Archive for March, 2015

(RADA) and DRS Technologies Team for the North American AESA Radar Market

NETANYA, Israel, March 31, 2015  — RADA Electronic Industries of Netanya, Israel announced today that it has signed a strategic teaming agreement with DRS Technologies, Inc. to bring RADA’s tactical active electronically scanned array (AESA) radar technology into the North American market.

Under this agreement, DRS will market, sell, produce and support tactical AESA radars as part of its tactical radar portfolio. The combination of RADA’s technology along with DRS market presence, customer awareness, engineering, and production capabilities is expected to produce significant interest in the North American defense industry market.

“We are excited to be able to offer our customers RADA’s proven technology that offers enhanced hostile-fire protection for our troops,” said Joseph Matteoni, Vice President/General Manager of DRS Sustainment Systems, Inc. “RADA’s cost-effective detection technology will allow DRS to continue its legacy of meeting the challenging needs of our growing radar customer base,” Matteoni said.

Zvi Alon, RADA’s CEO, added: “We value the North American market as the most promising growth market for our tactical radars technology, and are confident that this agreement will facilitate the adoption of this technology and growth of our radars business.”

About RADA

RADA Electronic Industries Ltd. is an Israel-based defense electronics contractor. The Company specializes in the development, production, and sale of Tactical Land Radars for Force and Border Protection, Inertial Navigation Systems for air and land applications, and Avionics Systems and Upgrades.

CONTACT: RADA
         Dubi Sella (CBDO)
         Tel: +972-9-892-1111
         mrkt@rada.com
         www.rada.com
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(OFIX) Secures Option to Acquire eNeura, Inc.

Orthofix International N.V. (NASDAQ:OFIX) (the Company), a diversified, global medical device company, today announced that it has entered into an option agreement that provides the Company with an 18-month option to acquire eNeura, Inc., a pioneer in the use of portable, non-invasive Transcranial Magnetic Stimulation (TMS) devices for the treatment of migraine headache.

In May 2014, eNeura received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpringTMS® migraine treatment device. SpringTMS is the first medical device available to patients in the United States for the acute treatment of pain associated with migraine headache with aura.

In consideration for the option to acquire eNeura, Orthofix has agreed to provide a $15 million collateralized loan to support commercialization of SpringTMS in the United States and Europe. If the option to purchase eNeura is exercised, Orthofix will pay $65 million to consummate the merger and eNeura will repay to Orthofix the unpaid principal payable under the loan. In addition, Orthofix may make future milestone and royalty payments to eNeura.

“This agreement underscores Orthofix’s commitment to pursue new growth opportunities in its BioStim strategic business unit that leverage our core competencies in pulsed electromagnetic field (“PEMF”) product design and manufacturing as well as our third party billing expertise,” said President and Chief Executive Officer Brad Mason. “We believe eNeura’s exciting application of electromagnetic field technology delivers a therapy that addresses a significant unmet need for patients and clinicians in the treatment of migraine headache.”

“Orthofix is an ideal partner for eNeura to expand commercial availability of SpringTMS to migraine patients in the United States and Europe,” commented Dr. David K. Rosen, President and CEO of eNeura. “We look forward to utilizing this financing to advance our product development and commercialization strategy for SpringTMS.”

Wells Fargo Securities served as financial advisor to eNeura.

About Migraine

The World Health Organization (WHO) estimates that 10 percent of adults worldwide suffer from migraine and 1.7 to 4 percent of adults have headaches 15 or more days per month. Migraine ranks as one of the top 20 most disabling conditions in the world, according to WHO.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company headquartered in Lewisville, TX. The Company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives, distributors and its subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as the Musculoskeletal Transplant Foundation and the Texas Scottish Rite Hospital for Children. For more information, please visit www.orthofix.com.

About eNeura

eNeura, Inc. is a privately held medical technology company that is pioneering the use of portable, non-invasive Transcranial Magnetic Stimulation devices for treatment of migraine. SpringTMS is a prescription-only device that utilizes single-pulse Transcranial Magnetic Stimulation (sTMS) to induce very mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal hyperactivity associated with migraine. The non-invasive, proprietary device is designed for convenient patient use. To treat, the device is placed at the back of the head where the push of a button generates a focused magnetic pulse with the intent to eliminate the pain of a migraine headache. For more information about eNeura, please visit http://www.eneura.com.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries and are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the uncertain results and timing of our anticipated filing of restated and revised financial statements for prior periods, the anticipated magnitude and nature of error corrections reflected by such filings, the timing of the filing of our late quarterly reports on Form 10-Q, potential delisting of our securities from the Nasdaq Stock Market, as well how these matters may impact our expenses, liquidity, legal liability, borrowing ability, product sales, relationships with customers, suppliers, strategic partners and third party reimbursement providers, ongoing compliance obligations under our corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services, deferred prosecution agreement with the U.S. Department of Justice and consent decree with the SEC, ability to remain in compliance with covenants and other obligations under our senior secured credit agreement, the cost and nature of our insurance coverage, and other factors described in our annual report on Form 10-K/A for the fiscal year ended December 31, 2013 and other subsequent periodic reports filed by the Company with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

For Orthofix:
Investor Contact
Mark Quick, 214-937-2924
markquick@orthofix.com
or
For eNeura:
Tiberend Strategic Advisors, Inc.
Claire Sojda / Jason Rando, 212-375-2686 / 2665
csojda@tiberend.com
jrando@tiberend.com

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(INS) Announces Sale of ChemFree Corporation Subsidiary

NORCROSS, Ga., March 31, 2015  — Intelligent Systems Corporation (NYSE MKT:INS) (www.intelsys.com) announced today that it has signed a Stock Purchase Agreement to sell its ChemFree Corporation subsidiary to CRC Industries, Inc., a privately held company, and simultaneously closed on the transaction as of the end of business March 31, 2015. The purchase price is approximately $21.6 million cash subject to certain post-closing adjustments.

“After carefully considering all of the options for enhancing value for shareholders, the Intelligent Systems Board of Directors concluded that this transaction would generate great value for shareholders and will position the remaining subsidiary, CoreCard Software, for long term success,” said Leland Strange, President and CEO of intelligent Systems. “We were able to achieve an attractive outcome and create additional balance sheet flexibility for growing CoreCard.”

Following the sale of ChemFree, the business of Intelligent Systems will consist primarily of its CoreCard Software subsidiary. The company will focus on the payments industry which it believes offers significant growth potential. Management will continue to explore various strategic alternatives that may include acquisitions or divestiture.

The transaction offers a favorable outcome for the employees and the business of ChemFree as CRC has deep expertise in the industrial MRO and automotive aftermarket marketplaces. “Aligning ChemFree with CRC will be advantageous for both companies. We look forward to expanding the reach of ChemFree’s unique bio-remediating SmartWasher® throughout our worldwide distribution network,” said Scott Grey, CEO of CRC Industries, Inc.

The company will have approximately $22 million in consolidated cash after certain closing adjustments and transaction expenses. Some of the transaction cash will be held in escrow as is typical in transactions of this type. While there will be some tax on the transaction, the company expects it to be minimal. It is the intention of the company to distribute or return in the near term approximately $5 million of the proceeds to its shareholders either as a dividend or stock re-purchase. The Board has yet to determine the specific mechanism.

Beginning in the first quarter ended March 31, 2015, the company will classify and report results of ChemFree as discontinued operation. It should be noted that, historically, profits from ChemFree have supported the development of CoreCard Software and Intelligent Systems expects to report losses for the next several years as it continues to invest in CoreCard’s software platform.

The company announced in the fourth quarter of 2014 that it would explore strategic alternatives for maximizing shareholder value and that process will continue. No timetable has been set for the company’s process and the company does not expect to comment further or update the market with any further information on the process unless and until its Board of Directors has approved a specific transaction or otherwise deems disclosure appropriate or necessary.

About Intelligent Systems Corporation

For over thirty-five years, Intelligent Systems Corporation (NYSE MKT:INS) has identified, created, operated and grown early stage technology companies. The company has operations and investments primarily in the information technology. The company’s principal majority-owned subsidiary is CoreCard Software, Inc. (www.corecard.com), a provider of software and services for prepaid and credit card processing. Further information is available on the company’s website at www.intelsys.com or by calling the company at 770/381-2900.

In addition to historical information, this news release may contain forward-looking statements relating to Intelligent Systems Corporation and its subsidiary and affiliated companies. These statements include all statements that are not statements of historical fact regarding the intent, belief or expectations of Intelligent Systems Corporation and its management with respect to, among other things, results of operations, product plans, and financial condition. The company does not undertake to update or revise any forward-looking statements, whether as a result of new developments or otherwise, except as required by law. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are instability in the financial markets, delays in product development, undetected software errors, competitive pressures, changes in customers’ requirements or financial condition, market acceptance of products and services, changes in the performance, financial condition or valuation of affiliate companies, the risks associated with investments in privately-held early stage companies and further declines in general economic and financial market conditions, particularly those that cause businesses to delay or cancel purchase decisions.

CONTACT: Bonnie Herron
         770-564-5504
         bherron@intelsys.com
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(DYAX) Announces Positive Results from Phase 1b Clinical Trial of DX-2930

Management to Host Conference Call with Detailed Data Presentation Today at 5:00 p.m. ET

Dyax Corp. (NASDAQ:DYAX) today announced positive safety, pharmacokinetic, biomarker, and efficacy results from the Phase 1b clinical study of their investigational product, DX-2930. Discovered by Dyax, DX-2930 is a fully human monoclonal antibody inhibitor of plasma kallikrein being developed for the prevention of hereditary angioedema (HAE) attacks.

The ongoing Phase 1b study is a multi-center, randomized, double-blind, placebo-controlled, multiple-ascending dose study designed to assess the safety, tolerability and pharmacokinetics of DX-2930 in HAE patients. An analysis of HAE attack rate was also conducted following a pre-specified statistical analysis plan. A total of 37 subjects were randomized to active drug or placebo in a 2:1 ratio across 4 dosing groups of 30, 100, 300, or 400 mg. Each subject received two doses of DX-2930 or placebo, separated by 14 days, and was followed for 15 weeks after the second dose.

DX-2930 was well tolerated at all dose levels. There were no deaths or subject discontinuations due to an adverse event. There were no serious adverse events in subjects treated with DX-2930 and no evidence of dose-limiting toxicity. There was no safety signal in treatment-emergent adverse events, clinical laboratory results, vital signs, or electrocardiograms. Subcutaneous injection was well tolerated.

Pharmacokinetic results demonstrated that DX-2930 has linear, dose-dependent exposure and a mean elimination half-life of approximately 14 days across all dose groups studied. Pharmacodynamic results from two different exploratory biomarker assays confirmed ex vivo plasma kallikrein inhibition in a dose- and time-dependent manner.

Primary proof-of-concept efficacy analyses were based on subjects in the 300 mg, 400 mg, and placebo dose groups who reported having at least 2 attacks in the 3 months prior to study entry. During the pre-specified, primary efficacy interval of 6 weeks (from days 8 to 50; corresponding to peak drug level), the HAE attack rate (adjusted for baseline attacks) was 0 in the 300 mg group and 0.045 attacks per week in the 400 mg group, compared to 0.37 attacks per week in the placebo group. This resulted in a 100% reduction for the 300 mg dose group as compared to placebo (P<0.0001), and an 88% reduction for the 400 mg dose group as compared to placebo (P=0.005). During this primary efficacy interval, 100% of subjects in the 300 mg group (P=0.026) and 82% of subjects in the 400 mg group (P=0.030) were attack-free compared with 27% of subjects in the placebo group. The study will be complete when all subjects in the 400 mg dose group finish the final safety assessments on study day 120.

Today Dyax also announced receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for the investigation of DX-2930 for HAE.

“These data provide important clinical proof-of-concept, dose response and safety information in the target patient population,” said Burt Adelman, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax. “The study met all of its primary objectives, and notably, DX-2930 also demonstrated statistically significant reductions in attack rate compared to placebo, an important characteristic for a prophylactic treatment. We look forward to communicating these results to the FDA to ensure that our product development plan is supportive of drug approval. We plan to take full advantage of the opportunities that Fast Track designation allows in order to maximize the possibility of a more rapid path to approval.”

“The positive results from this trial are a significant milestone for Dyax and will be integral in guiding the future clinical development of DX-2930,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “If approved, we believe that DX-2930, with its unique profile, is well positioned as a potential preventive treatment option for patients suffering from HAE.”

Conference Call & Webcast
Date: Tuesday, March 31, 2015
Time: 5:00 p.m. ET
Telephone Access: Domestic callers, dial 877-674-2415,
International callers, dial 708-290-1364,
Reference the Dyax conference call;
Online Access: Go to the Investor Relations section of the Dyax website (http://investor.dyax.com/index.cfm)
and follow instructions for accessing the live webcast. Please connect to the website
at least 15 minutes prior to the start of the conference call to ensure adequate time
for any software download that may be necessary.

About DX-2930
DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein (pKal) which is currently being developed as a subcutaneous injection for the prevention of HAE attacks. Uncontrolled pKal activity leads to excessive generation of bradykinin, a vasodilator thought to be responsible for the localized swelling, inflammation and pain characteristically associated with HAE.

About Hereditary Angioedema (HAE)
HAE is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, gastrointestinal tract, genitalia, and larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood. HAE is estimated to affect up to 1 in 50,000 individuals. Learn more at www.HAEHope.com.

About Dyax
Dyax is a fully integrated biopharmaceutical company focused on the development and commercialization of novel biotherapeutics for unmet medical needs. The Company currently markets KALBITOR® (ecallantide) for the treatment of acute attacks of HAE in patients 12 years of age and older. Dyax is also developing DX-2930, a fully human monoclonal antibody, for the potential prophylactic treatment of HAE.

