its U.S. and worldwide infrastructure and the capabilities of its teams.

Lazard served as financial advisors and Gibson, Dunn & Crutcher LLP and Polsinelli PC served as legal advisors to LMI. Credit Suisse served as financial advisors and Arnold & Porter Kaye Scholer and Husch Blackwell served as legal advisors to Sonaca.

About LMI Aerospace
LMI Aerospace Inc. is a leading supplier of structural assemblies, kits and components and provider of engineering services to the commercial, business and regional, and military aerospace markets. Manufacturing more than 40,000 products for a variety of platforms and providing turnkey engineering capabilities to support aircraft lifecycles, LMI offers complete, integrated solutions in aerostructures, engineering and program management. Headquartered in St. Louis, LMI has 21 locations across the United States and in Mexico, the United Kingdom and Sri Lanka. For more information, visit: www.lmiaerospace.com.

About Sonaca Group
Sonaca Group is a global Belgian company active in the development, manufacturing and assembly of advanced structures for civil, military and space markets. The group is especially known for its capability to design and produce advanced structures such as wing movables and complex fuselages. Headquartered in Gosselies, Belgium, it has production facilities in China, Romania, Canada and Brazil. Sonaca Group also supplies engineering services, large sheet metal elements, wing panels, composite structures and machined components. For more information, visit www.sonaca.com.

Additional Information and Where to Find It
This document may be deemed to be solicitation material with respect to the proposed merger. In connection with the proposed merger, LMI Aerospace, Inc. (the “Company”) will file a preliminary proxy statement and file or furnish other relevant materials with the Securities and Exchange Commission (the “SEC”). Once the SEC completes its review of the preliminary proxy statement, a definitive proxy statement and a form of proxy will be filed with the SEC and mailed to the shareholders of the Company. BEFORE MAKING ANY VOTING DECISION, THE COMPANY’S SHAREHOLDERS ARE URGED TO READ THE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT (IF ANY) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER AND THE PARTIES TO THE PROPOSED MERGER. Investors and shareholders may obtain a free copy of documents filed by the Company with the SEC at the SEC’s website at http://www.sec.gov. In addition, investors and shareholders may obtain a free copy of the Company’s filings with the SEC from the Company’s website at http://www.lmiaerospace.com or by directing a request to: LMI Aerospace, Inc., 411 Fountain Lakes Boulevard, St. Charles, Missouri 63301, Attention: Corporate Secretary, (636) 946-6525.

Participants in the Solicitation
The Company and certain of its directors, executive officers, and certain other members of management and employees of the Company may be deemed to be participants in the solicitation of proxies from shareholders of the Company in favor of the proposed merger. Information about directors and executive officers of the Company and their ownership of the Company’s common stock is set forth in the Company’s annual report on Form 10-K/A for the fiscal year ended December 31, 2015, as filed with the SEC on March 17, 2016, and its definitive proxy statement for its 2016 annual meeting of shareholders, as filed with the SEC on Schedule 14A on April 29, 2016. Certain directors, executive officers, other members of management and employees of the Company may have direct or indirect interests in the proposed merger due to securities holdings, vesting of equity awards and rights to severance payments. Additional information regarding the direct and indirect interests of these individuals and other persons who may be deemed to be participants in the solicitation will be included in the proxy statement with respect to the merger the Company will file with the SEC and furnish to the Company’s shareholders.

Forward-Looking Statements
Statements about the expected timing, completion and effects of the proposed merger and related transactions and all other statements in this report and the exhibits furnished or filed herewith, other than historical facts, constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. When used in this report, the words “expect,” “believe,” “anticipate,” “goal,” “plan,” “intend,” “estimate,” “may,” “will” or similar words are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the following cautionary statements. All forward-looking statements speak only as of the date hereof and are based on current expectations and involve a number of assumptions, risks, uncertainties and other factors that could cause the actual results to differ materially from such forward-looking statements, including, but not limited to (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement or conditions to the closing of the merger may not be satisfied or waived, (2) the failure to obtain the required shareholder approval or the failure to satisfy the closing conditions, (3) risks related to disruption of management’s attention from the Company’s ongoing business operations due to the proposed merger, (4) the effect of the announcement of the merger on the ability of the Company to retain and hire key personnel and maintain relationships with its customers, suppliers, operating results and business generally, (5) the transaction may involve unexpected costs, liabilities or delays, (6) the Company’s business may suffer as a result of the uncertainty surrounding the transaction, (7) the outcome of any legal proceeding relating to the transaction, (8) the Company may be adversely affected by other economic, business and/or competitive factors, and (9) other risks to consummation of the transaction, including the risk that the transaction will not be consummated within the expected time period or at all.

Contacts:

Amy Horton
LMI Aerospace
+1 636-916-2130
ahorton@lmiaerospace.com

Sandra Alonzo
Sonaca Group
+32 71 255 329
Sandra.alonzo@sonaca.com
Friday, February 17th, 2017 Uncategorized Comments Off on $LMIA to be #Acquired by #SonacaGroup

$CYAD Registers First Hematological Patient in #CART #NKR2 #THINK Trial

  • Opening of the hematological arm of the CAR-T NKR-2 THINK trial with first Multiple Myeloma patient.
  • No toxic events reported in patients enrolled in the solid arm of the study so far.

MONT-SAINT-GUIBERT, Belgium, Feb. 16, 2017 — Celyad (Euronext Brussels:CYAD) (Euronext Paris:CYAD) (NASDAQ:CYAD), a leader in the discovery and development of engineered cell-based therapies, today announced a further step in the CAR-T NKR-2 THINK trial with the registration of a first refractory Multiple Myeloma patient. This patient is expected to receive the first dose-level (3×108 CAR-T NKR-2 cells) in the coming weeks, opening the first cohort of the hematological arm of the study.

Following the registration of three patients in solid indications, the THINK trial is now following on from our previous NKR-2 Phase I trial which demonstrated the safety and signs of efficacy of CAR-T NKR-2 cells in cancer patients suffering from hematological cancers,” said Christian Homsy, CEO of Celyad. “We now look forward to enrolling patients suffering from AML or MM into the hematological arm of THINK and we hope that the related results will be as encouraging as they have been so far with lower dose levels.”

Multiple Myeloma causes approximately 10% of all hematologic malignancies, and while efficient treatments are available, most patients will eventually relapse. Celyad has generated breakthrough preclinical data in murine models, leading to 100% long-term survival. The enrollment of a first refractory Multiple Myeloma patient demonstrates the consistency of our clinical approach and highlights the unique ability of our CAR-T NKR-2 technology to target both solid and hematological malignancies,” remarked Dr. Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad.

About the THINK trial
THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous CAR-T NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).

The trial will test three dose levels adjusted to body weight: up to 3×108, 1×109 and 3×109 CAR-T NKR-2 cells. At each dose, the patients will receive three successive administrations, two weeks apart, of CAR-T NKR-2 cells. The dose escalation part of the study will enroll up to 24 patients while the extension phase would enroll 86 additional patients.

About Celyad
Celyad is a clinical-stage biopharmaceutical company focused on the development of specialized cell-based therapies. The Company utilizes its expertise in cell engineering to target severe diseases with significant unmet need, including cancer. Celyad’s Natural Killer Receptor based T-Cell (NKR-T) platform has the potential to treat a broad range of solid and liquid tumors. Its lead oncology candidate, the CAR-T NKR-2, has been evaluated in a single dose escalation Phase I clinical trial to assess the safety and feasibility of CAR-T NKR-2 cells in patients suffering from AML or MM. This Phase I study was successfully completed in September 2016. Celyad was founded in 2007 and is based in Mont-Saint-Guibert, Belgium, and Boston, Massachusetts. Celyad’s ordinary shares are listed on the Euronext Brussels and Euronext Paris exchanges, and its American Depository Shares are listed on NASDAQ Global Market, all under the ticker symbol CYAD. For more information about Celyad, please visit: www.celyad.com

About Celyad’s NKR-T Cell Platform

Celyad is developing a unique CAR-T cell platform, using Natural Killer Receptor (NKR) transduced on to T lymphocytes. The platform targets a wide range of solid and hematological tumors. Unlike traditional CAR-T cell therapy, which target only one tumor antigen, Natural Killer (NK) cell receptors enable a single receptor to recognize multiple tumor antigens.

Celyad’s lead candidate, CAR-T NKR-2, is a CAR-T-Cell engineered to express the human NK receptor, NKG2D, which is an activating receptor that triggers cell killing through the binding of NKG2D to any of eight naturally occurring ligands that are known to be overexpressed on more than 80% of tumors.

Preclinical results indicate that CAR- T NKR-2 has multiple mechanisms of actions and goes beyond direct killing by signifying that its encoded T-Cells attack the tumor cells, inhibits the mechanisms that enable tumors to evade the immune system, activates and recruits anti-tumor immune cells and disrupts the blood supply to the tumor. These mechanisms promote the induction of adaptive immunity, meaning the body develops a long-term cell immune memory against specific tumor antigens of the targeted tumor.

In contrast to traditional CAR-T therapeutic approaches, and based on strong preclinical evidence, Celyad’s current NKR-2 program does not employ patient lymphodepleting pre-conditioning, thereby avoiding the toxicities associated with chemotherapy and allowing the immune system to remain intact.

Celyad is developing both autologous and allogeneic CAR-T NKR-2 administrations. For autologous CAR‑T NKR-2, Celyad collects the patient’s own T-Cells and engineers them to express NKG2D in order to target cancer cells effectively. Celyad’s allogeneic platform engineers the T-Cells of healthy donors, that also express TCR Inhibitory Molecules (TIMs), to avoid having the engineered donor cells be rejected by the patient’s normal tissues (also called Graft vs. Host Disease).

The preclinical research underlying this technology was originally conducted at Dartmouth College by Dr. Charles Sentman and has been published extensively in peer-reviewed publications.

For more information, please contact:

For Europe: Consilium Strategic Communications
Chris Gardner and Chris Welsh   T: +44 (0)20 3709 5700  celyad@consilium-comms.com
For France: NewCap
Pierre Laurent and Nicolas Mérigeau – T: + 33(0)1 44 71 94 94   celyad@newcap.eu
For Belgium: Comfi
Gunther De Backer and Sabine Leclercq – T.: +32 (0)2 290 90 90 – celyad@comfi.be
For the U.S.: Stern Investor Relations
Will O’Connor and Michael Schaffzin – T.: +1 212.362.1200celyad@sternir.com

To subscribe to Celyad’s newsletter, visit www.celyad.com

Follow us on LinkedIn & Twitter @CelyadSA

Forward looking statements
In addition to historical facts or statements of current condition, this press release contains forward-looking statements, including statements about the potential safety and feasibility of CAR-T NKR-2 cell therapy and C-Cure, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements.

These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including risks associated with conducting clinical trials; the risk that safety, bioactivity, feasibility  and/or efficacy demonstrated in earlier clinical or pre-clinical studies may not be replicated in subsequent studies; risk associated with the timely submission and approval of anticipated regulatory filings; the successful initiation and completion of clinical trials, including Phase III clinical trials for C-Cure® and Phase I clinical trial for CAR-T NKR-2; risks associated with the satisfaction of regulatory and other requirements; risks associated with the actions of regulatory bodies and other governmental authorities; risks associated with obtaining, maintaining and protecting intellectual property, our ability to enforce our patents against infringers and defend our patent portfolio against challenges from third parties; risks associated with competition from others developing products for similar uses; risks associated with our ability to manage operating expenses; and risks associated with our ability to obtain additional funding to support our business activities and establish and maintain strategic business alliances and business initiatives.

A further list and description of these risks, uncertainties and other risks can be found in the Company’s Securities and Exchange Commission filings and reports, including in the Company’s Annual Report on Form 20-F filed with the SEC on April 8, 2016 and future filings and reports by the Company. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. The Company expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

 

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$AKER Allowed #US #Patent for #AkersWellness Tests Cartridge

THOROFARE, NJ–(Feb 16, 2017) – Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR), (the “Company” or “Akers Bio”), a developer of rapid health information technologies, announces that the United States Patent and Trademark Office has allowed a patent covering Akers Bio’s proprietary cartridge for the optical scanning device utilized in the Company’s BreathScan Lync™ technology. BreathScan Lync™ is the new bluetooth-enabled reading device from Akers Wellness™ which enables users to track the results of Akers Wellness™ breath-based tests via their mobile device.