Both KALBITOR and DX-2930 were identified using Dyax’s proprietary phage display technology. Dyax has broadly licensed this technology under its Licensing and Funded Research Portfolio (LFRP). The current portfolio includes one FDA approved product, Eli Lilly and Company’s CYRAMZA® (ramucirumab), for which Dyax receives royalties, and multiple product candidates in various stages of clinical development for which the Company is eligible to receive future milestones and/or royalties.

For additional information about Dyax, please visit www.dyax.com.

For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com.

Disclaimer
The press release contains forward-looking statements, including statements regarding the prospects for therapeutic benefits and treatment advantages of an investigational product, DX-2930, being developed for HAE. Statements that are not historical facts are based on Dyax’s current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this press release are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include the following: the results from our Phase 1b study may not be predictive of the results or success of future clinical trials that will be required to permit application for regulatory approval of DX-2930; even if DX-2930 progresses through clinical trials and gains regulatory approval, it may not gain market acceptance; others may develop technologies or products superior to DX-2930 or that reach the market before DX-2930; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, quality control, storage and clinical development of DX-2930; the costs of prosecuting, maintaining, defending and enforcing our patents and other intellectual property rights; the overall condition of the financial markets; and a variety of other risks common to our industry; changing requirements and costs associated with Dyax’s planned research and development activities; competition from new and existing treatments for HAE; the uncertainty of patent and intellectual property protection; and other risk factors described or referred to in Item 1A, “Risk Factors” in Dyax’s most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.

Dyax, the Dyax logo and KALBITOR are registered trademarks of Dyax Corp.
CYRAMZA® is a registered trademark of Eli Lilly and Company.

Dyax Corp.
Jennifer Robinson, 617-250-5741
Director, Investor Relations and Corporate Communications
jrobinson@dyax.com

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(GBSN) Receives Patents for Sample-to-Result Molecular Diagnostic Testing Technology

Patent Covers Methods of Isothermal Amplification Using Blocked Primers Patents Additionally Cover Systems and Methods for Point-of-Care Amplification and Detection of Polynucleotides As Well As Methods and Compositions for Amplifying a Detectable Signal

SALT LAKE CITY, March 31, 2015  — Great Basin Scientific, Inc. (NASDAQ: GBSN and GBSNU), a molecular diagnostics company, today announced that the United States Patent and Trademark Office (USPTO) issued a notice of allowance for patent 8,936,921 for the Company’s method of isothermal helicase-dependent amplification (HDA) using blocked primers (bp), or “bpHDA.” bpHDA creates a highly specific “hot-start” functionality which increases the amplification speed, improves assay sensitivity and expands multiplex capabilities of Great Basin’s sample-to-result molecular diagnostic testing technology. bpHDA is the basis of the Company’s Clostridium difficile (C. diff) molecular diagnostic test assay.

This newly issued patent further enhances the Company’s patent family, which includes U.S. patent 8,637,250 (issued Jan. 28, 2014) for systems and methods for point-of-care amplification and detection of polynucleotides covering isothermal amplification using HDA on the surface of chips. This patent permits future simplification of Great Basin’s chip technology which would further lower costs, increase speed, and potentially allow for a field-deployable approach for molecular diagnostics. U.S. patent 8,574,833 (issued on Nov. 5, 2013) covers methods and compositions for amplifying a detectable signal. The method, termed AMPED, is a cost-effective approach for direct detection of pathogens present in clinical samples such as blood, lung aspirates, urine, stool and swabs at low levels without the requirement of PCR-based target amplification.  Great Basin asserts that by eliminating the amplification step used in other methods, their technology has the potential to provide faster results at a lower cost.

“We believe that with these patents, Great Basin offers a platform for molecular diagnostics unlike any currently available system,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin. “Using one system, our technology is capable of answering both the ‘What is it?’ question, answered by a low-cost, low-plex assay, and the ‘What is causing it?’ question, identified by a multi-plex panel. We contend this will allow hospital labs to invest in fewer systems while providing more answers with an easy-to-use and cost effective system.”

About Great Basin Scientific
Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies.  The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the Company’s website at www.gbscience.com.

Forward-Looking Statements
Certain statements in this press release may be deemed to be forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding our potential future growth. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history or losses; (ii) our ability to develop and commercialize new products and the timing of commercialization; (iii) our ability to obtain capital when needed; and (iv) other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the quarter ended December 31, 2014. These forward-looking statements speak only as of the date hereof and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.

Media Contact:
Tony Russo, Ph.D. or Todd Davenport, Ph.D.
Russo Partners, LLC
212.845.4251
tony.russo@russopartnersllc.com
todd.davenport@russopartnersllc.com

Investor Relations Contact:
Bob Yedid
ICR
646.277.1250
bob.yedid@icrinc.com

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(NETE) Reports 2014 Annual Results and Provides Strategic Update

2014 Debt Reduced From $31 Million to $3 Million, G&A From $12 Million To $7 Million, Excluding Non-Cash Items

MIAMI, FL–(Mar 31, 2015) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a provider of global mobile payment technology solutions and value-added transactional services today reported financial results for the fiscal year ended December 31, 2014.

Key milestones (2014 – 2015 YTD):

  • Improved access to credit to implement strategic initiatives; established $10 million credit facility in the U.S. and enhanced our Russian borrowing capacity. New financing of $10 million triggered conversion of $11 million of debt to equity
  • Advanced service offering expansion by agreeing to acquire mobile payment technology innovator PayOnline
  • Reorganized mobile payments business — positive operating cash flow based on improved management of account receivables and restructure of business operations. Positive working capital allowed self-financing of growing mobile payments business during 2014
  • Migrated to proprietary billing system for mobile business operations
  • In January 2015, our mobile payments business exceeded 1 million recurring mobile subscribers
  • Eliminated $15.9 million of debt obligations in September 2014 through a debt-to-equity swap
  • General & administrative expenses reduced by $5 million including $1 million in salaries and $2 million in professional fees
  • Announced Apple Pay™ availability in Company’s U.S. POS terminal network
  • Enhanced board with appointment of financial services veteran William Healy and payments technology industry veteran Drew Freeman

2015 Initiatives:

  •  PayOnline closing and integration
  •  Mobile payments expansion into Middle East and India
  •  Expand Russia service offerings
  •  Creation of omni-channel, payments-as-a-service platform that can be profitably adapted to local businesses globally

“Now that we have strengthened our balance sheet by eliminating most of our debt and created a restructured operational foundation, we can advance our plan to grow market share, accelerate sales and expand profitability,” commented Oleg Firer, CEO.

“Our growing traditional and mobile technology base, our strengthened balance sheet and strategic emphasis on Small to Medium Enterprise (SME) are competitive advantages that we expect to capitalize on during 2015.”

2014 Operating Results

In an effort to present a more comparative period on period analysis, we have adjusted net loss to remove the effects of non-recurring expenses from discontinued operations, non-cash share based compensation, goodwill impairment, debt extinguishment and debt restructuring.

The adjusted loss from continuing operations for the year 2014 was $6.9 million, or a loss of $0.19 per share, as compared to an adjusted loss from continuing operations of $19.4 million or a loss of $0.68 per share, for the year ended December 31, 2013. The adjusted loss from 2014 primarily related to general and administrative expenses (primarily salaries and professional fees) of $7.1 million, interest expense of $3.7 million and depreciation and amortization of $2.4 million. This was offset by a recovery of bad debts of $1.2 million (net) resulting primarily from the recovery of Russian receivables and advances previously reserved in 2013.

Net revenues for the year 2014 were $21.2 million, as compared to $18.7 for the year 2013. The increase in net revenues is substantially due to an increase of $4.6 million in transaction processing revenues offset by $2.1 million of reduced Russian mobile payment processing revenues as we restructured our Russian business with new management and its own proprietary billing system starting late 2013 and concluding in April 2014. Russian mobile payment revenues were $1.8 million for the year 2014 compared to $3.9 million for the year 2013. The transaction processing services business was acquired in April 2013 and the operating results for 2013 reflect 8.5 months of transaction processing services activity.

Our gross margin for the year 2014 was $5.3 million versus $5.4 million for the year 2013. While the dollar value of gross margin remained consistent year over year, the mix of business was different. For 2014 our transaction processing gross margin was $0.7 million higher than in 2013 and the mobile payments gross margin decreased by $0.8 million between 2013 and 2014. The change in margin mix reduced our overall gross margin from 29% of revenues to 25% of revenues as detailed below. The mobile payments gross margin for 2014 and 2013 was affected by penalties assessed in 2013 and successfully abated during 2014. Excluding $0.2 million in penalties, gross margin for mobile payments was 92% in 2014 and 73% in 2013. Mobile payment margins were higher in 2014 (as adjusted) due to changes in our pricing and business operations.

Twelve Twelve
Months Ended Months Ended Increase /
Source of Revenues December 31, 2014 Mix December 31, 2013 Mix (Decrease)
Transaction Processing Services $ 19,373,877 91 % $ 14,801,383 79 % $ 4,572,494
Mobile Payments 1,820,584 9 % 3,948,087 21 % (2,127,503 )
Total $ 21,194,461 100 % $ 18,749,470 100 % $ 2,444,991
Cost of Revenues
Transaction Processing Services $ 15,925,924 82 % $ 12,094,998 82 % $ 3,830,926
Mobile Payments (42,243 ) -2 % 1,279,671 32 % (1,321,914 )
Total $ 15,883,681 75 % $ 13,374,669 71 % $ 2,509,012
Gross Margin
Transaction Processing Services $ 3,447,953 18 % $ 2,706,385 18 % $ 741,568
Mobile Payments 1,862,827 102 % 2,668,416 68 % (805,589 )
Total $ 5,310,780 25 % $ 5,374,801 29 % $ (64,021 )

General and administrative expenses, excluding non-cash compensation expense, were $7.1 million for 2014 as compared to $11.6 million for 2013. This was primarily due to reductions of $1.1 million in salaries and benefits; $1.7 million in professional fees; $0.6 million in transaction gains and losses and $0.4 in other general and administrative expenses. The reduction in salaries and benefits is due to net headcount reductions; professional fees are lower due to higher legal fees from our reorganization in 2013 after the Company’s merger transaction with Unified Payments.

Net Element’s recovery from loan loss provision was $1.2 million for 2014 as compared to an expense provision of $7.6 million of expense for 2013, representing a decrease of $8.8 million year over year. The Company recorded a net recovery in provision for loan losses for 2014 which consisted of a favorable adjustment to the bad debt allowance of $1.6 million that was associated with Russian operations, offset by loss provision for net ACH rejects of $0.4 million in U.S. credit card processing business. We reported a $7.6 million loss provision for 2013 primarily due to receivables and advances from Russian aggregators that were deemed uncollectible.

Cash provided by operating activities of continuing operations was $2.3 million for 2014 compared to cash used in operating activities of $9.8 million for 2013. Positive operating cash flow for 2014 was primarily due to the $7.9 million reduction of accounts receivable and aggregator advances offset primarily by $1.3 million of increases in accounts payable and accrued expenses.

Cash used in investing activities for 2014 was $1.8 million primarily due to $1.0 million used to purchase merchant portfolios and the write off of $0.8 million in fixed assets resulting primarily from closure of our Ukraine development office. For 2013, $4.1 million of cash was provided by investing activities primarily resulting from $4.9 million in collections of notes receivable offset by approximately ($0.8) of acquisition related costs.

Total liabilities were $8.8 million at December 31, 2014 compared to $37.9 million at December 31, 2013. The Company’s total debt was $3.3 million at December 31, 2014 versus total debt and related party payables of $31.0 million at December 31, 2013, representing a reduction of $27.7 million. Net Element has significantly reduced its debt and related interest expense. On September 15, 2014, the Company completed a debt exchange program which eliminated $15.9 million in debt obligations. Pursuant to the terms of our convertible debt agreement, we converted $11.2 million of debt to equity upon obtaining a new $10 million credit facility. Additionally, Net Element’s factoring lines were $0 at December 31, 2014 as compared to $8.5 million at December 31, 2013. We were able to successfully finance our Russian mobile payment business with operating cash flow generated internally. Our factoring facilities allow TOT Money to assign to the bank certain (but not all) of its accounts receivable suitable to the lender(s) under such facilities as security for financing. Accordingly, the amounts of our draws under such facilities from time to time will depend on the amounts of the accounts receivable suitable for such assignment as of the time we choose to draw under such facility. We have not drawn any funds under such credit facilities during 2014.

Reconciliation of Non-GAAP Financial Measures and Regulation G Disclosure

To supplement its consolidated financial statements presented in accordance with United Stated generally accepted accounting principles (“GAAP”), the Company provides additional measures of its operating results by disclosing its adjusted loss on a continuing operations basis and adjusted gross margin excluding penalties. Adjusted loss on a continuing operations basis is calculated as loss from continuing operations excluding discontinued operations, non-cash share based compensation, goodwill impairment, debt extinguishment and debt restructuring costs. Net Element discloses this amount on an aggregate and per share basis. Additionally, the Company is disclosing its mobile payments gross margin adjusted for penalties charged and recovered to analyze the trend of gross margin without penalties. These measures meet the definition of non-GAAP financial measures. The Company believes that application of these non-GAAP financial measures is appropriate to enhance the understanding of its historical performance through use of a metric that seeks to normalize period to period earnings and gross margin.

This press release contains non-GAAP financial measures within the meaning of Regulation G promulgated by the Securities and Exchange Commission. Pursuant to Regulation G, a reconciliation of these non-GAAP financial measures with the comparable financial measures calculated in accordance with GAAP for the twelve months ended December 31, 2014 and 2013 is presented in the following Non-GAAP Financial Measures Table.

Non-GAAP Financial Measures

Debt
Extingushment
Share- Intangible and Adjusted
based Goodwill Asset Debt Non-
GAAP Compensation Impairment Impairment Restructure GAAP
Twelve Months Ended December 31, 2014
Loss from continuing operations $ (10,214,766 ) $ 4,267,334 $ $ $ (980,939 ) $ (6,928,371 )
Basic and diluted earnings per share from continuing operations $ (0.27 ) $ 0.11 $ $ $ (0.03 ) $ (0.19 )
Basic and diluted shares used in computing earnings per share from continuing operations 37,255,052 37,255,052
Debt
Extingushment
Share- Intangible and Adjusted
based Goodwill Asset Debt Non-
GAAP Compensation Impairment Impairment Restructure GAAP
Twelve Months Ended December 31, 2013
Loss from continuing operations $ (48,009,020 ) $ 16,549,820 $ 11,200,000 $ 872,354 $ $ (19,386,846 )
Basic and diluted earnings per share from continuing operations $ (1.69 ) $ 0.58 $ 0.39 $ 0.03 $ $ (0.68 )
Basic and diluted shares used in computing earnings per share from continuing operations 28,470,169 28,470,169

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether the Company’s access to credit will result in the ability to implement its strategic initiatives, whether the PayOnline transaction will be consummated and if so, will result in an advanced service offering, whether the Company’s Board has in fact been improved by the appointment of the 2 new Directors, whether any of the referenced 2015 initiatives will materialize, whether the Company’s plan to grow market share, accelerate sales and expand profitability will materialize, whether the growth in user base and the strategic emphasis on Small to Medium Enterprise (SME) result in competitive advantages for the Company that can be capitalized on, whether the financial reporting and adjustments calculated to present a more comparative period on period analysis achieve the stated objective, whether the application by the Company of non-GAAP financial measures is appropriate to enhance the understanding of its historical performance, whether Net Element can secure any additional financing, and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element ‘s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element ‘s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element ‘s ability to successfully expand in existing markets and enter new markets; (iv) Net Element ‘s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element ‘s business; (viii) changes in government licensing and regulation that may adversely affect Net Element ‘s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element ‘s business; (x) Net Element ‘s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.

NET ELEMENT, INC.
CONSOLIDATED BALANCE SHEETS

December 31, 2014 December 31, 2013
ASSETS
Current assets:
Cash $ 503,343 $ 126,319
Accounts receivable, net 3,417,173 10,619,289
Advances to aggregators, net 18,455 1,109,538
Prepaid expenses and other assets 944,243 834,025
Total current assets 4,883,214 12,689,171
Fixed assets, net 70,918 137,267
Intangible assets, net 2,492,050 2,964,424
Goodwill 6,671,750 6,671,750
Other long term assets 204,737
Investment in affiliate 46,113
Total assets $ 14,322,669 $ 22,508,725
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable $ 2,698,257 $ 3,190,215
Deferred revenue 472,482 239,398
Accrued expenses 2,351,885 3,484,963
Short term loans 8,478,810
Notes payable (current portion) 98,493 3,816,093
Due to related parties 1,451,357
Total current liabilities 5,621,117 20,660,836
Note payable (non-current portion) 3,216,507 17,255,531
Total liabilities 8,837,624 37,916,367
STOCKHOLDERS’ EQUITY (DEFICIT)
Preferred stock ($.01 par value, 1,000,000 shares
authorized and no shares issued and outstanding)
Common stock ($.0001 par value, 200,000,000 shares
authorized and 45,881,523 and 32,273,298 shares issued and outstanding at December 31, 2014 and 2013, respectively) 4,589 3,229
Paid in capital 136,689,629 103,486,144
Stock subscription receivable (1,111,130 ) 329,406
Accumulated other comprehensive loss (1,251,461 ) (170,550 )
Accumulated deficit (129,116,344 ) (118,930,828 )
Noncontrolling interest 269,762 (125,043 )
Total stockholders’ equity (deficit) 5,485,045 (15,407,642 )
Total liabilities and stockholders’ equity (deficit) $ 14,322,669 $ 22,508,725

NET ELEMENT, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Twelve months ended December 31,
2014 2013
Net revenues $ 21,194,461 $ 18,749,470
Costs and expenses:
Cost of revenues 15,883,681 13,374,669
General and administrative (includes $4,267,334 and $16,549,820 of share basedcompensation for the twelve months ended December 31, 2014 and 2013 respectively)
11,353,244 28,166,387
(Recovery of) provision for loan losses (1,153,147 ) 7,640,008
Goodwill impairment charge 11,200,000
Intangible assets impairment charge 872,354
Depreciation and amortization 2,358,136 2,242,504
Total costs and operating expenses 28,441,914 63,495,922
Loss from operations (7,247,453 ) (44,746,452 )
Interest expense, net (3,705,694 ) (2,979,102 )
Gain on change in fair value and settlement of beneficial conversion derivative 5,569,158
Loss on debt extinguishment (6,184,219 )
Gain on debt restructure 1,596,000
Loss from asset disposal (87,151 )
Other expense (155,407 ) (160,182 )
Loss from continuing operations before income taxes (10,214,766 ) (47,885,736 )
Income taxes (213,284 )
Loss from continuing operations (10,214,766 ) (48,099,020 )
Net loss attributable to the noncontrolling interest 29,250 1,129,319
Net loss from continuing operations attributable to Net Element, Inc. (10,185,516 ) (46,969,701 )
Discontinued operations:
Loss from operations of discontinued entities (1,018,003 )
Loss on disposition of assets pertaining to discontinued operations (321,643 )
Net loss (10,185,516 ) (48,309,347 )
Foreign currency translation (1,080,911 ) (449,115 )
Comprehensive loss $ (11,266,427 ) $ (48,758,462 )
Loss per share – basic and diluted $ (0.27 ) $ (1.65 )
Loss per share – basic and diluted discontinued operations (0.05 )
Total loss per share $ (0.27 ) $ (1.70 )
Weighted average number of common shares outstanding – basic and diluted 37,255,052 28,470,169

NET ELEMENT, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

Common Stock Paid in Stock Comprehensive Non-controlling Accumulated Equity (Deficiency)
Shares Amount Capital Subscription Income interest Deficit in Assets
Balance December 31, 2012 (Restated) 28,303,659 $ 2,830 $ 87,452,060 $ $ 278,565 $ (103,437 ) $ (70,621,481 ) $ 17,008,537
Non cash compensation related to TOT Group stock exchange 2,812,771 281 12,197,823 1,107,713 13,305,817
Non cash compensation- other 1,265,109 129 3,243,874 3,244,003
Cash paid for repurchase of common shares (175,953 ) (17 ) (482,400 ) (482,417 )
Note Payable and other assumed by T1T Lab, net of contributions payable 685,449 685,449
Shares issued pursuant to purchase agreement 67,712 6 389,338 389,344
Unissued shares pursuant to purchase agreement 329,406 329,406
Foreign currency exchange (449,115 ) (449,115 )
Net loss (1,129,319 ) (48,309,347 ) (49,438,666 )
Balance Dec 31, 2013 32,273,298 $ 3,229 $ 103,486,144 $ 329,406 $ (170,550 ) $ (125,043 ) $ (118,930,828 ) $ (15,407,642 )
Share based compensation 1,755,749 176 3,677,937 3,678,113
Shares issued and issuable for acquisitions 57,288 6 329,400 (329,406 )
Shares issued to acquire non-controlling interest 323,085 32 617,060 424,055 1,041,147
Shares issued in connection with debt conversion 5,569,158 556 10,636,537 (1,111,130 ) 9,525,963
Shares issued in connection with debt restructuring 100,000 10 203,990 204,000
Shares issued in connection with note conversion 5,802,945 580 16,711,901 16,712,481
Extinguishment of T1T obligation 1,086,968 1,086,968
NASDAQ share registration fees (60,308 ) (60,308 )
Net loss (29,250 ) (10,185,516 ) (10,214,766 )
Comprehensive loss – foreign currency translation (1,080,911 ) (1,080,911 )
Balance Dec 31, 2014 45,881,523 $ 4,589 $ 136,689,629 $ (1,111,130 ) $ (1,251,461 ) $ 269,762 $ (129,116,344 ) $ 5,485,045

NET ELEMENT, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS

Twelve Months Ended December 31,
2014 2013
Cash flows from operating activities:
Net loss $ (10,185,516 ) $ (48,309,347 )
Loss from discontinued operations 321,643
Adjustments to reconcile net loss to net cash used in operating activities:
Non controlling interest 394,286 (1,129,319 )
Non cash compensation 4,267,334 16,549,820
Deferred revenue 233,084
Note receivable (current portion)
Depreciation and amortization 2,358,136 2,242,504
Impairment of Goodwill 11,200,000
Intangible assets impairment 872,354
Amortization of debt discount 1,644,626
(Recovery of ) provision for loan losses (1,649,858 ) 7,640,008
Loss on disposal of fixed assets 16,137
Gain on disposal of derivative (5,569,158 )
Loss on debt extinguishment 6,184,219
Gain on MBF debt restructure (1,596,000 )
Changes in assets and liabilities, net of acquisitions and the effect ofconsolidation of equity affiliates
Account receivable 6,974,701 (562,294 )
Advances to aggregators 934,816 (3,267,679 )
Prepaid expenses and other assets (445,555 ) 1,952,570
Accounts payable (338,618 ) 2,268,233
Accrued expenses (968,609 ) 429,556
Adjustments for operating activities of continuing operations 12,439,541 38,195,753
Adjustments for operating activities of discontinued operations (1,018,003 )
Net cash provided by (used in) operating activities 2,254,025 (10,809,954 )
Cash flows from investing activities- net of acquisitions:
Purchase of portfolio and client acquisition costs (1,039,752 )
Note receivable (2,650 ) 4,920,510
Acquisition of intangible assets (380,025 )
Acquisition of Aptito (458,747 )
Investment in subsidiary (46,113 )
(Purchase) disposal of fixed and other assets (750,936 ) 67,266
Net cash (used in) provided by investing activities (1,793,338 ) 4,102,891
Cash flows from financing activities- net of acquisitions:
Proceeds from indebtedness 10,088,870 2,000,000
Repayment of indebtedness (10,433,367 ) (272,103 )
Change in restricted cash 1,978,527
Cash paid for shares and warrants (482,417 )
Related party advances (payments) 418,099 (75,000 )
Net cash provided by financing activities 73,602 3,149,007
Effect of exchange rate changes on cash (157,265 ) 137,588
Net increase (decrease) in cash 377,024 (3,420,468 )
Cash at beginning of period 126,319 3,546,787
Cash at end of period $ 503,343 $ 126,319
Supplemental disclosure of cash flow information
Cash paid during the period for:
Interest $ 1,109,731 $ 1,635,360
Taxes $ 38,993 $ 196,425
Issuance of stock upon conversion of indebtedness $ 25,233,473 $
Issued and outstanding common stock (10% of TOT Group’s common stock) $ $ 609,000
Assumed debt 20,631,000
Total value of consideration for Unified Payments acquisition $ $ 21,240,000
Stock subscription in connection with acquisition of Aptito $ $ 718,750
Transfer of K1 note liability to T1T Lab, LLC in connection with divesture of OOO Music 1 $ $ 2,000,000

Net Element, Inc. Investor Inquiries:
investors@netelement.com
(786) 923-0502
www.netelement.com

Tuesday, March 31st, 2015 Uncategorized Comments Off on (NETE) Reports 2014 Annual Results and Provides Strategic Update

(HZNP) To Acquire (HPTX) for $46.00 per Share or $1.1 Billion in Cash

Addition of RAVICTI(R) (Glycerol Phenylbutyrate) Oral Liquid and BUPHENYL(R) (Sodium Phenylbutyrate) Tablets and Powder Significantly Expands Horizon’s Orphan Business; Transaction Is Expected to Be Immediately Accretive to Adjusted Earnings Per Share and Contribute Approximately $100 Million in Adjusted EBITDA in 2016; Conference Call Today at 8 A.M. ET to Discuss Transaction

DUBLIN, IRELAND and BRISBANE, CA–(Mar 30, 2015) – Horizon Pharma plc (NASDAQ: HZNP) and Hyperion Therapeutics, Inc. (NASDAQ: HPTX) today announced they have entered into a definitive agreement under which Horizon Pharma will acquire all of the issued and outstanding shares of Hyperion’s common stock for $46.00 per share in cash or approximately $1.1 billion on a fully diluted basis. The per share consideration represents a premium of approximately 35 percent to Hyperion’s volume weighted average price for the trailing 60-days. The proposed transaction has been unanimously approved by both companies’ boards of directors.

“The Hyperion acquisition will expand and diversify our product portfolio by adding two complementary orphan disease products, RAVICTI and BUPHENYL, and leverage as well as expand the existing infrastructure of our orphan disease business,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. “This transaction will be immediately accretive to adjusted EPS and we expect the contribution of RAVICTI and BUPHENYL in 2016 will add approximately $100 million to our adjusted EBITDA, including cost synergies contributing greater than $50 million. Additionally, this acquisition further accelerates our near- and long-term sales and adjusted EBITDA growth and provides significant value for both Horizon and Hyperion shareholders.”

“During the last two years, we have solidified our position in the orphan disease space and made significant progress in bringing life-changing medicines to people with urea cycle disorders,” said Donald J. Santel, president and chief executive officer, Hyperion Therapeutics, Inc. “I would like to thank my colleagues for their tireless commitment to advancing the clinical development and understanding of RAVICTI, BUPHENYL and urea cycle disorders. Horizon shares our commitment and I’m confident that the strength of its existing orphan business unit will continue to expand the reach of these important medicines to more patients impacted by these disorders.”