The patent covers the unique design of the disposable cartridge which contains the reagent for the detection of wellness markers. The reagent contained within is analyzed using optical scanning technology after contact with the user’s exhaled breath sample and produces a quantitative result through the Akers Wellness™ app on the user’s smartphone or tablet. Included in the patent are the unique form factor, optical lens and read elements and the unique ‘U’ shaped airflow pathway.

Akers Wellness™ breath tests, such as BreathScan OxiChek™ and BreathScan KetoChek™, are designed to help promote, track and/or encourage choices related to general health and wellbeing; or to support weight loss.

Update on Commercialization of Akers Wellness™ Tests

OxiChek™ is now fully commercialized and selling through the Company’s distributor, Aero-Med, to anti-aging, functional and integrative health and wellness treatment practitioners in the US.

OxiChek™ is the first disposable breath test to rapidly determine levels of oxidative stress in the body by measuring the levels of certain abundant free radicals. Frequent use of OxiChek™ may help health practitioners to monitor and adjust their clients’ regimen of nutritional supplementation in order to manage oxidative stress — an indicator of the overall health and wellbeing of a person.

The Company is ramping up marketing initiatives of OxiChek™ to professionals through enhanced e-commerce and social media platforms as well as through participation in large trade shows targeting naturopaths, wellness coaches, anti-aging practitioners, nutritionists and chiropractors.

In addition to targeting professionals, Akers Wellness™ intends to start marketing OxiChek™ through direct-to-consumer channels during 2017. This will include a television marketing campaign through the popular Balancing Act national television show on the Lifetime network. Balancing Act is America’s premier morning show that introduces positive solutions to busy, on-the-go modern women. Akers Wellness™ has completed filming of the program, which will be aired multiple times on Lifetime during Q2 2017 and syndicated to approximately 200 affiliates. This marketing initiative is targeting women aged 25-45 and will potentially reach approximately 98 million households and thousands of online viewers.

Akers Wellness™ is in discussions with potential distributors for the KetoChek™ test which rapidly determines if the subject is in the optimal fat-burning state for weight loss, known as ketosis. Achieving a state of ketosis — as indicated by the measure of breath ketones — is a goal of many individuals following low carbohydrate diets. KetoChek™ is a simple, non-invasive test to identify, track and quantitatively monitor breath ketones for individuals interested in maximizing weight loss.

The Company looks forward to providing further updates on the commercialization progress of Akers Wellness™ tests during 2017.

John J. Gormally, Chief Executive Officer of Akers Bio, commented:

“We believe Akers Bio’s technology for rapidly analyzing biomarkers in breath condensate is ideally suited for tests in the expansive US health and wellness market. I am pleased that this latest patent has been allowed as it is essential that we have robust protection over our valuable intellectual property.

“OxiChek™ is the first fully commercialized Akers Wellness™ test in which this cartridge is applied. We are pleased that initial sales of this test are being recorded and excited about the scope for ramping up sales through national television marketing initiatives and major tradeshow participation. I look forward to reporting further progress on the Akers Wellness™ product line during the course of 2017.”

About Akers Biosciences, Inc.

Akers Bio develops, manufactures, and supplies rapid screening and testing products designed to deliver quicker and more cost-effective healthcare information to healthcare providers and consumers. The Company has advanced the science of diagnostics while responding to major shifts in healthcare through the development of several proprietary platform technologies. The Company’s state-of-the-art rapid diagnostic assays can be performed virtually anywhere in minutes when time is of the essence. The Company has aligned with major healthcare companies and high volume medical product distributors to maximize product offerings, and to be a major worldwide competitor in diagnostics.

Additional information on the Company and its products can be found at www.akersbio.com. Follow us on Twitter @AkersBio.

Cautionary Statement Regarding Forward Looking Statements

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

For more information:

Akers Biosciences, Inc.
John J. Gormally, Chief Executive Officer
Raymond F. Akers, Jr. PhD, Vice Chairman
Tel. +1 856 848 8698

Taglich Brothers, Inc. (Investor Relations)
Chris Schreiber
Tel. +1 917 445 6207
Email: cs@taglichbrothers.com

finnCap (UK Nominated Adviser and Broker)
Adrian Hargrave / Scott Mathieson (Corporate Finance)
Steve Norcross (Broking)
Tel. +44 (0)20 7220 0500

Vigo Communications (Global Public Relations)
Ben Simons / Fiona Henson
Tel. +44 (0)20 7830 9704
Email: akers@vigocomms.com

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$IMMY Begins Dispensing from #FDA Registered 503B Outsourcing Facility

Improved efficiencies and additional revenue opportunities expected for Imprimis’ ophthalmic portfolio

SAN DIEGO, Feb. 16, 2017  — Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), an ophthalmology-focused pharmaceutical company, today announced that it has begun shipping its core sterile ophthalmic medications to select customers from its FDA-registered outsourcing facility without the need for a patient-specific prescription.  Over the next few weeks Imprimis’ flagship Dropless Therapy® injectable and LessDrops® topical formulations will become available to all customers.  New and existing customers can register for an ImprimisRx 503B account at http://www.imprimisrx.com/503b-prereg/.

Imprimis’ New Jersey-based outsourcing facility, which is equipped with robotics for automated filling and labeling of products, will initially produce and dispense Imprimis’ core sterile ophthalmic medications in compliance with current good manufacturing practice (cGMP) requirements for outsourcing facilities.  Imprimis customers are now able to purchase Dropless and LessDrops medications in convenient 20-unit boxes without the need for patient-specific prescriptions. To facilitate expected growth, the company is introducing a new integrated order and fulfillment system that provides “online shopping cart-type” functionality that bypasses customer service and moves orders directly to the facility’s fulfillment center.  Increased production, labor and ordering efficiencies are expected to result in improved customer satisfaction and increased margins.

Mark L. Baum, CEO of Imprimis, stated, “This is a significant milestone for our company.  We believe sales and adoption of our core ophthalmic formulations will increase considerably as a result of simplifying the ordering process for physicians, hospitals, group purchasing organizations and surgery centers.  The new facility will accommodate those customers who prefer, or in some cases, require medications purchased from an FDA-registered outsourcing facility compliant with the highest quality standards.  We are confident the investments we have made in infrastructure, improvements in operating efficiencies and our senior leadership team have positioned us to meet the current and anticipated increase in demand in our core ophthalmic business.”

“Through our commitment to quality and innovation, Imprimis is making strong inroads into the ophthalmic pharmaceutical business.  We expect our market capture trends to continue and increase as we move more business through our New Jersey outsourcing facility.  We also believe the New Jersey outsourcing facility will be instrumental in realizing an increase in margins from the current low 50 percent range to greater than 60 percent in 2017.  Our ophthalmology business growth was 20% in the fourth quarter 2016 versus the third quarter 2016, with preliminary unaudited ophthalmology sales of $3.6 million in the fourth quarter of 2016.  Over 1,450 customers have adopted our Dropless and LessDrops medications and we have serviced over 600,000 cataract and refractive surgeries since mid-2014.  A growing number of high-volume ophthalmic surgery practices, hospitals and ambulatory surgery centers throughout the U.S. have become customers and we expect this number to significantly increase with the opening of our new FDA-registered cGMP outsourcing facility.”

“Based on our successes in ophthalmology, we plan to expand our ophthalmology program and introduce additional innovative medications in 2017 for glaucoma, wet age-related macular degeneration and diabetic macular edema, dry eye disease and ocular infection and inflammation.  Our ophthalmology business currently represents 60 percent of total revenues and we expect this to increase to 80 percent in 2017 and beyond.  The efficiency of our model allows us to quickly innovate and safely deliver high-quality novel and clinically-relevant products to the market with less complications and at lower costs for our customers than our traditional pharmaceutical company competitors.”

About Imprimis Pharmaceuticals

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

Forward-Looking Statements

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

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

Media Contact
Deb Holliday
deb@pascalecommunications.com
412-877-4519

Investor Contact
Bonnie Ortega
bortega@imprimispharma.com
858-704-4587

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$CUR #Phase2 Enrollment Done, #NSI189 for Major Depressive Disorder #MDD

– Phase 2 Data Now Expected Ahead of Schedule in 3Q 2017 –

GERMANTOWN, Md., Feb. 16, 2017 — Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of central nervous system therapies based on its neural stem cell technology, today announced completion of subject enrollment in its Phase 2 clinical trial of NSI-189 for the treatment of major depressive disorder (MDD).  NSI-189 is a new chemical entity and the lead compound in Neuralstem’s neurogenic small molecule program.  Enrollment was completed ahead of schedule and data are expected in 3Q 2017.

“Completing the last subject enrolled in the Phase 2 study with NSI-189 for the treatment of MDD earlier than expected is a significant clinical development milestone for Neuralstem,” said Rich Daly, Chairman and CEO, Neuralstem.  “We now expect results from the Phase 2 study in the 3Q of 2017, and results from the subsequent, 6-month observational study to assess NSI-189’s durability effect will be available in the first half of 2018. We are thankful to the individuals and physicians who are participating in these studies and helping us to move closer to potentially bringing this new category of treatment forward.”

The double-blind, placebo-controlled Phase 2 study randomized 220 subjects to one of three oral treatment groups:  placebo, 40 mg once daily (QD), 40 mg twice daily (BID).  The primary efficacy endpoint is a reduction in depression symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).  Secondary endpoints encompass additional clinical outcomes including objective cognition improvement measures.  The trial is evaluating subjects over a 12-week dosing period with an observational follow-up period of six months to assess NSI-189’s potential for durability of benefits after the cessation of therapy.  The trial is being conducted in 12 select MDD trial sites across the United States.

“Our goal is to improve the success rate in the treatment of major depressive disorder, and fulfill the unmet medical need for effective and well tolerated therapies that work differently from antidepressants that are currently available,” said Maurizio Fava, MD, Slater Family Professor of Psychiatry at Harvard Medical School, Massachusetts General Hospital and principal investigator.  “The Phase 1 data have shown that NSI-189’s biological mechanism of action may provide an alternative for the treatment of MDD, with the potential for cognitive benefits and durability effects beyond the course of treatment.”

NSI-189 is a proprietary, new chemical entity that has shown to safely alleviate depression in a Phase 1b study with MDD patients.   In preclinical models, NSI-189 stimulated neurogenesis, synaptogenesis and increased hippocampal volume, all of which are believed to be effective in potentially reversing depression, enhancing cognition, and promoting neuroregeneration.

About the Trial
This Phase 2 double-blind, placebo-controlled study is testing NSI-189 in a study of 220 subjects with MDD in an out-patient setting. Inclusion criteria required subjects to have a MADRS score of 20 or greater at screening and baseline.  For context, a total MADRS score of 20 to 34 is suggestive of moderate depression while a score of 35 or greater is suggestive of severe depression.

Subjects were randomized to three cohorts: NSI-189 40 mg twice daily (BID), NSI-189 40 mg once daily (QD), or placebo. After the initial screening period, the randomized portion of the trial will be 12 weeks in duration.

Subjects are being evaluated along several depression measurement scales, including the MADRS, Symptoms of Depression Questionnaire (SDQ) and the Hamilton Depression Rating Scale (HAM-D), among others.  The study is 80% powered (p ≤ 0.05) to show an improvement in depression symptoms, compared to placebo, with an effect size of d=0.5.  Subjects will continue to be followed for an additional six months after the 12-week trial period.

About Neuralstem
Neuralstem’s patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential therapies for multiple central nervous system diseases and conditions.

Neuralstem’s technology enables the generation of small molecule compounds by screening hippocampal stem cell lines with its proprietary systematic chemical screening process.  The screening process has led to the discovery and patenting of molecules that Neuralstem believes may stimulate the brain’s capacity to generate new neurons, potentially reversing pathophysiologies associated with certain central nervous system (CNS) conditions.

The company has completed Phase 1a and 1b trials evaluating NSI-189, a novel neurogenic small molecule product candidate, for the treatment of major depressive disorder or MDD, and is currently conducting a Phase 2 efficacy study for MDD.

Neuralstem’s stem cell therapy product candidate, NSI-566, is a spinal cord-derived neural stem cell line. Neuralstem is currently evaluating NSI-566 in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

Neuralstem is conducting a Phase 1 safety study for the treatment of paralysis from chronic motor stroke at the BaYi Brain Hospital in Beijing, China.  In addition, NSI-566 was evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS.  Subjects from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits.