Strategic and financial benefits of the transaction:

  • Increases the number of Horizon’s products from five to seven, with the addition of RAVICTI and BUPHENYL to Horizon’s orphan business unit, providing additional revenue diversification
  • Leverages Horizon’s orphan business unit offering attractive revenue and operating synergies
  • Expected 2016 adjusted EBITDA of approximately $100 million from the acquired business with expected cost synergies of more than $50 million

RAVICTI and BUPHENYL are medicines for people with urea cycle disorders (UCDs), a collection of inherited metabolic disorders, which impact approximately 2,100 people in the United States with approximately 1,100 diagnosed. A marketing authorization application has been filed for European marketing of RAVICTI. The prevalence of UCD is similar in Europe and other international markets.

Net sales of RAVICTI and BUPHENYL for Q4 2014 and full year 2014 were $30.8 million and $113.6 million, respectively.

Transaction Terms
The acquisition is structured as an all cash tender offer for all the issued and outstanding shares of Hyperion common stock at a price of $46.00 per share followed by a merger in which each remaining untendered share of Hyperion common stock would be converted into the $46.00 per share cash consideration paid in the tender offer.

Horizon has entered into agreements with certain stockholders of Hyperion, including certain members of the Hyperion management team and certain funds affiliated with members of the Hyperion board of directors, pursuant to which each of these stockholders has agreed to tender the Hyperion common shares owned of record or beneficially by such stockholder, which in the aggregate represent approximately 21 percent of the outstanding Hyperion common shares as of the date of the agreements.

Closing of the transaction is subject to customary conditions, including the tender of a majority of the outstanding Hyperion shares and expiration or termination of the HSR waiting period. It is anticipated that the transaction will close in the second quarter of 2015.

Financing
Horizon has secured $900 million in debt commitments from Citigroup Global Capital Markets Inc. and Jefferies LLC, which in addition to Horizon’s cash and cash equivalents, is available to finance the transaction, repay Horizon’s $300 million Senior Secured Credit Facility and pay fees as well as expenses related to the transaction. Horizon plans to replace a portion of the debt commitments through new debt issuances and the use of Hyperion’s cash and cash equivalents.

Advisors
Jefferies LLC, Citigroup Global Markets Inc. and Cowen and Company acted as advisors to Horizon Pharma in the transaction. Citigroup Global Markets Inc. and Jefferies LLC are initial lenders and lead arrangers for the debt commitments in place to finance the transaction. Horizon Pharma’s legal advisors are Cooley LLP and McCann FitzGerald.

Centerview Partners LLC acted as financial advisor and provided a fairness opinion to Hyperion and Shearman & Sterling LLP acted as legal advisor. Houlihan Lokey Capital, Inc. also provided financial advice to the board of Hyperion.

Conference Call Today at 8 A.M. ET
At 8 a.m. Eastern Time today, Horizon’s management will host a conference call and live audio webcast to review the transaction and related matters. The live webcast and a replay may be accessed by visiting the investors section of Horizon’s website at http://ir.horizon-pharma.com. Please connect to the company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 888-338-8373 (U.S.) or 973-872-3000 (international) to listen to the conference call. The conference ID number for the live call is 17958843. Telephone replay will be available approximately two hours after the call. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international). The conference ID number for the replay is 17958843. An archived version of the webcast will be available for at least one week on the investors section of Horizon’s website at http://ir.horizon-pharma.com.

About Horizon Pharma plc
Horizon Pharma plc is a specialty biopharmaceutical company focused on improving patients’ lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs. The company markets a portfolio of products in arthritis, inflammation and orphan diseases. The company’s U.S. marketed products are ACTIMMUNE® (interferon gamma-1b), DUEXIS® (ibuprofen/famotidine), PENNSAID® (diclofenac sodium topical solution) 2% w/w, RAYOS® (prednisone) delayed-release tablets and VIMOVO® (naproxen/esomeprazole magnesium). Horizon’s global headquarters are in Dublin, Ireland. For more information, please visit www.horizonpharma.com.

About Hyperion Therapeutics, Inc.
Hyperion Therapeutics is a commercial-stage biopharmaceutical company committed to developing and delivering life-changing treatments for orphan diseases. The company’s first commercial product, RAVICTI® (glycerol phenylbutyrate) Oral Liquid, was approved in February 2013 and is currently being marketed in the United States. The company also owns worldwide rights to BUPHENYL® (sodium phenylbutyrate) Tablets and Powder, which it markets in the United States. BUPHENYL is also marketed internationally through business partners. In addition, the company is developing RAVICTI for the potential treatment of hepatic encephalopathy. For more information, please visit www.hyperiontx.com.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to Horizon’s anticipated acquisition of Hyperion and the timing and benefits thereof, estimated future financial results and performance of RAVICTI and BUPHENYL and Horizon’s business as a whole, Horizon’s financing plans, the combined company’s strategy, plans, objectives, expectations and intentions, anticipated product portfolio, and other statements that are not historical facts. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Horizon’s ability to complete the acquisition on the proposed terms and schedule; whether Horizon or Hyperion will be able to satisfy their respective closing conditions related to the acquisition; whether sufficient Hyperion stockholders tender their shares in the acquisition; whether Horizon will obtain financing for the transaction on the expected timeline and terms; the outcome of legal proceedings that may be instituted against Hyperion and/or others relating to the acquisition; the possibility that competing offers will be made; risks associated with business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the acquisition will not occur; risks related to future opportunities and plans for the combined company, including uncertainty of the expected financial performance and results of the combined company following completion of the proposed acquisition; disruption from the proposed acquisition, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; and the possibility that if the combined company does not achieve the perceived benefits of the proposed acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Horizon’s shares could decline, as well as other risks related to the Horizon and Hyperion businesses, including the ability to grow sales and revenues from existing products; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight; and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Horizon’s and Hyperion’s respective SEC filings and reports, including their respective Annual Reports on Form 10-K for the year ended December 31, 2014. Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or changes in its expectations.

Additional Information and Where to Find It
The tender offer described in this communication (the “Offer”) has not yet commenced, and this communication is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Hyperion or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the SEC by Horizon and a Solicitation/Recommendation Statement on Schedule 14D-9 will be filed with the SEC by Hyperion. The offer to purchase shares of Hyperion common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The tender offer statement will be filed with the SEC by Ghrian Acquisition Inc., a wholly owned subsidiary of Horizon Pharma, Inc., which is an indirect wholly owned subsidiary of Horizon Pharma plc, and the solicitation/recommendation statement will be filed with the SEC by Hyperion. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement.

Note Regarding Use of Non-GAAP Financial Measures
EBITDA, or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA are used and provided by Horizon as non-GAAP financial measures. Adjustments to expected EBITDA related to RAVICTI and BUPHENYL exclude acquisition transaction related expenses, loss on debt extinguishment, as well as non-cash items such as stock compensation, depreciation and amortization, royalty accretion, non-cash interest expense, and other non-cash adjustments. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Horizon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon’s financial performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of Horizon’s expected operational results and trends. In addition, these non-GAAP financial measures are among the indicators Horizon’s management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. The Company has not provided a reconciliation of expected 2016 adjusted EBITDA related to RAVICTI and BUPHENYL to a net income (loss) outlook because certain items that are a component of net income (loss) but not part of adjusted EBITDA, such as stock compensation and acquisition related expenses, cannot be reasonably projected, either due to the significant impact of changes in Horizon’s stock price on stock compensation, or the variability associated with acquisition related expenses due to timing and other factors.

For full prescribing information refer to the individual product websites.

Contacts:

Company:
Robert F. Carey
Executive Vice President, Chief Business Officer
Email Contact

Investors:
Ami Bavishi
Burns McClellan
Email Contact

International Media:
Ray Gordon
Gordon MRM
Email Contact

U.S. Media:
Geoff Curtis
DJE Science
Email Contact

Monday, March 30th, 2015 Uncategorized Comments Off on (HZNP) To Acquire (HPTX) for $46.00 per Share or $1.1 Billion in Cash

(CTRX) and OptumRx to combine

Clients and individuals will benefit from enhanced services and cost trend management; combined organization expects to fulfill more than one billion scripts

Combining OptumRx’s unique medical synchronization, information capabilities with Catamaran’s technology leadership and flexible services will advance innovative value-added offerings

Creates business well-positioned to help customers manage growth in high-cost specialty pharmaceuticals

NEW YORK, NY and SCHAUMBURG, IL, March 30, 2015  – OptumRx and Catamaran Corporation [NASDAQ: CTRX, TSX: CCT], a leading provider of pharmacy benefit management (“PBM”) services and technology solutions, announced today they have agreed to combine.  OptumRx is UnitedHealth Group’s [NYSE: UNH] free-standing pharmacy care services business.

The agreement calls for the acquisition of Catamaran’s outstanding common stock for $61.50 per share in cash. The transaction is expected to close during the fourth quarter of 2015, subject to Catamaran shareholders’ approval, regulatory approvals and other customary closing conditions. The combination diversifies OptumRx’s customer and business mix, while accelerating its technology leadership and flexible service offerings.

The acquisition is expected to be accretive to UnitedHealth Group’s net earnings in the area of $0.30 per share in 2016.  UnitedHealth Group plans to finance the acquisition from existing cash resources and new debt.  The company affirmed its $6.00 to $6.25 per share earnings outlook assuming the absorption of all merger costs, the ongoing commitment to advance its dividend policy as planned, and a continued but moderated level of share repurchase.

Upon closing, Mark Thierer, Catamaran’s chairman and chief executive officer, will serve as chief executive officer of OptumRx and Timothy Wicks, the current chief executive officer of OptumRx, will become president. Jeff Park, who currently serves Catamaran as executive vice president, Operations, will become the chief operating officer for OptumRx. Jeffrey Grosklags, currently the chief financial officer of OptumRx, will continue in that role.

OptumRx and Catamaran will create significant value for their combined customer base beyond the scale and enhanced service resulting from integration of their businesses.  This combination is expected to create a dynamic competitor in the PBM market by combining the strengths of Catamaran’s industry-leading technology platform with the data and analytics capabilities of Optum. The combined company is expected to deliver an innovative and compelling consumer and payer services offering that will link demographic, lab, pharmaceutical, behavioral and medical treatment data to engage individuals to make better decisions as they seek the best, most effective care and improve compliance with pharmaceutical use and care protocols.

OptumRx’s advanced Clinical Synchronization approach connects pharmacy and care management systems, processes and teams to create deeper insights for higher quality, more consistent and compliant patient outcomes and savings for individuals and plan sponsors. Synchronization presents the entire patient health profile, rather than discrete pieces of an individual’s profile – a distinctive and critically important capability given the growth in U.S. spending on specialty pharmaceuticals.

Catamaran offers retail pharmacy network management, mail service pharmacy, pharmacy claims management and patient-centric specialty pharmacy services to a broad client portfolio, including health plans and employers, as well as health care information technology solutions to the industry. In 2015 Catamaran expects to fulfill more than 400 million prescriptions which, combined with OptumRx’s roughly 600 million annual scripts, will enable the combined entity to be a competitive force in the PBM industry.  Enhanced purchasing and administrative improvements from the combination are expected to drive substantial value, with the majority of savings expected to directly benefit clients and individuals through reduced costs for prescriptions and enhanced pharmaceutical services.

Both companies have distinctive, rapidly growing specialty pharmacy services businesses.  The combined organization will help customers manage the complex costs and outcomes as this portion of the pharmaceutical market expands from an estimated $100 billion in revenues in 2014 to potentially $400 billion annually by 2020.

Larry Renfro, chief executive officer of Optum said, “Catamaran’s capabilities are impressive and their leadership team has delivered the fastest growth in the industry. We believe the combination of the two companies will create a unique offering in the industry unparalleled by current participants. Optum’s longstanding business relationship with Catamaran as a technology partner means we operate on the same adjudication platform, simplifying integration and giving us confidence our combined organizations will quickly become an innovative force moving the pharmacy care services marketplace forward. We believe this combination will create significant value for health plan, government, third party administrator and employer customers and, most importantly, the individual consumers who depend on us for accurate, affordable and convenient pharmacy benefit products and services.”

Mark Thierer, chairman and chief executive officer of Catamaran, said, “Our Board of Directors carefully considered a variety of strategic options and unanimously concluded that this combination is clearly in the best interests of our shareholders.  The creation of a differentiated, channel-agnostic delivery model will provide payers and individuals a broader portfolio of services and a deeper product offering while aggressively focusing on managing costs.  Together, we believe we will have the talent, scale, technology resources and innovative spirit to build the most modern, effective and consumer-focused PBM in the history of the industry.”

About Catamaran

Catamaran, the industry’s fastest-growing pharmacy benefits manager, helps organizations and the communities they serve take control of prescription drug costs. Managing more than 400 million prescriptions each year on behalf of 35 million members, our flexible, holistic solutions improve patient care and empower individuals to take charge of their health. Processing one in every five prescription claims in the U.S., Catamaran’s skill and scale deliver compelling financial results and sustainable improvement in the overall health of members. Catamaran is headquartered in Schaumburg, Ill., with multiple locations in the U.S. and Canada. For more information, please visit www.CatamaranRx.com, and for industry news and information follow Catamaran on Twitter, @CatamaranCorp.

About OptumRx

OptumRx is an innovative pharmacy benefit management business managing the prescription drug benefits of commercial, Medicare, Medicaid and other governmental health plans, as well as those of employers and unions through a national network of 66,000 community pharmacies and state-of-the-art mail service pharmacies in California and Kansas, both of which have earned the prestigious Verified Internet Pharmacy Practice Sites™ (VIPPS) accreditation by the National Association of Boards of Pharmacy. OptumRx is part of Optum, a leading information and technology-enabled health services business dedicated to making the health system work better for everyone. Visit www.optum.com for more information.

About UnitedHealth Group

UnitedHealth Group (NYSE: UNH) is a diversified health and well-being company dedicated to helping people live healthier lives and making health care work better. UnitedHealth Group offers a broad spectrum of products and services through two distinct platforms: UnitedHealthcare, which provides health care coverage and benefits services; and Optum, which provides information and technology-enabled health services. Through its businesses, UnitedHealth Group serves more than 85 million people worldwide. For more information, visit UnitedHealth Group at www.unitedhealthgroup.com or follow @UnitedHealthGrp on Twitter.

Cautionary Statement Regarding Forward-Looking Statements:

This communication may contain statements, estimates, projections, guidance or outlook that constitute “forward-looking statements” or “forward looking information” as defined under U.S. federal and Canadian provincial securities laws. Generally the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “plan,” “project,” “should” and similar expressions identify forward-looking statements or information, which generally are not historical in nature. Such statements or information may contain information about financial prospects, economic conditions and trends and involve risks and uncertainties. We caution that actual results could differ materially from those that management expects, depending on the outcome of certain factors, including the failure to complete or receive the anticipated benefits from UnitedHealth Group Incorporated’s (“UnitedHealth Group”) acquisition of Catamaran Corporation (“Catamaran”); the possibility that the parties may be unable to successfully integrate Catamaran’s operations into those of UnitedHealth Group; such integration may be more difficult, time-consuming or costly than expected; revenues following the transaction may be lower than expected; operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients or suppliers) may be greater than expected following the transaction; the retention of certain key employees at Catamaran may not be achieved; the conditions to the completion of the transaction may not be satisfied, or the regulatory approvals required for the transaction may not be obtained on the terms expected or on the anticipated schedule; the failure to obtain Catamaran shareholder approval in a timely manner or otherwise; the parties may be unable to meet expectations regarding the timing, completion and accounting and tax treatments of the arrangement; UnitedHealth Group and Catamaran are subject to intense competition; factors that affect UnitedHealth Group’s ability to generate sufficient funds to maintain UnitedHealth Group’s quarterly dividend payment cycle; foreign currency translation fluctuations and changes in capital markets conditions, UnitedHealth Group’s capital requirements or its estimated results of operations that may result in debt to capital ratio that is lower or higher than anticipated; and the other factors discussed in “Risk Factors” in UnitedHealth Group’s Annual Report on Form 10-K for the year ended December 31, 2014, which was filed with the United States Securities and Exchange Commission (“SEC”) on February 10, 2015, and on UnitedHealth Group’s website, at http://www.unitedhealthgroup.com, and UnitedHealth Group’s other filings with the SEC, which are available at http://www.sec.gov, and the other factors discussed in “Risk Factors” in Catamaran’s Annual Report on Form 10-K for the year ended December 31, 2014, which was filed with the SEC and the Canadian Securities Commissions on March 2, 2015, and on Catamaran’s website at www.CatamaranRx.com, and Catamaran’s other filings with the SEC which are available on http://www.sec.gov. UnitedHealth Group and Catamaran assume no obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not to place undue reliance on these forward-looking statements or information, which speak only as of the date hereof.

Additional Information and Where to Find It:

This communication may be deemed under U.S. federal securities laws to be solicitation material in respect of the proposed acquisition of Catamaran Corporation by UnitedHealth Group. This communication shall not constitute an offer to sell, or the solicitation of an offer to sell, or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. In connection with the proposed acquisition, UnitedHealth Group and Catamaran intend to file relevant materials with the SEC and the Canadian Securities Administrators, as required, including Catamaran’s proxy circular and proxy statement on Schedule 14A. BEFORE MAKING ANY VOTING OR INVESTMENT DECISIONS, SHAREHOLDERS OF CATAMARAN ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC AND CANADIAN SECURITIES COMMISSIONS, INCLUDING CATAMARAN’S PROXY CIRCULAR AND PROXY STATEMENT, CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain the documents free of charge at the SEC’s web site, http://www.sec.gov, and at the Canadian Securities Administrator’s website, www.sedar.com, and Catamaran shareholders will receive information at an appropriate time on how to obtain transaction-related documents for free from Catamaran. Such documents are not currently available.

Participants in Solicitation:

UnitedHealth Group and its directors and executive officers, and Catamaran and its directors and executive officers, may be deemed under U.S. federal securities laws to be participants in the solicitation of proxies from the holders of Catamaran common stock in respect of the proposed transaction. Information about the directors and executive officers of UnitedHealth Group can be found in UnitedHealth Group’s Annual Report on Form 10-K for the year ended December 31, 2014, which was filed with the SEC on February 10, 2015, and on UnitedHealth Group’s website, at http://www.unitedhealthgroup.com. Information about the directors and executive officers of Catamaran is set forth in the Proxy Circular and Proxy Statement for Catamaran’s 2015 Annual Meeting of Shareholders, which was filed with the SEC and the Canadian Securities Administrators on March 27, 2015. Investors may obtain additional information regarding the interest of such participants in the proposed transaction by reading the proxy circular and proxy statement regarding the acquisition when it becomes available.

Contacts:

Media:
Brian Kane
Optum
Tel: (952) 917-7244
brian.kane@optum.com

Tyler Mason
UnitedHealth Group
Tel:  (424) 333-6122
tyler.mason@uhg.com

Lauren Denz
Catamaran
Tel: (630) 945-2532
lauren.auren.denz@catamaranrx.com

Investors:
John Penshorn
UnitedHealth Group
Tel: (952) 936-7214
John_s_penshorn@uhg.com

Brett Manderfeld
UnitedHealth Group
Tel: (952) 936-7216
Brett_manderfeld@uhg.com

Tony Perkins
Catamaran
Tel: (312) 261-7805
tony.perkins@catamaranrx.com

Monday, March 30th, 2015 Uncategorized Comments Off on (CTRX) and OptumRx to combine

(REFR) Patented SPD-SmartGlass Technology Used In New Lincoln Continental Concept Car

WOODBURY, NY–(March 30, 2015) –  The Lincoln Motor Company, the luxury automotive brand of the Ford Motor Company revived the Continental name and announced today the introduction of the Lincoln Continental Concept using an SPD-SmartGlass electronically tinting sunroof using patented technology from Research Frontiers Inc. (NASDAQ: REFR). This concept is a preview of an all-new full size sedan coming from Lincoln next year and can be seen at the Lincoln booth at the upcoming 2015 New York International Auto Show, which opens to the press this Wednesday April 1, and to the public April 3-12.

As noted in Lincoln’s official press release, “New technology is a hallmark of this vehicle.” Ford Motor Company president and CEO Mark Fields said, “The Continental Concept showcases the promise of quiet luxury from Lincoln going forward. It also is a strong indication of what’s to come next year as we introduce our new Lincoln Continental full-size luxury sedan.” Ford highlighted SPD-SmartGlass in this vehicle by saying, “Rear-seat comfort is further highlighted by an SPD-SmartGlass tinting sunroof, which allows passengers to control heat from direct sunlight. With the touch of a button, the glass can cool the vehicle interior by as much as 18 degrees Fahrenheit, while blocking 99 percent of UV rays.”

Please see a video of the SPD-SmartGlass tinting sunroof switching on the Lincoln Continental Concept. More links and updated information about the Lincoln Continental Concept and its SPD-SmartGlass sunroof is available on Research Frontiers’ SmartGlass.com website and on its social media sites.

Kumar Galhotra, Lincoln’s president, noted the importance of benefits to the customer: “Lincoln is different. For us it is more than the machine. It is about what our vehicles do for our clients.”

Joseph M. Harary, President and CEO of Research Frontiers Inc., the company which invented the SPD-SmartGlass technology used in the Lincoln Continental variable tint sunroof, noted: “Light is the new luxury and Ford has seen first-hand how sales of panoramic roofs have been embraced by their customers. With large glass roof areas becoming more and more popular in cars today, especially in luxury brands, the need to control the amount of heat, light and glare coming through these panoramic roofs becomes even more important. Lincoln has chosen the best-performing smart glass technology in the world for their Continental Concept. SPD-SmartGlass makes this luxury car, which was so elegantly designed by Lincoln design director David Woodhouse and his team, even more remarkable and comfortable.”

SPD-SmartGlass technology has proven itself in many aspects in the automotive industry, from durability and performance, to sales. The Mercedes-Benz MAGIC SKY CONTROL panoramic roof feature using SPD-SmartGlass technology is now in use on tens of thousands of cars around the world. SPD-SmartGlass technology has been put through rigorous durability and performance testing in some of the most extreme conditions on Earth, including testing in the arctic cold of Scandinavia and the blistering desert heat of Death Valley, California.

About the Lincoln Motor Company

The Lincoln Motor Company is the luxury automotive brand of Ford Motor Company, committed to creating compelling vehicles with an exceptional ownership experience to match. The Lincoln Motor Company is in the process of introducing four all-new vehicles through 2016. For more information about the Lincoln Motor Company, please visit media.lincoln.com or www.lincoln.com.

About Research Frontiers Inc.

Research Frontiers is the developer of SPD-Smart light-control technology which allows users to instantly, precisely and uniformly control the shading of glass or plastic, either manually or automatically. Research Frontiers has built an infrastructure of over 40 licensed companies that collectively are capable of serving the growing global demand for smart glass products in automobiles, homes, buildings, museums, aircraft and boats. For more information, please visit our website at www.SmartGlass.com, and on Facebook, Twitter, LinkedIn and YouTube.

Note: From time to time Research Frontiers may issue forward-looking statements which involve risks and uncertainties. This press release contains forward-looking statements. Actual results could differ and are not guaranteed. Any forward-looking statements should be considered accordingly. “SPD-Smart” and “SPD-SmartGlass” are trademarks of Research Frontiers Inc. Mercedes-Benz and MAGIC SKY CONTROL are trademarks of Daimler A.G. “Lincoln Continental” is a trademark of the Ford Motor Company.

For further information, please contact:

Joseph M. Harary
President and CEO
Research Frontiers Inc.
+1-516-364-1902
Info@SmartGlass.com

Monday, March 30th, 2015 Uncategorized Comments Off on (REFR) Patented SPD-SmartGlass Technology Used In New Lincoln Continental Concept Car

(ICEL) To Be Acquired By Fujifilm

TOKYO and MADISON, Wis., March 30, 2015  — FUJIFILM Holdings Corporation (President: Shigehiro Nakajima,) (TSE: 4901) (“Fujifilm”) and Cellular Dynamics International, Inc. (CEO: Robert J. Palay,) (NASDAQ: ICEL) (“CDI”), a leading developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications, today announced that the two companies have entered into a definitive agreement whereby Fujifilm will acquire CDI via an all-cash tender offer to be followed by a second step merger. Fujifilm aims to acquire all issued and outstanding shares of CDI’s common stock for $ 16.5 per share or approximately $ 307 million (on a fully diluted basis). The offer represents a premium of 108% to CDI’s closing price on March 27. Upon completion of the transaction, CDI will continue to run its operations in Madison, Wisconsin and Novato, California as a consolidated subsidiary of Fujifilm. The announced transaction was unanimously approved by the Boards of Directors of both companies.

Under the terms of the agreement, Fujifilm will commence an all-cash tender offer no later than April 6, 2015. The transaction is conditioned on the tender achieving the minimum acceptance threshold, regulatory approvals and other customary conditions. Fujifilm will finance the transaction from the cash on its balance sheet and the completion of the acquisition is not subject to any financing conditions. It is anticipated that the tender offer will close during the second calendar quarter of 2015.

CDI was founded in 2004 and listed on NASDAQ in July 2013. The company had global revenues of $16.7 million in the year ended, December 31, 2014 and had 155 employees as of December 31, 2014.

CDI’s technology platform enables the production of high-quality fully functioning human cells, including induced pluripotent stem cells (iPSCs), on an industrial scale. Customers use CDI’s products, among other purposes, for drug discovery and screening, to test the safety and efficacy of their small molecule and biological drug candidates, for stem cell banking, and in the research and development of cellular therapeutics. CDI’s proprietary iCell product catalogue encompasses 12 different iPSC based cell types, including iCell Cardomyocytes, iCell Hepatocytes, and iCell Neurons. During 2014 CDI sold to 18 of 20 top biopharmaceutical companies.

CDI’s technology platform was selected by the California Institute for Regenerative Medicine[1] to establish iPS disease cell banks. CDI recently announced the completion of 2 cGMP[2]-compliant iPS cell lines with HLA[3] types which may reduce the likelihood of transplant immune rejection. CDI also is developing iPS cells for preclinical studies focused on dry age-related macular degeneration4 for a National Eye Institute5 program.

Tapping into technologies and know-how accumulated as a result of leading the field of photographic films, Fujifilm has developed highly-biocompatible recombinant peptides[4] that can be shaped into a variety of forms for use as a cellular scaffold[5] in regenerative medicine[6] in conjunction with CDI’s products. Fujifilm has been strengthening its presence in the regenerative medicine field over several years, including by acquiring a majority of shares of Japan Tissue Engineering Co., Ltd. (J-TEC) in December 2014.

This acquisition of CDI will allow Fujifilm to gain entry into the area of iPS cell-based drug discovery support services. Fujifilm also plans to benefit from the combination of CDI’s iPS cell technology and experience and Fujifilm’s expertise in material science, engineering, and J-TEC’s quality management systems. The combination of these will help accelerate product development in regenerative medicine while expanding the commercial opportunities.

Commenting on the transaction, Shigetaka Komori, Chairman and CEO of Fujifilm, said, “We are delighted to be able to pursue the business from drug discovery to regenerative medicine with CDI, which develops and manufactures iPS cells. We have optimal scaffolding material, ‘recombinant peptides’, for cell generation and technologies useful for regenerative medicines such as material science and engineering. Our group company, Japan Tissue Engineering, markets regenerative medicine products in Japan. By welcoming CDI to the Fujifilm Group and by combining the technologies and knowhow of both companies, we will seek synergies and efficiencies to be more competitive in the field of drug discovery and regenerative medicine.”