Cautionary Statement Regarding Forward Looking Information
This news release contains “forward-looking statements” made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek” or “will.” Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2015, and Form 10-Q for the nine months ended September 30, 2016, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

Contact:
Danielle Spangler
Investor Relations
Neuralstem, Inc
301.366.1481

Lori Rosen
Public Relations
LDR Communications
917.553.6808
Thursday, February 16th, 2017 Uncategorized Comments Off on $CUR #Phase2 Enrollment Done, #NSI189 for Major Depressive Disorder #MDD

$RGSE Issues Business Update

Company Raises Net Proceeds of $16.0 million; Regains Nasdaq Compliance and Now Debt-Free

DENVER, CO, Feb. 16, 2017 — RGS Energy (NASDAQ:RGSE), a residential and small commercial solar company since 1978, provided a business update following its recently completed offerings that raised total net proceeds of $16.0 million. The company reported updated pro forma unaudited results that include the additional capital and debt repayments as if completed on December 31, 2016.

“Since our last business update, we successfully took advantage of capital market opportunities and raised additional financial capital,” said Dennis Lacey, CEO of RGS Energy. “As planned, we are now Nasdaq compliant. We also have a much stronger balance sheet which is debt-free. Our focus is on executing our growth strategy. For this purpose, we have recently expanded our sales organization, including our on the ground field sales teams and our call center based sales team. We will continue to expand our sales organization this year. Additionally, we are currently competing for solarize programs across the East Coast.”

“Last year, our financial position made it challenging to win solarize programs,” added Lacey. “This year, however, we expect that our much stronger financial position will enable us to be the chosen installer for solarize programs.”

Preliminary Fourth Quarter Results and Pro Forma
The following unaudited preliminary results are subject to the completion of RGS Energy’s quarterly closing and review procedures, as well as the regular annual audit by the company’s independent registered public accounting firm. These results are therefore subject to change. RGS Energy plans to file its 2016 annual report on Form 10-K in the second week of March.

The pro forma results below present the company’s balance sheet as if the net proceeds of the $16.0 million raised last week and the debt repayments made in January were completed on December 31, 2016.

(000’s omitted and unaudited) Pro Forma
Dec 31, 2016
Preliminary
Dec. 31, 2016
Last Quarter
Reported
Sept. 30, 2016
Year Ago Quarter
Reported

Dec. 31, 2015
Selected Balance Sheet Items:
Cash $ 18,250 $ 2,900 $ 1,378 $ 594
Line of Credit Balance 0 660 3,598 774
Convertible Debt 1 140 2,309 0
Total Debt 1 800 5,907 774
Stockholder’s Equity (Deficit) 21,149 5,000 (5,578 ) (1,013 )
Selected Income Statement Items:
Revenue for Quarter $ 5,100 $ 2,463 $ 9,749
Gross Margin Percentage 23 % 5 % 16 %
Operating Loss (1,900 ) (3,038 ) (4,020 )
Non-Cash Income (Expense) (8,400 ) (3,366 ) 203
Net Loss (10,500 ) (7,735 ) (4,209 )
Other Items:
Working Capital (Deficit)  $ 18,549 $ 2,400 $ (3,210 ) $ (5,060 )
Backlog 8,400 12,593 16,698
Debt-to-Equity Ratio 16 %

 

Nasdaq Compliance
As previously reported on Form 8-Ks, the Company received notification from Nasdaq that it is in compliance with (i) the minimum trading price of $1.00 a share and (ii) the minimum stockholders’ equity requirement of $2.5 million and will be monitored by Nasdaq for the next 12 months for maintaining stockholders’ equity of at least $2.5 million.

Repayment in Full of Revolving Line of Credit Facility
As previously reported on Form 8-K, the company repaid in full its revolving line of credit facility and terminated the revolving line of credit facility and a supply agreement with the lender in February 2017.

“With our level of cash and working capital, there is no reason for a revolving line of credit facility,” said Alan Fine, Principal Financial Officer and Treasurer of RGS Energy. “We also terminated the related supply agreement with the lender which by elimination of the lender’s mark-up, will allow us to purchase materials at a lower price, which is beneficial for our gross margin percentage.”

Upcoming Investor Conference
RGS Energy plans to present and participate in one-on-one meetings at the 29th Annual Roth Conference being held on March 13-15, 2017 at The Ritz-Carlton in Dana Point, California. Management will discuss the company’s growth strategy, including expanding its sales organization and national footprint. The company’s presentation date and time will be announced when available.

This conference will feature presentations from hundreds of growth companies, Q&A sessions, expert panels and thousands of management one-on-one / small group meetings, and is one of the largest of its kind in the U.S. This event is designed to provide investors with a unique opportunity to gain insight into emerging growth companies across a variety of sectors including: Cleantech, Consumer & Retail, Energy & Industrial, Enterprise Software, Healthcare, Resources, Semiconductors & Electronics, Services and Technology & Media.

About RGS Energy
RGS Energy (NASDAQ:RGSE) is a residential and small commercial solar Company since 1978 which has installed more than 25,000 solar power systems. RGS Energy makes it very convenient for customers to save on their energy bill by providing turnkey solar solutions – from system design, construction planning, customer financing assistance, installation, to interconnection and warranty.

For more information, visit RGSEnergy.com, on Facebook at www.facebook.com/rgsenergy and on Twitter at www.twitter.com/rgsenergy. Information on such websites is not incorporated by reference into this press release.

RGS Energy is the company’s registered trade name. The Company files periodic and other reports with the Securities and Exchange Commission under its official name “Real Goods Solar, Inc.”

Forward-Looking Statements and Cautionary Statements
The preliminary financial data discussed above consists of estimates derived from RGS Energy’s internal books and records and has been prepared by, and are the responsibility of, the company’s management. The preliminary estimates discussed above are subject to the completion of financial closing procedures, final adjustments and other developments that may arise between now and the time the financial results for the fourth quarter are finalized. Therefore, actual results may differ materially from these estimates and all of these preliminary estimates are subject to change.

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements regarding the RGS Energy’s results of operations and financial positions, and RGS Energy’s business and financial strategies.  Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they provide our current beliefs, expectations, assumptions, forecasts, and hypothetical constructs about future events, and include statements regarding our future results of operations and financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations. The words “hypothetical,” “expect,” “plan,” “estimate,” “future,” “believe,” “may,” “will” and similar expressions as they relate to us are intended to identify such forward-looking statements.

Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved, if at all.  Forward looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward looking statements.  Therefore, RGS Energy cautions you against relying on any of these forward-looking statements.

Key risks and uncertainties that may cause a change in any forward-looking statement or that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include: the effect of electric power generation industry regulations in the states where RGS Energy operates, net electric power metering and related policies; the effect of future changes to federal and state incentives for renewables; the level of demand for RGS Energy’s solar energy systems; the availability of a sufficient, timely, and cost-effective supply of solar panels; RGS Energy’s ability to implement its growth strategy, achieve its target level of sales, to generate cash flow from operations and to be awarded community solarize programs; RGS Energy’s ability to achieve break-even and better results; and the resolution of contract disputes in its discontinued operations.

You should read the section entitled “Risk Factors” in our 2015 Annual Report on Form 10-K and in our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2016, June 30, 2016 and September 30, 2016, each of which has been filed with the Securities and Exchange Commission, which identify certain of these and additional risks and uncertainties.  Any forward-looking statements made by us in this press release speak only as of the date of this press release. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We do not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

 

Investor Relations Contact
Ron Both
Managing Partner, CMA
Tel 1-949-432-7566
RGSE@cma.team
Thursday, February 16th, 2017 Uncategorized Comments Off on $RGSE Issues Business Update

$SCON Awarded #US #Patent for Unique Manufacturing Process

– Strengthens Conductus Superconducting Wire IP portfolio –

AUSTIN, Texas, Feb. 16, 2017 — Superconductor Technologies Inc. (STI) (Nasdaq:SCON) was awarded a U.S. Patent enabled by STI’s proprietary superconducting wire manufacturing method. This patented process improves Conductus® wire’s performance in the presence of a strong magnetic field.

U.S. Patent No. 9,564,258 entitled “Coated Conductor High Temperature Superconductor Carrying High Critical Current Under Magnetic Field By Intrinsic Pinning Centers, And Methods Of Manufacture Of Same” from the U.S. Patent and Trademark Office (USPTO), associated with U.S. Patent No. 9,362,025 announced in June 2016, provides additional protection for STI’s unique manufacturing process.

“This new patent protects the foundation from which we will build high performance wire for our customers,” said Jeff Quiram, STI’s President and CEO. “The flexibility provided by our proprietary manufacturing process enables STI to build superconducting wire in very unique ways.”

The ability to carry high electrical current in the presence of a strong magnetic field is a key enabler for the superconducting applications of the future. Using a technique called pinning, superconducting wire performance is dramatically improved. The traditional approach is to add more elements when manufacturing the superconducting layer, thereby increasing the complexity of an already challenging process.

Quiram continued, “STI has demonstrated the ability to incorporate pinning into our superconductor without using additional elements. This technique is now protected, allowing STI to meet the needs of our customers without the cost and difficulty of an increasingly complex manufacturing process. We believe that this will allow us to deliver the highest performing wire with high manufacturing yields, enabling us to be a market leader. Our proprietary RCE-CDR process makes Conductus wire ideal for applications such as motors, generators, MRI and NMR machines that require high in-field performance. We are excited about the growing demand for more efficient alternatives to traditional materials and designs, as well as our positioning in the industry.”

Reactive Co-evaporation and Cyclic Deposition Reaction
Rare Earth, Barium, Copper Oxide (ReBCO) materials are recognized as a superior superconductor by offering better performance in a magnetic field. STI’s RCE-CDR process grows a ReBCO superconductor film onto a flexible template. This process requires accurate temperature, uniform pressure, precise ratios of elements and the presence of oxidizing atmospheres to grow high performance superconducting materials. The company’s RCE-CDR system is scaled for large batch operation to insure every portion of superconducting wire has uniform material properties.

About Superconductor Technologies Inc. (STI)
Superconductor Technologies Inc. is a global leader in superconducting innovation. Its Conductus® superconducting wire platform offers high performance, cost-effective and scalable superconducting wire. With 100 times the current carrying capacity of conventional copper and aluminum, superconducting wire offers zero resistance with extreme high current density. This provides a significant benefit for electric power transmission and also enables much smaller or more powerful magnets for motors, generators, energy storage and medical equipment. Since 1987, STI has led innovation in HTS materials, developing more than 100 patents as well as proprietary trade secrets and manufacturing expertise. For more than 20 years STI utilized its unique HTS manufacturing process for solutions to maximize capacity utilization and coverage for Tier 1 telecommunications operators. Headquartered in Austin, TX, Superconductor Technologies Inc.’s common stock is listed on the NASDAQ Capital Market under the ticker symbol “SCON.” For more information about STI, please visit http://www.suptech.com.

Safe Harbor Statement 
Statements in this press release regarding our business that are not historical facts are “forward-looking statements” that involve risks and uncertainties. Forward-looking statements are not guarantees of future performance and are inherently subject to uncertainties and other factors, which could cause actual results to differ materially from the forward-looking statements. These factors and uncertainties include, but are not limited to: our limited cash and a history of losses; our need to materially grow our revenues from commercial operations and/or to raise additional capital (which financing may not be available on acceptable terms or at all) in the very near future, before cash reserves are depleted (which reserves are expected to be sufficient into the first quarter of 2017), to implement our current business plan and maintain our viability; the performance and use of our equipment to produce wire in accordance with our timetable; overcoming technical challenges in attaining milestones to develop and manufacture commercial lengths of our HTS wire; the possibility of delays in customer evaluation and acceptance of our HTS wire; the limited number of potential customers and customer pressures on the selling prices of our products; the limited number of suppliers for some of our components and our HTS wire; there being no significant backlog from quarter to quarter; our market being characterized by rapidly advancing technology; the impact of competitive products, technologies and pricing; manufacturing capacity constraints and difficulties; the impact of any financing activity on the level of our stock price; the dilutive impact of any issuances of securities to raise capital; the steps required to maintain the listing of our common stock with a U.S. national securities exchange and the impact on the liquidity and trading price of our common stock if we fail to maintain such listing; the cost and uncertainty from compliance with environmental regulations; and local, regional, and national and international economic conditions and events and the impact they may have on us and our customers.

Forward-looking statements can be affected by many other factors, including, those described in the “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of STI’s Annual Report on Form 10-K for the year ended December 31, 2015 and in STI’s other public filings. These documents are available online at STI’s website, www.suptech.comor through the SEC’s website, www.sec.gov. Forward-looking statements are based on information presently available to senior management, and STI has not assumed any duty to update any forward-looking statements.