Robert J. Palay, Chairman and CEO of CDI, added, “CDI has become a leader in the development and manufacture of fully functioning human cells in industrial quantities to precise specifications. CDI and Fujifilm share a common strategic vision for achieving leadership in the field of regenerative medicine. The combination of CDI’s technology with Fujifilm’s technologies, know-how, and resources brings us ever closer to realizing the promise of discovering better, safer medicines and developing new cell therapies based on iPSCs.”

Fujifilm has successfully transformed its business structure for growth by expanding from traditional photographic film to other priority business fields. Positioning the healthcare business as one of its key growth areas, Fujifilm is seeking to cover “prevention, diagnosis, and treatment” comprehensively.

Fujifilm will disclose the impact of the purchase on its consolidated financial results for the fiscal year ending March 2016 once said impact is determined.

Goldman, Sachs & Co. is acting as financial advisor to Fujifilm and Morrison & Foerster LLP is acting as its legal counsel. JP Morgan is acting as financial advisors to CDI and Sidley Austin LLP is acting as legal counsel.

MEDIA CONTACTS:

  • FUJIFIILM Holdings Corporation, Corporate Planning Division, Corporate Communications office :
    Tel: +81-3- 6271-2000
  • Edelman U.S.A.:
    Tel. +1-212-729-2463; Mobile +1-646-775-8337 (Suvanto)
    Tel. +1- 212-642-7737; Mobile +1-917-283-8437 (Bowles)
  • CDI Corporate Communications:
    Tel. +1-608-310-5142
    Joleen Rau Senior Director, Marketing & Communications,
    Cellular Dynamics International, Inc.
    jrau@cellulardynamics.com

NOTES TO EDITORS

About Cellular Dynamics International, Inc.
Cellular Dynamics International Inc., (CDI) is a developer and manufacturer of fully functioning cells in industrial quantities to precise specifications. CDI’s proprietary products include true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell Products). CDI’s products provide standardized, easy-to-use, cost-effective access to the human cell, the smallest fully functioning operating unit of human biology. Customers use our products, among other purposes, for drug discovery and screening, to test the safety and efficacy of their small molecule and biological drug candidates, for stem cell banking, and in the research and development of cellular therapeutics. CDI was founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research at the University of Wisconsin-Madison. CDI’s facilities are located in Madison, Wisconsin, with a second facility in Novato, California.
See: www.cellulardynamics.com.

About FUJIFILM Holdings Corporation
FUJIFILM Holdings Corporation is the holding company of the Fujifilm Group with three operating companies, FUJIFILM Corporation, Fuji Xerox Co., Ltd. and Toyama Chemical Co., Ltd. under its umbrella. The group’s priority business fields are: healthcare such as medical equipment, pharmaceuticals, functional skin care cosmetics and nutritional supplements; graphic arts such as printing materials and equipment; documents such as office equipment/printing; optical devices such as TV camera lenses; highly functional materials such as LCD materials; digital imaging such as digital cameras, and Photobook.
See: www.fujifilmholdings.com/en/index.html.

Cautionary statement about forward-looking statements
This announcement contains certain statements which constitute “forward-looking statements”. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. The forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Many of these risks and uncertainties relate to factors that are beyond Fujifilm’s and CDI’s abilities to control or estimate precisely, such as future market conditions, the behaviors of other market participants, the effects of the transaction making it more difficult to maintain existing relationships with employees, customers or business partners, and other business effects, including the effects of industry, economic or political conditions, and therefore undue reliance should not be placed on such statements. Examples of forward-looking statements in this press release include, but are not limited to, statements regarding the proposed acquisition of CDI by Fujifilm, such as: the timing of the tender offer and the merger; results of the review of the transaction by regulatory agencies, and any conditions imposed in connection with consummation of the transaction; and satisfaction of various other conditions to the closing of the transaction. Actual results may differ materially from those in the forward-looking statements. For information regarding other related risks, please see the “Risk Factors” section of CDI’s filings with the Securities and Exchange Commission (the “SEC”), including its most recent filings on Form 10-K and Form 10-Q. CDI and Fujifilm assume no obligation to update these forward-looking statements, except as required pursuant to applicable law.

Note to investors
The tender offer to purchase shares of CDI common stock referenced in this press release has not yet commenced, and this press release is neither an offer to purchase, nor a solicitation of an offer to sell, any securities. The tender offer to purchase shares of CDI common stock will be made only pursuant to a Tender Offer Statement on Schedule TO containing an offer to purchase, forms of letters of transmittal and other documents relating to the tender offer (the “Tender Offer Statement”), which Fujifilm will file with the SEC and mail to CDI stockholders. At or shortly after the time the tender offer is commenced, CDI will file a Solicitation / Recommendation Statement on Schedule 14D-9 with respect to the tender offer (the “Recommendation Statement”). Investors and security holders of CDI are advised to read the Tender Offer Statement and Recommendation Statement carefully when they become available, before making any investment decision with respect to the tender offer because they will contain important information about the tender offer. Investors and security holders of CDI also are advised that they may obtain free copies of the Tender Offer Statement and other documents filed by Fujifilm with the SEC (when these documents become available) and the Recommendation Statement and other documents filed by CDI (when these documents become available) on the SEC’s website at http://www.sec.gov. In addition, free copies of the Tender Offer Statement and related materials may be obtained (when these documents become available) from Fujifilm’s website at http://www.fujifilmholdings.com/en/investors/index.html; and free copies of the Recommendation Statement and related materials may be obtained (when these documents become available) from CDI’s website at www.cellulardynamics.com.

1 CIRM was established in 2004 to research stem cell and regenerative medicine technologies for application in diagnosis and therapy of chronic disease and injury.

2 Good Manufacturing Practice is a set of standards for managing quality in the manufacture of pharmaceuticals. Originally produced by the World Health Organization (WHO), each country adapts it to its own needs. In the US, the Food and Drug Administration (FDA) has outlined what it calls cGMP (current GMP).

3 Human leukocyte antigen exists in nearly all cells and fluids, and plays a key role in determining tissue compatibility (key to the human immune system). Matching HLA types is key to hematopoietic stem cell transplants and organ transplants, as cells without matching HLA are considered foreign invaders by the immune system and attacked (resulting in immune rejection).

4 Age-related macular degeneration occurs when the macular area at the center of the retina, which senses light at the back of the eye, degenerates due to age. As the condition progresses, it can lead to blindness. The wet form of the condition occurs when fragile blood vessels descend from the bottom of the retina, while the dry form of the condition is due to other causes. The worldwide patient population is estimated at 30 million people. Current treatments for wet macular degeneration are photodynamic therapy, photocoagulation therapy, and anti-VEGF drugs, although none of these results in a complete cure. There are currently no effective treatments for the dry form of the disease. In Japan the wet form of the disease accounts for about 90% of cases, while in the U.S. the dry form accounts for about 90% of cases.

5 The NEI is a division of the US National Institute of Health devoted to researching and supporting treatments for eye diseases.

6 Synthetic proteins modelled on human Type 1 collagen manufactured with yeast cells using genetic engineering techniques.

7 Cells attach to an extracellular material (also called extracellular matrix or scaffold), which provides a structure necessary for normal growth.

8 Regenerative medicine uses artificially-grown cells and tissues to regenerate damaged organs or tissues to restore functionality to affected areas. Regenerative medicine involves three key facets: 1) cells which differentiate and proliferate to become human tissue, 2) growth factor cytokines to induce cell differentiation and proliferation, and 3) a scaffold on which cells can grow and proliferate normally.

Monday, March 30th, 2015 Uncategorized Comments Off on (ICEL) To Be Acquired By Fujifilm

(NETE) Schedules Conference Call to Discuss 2014 Financial Results

MIAMI, FL–(Mar 30, 2015) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a technology provider in global mobile payments and value-added transactional services, today announced the scheduling of a conference call at 2:30 Eastern Time Tuesday, March 31, 2015 to review operating results for its fiscal year ended December 31, 2014.

Participating will be Net Element chief executive Oleg Firer and chief financial officer Jonathan New, both of whom will discuss operational and financial highlights.

Conference Call Information

Date: Tuesday, March 31, 2015
Time: 14:30 Eastern Time

Conference ID: 1798030

Participant Toll-Free Dial-In Number: (877) 303-9858
Participant International Dial-In Number: (Outside of the U.S. & Canada): +1 (408) 337-0139

Listen Only Toll-Free Dial-In Number: (800) 514-8534
Listen Only International Dial-In Number: +1 (408) 940-3842

To join the live conference call, please dial into the above referenced telephone numbers five to ten minutes prior to the scheduled conference call time.

An archive of the call will also be available on Net Element’s website at: http://www.netelement.com/en/ir.

About Net Element
Net Element (NASDAQ: NETE) is a global payments-as-a-service, technology provider with an integrated mobile and transactional services platform serving millions of emerging market clients. Its wholly owned subsidiary, TOT Group operates Unified Payments, a U.S. focused transaction processing and value-added services brand, Aptito, a next generation, cloud-based point of sale payments platform and TOT Money, a leading mobile payments service provider that is gaining significant traction in the mobile payments market in Russia and for two consecutive years, has been ranked in the Top 3 mobile payments providers by Beeline, Russia’s second largest telecommunications operator. Further information is available at www.netelement.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether Net Element can secure any additional financing, and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.

Investor Contact:
Net Element, Inc.
+1 786-923-0502
investors@netelement.com
www.netelement.com

Monday, March 30th, 2015 Uncategorized Comments Off on (NETE) Schedules Conference Call to Discuss 2014 Financial Results

(NWBO) Reports Promising Survival Data In 51 GBM Patients Treated With Dcvax®-L

Patients Too Sick for Enrollment in Phase III Trial for Newly Diagnosed GBM

BETHESDA, Md., March 27, 2015  — Northwest Biotherapeutics, Inc. (NASDAQ: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for cancer, announced today that Dr. Marnix Bosch, the Company’s Chief Technical Officer, presented encouraging survival data on 51 Glioblastoma multiforme (GBM) brain cancer patients treated with DCVax®-L.  The data showed substantially longer than expected survival in patients with apparent early progression (recurrence) of their cancer, including patients with such aggressive cancer that the tumor was already re-growing by the end of 6 weeks of daily radiotherapy and chemotherapy after surgical removal of the original tumor.

As previously announced, Dr. Bosch’s presentation was made at the 2nd Immunotherapy of Cancer (ITOC) Conference in Munich, Germany, yesterday and was webcast.  The webcast of the presentation, entitled “Prolonged Survival In Patients With Recurrent GBM Who Are Treated With Tumor Lysate-Pulsed Autologous Dendritic Cells,” can be seen for up to 30 days at http://nwbio.com/webcasts/  The presentation poster can be found on the Company’s website.

The 51 GBM patients were treated in an Information Arm outside the Company’s Phase III clinical trial because they were not eligible for the trial, due to evidence of early tumor re-growth following 6 weeks of daily radiotherapy and chemotherapy which are standard of care.  Overall Survival data is available for all 51 patients; however, MRI images are only available for 46 of the 51 patients.  These 46 patients were classified by an independent medical imaging company into 3 groups, as follows.  The other 5 patients remained unclassified, due to lack of available images.

  • 20 Rapid-Progressor Patients: Patients with a new lesion ≥ 1 cm. in size, or tumor growth of ≥25% both at a Baseline Visit and at Month 2 thereafter;
  • 25 Indeterminate Patients: Patients with evidence of progression at the Baseline Visit (rendering them ineligible for the trial), followed by stable disease, modest progression and/or modest regression (or unclear tumor measurements), neither of which is enough to classify them as either a Rapid-Progressor or a Pseudo-Progressor;
  • 1 Pseudo-Progressor: A patient whose Month 2 image showed resolution of most of the prior appearance of tumor growth that had been seen at the Baseline Visit.

The prognosis for Rapid Progressor patients is especially poor:  their median Overall Survival is only about 8 to 10 months, according to published scientific literature, and they generally are not expected to respond much to any treatments.  There is no established benchmark for Overall Survival of the Indeterminate Patients, however, they can be compared to the general population of GBM patients, for whom median Overall Survival is 14.6 months.

The survival to date, for each of these groups of Information Arm patients treated with DCVax-L, is as follows:

  • Overall: The median OS of the group of 51 Information Arm patients as a whole is 18.3 months. About 30% of the patients (15 of the 51) lived beyond 2 years, and most of these patients (12 of the 15) remain alive.
  • 20 Rapid-Progressors: The median OS among these 20 DCVax-L treated patients is 15.3 months (with patients surviving as long as 37.1 months), compared to expected median OS of 8.3 – 10.8 months with existing treatments, based on published literature on comparable patient populations — a 50% improvement over the expected survival time. Further, one-third of these patients (7 of the 20) lived beyond 18 months – a doubling of the expected survival time with existing treatments.
  • 25 Indeterminate Patients: The median OS among these DCVax-L treated patients is 21.5 months (with patients surviving as long as 40.7 months), compared to median OS in the general population of newly diagnosed GBM patients of 14.6 months – a 50% improvement over the expected survival time. Further, 9 of these 25 patients remain alive today at more than 24 months, 6 of these 9 patients have exceeded 30 months, and 4 of these 9 patients have reached 35-40+ months.
  • 1 Pseudo-Progressor: This patient is still alive, with OS of 30.1 months to date.
  • 5 Unclassified Patients: The median OS is 9.2 months (with patients surviving as long as 30.1 months).

As reflected in these data, both Rapid-Progressor Patients and Indeterminate Patients (as well as the Pseudo-Progressor Patient) treated with DCVax-L in the Company’s Information Arm are  surviving substantially longer than would be expected based on clinical experience reported in the literature.

DCVax-L also continues to show an excellent safety profile, with no serious adverse events observed in these Information Arm patients.