Investor Relations Contact
Cathy Mattison or Kirsten Chapman
LHA      +1-415-433-3777       invest@suptech.com

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$FLIR $50 Million @USCG Contract #SINS2

WILSONVILLE, OR–(Feb 15, 2017) – FLIR Systems, Inc. (NASDAQ: FLIR) announced today that it has been awarded a $50 million indefinite delivery, indefinite quantity contract to provide marine electronics systems under the U.S. Coast Guard’s Scalable Integrated Navigation Systems 2 (SINS-2) program over a five-year period providing the purchaser a right to extend delivery for an additional five years. FLIR will provide electronics systems that will be standard fit on over 2,000 U.S. Coast Guard vessels, ranging from small-class boats through large cutter-class vessels. The systems include Raymarine multi-function navigation displays, radars, sonars, remote instrument displays, and autopilots. All of these components will be integrated with the Raymarine Lighthouse operating system for simple operation, single-point upgradeability, and will include advanced features specifically developed for the U.S. Coast Guard.

To support the U.S. Coast Guard’s search and rescue mission, the Raymarine LightHouse operating system offers pre-programmed SAR (search and rescue) patterns, allowing the U.S. Coast Guard to more effectively execute coordinated multi-vessel SAR operations. The LightHouse based SINS-2 system also features advanced graphical target intercept tools and encrypted communications designed to increase safety, ensure situational awareness, and enhance mission success rates.

Additionally, FLIR’s SINS-2 products offer a rich integration with existing FLIR M-Series and SeaFLIR® thermal imaging cameras currently in use by many U.S. Coast Guard boats and cutters. This integration will help the U.S. Coast Guard streamline configuration management, installation, and crew readiness while improving overall efficiency.

“We are very pleased to have been chosen by the U.S. Coast Guard as their supplier for the next generation of advanced situational awareness and marine navigation equipment. Produced under our unique Commercially Developed – Military Qualified (CDMQ™) model, the FLIR SINS-2 product suite offers powerful functionality, proven reliability, and simple operation, leveraging the strengths of both our FLIR and Raymarine product lines,” said Andy Teich, President and CEO of FLIR. “Enhancing safety and situational awareness is at the heart of what we do every day at FLIR. We look forward to continuing our successful long-standing relationship with the U.S. Coast Guard in supporting their important lifesaving and homeland security missions.”

FLIR’s Maritime segment will commence delivery of SINS-2 marine electronics within the next three months.

About FLIR Systems
FLIR Systems, Inc. is a world leader in the design, manufacture, and marketing of sensor systems that enhance perception and awareness. FLIR’s advanced thermal imaging and threat detection systems are used for a wide variety of imaging, thermography, and security applications, including airborne and ground-based surveillance, condition monitoring, research and development, manufacturing process control, search and rescue, drug interdiction, navigation, transportation safety, border and maritime patrol, environmental monitoring, and chemical, biological, radiological, nuclear, and explosives (CBRNE) detection. For more information, go to FLIR’s web site at www.FLIR.com.

Forward-Looking Statements
The statements in this release by
Andy Teich and the other statements in this release about the products described above are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are based on current expectations, estimates, and projections about FLIR’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements due to numerous factors, including the following: the ability to manufacture and deliver the systems referenced in this release, changes in pricing of FLIR’s products, changing demand for FLIR’s products, product mix, the impact of competitive products and pricing, constraints on supplies of critical components, excess or shortage of production capacity, the ability of FLIR to manufacture and ship products in a timely manner, FLIR’s continuing compliance with U.S. export control laws and regulations, and other risks discussed from time to time in FLIR’s Securities and Exchange Commission filings and reports. In addition, such statements could be affected by general industry and market conditions and growth rates, and general domestic and international economic conditions. Such forward-looking statements speak only as of the date on which they are made and FLIR does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of this release, or for changes made to this document by wire services or Internet service providers.

Media Contact
Tim McDowd
503-498-3146
Email Contact

Investor Relations
Shane Harrison
503-498-3547
Email Contact

Wednesday, February 15th, 2017 Uncategorized Comments Off on $FLIR $50 Million @USCG Contract #SINS2

$INSY Announces Use of #CBD #Oral Solution for #CompassionateUse Studies

CHANDLER, Ariz., Feb. 15, 2017  — Insys Therapeutics, Inc. (NASDAQ:INSY) (“Insys” or “the Company”) today announced that the Company is providing for the use of Cannabidiol Oral Solution at doses up to 40 mg/kg/day in compassionate use studies in subjects with refractory pediatric epilepsy following completion of 48 weeks of treatment in the ongoing long-term safety study.  The long-term safety study permitted subjects who had completed the initial safety and pharmacokinetic (PK) study to receive Cannabidiol Oral Solution at doses up to 40 mg/kg/day for up to 48 weeks.  In the initial safety and PK study, 61 subjects with refractory epilepsy, between the ages of one and 17 years, received total daily doses of 10 mg/kg, 20 mg/kg or 40 mg/kg.  In nine of the 61 subjects where Delta-9-THC was measured, no quantifiable plasma levels of Delta-9-THC were detected. Cannabidiol Oral Solution was generally well tolerated.

From the initial safety and PK study, 53 subjects continued into the long-term safety study, of which 15 subjects have completed 48 weeks of treatment with Cannabidiol Oral Solution across multiple investigative sites in the United States.

“We are pleased that investigators have deemed it appropriate to continue patients on Cannabidiol Oral Solution beyond 48 weeks of treatment and we remain dedicated to making our product available to them,” said Dr. Santosh Vetticaden, Insys’ Interim CEO, and Chief Medical Officer.

Cannabidiol Oral Solution for the compassionate use studies is being provided at no cost to patients or investigators. Currently, several investigators have received FDA approval for compassionate use and have patients currently enrolled in this program.

“I am pleased that Insys is making Cannabidiol Oral Solution available on a compassionate use basis and I look forward to participating in this program,” stated Maria Roberta Cilio, MD, PhD at the University of California, San Francisco Pediatric Epilepsy Center and an investigator participating in the Company’s long-term safety study.

Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs (i.e., one that has not been approved by FDA).

About Insys Therapeutics, Inc.

Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, Insys is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. Insys currently markets one product, SUBSYS® (fentanyl sublingual spray) but has received approval for the marketing of SYNDROS™ (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol that Insys believes has distinct advantages over the current formulation of dronabinol in soft gel capsule.  Insys is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with high unmet need.

SUBSYS® and SYNDROS™ are trademarks of Insys Development Company, Inc., a subsidiary of Insys Therapeutics, Inc.

 

Contact: 
Lisa Wilson
T: 212-452-2793
E: lwilson@insitecony.com
Wednesday, February 15th, 2017 Uncategorized Comments Off on $INSY Announces Use of #CBD #Oral Solution for #CompassionateUse Studies

$WIX Breaks 100 Million Registered Users

Company to Recognize Most Stunning Sites with #StunningAwards

NEW YORK, Feb. 15, 2017 — Wix.com Ltd. (Nasdaq: Wix) has reached a significant milestone, surpassing more than 100 million registered users. Entrepreneurs, solopreneurs, artists and businesses around the world are now using the Wix platform for website design, brand management and operations. The company has doubled its registered user base in the past two and a half years, with the United States being one of its fastest growing markets.

“Consumers and businesses want stunning websites that are simple to create and navigate,” said Nir Zohar, Wix President and COO. “Every day we ask ourselves, how can we help our users do more? By keeping that question central to everything we do, we have exceeded even our wildest growth expectations.”

Share:
Tweet: Breaking News: @Wix just passed 100 million registered users. Way to go! #ShapingTheWeb #WixLove

Tweet: This just in! A #stunning milestone for @Wix: The web development platform passed 100 million registered users #WixLove

Growing By Meeting Customer Needs
Wix has put meeting untapped customer needs at the center of its development philosophy and it has delivered significant results. Specifically, it addressed many of the top barriers to website design, online brand establishment and the enablement of small businesses with a powerful cloud based operating system. Significantly, over the past year, Wix has:

  • Launched Wix ADI – Employing artificial intelligence to simplify website design and creation.
  • Simplified commerce – Made its ecommerce capabilities even more attractive, bridging online and offline commerce capabilities with a Square partnership.
  • Provided mobile management – Allowing customers to access the powerful Wix OS via the Wix App. Wix users have created over 22 million mobile sites to date, making Wix one of the largest mobile site development platforms globally.
  • Introduced new tools for artists and photographers –Providing industry leading portfolio management, editing and image protection for photographers and artists.

To further celebrate the stunning websites Wix users create on a daily basis, Wix has created the global #StunningAwards to recognize the best design and creativity on the platform. The creators of three stunning sites will receive an experience of a lifetime. More details will be announced in early March.

About Wix.com
Wix.com is a leading cloud-based web development platform with more than 100 million registered users worldwide. Wix was founded on the belief that the Internet should be accessible to everyone to develop, create and contribute. Through free and premium subscriptions, Wix empowers millions of businesses, organizations, professionals and individuals to take their businesses, brands and workflow online. Wix ADI, the Wix Editor and a highly curated App Market enable users to build and manage a fully integrated and dynamic digital presence. Wix’s headquarters are in Tel Aviv with offices in Be’er Sheva, San Francisco, New York, Miami, Berlin, Vilnius and Dnepropetrovsk.

Visit us: on our blogFacebook, Twitter, Instagram, LinkedIn, Pinterest and Google+.

Download: Wix App for free in Google Play and in the App Store.

Contact:
Vivian Hernandez
pr@wix.com

Wednesday, February 15th, 2017 Uncategorized Comments Off on $WIX Breaks 100 Million Registered Users

$IFMK Merger with #NymHolding Overseen by $RILY

LOS ANGELES, Feb. 15, 2017  — B. Riley & Co., LLC (B. Riley), a full service investment bank and a wholly-owned subsidiary of B. Riley Financial, Inc. (NASDAQ: RILY) acted as the investment banking advisor to iFresh, Inc., formerly known as E-Compass Acquisition Corporation (ECAC), in its merger with NYM Holding, Inc. (NYM), a fast-growing Asian/Chinese grocery supermarket chain in the north-eastern U.S.  With the closing of this transaction, ECAC reincorporated in Delaware and has been renamed iFresh, Inc. and now trades on the Nasdaq market (NASDAQ: IFMK).

In addition to acting as investment banking advisor to ECAC / iFresh, B. Riley was the Debt Placement Agent to NYM in obtaining debt financing from KeyBank National Association.

About E-Compass Acquisition Corp.

E-Compass Acquisition Corp. was a Cayman Islands exempted company incorporated on September 23, 2014 as a blank check company formed for the purpose of entering into a share exchange, asset acquisition, share purchase, recapitalization, reorganization or other similar business combination with one or more businesses or entities, or entering into contractual arrangements that give us control over such a target business.

About B. Riley & Co.

B. Riley & Co., LLC is a leading investment bank which provides corporate finance, research, and sales & trading to corporate, institutional and high net worth individual clients. Investment banking services include initial, secondary and follow-on offerings, institutional private placements, and merger and acquisitions advisory services. The firm is nationally recognized for its highly ranked proprietary equity research. B. Riley & Co., LLC is a member of FINRA and SIPC.

B. Riley Financial, Inc. is a publicly traded, diversified financial services company which takes a collaborative approach to the capital raising and financial advisory needs of public and private companies and high net worth individuals. The Company operates through several wholly-owned subsidiaries, including B. Riley & Co., LLC (www.brileyco.com), Great American Group, LLC (www.greatamerican.com), and B. Riley Capital Management, LLC (which also includes B. Riley Asset Management (www.brileyam.com) and B. Riley Wealth Management, (www.brileywealth.com)). The Company also makes proprietary investments in other businesses, such as the acquisition of United Online, Inc. (www.untd.com) in July 2016, where B. Riley Financial, Inc. is uniquely positioned to leverage its expertise and assets in order to maximize value.

Wednesday, February 15th, 2017 Uncategorized Comments Off on $IFMK Merger with #NymHolding Overseen by $RILY

$MDCA Big Equity Investment from $GS

$95 million Convertible Preference Shares Investment Strengthens MDC Partners’ Balance Sheet

$10 Conversion Price Represents a 48% Premium to the 30-day Average Closing Price of $6.75 Per Share

NEW YORK, Feb. 15, 2017  — (NASDAQ: MDCA) — MDC Partners Inc. (“MDC Partners” or the “Company”) today announced that it has entered into a definitive agreement with an affiliate of the Merchant Banking Division of Goldman Sachs (“Goldman Sachs”) pursuant to which Goldman Sachs has agreed to invest $95 million in MDC Partners through the purchase of non-voting convertible preference shares (the “Preference Shares”).  In connection with the closing of the transaction, Bradley J. Gross, a managing director in the Merchant Banking Division of Goldman Sachs, will join the MDC Partners Board of Directors, which will expand to seven members.  Subject to the satisfaction of certain conditions, the transaction is expected to close in the first quarter of 2017.

Scott L. Kauffman, Chairman and Chief Executive Officer of MDC Partners, said, “We are extremely pleased to be partnering with Goldman Sachs.  Their investment in MDC affirms the value of our world-class agency portfolio, strengthens our balance sheet, and validates a solid finish to 2016 and our prospects going forward.  Brad and his team bring an exceptional track record and important expertise to our continued pursuit of maximizing long-term shareholder value.”

Bradley J. Gross, Managing Director of Goldman Sachs, said, “We are excited to partner with MDC to help drive growth and innovation in the marketing and communications industry.  The MDC partner agencies are market leaders with strong reputations and a demonstrated history of serving their clients. We look forward to working with Scott and his team to further position the company for long term growth.”

Upon completion of the transaction, Goldman Sachs will own approximately 15% of the outstanding equity of the Company, assuming the full conversion of the Preference Shares into the Company’s Class A common shares (the “Class A Shares”). The Preference Shares will have a liquidation preference that accretes at a rate of 8.0% per annum, compounded quarterly until the five-year anniversary of the issuance date of the Preference Shares.

The Preference Shares will be convertible at the option of the holder into Class A Shares at an initial conversion price of $10.00 per Preference Share (subject to customary adjustments for share splits and combinations, dividends, recapitalizations and other matters), which represents a 48% premium to the 30-day average closing price of $6.75 per Class A Share. The Company may force conversion of the Preference Shares into Class A Shares after two years if the Class A Shares close at or above 125% of the then-applicable conversion price for at least 30 consecutive trading days, and after five years if the Class A Shares close at or above 100% of the then-applicable conversion price for at least 30 consecutive trading days.

MDC Partners expects to use the net proceeds from the investment to pay down existing debt under the Company’s credit facility and for general corporate purposes.

LionTree Advisors acted as lead advisor in connection with their previously-announced engagement to conduct a comprehensive review of the Company’s financial and capital structure, which is now concluded. LionTree and JPMorgan acted as financial advisors to the Company on this transaction.

About MDC Partners Inc.

MDC Partners is one of the fastest-growing and most influential marketing and communications networks in the world.  Its 50+ advertising, public relations, branding, digital, social and event marketing agencies are responsible for some of the most memorable and engaging campaigns for the world’s most respected brands.  As “The Place Where Great Talent Lives,” MDC Partners is known for its unique partnership model, empowering the most entrepreneurial and innovative talent to drive competitive advantage and business growth for clients.  By leveraging technology, data analytics, insights, and strategic consulting solutions, MDC Partners drives measurable results and optimizes return on marketing investment for over 1,700 clients worldwide.  For more information about MDC Partners and its partner firms, visit our website at www.mdc-partners.com and follow us on Twitter at http://www.twitter.com/mdcpartners.

About Goldman Sachs’ Merchant Banking Division

Founded in 1869, The Goldman Sachs Group, Inc., is a leading global investment banking, securities and investment management firm. Goldman Sachs’ Merchant Banking Division (MBD) is the primary center for the firm’s long-term principal investing activity. With nine offices across seven countries, MBD is one of the leading private capital investors in the world with equity and credit investments across corporate, real estate, and infrastructure strategies. Since 1986, the group has invested approximately $180 billion of levered capital across a number of geographies, industries and transaction types.

 

This press release contains forward-looking statements. The Company’s representatives may also make forward-looking statements orally from time to time. Statements in this press release that are not historical facts, including statements about the Company’s beliefs and expectations, earnings guidance, recent business and economic trends, potential acquisitions, and estimates of amounts for redeemable noncontrolling interests and deferred acquisition consideration, constitute forward-looking statements.  These statements are based on current plans, estimates and projections, and are subject to change based on a number of factors, including those outlined in this section.  Forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update publicly any of them in light of new information or future events, if any.

Forward-looking statements involve inherent risks and uncertainties.  A number of important factors could cause actual results to differ materially from those contained in any forward-looking statements. Such risk factors include, but are not limited to, the following:

  • the successful completion of the Goldman Sachs investment on the anticipated terms and conditions;
  • risks associated with severe effects of international, national and regional economic downturn;
  • the Company’s ability to attract new clients and retain existing clients;
  • the spending patterns and financial success of the Company’s clients;
  • the Company’s ability to retain and attract key employees;
  • the Company’s ability to remain in compliance with its debt agreements and the Company’s ability to finance its contingent payment obligations when due and payable, including but not limited to those relating to redeemable noncontrolling interests and deferred acquisition consideration;
  • the successful completion and integration of acquisitions which complement and expand the Company’s business capabilities;
  • risks related to the Company’s class action litigation claims; and
  • foreign currency fluctuations.

The Company’s business strategy includes ongoing efforts to engage in acquisitions of ownership interests in entities in the marketing communications services industry.  The Company intends to finance these acquisitions by using available cash from operations, from borrowings under its credit facility and through incurrence of bridge or other debt financing, any of which may increase the Company’s leverage ratios, or by issuing equity, which may have a dilutive impact on existing shareholders proportionate ownership.  At any given time the Company may be engaged in a number of discussions that may result in one or more acquisitions.  These opportunities require confidentiality and may involve negotiations that require quick responses by the Company.  Although there is uncertainty that any of these discussions will result in definitive agreements or the completion of any transactions, the announcement of any such transaction may lead to increased volatility in the trading price of the Company’s securities. 

Investors should carefully consider these risk factors and the additional risk factors outlined in more detail in the Annual Report on Form 10-K under the caption “Risk Factors” and in the Company’s other SEC filings.

CONTACT: Matt Chesler, CFA
VP, Investor Relations
646-412-6877
mchesler@mdc-partners.com
Wednesday, February 15th, 2017 Uncategorized Comments Off on $MDCA Big Equity Investment from $GS

$CUI Awarded #BioMethane Contract Valued In Excess of $750,000

HOUSTON, Feb. 14, 2017  — CUI Global, Inc.’s (NASDAQ: CUI) wholly-owned United Kingdom (UK) energy subsidiary, Orbital Gas Systems Ltd., (Orbital), has been awarded a contract valued in excess of $750,000 by a major European industrial company operating bio-methane-to-grid plants throughout Europe.

Under the contract, Orbital will provision two BioMethane units, the company’s bio-methane-to-grid system, for delivery to the client in 2017. The award follows an extensive audit and assessment of Orbital’s technical, innovation, and support capabilities with the intention of creating a long-standing partnership for BioMethane solutions. Orbital’s 100% success rate in achieving ‘gas-to-grid’ deadlines and its world-class design, manufacturing and technical support facilities were pivotal factors in securing the contract.

Orbital President, Richard Law, stated, “This contract recognizes Orbital’s deep technical expertise in the field of BioMethane by one of Europe’s largest industrial companies. Our world-class facilities, innovative technologies and track record of achievement together enabled us to secure this opportunity.”

William Clough, CUI Global’s president & CEO, commented, “As the natural gas sector increasingly turns to BioMethane to meet energy and environmental needs, Orbital’s recognized expertise in the renewable gas market puts it at the forefront of a growing market opportunity. Awards from industry leaders should spur adoption of our BioMethane system, as well as our solutions for the pipeline gas measurement and power generation markets, and drive our penetration of sizeable addressable markets in Europe, North America and elsewhere.”

About CUI Global, Inc.
Delivering Innovative Technologies for an Interconnected World . . . . .

CUI Global, Inc. is a publicly traded company dedicated to maximizing shareholder value through the acquisition and development of innovative companies, products and technologies. From Orbital’s advanced GasPT2 platform targeting the energy sector, to CUI Inc.’s digital power platform serving the networking and telecom space, CUI Global and its subsidiaries have built a diversified portfolio of industry leading technologies that touch many markets. As a publicly traded company, shareholders are able to participate in the opportunities, revenues and profits generated by the products, technologies and market channels of CUI Global and its subsidiaries. But most importantly, a commitment to conduct business with a high level of integrity, respect and philanthropic dedication allows the organization to make a difference in the lives of their customers, employees, investors and global community.

For more information please visit www.cuiglobal.com

About Orbital
Orbital Gas Systems (Orbital), a CUI Global Company, is the leader in innovative gas solutions, having more than 30 years of experience in design, installation and the commissioning of industrial gas sampling, measurement and delivery systems. Operating globally to energy, power and processing markets, Orbital manufactures and delivers a broad range of applications including environmental monitoring, gas metering, process control, telemetry, gas sampling and BioMethane.

For more information please visit www.orbitalgas.com.

Important Cautions Regarding Forward Looking Statements
This document 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. Such statements are subject to risks and uncertainties that could cause actual results to vary materially from those projected in the forward-looking statements. The company may experience significant fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, our reliance on third-party manufacturers and suppliers, government agency budgetary and political constraints, new or increased competition, changes in market demand, and the performance or reliability of our products. These factors and others could cause operating results to vary significantly from those in prior periods, and those projected in forward-looking statements. Additional information with respect to these and other factors, which could materially affect the company and its operations, are included in certain forms the company has filed with the Securities and Exchange Commission.

Tuesday, February 14th, 2017 Uncategorized Comments Off on $CUI Awarded #BioMethane Contract Valued In Excess of $750,000

$GBT #GBT440 Discovery Process Detail in Opcoming ACS Medicinal Chemistry Letters

SOUTH SAN FRANCISCO, Calif., Feb. 14, 2017  — Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT) today announced that a paper describing the discovery of GBT440 and its ability to bind to hemoglobin and prevent red blood cells from sickling was published online in ACS Medicinal Chemistry Letters, a peer-reviewed publication of the American Chemical Society. GBT440 is in Phase 3 development as a potentially disease-modifying therapy for sickle cell disease (SCD). The publication can be accessed at http://pubs.acs.org/doi/full/10.1021/acsmedchemlett.6b00491.

“The underlying cause of SCD is the polymerization of sickle hemoglobin under low oxygen conditions, resulting in red blood cells taking on a sickle-like shape. These sickled cells are unable to pass through narrow blood vessels, resulting in severe painful crises for patients, anemia, multi-organ damage and premature death,” said Ted W. Love, M.D., president and chief executive officer of GBT. “This newly published paper further validates GBT440’s mechanism to increase the affinity of hemoglobin for oxygen and consequently inhibits the polymerization of sickle hemoglobin. As a result, GBT440 has the potential to fundamentally modify the course of SCD, which we are evaluating in our ongoing Phase 3 HOPE Study.”

The published paper describes the process by which scientists discovered GBT440. The researchers first developed a series of compounds that increased the oxygen affinity of sickle hemoglobin (HbS) — both on the isolated hemoglobin protein and in whole blood from sickle cell patients. They then selected compounds that demonstrated the best time to onset of polymerization of HbS. One compound in particular, now known as GBT440, demonstrated favorable pharmacokinetics in several animal species, showing that it could be given orally. Additionally, GBT440 was found to accumulate highly and favorably into red blood cells, suggesting that potentially therapeutic concentrations of GBT440 can be achieved in red blood cells at comparatively low plasma concentrations.

About GBT440 in Sickle Cell Disease
GBT440 is being developed as an oral, once-daily therapy for patients with SCD. GBT440 works by increasing hemoglobin’s affinity for oxygen. Since oxygenated sickle hemoglobin does not polymerize, GBT believes GBT440 blocks polymerization and the resultant sickling of red blood cells. With the potential to restore normal hemoglobin function and improve oxygen delivery, GBT believes that GBT440 may potentially modify the course of SCD.

In recognition of the critical need for new SCD treatments, the U.S. Food and Drug Administration (FDA) has granted GBT440 for the treatment of patients with SCD both fast track and orphan drug designations, and the European Commission (EC) has designated GBT440 for the treatment of patients with SCD as an orphan medicinal product. GBT is currently evaluating GBT440 in the HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) Study, a Phase 3 clinical trial in patients age 12 and older with SCD. Additionally, GBT440 is being studied in the ongoing Phase 1/2 GBT440-001 trial and in an open-label, single and multiple dose study in adolescents (age 12 to 17) with SCD designed to assess the safety, tolerability, pharmacokinetics and exploratory treatment effect of GBT440.