“We are quite encouraged to see survival times in our DCVax-L treated Information Arm patients that exceed the expected survival times with existing treatments by 50% or more,” commented Linda Powers, CEO of NW Bio.  “This survival data, which has been collected by the independent CRO managing our Phase III trial, provides an encouraging insight into the potential results of the DCVax-L treatments for newly diagnosed patients in the Phase III trial.  The survival data also reinforce the results we have seen with extended survival in our prior Phase I/II trials, and reinforce NW Bio’s position as a leader in immune therapies for cancer.”

Background

The Company treated a total of 55 patients in an “Information Arm” outside of the Company’s ongoing Phase III clinical trial of DCVax-L for newly diagnosed GBM:  51 of these 55 patients were not eligible for the trial because they had evidence of early progression (tumor growth) at a Baseline Visit at the end of 6 weeks of daily radiotherapy and chemotherapy after surgical resection of their brain tumor; 4 of the  patients were not eligible for the trial for other reasons (e.g., insufficient doses of DCVax-L).

These Information Arm patients received the same DCVax-L product, on the same treatment schedule, in the same medical centers, in the same time period as the Phase III clinical trial, and the data have been collected and maintained by the same contract research organization (CRO) managing the Phase III trial.

As Dr. Bosch described in his conference presentation, as part of the eligibility assessment for the Phase III clinical trial, patients underwent MRI imaging at a Baseline Visit at the end of the 6 weeks of daily radiotherapy and chemotherapy which is standard of care following the surgical removal of the original tumor.  Patients who already have disease progression (tumor re-growth) so quickly, and in the midst of such daily treatments, are generally considered to be “Rapid Progressors.”  Such patients are usually excluded or segregated in studies and analyses because their disease is so accelerated that it is not comparable to regular GBM patients.

The patients in NW Bio’s Information Arm were evaluated through MRI imaging at the Baseline Visit and at Month 2 thereafter.  All images were reviewed and analyzed by an independent specialized medical imaging company.  Each image was reviewed separately by two independent reviewers, and any material differences were resolved by a third independent reviewer.  Reviews were conducted using both RANO and McDonald criteria.

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe.  The Company has a broad platform technology for DCVax dendritic cell-based vaccines.  The Company’s lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM).  GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.”  The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression.  It has completed enrollment in the Phase I portion of the trial.  The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer.  The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.  In Germany, the Company has received approval of a 5-year Hospital Exemption for the treatment of all gliomas (brain cancer) patients outside the clinical trial.

Disclaimer

Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements.  Actual results may differ materially from those projected in any forward-looking statement.  Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s and Cognate’s abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing.  Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings.  Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement.  You should not place undue reliance on any forward-looking statements.  The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

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(MSG) Announces Separation of Sports and Entertainment Businesses From Media Business

NEW YORK, March 27, 2015  — The Madison Square Garden Company (Nasdaq:MSG) today announced the filing of an initial Form 10 Registration Statement with the U.S. Securities and Exchange Commission (“SEC”) in connection with MSG’s previous announcement that it was exploring a possible separation of its businesses into two publicly traded companies. The planned separation would be structured as a tax-free spin-off of the sports and entertainment business to MSG shareholders on a pro rata basis. The transaction is currently expected to be completed during 2015, subject to certain conditions.

After review, MSG’s Board of Directors believes that, while MSG has created significant shareholder value since it was established as a public company five years ago, separating MSG’s live sports and entertainment businesses from its media business now would further enhance the long-term value-creation potential of both businesses. While the companies would continue to benefit from commercial arrangements between them, the separation would provide each company with increased strategic flexibility to pursue its own distinctive business plan and allow each to have a capital structure and capital return policy that is appropriate for its business.  Upon completion of the spin-off, MSG shareholders would own shares in both companies and have the ability to evaluate each company’s current business and future prospects in making investment decisions.

The live sports and entertainment company would comprise a portfolio of celebrated venues, legendary sports teams and exclusive entertainment productions, including:

  • Professional sports franchises: the New York Knicks, the New York Rangers and the New York Liberty, along with development teams: the Hartford Wolf Pack and the Westchester Knicks
  • World-class, award-winning venues including Madison Square Garden Arena, The Theater at Madison Square Garden, Radio City Music Hall, the Beacon Theater, the Forum in Inglewood, CA, The Chicago Theater, and the Wang Theater in Boston
  • Live productions, including the Radio City Christmas Spectacular, the nation’s #1 live holiday family show featuring the legendary Rockettes, and New York Spring Spectacular, a new large scale theatrical production that officially debuted on March 26
  • MSG’s first-class venue management capabilities and industry-leading expertise in bookings, as well as its sponsorship, marketing, ticketing and promotional expertise and platforms
  • MSG’s strategic entertainment joint ventures
  • MSG’s interest in Fuse Media, the parent company of NUVOtv and Fuse networks

The media company would continue to distribute exclusive, award-winning sports and entertainment content across multiple platforms, including two of the most successful regional sports and entertainment networks in the country, MSG Network and MSG+. In connection with the separation, the companies expect to enter into long-term media rights agreements that will ensure MSG Network and MSG+ continue to serve as the exclusive local broadcast home of the Knicks and Rangers.

The separation remains subject to various conditions, including completion and effectiveness of the Form 10 registration statement filed today, receipt of a private letter ruling from the Internal Revenue Service and certain approvals and consents, as well as final MSG Board approval.  The initial Form 10 is available in the Investor Relations section on MSG’s website, www.themadisonsquaregardencompany.com.

J.P. Morgan and LionTree Advisors are acting as financial advisors to MSG for the spin-off and Sullivan & Cromwell LLP is acting as legal advisor.

About The Madison Square Garden Company

The Madison Square Garden Company is comprised of three business segments: MSG Sports, MSG Media and MSG Entertainment and is built on a foundation of iconic venues and compelling content that the company creates, produces, presents and/or distributes through its programming networks and other media assets. MSG Sports owns and operates the following sports franchises: the New York Knicks (NBA), the New York Rangers (NHL), the New York Liberty (WNBA), the Westchester Knicks (NBADL) and the Hartford Wolf Pack (AHL). MSG Sports also features the presentation of a wide variety of live sporting events including professional boxing, college basketball, bull riding and tennis. MSG Media is a leader in production and content development for multiple distribution platforms, including content originating from the Company’s venues. MSG Media’s television networks consist of regional sports networks, MSG Network and MSG+, collectively referred to as MSG Networks. MSG Entertainment is one of the country’s leaders in live entertainment. MSG Entertainment creates, produces and/or presents a variety of live productions, including the Radio City Christmas Spectacular featuring the Rockettes. MSG Entertainment also presents or hosts other live entertainment events such as concerts, family shows and special events in the Company’s diverse collection of venues. These venues consist of Madison Square Garden, The Theater at Madison Square Garden, Radio City Music Hall, the Beacon Theatre, the Forum in Inglewood, CA, The Chicago Theatre, and the Wang Theatre in Boston, MA. More information is available at www.themadisonsquaregardencompany.com.

The Madison Square Garden Company logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=15647

This press release may contain statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that any such forward-looking statements are not guarantees of future performance or results and involve risks and uncertainties, and that actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors, including financial community and rating agency perceptions of the Company and its business, operations, financial condition and the industry in which it operates and the factors described in the Company’s filings with the Securities and Exchange Commission, including the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained therein. The Company disclaims any obligation to update any forward-looking statements contained herein.

CONTACT: Kimberly Kerns
         Communications
         kimberly.kerns@msg.com
         (212) 465-6442

         Ari Danes, CFA
         Investor Relations
         ari.danes@msg.com
         (212) 465-6072
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(TRIL) Announces Appointment of Eric L. Sievers, M.D. as Chief Medical Officer

TORONTO, March 27, 2015  — Trillium Therapeutics Inc. (“Trillium”) (Nasdaq:TRIL) (TSX:TR), an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that Eric L. Sievers, M.D., has assumed the position of Chief Medical Officer. In this role, he will lead the company in evaluating and implementing clinical development strategies for advancement and approval of its clinical programs, with initial emphasis on the company’s CD47 program.

Dr. Sievers brings more than 25 years’ experience in the biotechnology industry and academia. His expertise spans across multiple cancer indications including acute myeloid leukemia, myelodysplastic syndromes, Hodgkin and non-Hodgkin lymphoma, melanoma, and renal cell carcinoma. He is an accomplished educator, guest speaker, and strategist, with deep understanding of trial design, experimental medicine, and both early and late stages of clinical development. Dr. Sievers most recently served as Senior Vice President, Clinical Development at Seattle Genetics, where he also held several other senior clinical leadership positions over the past nine years. Notably, during his tenure at Seattle Genetics he played a key role in the development and approval of ADCETRIS®. Dr. Sievers started his industry career as Medical Director at ZymoGenetics. Prior to joining the biotechnology industry, Dr. Sievers spent over a decade at the Fred Hutchinson Cancer Research Center practicing medicine in the areas of hematology and oncology. He received his Medical and Bachelor of Arts degrees from Brown University.

“Eric’s breadth of clinical experience, coupled with his deep regulatory and drug development skills, make him uniquely qualified for this position at Trillium. We are delighted to have someone with his acumen join the management team at this critical juncture of initiating the clinical development of our lead program,” commented Trillium’s Chief Executive Officer, Dr. Niclas Stiernholm.

“Trillium’s novel approach to blocking CD47 is exciting,” said Dr. Sievers. “I’m particularly intrigued by the mechanism of action of SIRPaFc and compelled by the excellence of both the management team and the Board of Directors of this promising program. My commitment is to bring breakthrough technology to market to meaningfully improve and extend patients’ lives.”

About Trillium Therapeutics:

Trillium Therapeutics Inc. is an immuno-oncology company developing innovative therapies for the treatment of cancer. The Company has two premier preclinical programs, SIRPaFc and a CD200 monoclonal antibody (mAb), which target two key immunoregulatory pathways that tumor cells exploit to evade the host immune system. SIRPaFc is an antibody-like fusion protein that blocks the activity of CD47, a molecule that is upregulated on tumor cells in acute myeloid leukemia (AML) and numerous other malignancies. The CD200 mAb is a fully human monoclonal antibody that blocks the activity of CD200, an immunosuppressive molecule that is overexpressed by many hematopoietic and solid tumors.

For more information visit: www.trilliumtherapeutics.com

Caution Regarding Forward-Looking Information:

This press release may contain forward-looking statements, which reflect Trillium’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties are described in the company’s ongoing quarterly and annual reporting. Except as required by applicable securities laws, Trillium undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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

CONTACT: Trillium Therapeutics Inc.
         James Parsons
         Chief Financial Officer
         +1 416 595 0627 x232
         james@trilliumtherapeutics.com
         www.trilliumtherapeutics.com
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(CNIT) Wins Sole Naming Right of 2015 Annual Luoyang Peony Festival

SHENZHEN, China, March 27, 2015  — China Information Technology, Inc. (the “Company” or “CNIT”) (Nasdaq GS: CNIT), a leading provider of integrated cloud-based platform, exchange, and big data solutions to the Chinese new media industry, today announced that the Company has been selected by Luoyang City to promote its 2015 Annual Luoyang Peony Festival (“Festival”) using the Company’s cloud-based new media solutions. The Company also won the sole naming right to the Festival and its opening ceremony.

The 33rd Annual Peony Festival will be held from April 4 to May 5, 2015 in Luoyang City of Henan Province. During the Festival, the Company will deploy large-scale, cloud-based digital display terminals throughout Luoyang to broadcast festival highlights, various programs on city sightseeing, sports contests, exhibitions and tradeshows, as well as advertisements. To be installed at high-traffic venues such as the airport, department stores, hotels and residential communities, the CNIT display terminals will also display festival-related public information and local lifestyle guides.

“Our Cloud-App-Terminal (CAT) new media solutions are disrupting the traditional promotional methods which rely on newspaper and television,” said Mr. Jiang Huai Lin, Chairman and CEO of the Company. “Through our cloud-based digital display terminals, program highlights and public information from the spectacular Peony Festival can be broadcast live to a larger audience at more places. At the Festival, we will showcase the exciting capabilities in promotion, presentation and information dissemination of our cloud-based new media solutions, and look forward to bringing new dynamics to traditional cultural events through the use of internet technology. In addition, CNIT will further develop cooperation and partnership with Luoyang government to leverage local resources in tourism, cultural exchange, and media, which could potentially create significant business opportunities for CNIT. ”

Luoyang, the ancient capital of 13 dynasties in China, has thousands of years of historical and cultural heritage. Beginning in 1983, the Annual Luoyang Peony Festival has been selected as one of China’s Intangible Cultural Heritage, and is held each year from April to May. A state-level cultural event that combines cultural exchange, trade shows and tourism, the Festival has evolved into an ideal stage for corporate branding and promotion.

About China Information Technology, Inc.

China Information Technology, Inc. (CNIT) is on a mission to make advertising accessible and affordable for businesses of all sizes. CNIT is a leading provider of integrated cloud-based platform, exchange, and big data solutions to the Chinese new media industry. Its Internet ecosystem enables all participants of the new media community to efficiently promote brands, disseminate knowledge, and exchange resources. Through continuous innovation, CNIT is leveraging its proprietary Cloud-Application-Terminal technology to level the competitive landscape in the new media industry and deliver value for its shareholders, employees, customers, and the community. To learn more, please visit www.chinacnit.com.

Safe Harbor Statement

This press release may contain certain “forward-looking statements” relating to the business of China Information Technology, Inc., and its subsidiaries and other consolidated entities. All statements, other than statements of historical fact included herein, are “forward-looking statements” in nature within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, often identified by the use of forward-looking terminologies such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company and its subsidiaries and other consolidated entities or persons acting on their behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

For further information, please contact:

China Information Technology, Inc. 