About Sickle Cell Disease (SCD)
SCD is a lifelong inherited blood disorder caused by a genetic mutation in the beta-chain of hemoglobin, which leads to the formation of abnormal hemoglobin known as sickle hemoglobin (or HbS). In its deoxygenated state, HbS has a propensity to polymerize, or bind together, forming long, rigid rods within a red blood cell (or RBC). The polymer rods deform RBCs to assume a sickled shape and to become inflexible, which can cause blockage in capillaries small blood vessels. Beginning in childhood, SCD patients suffer unpredictable and recurrent episodes or crises of severe pain due to blocked blood flow to organs, which often lead to psychosocial and physical disabilities. This blocked blood flow, combined with hemolytic anemia (the destruction of RBCs), can eventually lead to multi-organ damage and early death. Currently, the only FDA-approved therapy for SCD is hydroxyurea.

About Global Blood Therapeutics
Global Blood Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developing its lead product candidate, GBT440, as an oral, once-daily therapy for sickle cell disease. GBT is also investigating GBT440 for the treatment of hypoxemic pulmonary disorders in two ongoing Phase 2a studies in patients with idiopathic pulmonary fibrosis. To learn more, please visit: www.globalbloodtx.com.

Forward-Looking Statements
Statements we make in this press release may include statements that are not historical facts and are considered forward-looking 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. We intend these forward-looking statements, including statements regarding the therapeutic potential and safety profile of GBT440, data and results pertaining to GBT440, our ability to implement our clinical development plans for GBT440, the timing of, and our ability to generate data from our ongoing clinical trials of GBT440 for sickle cell disease, including our ability to enroll patients in, conduct and complete our HOPE Study, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. We can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved, and furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, the risks that our clinical and preclinical development activities may be delayed or terminated for a variety of reasons, that regulatory authorities may disagree with our clinical development plans or require additional studies or data to support further clinical investigation of our product candidates, and that drug-related adverse events may be observed in later stages of clinical development, along with those risks set forth in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, and in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2016, June 30, 2016 and September 30, 2016, as well as discussions of potential risks, uncertainties and other important factors in our subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information: 
Myesha Lacy (investors)
GBT
650-351-4730
investor@globalbloodtx.com

Julie Normart (media)
Pure Communications
415-946-1087
media@globalbloodtx.com
Tuesday, February 14th, 2017 Uncategorized Comments Off on $GBT #GBT440 Discovery Process Detail in Opcoming ACS Medicinal Chemistry Letters

$VRML Announces Equity Financing of $5.6 Million

AUSTIN, Texas, Feb. 14, 2017  — Vermillion, Inc. (Nasdaq: VRML), a bio-analytical solutions company, announced today that investors, including several Vermillion directors and members of management as well as certain significant stockholders, have agreed to purchase approximately $5.6 million of unregistered shares of Vermillion’s common stock and warrants to purchase unregistered shares of Vermillion’s common stock in a private placement. Under the terms of the private placement, Vermillion has agreed to sell an aggregate of 3,747,125 shares of its common stock at the price of $1.40 per share, the closing price quoted on NASDAQ on February 10, 2017. In addition, the investors will receive warrants to purchase up to an aggregate of 2,810,338 shares of Vermillion’s common stock at an exercise price of $1.80 per share. The warrants become exercisable six months after the closing of the private placement and expire five years from the date of issuance or, if earlier, five business days after Vermillion delivers notice that the closing price per share of its common stock exceeded the exercise price for 20 consecutive trading days during the exercise period.

The closing of the private placement is expected to occur on February 17, 2017, subject to customary closing conditions. At the closing, Vermillion will receive $5.6 million in gross proceeds. If all of the warrants are exercised, Vermillion would receive an additional $5.1 million in gross proceeds, resulting in total proceeds from the private placement of up to $10.7 million before transaction costs. Vermillion intends to use the net proceeds from the private placement for general corporate and working capital purposes.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities. The securities offered and sold in the private placement have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration under the Securities Act and applicable state securities laws.

About Vermillion
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, discovers, develops, and delivers innovative diagnostic and technology tools that help women with serious diseases.

Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant risks and uncertainties, including statements regarding the closing of the private placement and the use of proceeds therefrom. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. The forward- looking statements contained in this press release are based on Vermillion’s expectations as of the date of this press release. A variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements, including delays in satisfying or failure to satisfy closing conditions for the private placement, changes to interpretations of existing laws and regulations and other factors that are described in Vermillion’s Form 10-K for the year ended December 31, 2015 and Form 10-Q for the quarter ended March 31, 2016 as filed with the Securities and Exchange Commission. Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.

Investor Relations Contact:
Michael Wood
LifeSci Advisors LLC
Tel 1-646-597-6983
mwood@lifesciadvisors.com

Tuesday, February 14th, 2017 Uncategorized Comments Off on $VRML Announces Equity Financing of $5.6 Million

$APOP Dual-Listed #Cellect to Voluntarily File for #Delisting from #TASE

Company’s Securities to Continue Trading Only on NASDAQ Stock Exchange in US

TEL AVIV, Israel, Feb. 14, 2017 — Cellect Biotechnology Ltd. (Nasdaq:APOP) (TASE:APOP), a developer of stem cells isolation technology, announced today that it will file a petition with the Israeli court and Company shareholders to voluntarily delist Cellect from the Tel-Aviv Stock Exchange (TASE) in accordance with section 350 to the Israeli Company Law. Should the petition be approved, all shareholders will retain their pro-rated holdings, as trading will migrate to the NASDAQ Stock Exchange in the US.

Company Chairman, Mr. Nuriel Chirich Kasbian commented, “Cellect is a leader in the Stem Cells therapeutic area with multi-billion dollar market potential for our transformative, patented technology and products. In order to maximize the value of the Company for all stakeholders, we believe being solely listed on NASDAQ in the US is most appropriate for Cellect at this time.  Based on our experience, it is clear to us that the US market better understands our vision and will demonstrate a stronger appreciation for the attractive long-term investment opportunity Cellect represents.”

The key factors driving Cellect’s voluntary request for delisting from TASE include:

  • Investors globally have demonstrated a stronger appreciation for life sciences companies listed solely on NASDAQ as opposed to companies with similar profiles listed on TASE or with dual listings on TASE and NASDAQ.
  • Cellect expects higher trading liquidity over time with a sole listing on NASDAQ vs. remaining dual listed.

Dr. Shai Yarkoni, Cellect CEO commented, “We are proud to be an Israeli company with innovative technology in a field that has the potential to transform medicine. It is our duty to ensure that our shares are traded on an exchange where our technology and business can be appropriately valued by investors.  To date, Cellect has successfully executed on its development and business goals, as planned, and we look forward to achieving further progress with our ongoing clinical trial and securing additional value-creating partnerships for the Company’s technology.  Cellect remains focused on creating long-term shareholder value, and we are confident that a sole listing on NASDAQ is an important step toward accomplishing this objective.”

About Cellect Biotechnology Ltd.

Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP) (NASDAQ:APOPW) (TASE:APOP). The Company has developed a breakthrough technology for the isolation of stem cells from any given tissue that aims to improve a variety of stem cells applications.

The Company’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells for in quantity and quality that will allow stem cells related treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of bone marrow transplantations.

Forward Looking Statements          
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss the anticipated petition to be filed in the Israeli courts seeking to delist Cellect’s ordinary shares from the TASE, the long term attractive investment opportunity represented by Cellect, the expectation of increased liquidity as a result of a sole listing on Nasdaq and Cellect’s future progress with respect to its ongoing clinical trial and securing additional value-creating partnerships for its technology. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.’s final prospectus dated July 29, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. and in the Company’s period filings with the SEC and the Tel-Aviv Stock Exchange.

Contact
Cellect Biotechnology Ltd. 
Eyal Leibovitz, Chief Financial Officer
www.cellectbio.com
+ 972-9-974-1444

LifeSci Advisors
Bob Yedid, Managing Director
646-597-6989
bob@lifesciadvisors.com
Tuesday, February 14th, 2017 Uncategorized Comments Off on $APOP Dual-Listed #Cellect to Voluntarily File for #Delisting from #TASE

$CYNO to be #Acquired by $HOLX

-Expands Hologic’s Scientific and Commercial Expertise into Large, Adjacent Medical Device Segment Growing at Double-Digit Rate – -Accelerates Hologic’s Top- and Bottom-Line Growth Rates and is Immediately Accretive to Non-GAAP Earnings per Share –

MARLBOROUGH, Mass. and WESTFORD, Mass., Feb. 14, 2017  — Hologic, Inc. (Nasdaq: HOLX), a leader in women’s health, and Cynosure, Inc. (Nasdaq: CYNO), a leader in medical aesthetics systems and technologies, announced today they have signed a definitive agreement for Hologic to acquire all outstanding Cynosure shares for $66.00 per share in cash, which corresponds to an equity value of approximately $1.65 billion and an enterprise value of $1.44 billion net of cash.

The transaction, which has been approved unanimously by the boards of directors of both companies, would extend Hologic’s scientific and commercial capabilities into one of the fastest-growing segments in medical technology, while expanding Cynosure’s customer reach and addressable market.

“Acquiring Cynosure will accelerate our transformation into a higher-growth company by leveraging our core women’s health expertise and OB/GYN channel leadership into an adjacent, cash-pay segment that is expanding at a low double-digit rate,” said Steve MacMillan, Hologic’s Chairman, President and Chief Executive Officer (CEO).  “We had identified medical aesthetics as an attractive and complementary growth opportunity through our strategic planning process, and are pleased to have agreed to acquire Cynosure, the best-in-class company in the space.  Together, we can strengthen our shared focus on innovation, market-leading products with demonstrated clinical benefits, and strong customer relationships. ”

Cynosure has a broad portfolio of more than 20 products across major categories including non-invasive body contouring, hair removal, skin revitalization and women’s health.  Cynosure sells its products through a combination of direct sales and distributors in over 130 countries.  The company has a history of organic innovation, most recently with the introduction of SculpSure®, the world’s first FDA-cleared laser treatment for non-invasive body contouring.  Cynosure also markets MonaLisa Touch®, a novel CO2 laser for women’s health.  Cynosure, which reported revenues of $433.5 million in 2016, has posted 28 consecutive quarters of year-over-year top-line growth.

“We are thrilled at the prospect of becoming part of Hologic through a transaction that provides excellent value for all of our stakeholders,” said Michael Davin, Cynosure’s Chairman, President and CEO.  “Strategically, this deal enables Cynosure to further capitalize on growth opportunities in the core and non-core aesthetic market, rapidly strengthens our position in women’s health – where Hologic has a leading commercial presence – and accelerates our R&D initiatives.”

Benefits of the Transaction

  • Provides Hologic entry into large, fast-growing medical aesthetics segment. The medical aesthetics segment exceeds $2 billion globally and is expected to grow at a low-double-digit rate over the next several years, making it one of the fastest-growing segments in the medical technology industry. Growth is being driven by physicians’ desire to increase their cash-based procedures, and by increasing interest in aesthetics and lifestyle health from an aging population.
  • Leading medical aesthetics platform complements Hologic’s strong position in the OB/GYN and women’s health channels. Cynosure has a broad product portfolio built from a legacy of innovation, and has begun to capitalize on the fast-growing areas of non-invasive fat body contouring and women’s health. Approximately 60 percent of Cynosure’s business is derived from physicians outside the traditional areas of plastic surgery and dermatology, with a significant focus on the OB/GYN channel. Cynosure’s products provide a strong complement to Hologic’s leadership positions and existing products in this channel, and together the companies can further capitalize on the trend toward minimally and non-invasive surgical procedures.
  • Accelerates top- and bottom-line growth rates. This transaction, coupled with the recently completed blood screening divestiture, continues Hologic’s transformation into a higher growth company. Hologic estimates that together, the transactions will enable the Company to accelerate pro-forma revenue growth by roughly 150 basis points, and increase non-GAAP earnings per share (EPS) at a solid double-digit rate, over the next several years.
  • Delivers attractive financial benefits. The transaction is expected to be fully funded with cash on hand, including proceeds from the recently completed blood screening divestiture. Hologic estimates the deal will provide a high-single-digit return on invested capital (ROIC) by year five, exceeding the Company’s cost of capital. The transaction is expected to be dilutive to GAAP earnings per share. On a non-GAAP basis, however, Hologic forecasts the deal will be immediately accretive, adding approximately $0.03 to $0.05 to the Company’s non-GAAP EPS in the balance of fiscal 2017, adding approximately $0.13 to $0.15 in non-GAAP EPS in fiscal 2018, and becoming increasingly accretive in fiscal 2019 and beyond. Hologic expects to realize annualized cost synergies of approximately $25 million by the third year after the close.

Transaction Details and Advisers

Under the terms of the agreement, a subsidiary of Hologic will commence a tender offer to purchase any and all of the outstanding shares of Cynosure common stock for $66.00 per share in cash.  The completion of the tender offer is subject to customary terms and closing conditions, including Cynosure stockholders tendering a majority of Cynosure’s outstanding shares, and receipt of specified regulatory approvals.  Following the successful completion of the tender offer, the agreement provides that Cynosure will merge with a subsidiary of Hologic and become a wholly-owned subsidiary of Hologic, and all remaining outstanding shares of Cynosure will receive the same consideration paid to other stockholders in the tender offer.  Following the completion of the transaction, Cynosure shares will be delisted from NASDAQ.  The tender offer is expected to be completed in late March or April of 2017, subject to the satisfaction or waiver of the offer conditions.

Morgan Stanley & Co. LLC is serving as financial adviser to Hologic, and Wachtell, Lipton, Rosen & Katz is serving as legal adviser.

Leerink Partners LLC is serving as financial adviser to Cynosure, and Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal adviser.

Conference Call and Webcast

Hologic’s management will host a conference call at 8:30 a.m. ET today to discuss this transaction.  Approximately 10 minutes before the call, dial 877-591-4951 (U.S. and Canada) or 719-325-4796 (international) and enter access code 473536.  A replay will be available starting two hours after the call ends through March 9, 2017 at 888-203-1112 (U.S. and Canada) or 719-457-0820 (international), access code 473536, pin 9876.  The Company will also provide a live webcast of the call at http://investors.hologic.com.

About Hologic, Inc.

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products.  The Company’s core business units focus on diagnostics, breast health, GYN surgical, and skeletal health.  With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure.  For more information on Hologic, visit www.hologic.com.

Hologic and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

About Cynosure

Cynosure develops, manufactures and markets aesthetic treatment systems that enable plastic surgeons, dermatologists and other medical practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and benign pigmented lesions, remove multi-colored tattoos, revitalize the skin, reduce fat through laser lipolysis, reduce cellulite, clear nails infected by toe fungus, ablate sweat glands and improve women’s health.  The Company also markets radiofrequency (RF) energy-sourced medical devices for precision surgical applications such as facial plastic and general surgery, gynecology, ear, nose, and throat procedures, ophthalmology, oral and maxillofacial surgery, podiatry and proctology.  Cynosure’s product portfolio is composed of a broad range of energy sources including Alexandrite, diode, Nd: YAG, picosecond, pulse dye, Q-switched lasers, intense pulsed light and RF technology.  Cynosure sells its products globally under the Cynosure, Palomar, ConBio and Ellman brand names through a direct sales force in the United States, Canada, France, Morocco, Germany, Spain, the United Kingdom, Australia, China, Japan and Korea, and through international distributors in approximately 120 other countries.  For corporate or product information, visit Cynosure’s website at www.cynosure.com.

Non-GAAP Financial Measures

This press release discusses non-GAAP diluted EPS, which is a non-GAAP financial measure.  Hologic defines its non-GAAP EPS presented in this press release to exclude transaction costs, the amortization of intangible assets and purchase accounting effects related to recording inventory, fixed assets and deferred revenue to fair value, among other items, as well as potential charges for integration costs including retention, and the related income taxes related to such adjustments.

Non-GAAP diluted EPS adjusts for specified items that may be non-cash, or can be highly variable or difficult to predict.  In the context of forward-looking statements, the non-GAAP financial measures facilitate period-to-period comparisons by excluding the effects of events that have occurred in the past or may occur in the future and have accounting consequences that can mask underlying operational trends, such as acquisitions, restructurings, debt extinguishment and impairments.

This non-GAAP financial measure should be considered supplemental to, and not a substitute for, financial information prepared in accordance with GAAP.  Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety.

Future GAAP EPS may be affected by changes in ongoing assumptions and judgments, and may also be affected by non-recurring, unusual or unanticipated charges, expenses or gains, which are excluded in the calculation of the Company’s non-GAAP EPS forecast as described in this press release.

When Hologic provides its expectations for non-GAAP EPS on a forward-looking basis, a reconciliation of the differences between this non-GAAP expectation and the corresponding GAAP measure (GAAP EPS) is not available without unreasonable effort because Hologic has not estimated the fair value of the assets and liabilities expected to be acquired in the transaction.  Nor has the Company determined the fair value of acquired intangible assets and related annual amortization expense that would be required in order to provide the corresponding GAAP measure.  The variability of the items that have not yet been determined may have a significant, and potentially unpredictable, impact on Hologic’s future GAAP results.

Additional Information and Where to Find It

The tender offer for the outstanding shares of Cynosure referenced in this document has not yet commenced.  This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares, nor is it a substitute for the tender offer materials that Hologic and its subsidiary will file with the Securities and Exchange Commission (“SEC”).  At the time the tender offer is commenced, Hologic and its subsidiary will file tender offer materials on Schedule TO, and thereafter Cynosure will file a Solicitation/Recommendation Statement on Schedule 14D-9, with the SEC with respect to the tender offer.  THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION.  HOLDERS OF SHARES OF Cynosure COMMON STOCK ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF SHARES OF Cynosure COMMON STOCK SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES.  The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of shares of Cynosure common stock at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov.  Additional copies of the tender offer materials may be obtained for free by contacting Hologic, Inc. at 250 Campus Drive, Marlborough, MA 01752, Attention: Investor Relations.  In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Hologic and Cynosure file annual, quarterly and current reports and other information with the SEC.  You may read and copy any reports or other information filed by Hologic or Cynosure at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549.  Please call the Commission at 1-800-SEC-0330 for further information on the public reference room.  Hologic’s and Cynosure’s filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

Forward-Looking Statements

This news release contains forward-looking information that involves risks and uncertainties, including statements about each company’s plans, objectives, expectations and intentions.  Such statements include, without limitation: financial or other information based upon or otherwise incorporating judgments or estimates relating to future performance, events or expectations; each company’s strategies, positioning, resources, capabilities, and expectations for future performance; and each company’s outlook and financial and other guidance.  Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” estimates and similar expressions) should also be considered to be forward‑looking statements. These forward-looking statements are based upon assumptions made as of this date and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated.

Risks and uncertainties that could adversely affect the either company’s business and prospects, and otherwise cause actual results to differ materially from those anticipated, include without limitation: the possibility that the anticipated benefits from the proposed transaction cannot be fully realized or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of Cynosure’s operations with those of Hologic will be greater than expected; the ability of the combined company to retain and hire key personnel; the ability of the parties to timely and successfully receive required regulatory approvals; the effect of the continuing worldwide macroeconomic uncertainty, including the UK’s decision to leave the European Union, on each company’s business and results of operations; the coverage and reimbursement decisions of third-party payors and the guidelines, recommendations, and studies published by various organizations relating to the use of products and treatments; the uncertainty of the impact of cost containment efforts and federal healthcare reform legislation on each company’s business and results of operations; the impact to Hologic’s results of operations from the disposal of its blood screening business to Grifols, and the operational challenges of separating this business unit from Hologic’s molecular diagnostics business; the ability to successfully manage ongoing organizational and strategic changes, including Hologic’s ability to attract, motivate and retain key employees; the impact and anticipated benefits of completed acquisitions and acquisitions Hologic may complete in the future; the ability to consolidate certain of Hologic’s manufacturing and other operations on a timely basis and within budget, without disrupting Hologic’s business and to achieve anticipated cost synergies related to such actions; the development of new competitive technologies and products; regulatory approvals and clearances for products; production schedules for products; the anticipated development of markets in which products are sold into and the success of products in these markets; the anticipated performance and benefits of products; business strategies; estimated asset and liability values; the impact and costs and expenses of any litigation the companies may be subject to now or in the future; compliance with covenants contained in Hologic’s debt agreements; anticipated trends relating to Hologic’s financial condition or results of operations, including the impact of interest rate and foreign currency exchange fluctuations; and Hologic’s capital resources and the adequacy thereof.

The risks included above are not exhaustive.  Other factors that could adversely affect each company’s business and prospects are described in the filings made by the applicable company with the SEC. Hologic and Cynosure expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Contact

Hologic

Michael Watts
Vice President, Investor Relations and Corporate Communications
(858) 410-8588

Cynosure

Scott Solomon
Senior Vice President
Sharon Merrill Associates
(617) 542-5300
CYNO@investorrelations.com

Tuesday, February 14th, 2017 Uncategorized Comments Off on $CYNO to be #Acquired by $HOLX

$EXPI #SuperBowl QB #VinceFerragamo Joins @eXpRealty

Will Build Real Estate Team Across Markets with Agent-Owned Cloud Brokerage(R)

BELLINGHAM, WA–(February 14, 2017) – eXpWorld Holdings, Inc. (OTCQB: EXPI) announced today that real estate veteran and former quarterback for the Los Angeles Rams, Vince Ferragamo, has joined eXp Realty, the Agent-Owned Cloud Brokerage®.

“eXp Realty is exciting to me because the company recognizes and believes as I do that when good people work together with shared purpose and common goals there is nothing that cannot be achieved,” said Ferragamo. “There are good real estate professionals across this country who have expressed interest in being part of the Ferragamo real estate brand but until the eXp opportunity presented itself, I didn’t have a way in which to work with, learn from, collaborate with or coach agents outside of Southern California. I am excited to be part of the team, part of the family and someone who can both participate in agent ownership as well as introduce it to others.”

“Vince understands the value of teamwork as well as anyone and knows how to lead teams to achieve success,” said eXp Realty CEO, Jason Gesing. “From his success in sports and business to his tireless dedication to causes he cares about and supports through his foundation, Vince is a tremendous representation of and perfect addition to the eXp Realty team and our family of agent owners.”

Ferragamo is perhaps most recognized for his 10 year career in the National Football League during which he set numerous team records for the Los Angeles Rams. Today, he remains the only quarterback ever to lead the Rams to the Superbowl. Ferragamo also played one season for the Buffalo Bills and the Green Bay Packers.

Ferragamo has been active in the real estate industry ever since his retirement from the NFL as a brokerage owner and as a professional in service to his clients. Ferragamo remains active in the football community, both with the Rams, and in appearances with KABC, CBS, and FOX Sports.

Ferragamo is very active within the greater Los Angeles community and lends his efforts to numerous charitable organizations including the Special Olympics; the Speech & Language Development Center; the Alzheimer’s Association; the Boys and Girls Club; and, the Ronald McDonald House. In addition, The Ferragamo Foundations sponsors the “Fight with Grace” annual luncheon benefiting the Orange Coast Memorial Foundation and their fight against breast cancer.

Ferragamo plans to attend the company’s 3rd annual meeting of present and future agent owners and shareholders, scheduled for April 27-28 in Coronado, California.

To learn more about the Ferragamo Group at eXp Realty contact Nelida Mora at nelida.mora@exprealty.com or 714-993-7772.

Disclosures/Trademark Attributions

Super Bowl is a registered trademark of the NFL and is used herein for factual reference purposes only. eXp Realty and eXp World Holdings and their affiliates are not affiliated with the Super Bowl, or any of the following trademarks/names referenced herein:

NFL, which is a trademark of NFL Properties, LLC
Los Angeles Rams, which is a trademark of The Los Angeles Rams, LLC
Buffalo Bills, which is a trademark of Buffalo Bills, LLC
Green Bay Packers, which is a trademark of Green Bay Packers, Inc.
CBS, which is a trademark of CBS Broadcasting
FOX Sports, which is a trademark of Twentieth Century Fox Film Corporation
KABC, which is a trademark of KABC IP, LLC
Special Olympics
Speech & Language Development Center
Alzheimer’s Association
Boys and Girls Club
Ronald McDonald House
Orange Coast Memorial Foundation

About eXp World Holdings, Inc.

eXp World Holdings, Inc. is the holding company for a number of companies most notably eXp Realty LLC, the Agent-Owned Cloud Brokerage® as a full-service real estate brokerage providing 24/7 access to collaborative tools, training, and socialization for real estate brokers and agents through its 3-D, fully-immersive, cloud office environment. eXp Realty, LLC and eXp Realty of Canada, Inc. also feature an aggressive revenue sharing program that pays agents a percentage of gross commission income earned by fellow real estate professionals who they attract into the Company.

As a publicly-traded company, eXp World Holdings, Inc. uniquely offers professionals within its ranks opportunities to earn equity awards for production and contributions to overall company growth.

For more information you can follow eXp World Holdings, Inc. on Twitter, LinkedIn, Facebook, YouTube, or visit eXpWorldHoldings.com. For eXp Realty please visit: eXpRealty.com.

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Such forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to revise or update them. These statements include, but are not limited to, statements about the Company’s expansion, revenue growth, operating results, financial performance and net income changes. Such statements are not guarantees of future performance. Important factors that may cause actual results to differ materially and adversely from those expressed in forward-looking statements include changes in business or other market conditions; the difficulty of keeping expense growth at modest levels while increasing revenues; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings, including but not limited to the most recently filed Annual Report on Form 10-K.

Investor Relations Contact Information:
Glenn Sanford, Chairman & CEO
eXp World Holdings, Inc.
glenn@expworldholdings.com
360-389-2426

Media Contact Information:
Russ Cofano, President
eXp World Holdings, Inc.
russ.cofano@exprealty.com
573-825-0780

Trade Contact Information:
Jason Gesing, CEO
eXp Realty, LLC
jason.gesing@exprealty.com
617-970-8518

Tuesday, February 14th, 2017 Uncategorized Comments Off on $EXPI #SuperBowl QB #VinceFerragamo Joins @eXpRealty

$DMPI and MD Anderson Clinical Trial of #VAL083 in #GBM

Study will enroll 48 MGMT-unmethylated Avastin (bevacizumab)-naïve recurrent GBM patients

VANCOUVER, British Columbia and MENLO PARK, Calif., Jan. 25, 2017  — DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) (“DelMar” and the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, is pleased to announce the opening of enrollment of a Phase II study of VAL-083 at the University of Texas MD Anderson Cancer Center in Houston, Texas.

The Phase II study of VAL-083 (dianhydrogalactitol) in patients with MGMT-unmethylated, Avastin (bevacizumab)-naïve recurrent glioblastoma will enroll 48 patients in a single-arm design to determine if treatment with VAL-083 improves overall survival, compared to historical control.  Further information regarding the clinical trial can be found on DelMar’s website and at clinicaltrials.gov (clinicaltrials.gov identifier:  NCT02717962).

“This study is a keystone in our strategy to expand the development of VAL-083 to target MGMT-unmethylated GBM, a significant unmet medical need,” said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals. “We are pleased to launch this important trial in collaboration with the University of Texas MD Anderson Cancer Center, one of the world’s most respected medical centers devoted exclusively to cancer patient care, research, education and prevention.”

Approximately two-thirds of newly diagnosed GBM patients have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme, MGMT.  Published studies have documented that expression of MGMT is an important factor in predicting the outcome of GBM patients treated with alkylating agents such as temozolomide (TMZ), carmustine (BCNU), and lomustine (CCNU).

Patients whose tumors exhibit high expression of MGMT have a poor prognosis and significantly shorter progression free survival (PFS) and overall survival (OS) in comparison to patients with a methylated MGMT promoter and low MGMT expression. In a 2011 study of more than 800 GBM patients, those with tumors carrying the unmethylated MGMT promoter had a median overall survival of 14 months versus 21 months for those with a methylated MGMT promoter. The difference in progression-free survival – the period after treatment during which the cancer does not worsen – was 5.7 and 8.7 months, respectively.

About VAL-083

VAL-083 is a “first-in-class,” small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes. DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro.  Further details can be found at http://www.delmarpharma.com/scientific-publications.html.

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

DelMar has also announced plans to advance VAL-083 into a pivotal randomized multi-center Phase III clinical trial for the treatment of bevacizumab-failed GBM and into a separate international Phase II trial for newly diagnosed GBM patients with an unmethylated MGMT promoter.

“We believe that data from these upcoming clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available chemotherapy,” added Mr. Bacha.

“Our data demonstrating that VAL-083’s activity against GBM is independent of MGMT expression combined with VAL-083’s established clinical activity against GBM from published NCI-sponsored clinical studies provides confidence to our hope that VAL-083 will give doctors and their patients a new and unique chemotherapy to address this enormous global unmet medical need.”

About Glioblastoma Multiforme (GBM)

GBM is the most common and the most lethal form of glioma. Approximately 15,000 new cases of GBM are expected to be diagnosed in the United States during 2017. GBM progresses quickly and patients deteriorate rapidly. Common symptoms include headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly. The majority of GBM patients do not survive for more than two years following diagnosis, and the median survival in newly diagnosed patients with best available treatments is less than 15 months.

About DelMar Pharmaceuticals, Inc.

DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company’s lead drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by the U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients.

For further information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: ir@delmarpharma.com / (604) 629-5989. Connect with the Company on Twitter, LinkedIn, Facebook, and Google+.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including our current reports on Form 8-K.

Monday, February 13th, 2017 Uncategorized Comments Off on $DMPI and MD Anderson Clinical Trial of #VAL083 in #GBM

$SAGE Advances #SAGE217 into #Phase2 in Major Depressive Disorder #MDD

Open-label Pilot Study of Once Daily, Orally Administered Molecule Demonstrates Positive Signal of Activity and Tolerability

Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced encouraging top-line results from its Phase 2 clinical trial of orally-administered SAGE-217 for the treatment of major depressive disorder (MDD). The primary endpoint of the 13 patient Part A open-label trial was to evaluate safety and tolerability. SAGE-217 was found to be generally well-tolerated with no serious adverse events or discontinuations reported. The trial also examined the effect of SAGE-217 on the Hamilton Rating Scale for Depression (HAM-D) total score, in addition to other secondary measures. Patients in the trial had a mean HAM-D total score of 27.2 at baseline. Data demonstrated a mean reduction from baseline in the HAM-D of 19.9 points at Day 15, with 85% (11 of 13) patients showing at least a 50% reduction of their HAM-D and 62% (8 of 13) of patients achieving remission, as determined by a HAM-D ≤7. Statistically significant mean change from baseline was observed by Day 2 of the study, following the first of once-daily, nighttime oral dosing of 30 mg of SAGE-217. A significant mean change from baseline was maintained throughout the treatment period (p<0.0001 at Day 15). The reduction from baseline in depression ratings seen in Part A of the trial met the company’s criteria for advancing SAGE-217 into a planned double-blind, placebo-controlled study (Part B).

“Understanding the caveats associated with open-label data, we are highly encouraged by the strong signal we achieved in this study, which met our internal criteria for achieving a positive signal and thus supported our plan to proceed to the double-blind, placebo-controlled part of the Phase 2 trial,” said Jeff Jonas, M.D., Chief Executive Officer of Sage. “These initial results in MDD were achieved utilizing our data-driven approach to CNS drug development – employing efficient human proof-of-concept studies to both uncover activity signals and help understand future trial methodology, before investing in larger clinical programs.”

“Our novel, orally-administered molecule, SAGE-217, was designed to reproduce the important GABA-related pharmacology of our intravenous agent SAGE-547, and is an example of our translational approach to drug development. The positive results from this clinical trial, along with the outcomes observed with SAGE-547 in postpartum depression, further validate studying this mechanism as a potential broad therapy for the treatment of mood disorders,” said Steve Kanes, M.D., Ph.D., Chief Medical Officer of Sage. “SAGE-217 has the potential to be a rapid-acting, once-daily oral therapy for MDD, with a novel mechanism of action.”

The major depressive disorder program is a two-part Phase 2 clinical trial evaluating the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in moderate to severe MDD patients. Part A of the Phase 2 trial was an open-label study evaluating SAGE-217 in 13 patients. The primary endpoint for the Part A study was to evaluate the safety and tolerability of SAGE-217. The secondary endpoint was to evaluate the effect of SAGE-217 compared to baseline following two weeks of once-daily treatment as measured by the HAM-D total score. The Part B phase of the trial will be a randomized, double-blind, parallel-group, placebo-controlled study evaluating SAGE-217 as a treatment for MDD. The design of this study will be finalized after analyses of the Part A data set are complete.

Summary of Top-Line Results from Part A of Phase 2 Study

Safety and Tolerability (Primary Endpoint):

  • SAGE-217 was generally well tolerated in Part A of the study. There were no deaths, serious adverse events or discontinuations.
  • The most common adverse events were sedation/somnolence, headache, dizziness, and myalgia.

Effect on Depressive Symptoms at Day 15:

  • SAGE-217 reduced depressive symptoms as assessed by the HAM-D total score, with patients experiencing a 19.9 mean reduction in their HAM-D total score at Day 15, a decrease from a mean total score of 27.2 at baseline to 7.3 at Day 15.
  • At least a 50% reduction in HAM-D total score was demonstrated in 11 of 13 patients (85%).
  • Remission from depression, as determined by a HAM-D total score less than or equal to 7, was seen in 8 of 13 patients (62%).

About SAGE-217

SAGE-217 is a next generation positive allosteric modulator that has been optimized for selectivity to synaptic and extrasynaptic GABA receptors and a pharmacokinetic profile intended for daily oral dosing. The GABA system is the major inhibitory signaling pathway of the brain and CNS, and contributes significantly to regulating CNS function. In a Phase 1 clinical program, SAGE-217 was studied in single and multiple ascending doses and the results were consistent with the predicted pharmacokinetic and pharmacologic profile. SAGE-217 is currently being developed for certain mood and movement disorders.

About the Hamilton Rating Scale for Depression (HAM-D)

HAM-D is a validated rating scale used to provide an assessment of depression, and as a guide to evaluate recovery. This scale is an accepted regulatory endpoint for depression. The scale is used to rate the severity of the patient’s depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation, anxiety, weight loss, and somatic symptoms.

About Major Depressive Disorder

Major depression disorder (MDD) is a common but serious mood disorder in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. Approximately 16 million people in the U.S. suffer from MDD each year.1 While antidepressants are widely used for treatment, large scale studies have demonstrated the need for additional therapies.2,3

About Sage Therapeutics

Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage has a portfolio of novel product candidates targeting critical CNS receptor systems, GABA and NMDA. Sage’s lead program, SAGE-547, is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder, and for postpartum depression. Sage is developing its next generation modulators, including SAGE-217 and SAGE-718, with a focus on acute and chronic CNS disorders. For more information, please visit www.sagerx.com.

Forward-Looking Statements

Various statements in this release concern Sage’s future expectations, plans and prospects, including without limitation, our expectations regarding further development and the potential of SAGE-217 in the treatment of MDD; our plans to commence additional clinical trials, and the potential timing of such efforts; our view of the potential of the GABA mechanism and our product candidates in the treatment of CNS diseases and disorders; and our views as to the unmet need for additional treatment options in MDD and estimated number of patients with MDD. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may not be able to successfully demonstrate the efficacy and safety of our product candidates at each stage of development; success in early stage clinical trials may not be repeated or observed in ongoing or future studies involving the same compound or other product candidates; and ongoing and future clinical results may not support further development of a product candidate or be sufficient to gain regulatory approval to market any product; decisions or actions of regulatory agencies may affect the initiation, timing, progress and cost of clinical trials, and our ability to proceed with further clinical trials of a product candidate in a particular indication or at all or our ability to obtain marketing approval; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; the number of patients with a particular disease or the unmet need for additional treatment options in a disease may be significantly smaller than we expect; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates; as well as those risks more fully discussed in the section entitled “Risk Factors” in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

1 Nat. Inst. of Mental Health website, 2015; Available at https://www.nimh.nih.gov/health/statistics/prevalence/major-depression-among-adults.shtml.

2 Trivedi MH et al. Evaluation of Outcomes with Citalopram for Depression using Measurement-Based Care in STAR*D: Implications for Clinical Practice. Am J Psychiatry, 2006,163:1, 28-40. doi: 10.1176/appi.ajp.163.1.28.

3 Rush AJ et al. Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report. Am J. Psychiatry, 2006,163:11, 1905-1917. doi: 10.1176/ajp.2006.163.11.1905.

 

Investors:
Sage Therapeutics
Paul Cox, 617-299-8377
paul.cox@sagerx.com
or
Media:
Suda Communications LLC
Maureen L. Suda, 585-387-9248
maureen.suda@sagerx.com

Monday, February 13th, 2017 Uncategorized Comments Off on $SAGE Advances #SAGE217 into #Phase2 in Major Depressive Disorder #MDD