Tiffany Pan
Tel: +86 755 8370 4767
Email: IR@chinacnit.com
http://www.chinacnit.com

Grayling
Shiwei Yin
Investor Relations
Tel: +1.646.284.9474
Email: cnit@grayling.com

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(INVT) Announces CEO & Chairman Joe Beyers to Present at IPBC Global 2015

CAMPBELL, CA–(Mar 27, 2015) – Inventergy Global, Inc. (NASDAQ: INVT) (“Inventergy”), today announced that its CEO, Chairman and Founder, Joe Beyers will be presenting Tuesday, June 16th at the IPBC Global 2015, presented by Intellectual Asset Magazine (see http://www.ipbusinesscongress.com/2015). Mr. Beyers will be speaking about how to build and maintain a successful licensing-based company, including:

  • Understanding the challenges of the licensing landscape
  • Building a robust IP portfolio
  • Providing insight on new IP related business models

As described by the organizers, “IPBC Global is the world’s pre-eminent gathering of senior IP business decision makers. Drawing on the large community of thought leaders based in San Francisco and Silicon Valley, as well those from further afield in the United States and abroad, the 2015 event will offer unrivalled opportunities to discuss cutting-edge issues and network with the people who make the IP weather.”

About Inventergy Global, Inc.
Inventergy Global, Inc. is Silicon Valley-based intellectual property company dedicated to identifying, acquiring and licensing the patented technologies of market-significant technology leaders. Led by IP industry pioneer and veteran Joe Beyers, the Company leverages decades of corporate experience, market and technology expertise, and industry connections to assist Fortune 500 companies in leveraging the value of their innovations to achieve greater returns. For more information about Inventergy Global, visit www.inventergy.com.

Contact:
Robert Haag
IRTH Communications
INVT@irthcommunications.com
866-976-4784

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(ROSG) Receives Key U.S. Patent Allowance for its Novel Kidney Cancer Test

Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces receipt of a Notice of Allowance for U.S. Patent Application No. 13/412,020, entitled, “Gene Expression Signature for Classification of Kidney Tumors.” The patent is owned jointly with Tel Hashomer Medical Research Ltd., the technology transfer company of the Chaim Sheba Medical Center in Israel.

The allowed patent claims a method for distinguishing four different types of kidney cancer: oncocytoma, clear cell renal cell carcinoma (RCC), papillary (chromaphil) RCC and chromophobe RCC in a human subject with renal cancer, through the expression profile of a unique set of 24 microRNAs and a classifier algorithm.

The impact of the limitation of diagnostic capability in renal oncocytoma was highlighted by a recent health economics outcome review of the management of kidney masses1. This study clearly demonstrated the adverse economic and health outcomes impact of poor pre-operative diagnosis, and confirmed the reported very low rates of pre-nephrectomy biopsy. In their analysis of the IMS LifeLink database, covering more than 60 million commercially insured patients in the U.S., the authors found that approximately 1 in 6 who underwent a nephrectomy for suspected renal cell cancer were subsequently identified as having benign disease, with an economic impact of approximately $26,500 per patient. This is in contrast to total expenditures of approximately $1,300 pre-operatively today, most commonly for one or more CT examinations. They projected that this represents more than 10,000 unnecessary surgeries annually in the U.S. alone.

“This U.S. patent allowance will provide core protection for the Rosetta Kidney Cancer Test which accurately distinguishes between the four main subtypes of kidney cancer. We believe that the different long-term prognosis for these four subtypes makes the correct pathological diagnosis of a renal cancer critically important for the clinician, especially for oncocytomas so as to avoid unnecessary surgeries, ” said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. “In addition to reducing the number of unnecessary surgeries in the case of oncocytomas, new molecularly-targeted therapeutics for kidney cancer are making accurate sub-classification of tumor type important for optimizing treatment choices and improving outcomes.”

“With 42 issued patents, four allowed patents and 46 patents pending worldwide, our growing intellectual property position continues to provide protection for and solidify our global leadership position in microRNA biomarker technology and in creating differentiated and proprietary content in the area of personalized medicine,” concluded Mr. Berlin.

Kidney cancer is among the ten most common cancers in both men and women. Kidney cancers account for more than 3% of adult malignancies and cause more than 14,000 deaths per year in the U.S. alone.

About Rosetta Cancer Testing Services

Rosetta Cancer Tests are a series of microRNA-based diagnostic testing services offered by Rosetta Genomics. The Rosetta Cancer Origin Test can accurately identify the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP). The Rosetta Lung Cancer Test accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. The Rosetta Kidney Cancer Test accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. Rosetta’s assays are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the Rosetta Cancer Origin Test, 65,000 from the Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta Lung Cancer Test. The Company’s assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. In addition to its proprietary products, the Company markets the Rosetta Genomics PGxOne test and the EGFR and KRAS sequencing services for Admera Health, as well as Precipio’s oncology tests, which include bone marrow and peripheral blood testing for hematological malignancies, such as leukemias and lymphomas. For more information, please visit www.rosettagenomics.com. Parties interested in ordering these tests can contact Rosetta Genomics at (215) 382-9000 ext. 309.

About Rosetta Genomics

Rosetta develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, Rosetta’s integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. The Company also leverages its commercial infrastructure by marketing tests and sequencing services for Admera Health and Precipio. Rosetta’s cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future expectations, plans and prospects, including without limitation, statements that the patent allowance will provide core protection for the Rosetta Kidney Cancer Test and statements relating to the benefits of the Rosetta Kidney Cancer Test, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those risks more fully discussed in the “Risk Factors” section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2014 as filed with the SEC. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

1 Asnis-Alibozek AG, Fine MJ, Russo P, McLaughlin T, Farrelly EM, LaFrance N, Lowrance W. Cost of care for malignant and benign renal masses. AJMC 2013: 19(8) 617-24. [PMID: 24304211]

Company:
Rosetta Genomics
Ken Berlin, 609-419-9003
President & CEO
investors@rosettagenomics.com
or
Investor:
LHA
Anne Marie Fields, 212-838-3777
afields@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com

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(DRRX) Announces First Patient Dosed in Relday Multi-Dose Clinical Study

Results Anticipated in Third Quarter 2015, Positioning Zogenix for Potential World-Wide Partnering Opportunities for Relday

SAN DIEGO, March 26, 2015  — Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, announced today that dosing has begun in patients enrolled in its Relday™ multi-dose Phase 1b clinical study. Relday is a proprietary, long-acting, subcutaneously injected formulation of risperidone being investigated for the treatment of schizophrenia.

Relday has been designed to provide potentially significant improvements over current long-acting injection treatment options for patients suffering from schizophrenia. In a Phase 1 single-dose clinical study in schizophrenic patients, Relday demonstrated the ability to achieve therapeutic plasma levels of risperidone on the first day of dosing, followed by a controlled release profile over the remaining four-week period. This pharmacokinetic profile of Relday may eliminate the requirement for long-acting risperidone injections to be supplemented with daily oral therapy for several weeks during therapy initiation or when patients are not fully compliant with an injection regimen over the course of long-term therapy. In addition, dose-proportionality for Relday has been established across all doses, as well as the duration of treatment being consistent with once-monthly dosing. Unlike all currently marketed long-acting injectable treatment options which are administered via intramuscular injection, Relday is administered subcutaneously. Moreover, unlike some leading injectable products in the category, Relday does not require reconstitution prior to use.

Fifty-six subjects with schizophrenia or schizoaffective disorder are planned to be enrolled in this open label, multi-dose, safety and pharmacokinetic (PK) study. Subjects will be administered Relday or Risperdal® Consta® (risperidone), an approved long-acting intramuscular injectable with the same active ingredient as Relday. Patients being administered Risperdal Consta will also receive daily oral risperidone supplementation during a three-week initiation period, and will be dosed every two weeks, as required by its prescribing label. Subjects will be followed for up to 20 weeks in order to confirm and compare the time to reach drug concentrations within the therapeutic range and to compare steady state pharmacokinetics for Relday and Risperdal Consta. The Company anticipates that results from the Relday multi-dose study will be available in the third quarter of 2015.

The Company also plans to initiate efforts to secure an ex-U.S. strategic development and commercialization partner for Relday during this development stage and is targeting an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by early 2016. If completed, these milestones would position the Company to begin a Phase 3 clinical study for Relday in 2016.

Brad Galer, M.D., chief medical officer of Zogenix, stated, “We are pleased to move the Relday development program forward into this next clinical study. We expect the data to continue to demonstrate that Relday’s novel formulation has a differentiated product profile amongst currently marketed long-acting injections for the treatment of schizophrenia that should enhance the treatment for this patient population.”

In July 2011, Zogenix licensed from DURECT (Nasdaq:DRRX) exclusive global rights to develop and commercialize this proprietary formulation which utilizes DURECT’s SABER® depot technology.

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: delivery and dosing benefits of Relday and the potential to demonstrate that Relday has a differentiated product profile amongst currently marketed long-acting injections; timing for the availability of results from the Phase 1b clinical trial, an end-of-Phase 2 meeting with the FDA, and the initiation of a Phase 3 clinical trial for Relday; and the initiation of efforts to secure potential partners for rest-of-world development and commercialization of Relday. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as Relday, including potential delays in enrollment and completion of clinical trials; competition from other pharmaceutical or biotechnology companies; inadequate therapeutic efficacy or unexpected adverse side effects relating to Relday that could prevent its development or commercialization; difficulties in identifying, negotiating, executing and carrying out strategic transactions relating to Relday; the terms of any development or commercialization partnership for Relday may not be favorable, and the partner may not perform as expected; the market potential for anti-psychotics, and Zogenix’s ability to compete within that market; Zogenix’s ability to obtain, and the validity and duration of, patent protection and other intellectual property rights for Relday; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Relday™ is a trademark of Zogenix, Inc.

SABER® is a registered trademark of DURECT Corporation.

Risperdal® Consta® is a registered trademark of Janssen Pharmaceuticals, Inc.

CONTACT: Investors
         Zack Kubow, The Ruth Group
         646.536.7020, zkubow@theruthgroup.com
Thursday, March 26th, 2015 Uncategorized Comments Off on (DRRX) Announces First Patient Dosed in Relday Multi-Dose Clinical Study

(OTIV) Receives Favorable Patent Infringement Ruling Against T-Mobile

U.S. District Court Grants Summary Judgment of Infringement on oti’s Standard-Essential NFC Patent

ROSH PINA, ISRAEL–(Mar 26, 2015) – On Track Innovations Ltd. (oti) (NASDAQ: OTIV), a global provider of near field communication (NFC) and cashless payment solutions, has received a favorable ruling by the U.S. District Court, Southern District of New York, that mobile phones sold by T-Mobile USA, Inc. which were enabled with NFC technology infringes oti’s U.S. Patent No. 6,045,043.

In the publicly issued order, the court stated: “On Track Innovation’s motion for summary judgment on infringement…is granted.” This order means that at trial, T-Mobile will not be allowed to challenge infringement of the patent and the jury will be instructed that T-Mobile infringes the patent.

The Court also ruled on other motions, mostly in oti’s favor. The Court granted oti’s motion for summary judgment on T-Mobile’s affirmative defenses of laches, estoppel, acquiescence, patent misuse and inequitable conduct. The Court also denied T-Mobile’s motion for non-infringement or invalidity, finding that T-Mobile has not shown by uncontroverted evidence that the patent is invalid.

The Court also ruled on issues related to expert testimony. Judge Nathan granted, in part, oti’s motion to exclude certain opinion testimony of T-Mobile’s expert witness, Michael Davies; denied T-Mobile’s motion to exclude opinion testimony of oti’s technical expert, Professor Alyssa Apsel on infringement; and granted T-Mobile’s motion to exclude opinion testimony of oti’s damages expert, Dr. Christine Meyer. oti filed the lawsuit in March 2012.

“We are pleased with this decision and are preparing for the next stage of this trial,” said oti America’s CEO, Dimitrios Angelis.

The patent is part of oti’s extensive intellectual property portfolio that includes 34 families of patents and patent applications, with a number of patents issued in various jurisdictions with respect to oti’s technologies, as well as pending patent applications, trademarks and designs encompassing product applications, software and hardware platforms, system and product architecture, product concepts and more, in the fields of NFC, manufacturing techniques, contactless cards and payments, petroleum and parking solutions.

oti is a pioneer in the contactless payment market and supported MasterCard® and Visa®, among others, in the creation and implementation of contactless transaction processing and payment solutions. oti provides NFC devices and reader solutions, including oti WAVE device, which adds NFC capability to non-NFC enabled mobile phones.

About oti
On Track Innovations Ltd. (oti) is a leader in contactless and NFC applications based on its extensive patent and IP portfolio. oti’s field-proven innovations have been deployed around the world to address NFC and other cashless payment solutions, petroleum payment and management, cashless parking fee collection systems and mass transit ticketing. oti markets and supports its solutions through a global network of regional offices and alliances. For more information, visit www.otiglobal.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Whenever we use words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate” or similar expressions, we are making forward-looking statements. Because such statements deal with future events and are based on oti’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of oti could differ materially from those described in or implied by the statements in this press release. Forward-looking statements could be impacted by the effects of the protracted evaluation and validation periods in the U.S. and other markets for contactless payment cards, or new and existing products and our ability to execute production on orders, as well as other risks and uncertainties, including those discussed in the “Risk Factors” section and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2013, and in subsequent filings with the Securities and Exchange Commission. Although we believe that the expectations reflected in such forward-looking statements are based on reasonable assumptions, we can give no assurance that our expectations will be achieved. Except as otherwise required by law, oti disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise. The content of the web site links in the press release do not form part of it.

Trademarks are the property of their respective owners.

oti Investor Contact:
Scott Liolios or Matt Glover
Liolios Group, Inc.
949-574-3860
Email Contact

oti Press Contact:
Inbar Ben-Hur
oti Marketing Communication Manager
Email Contact

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(CNAT) Announces Successful Top-Line Results From NAFLD/NASH Clinical Trial of Emricasan

– Conclusions Support Registration Strategy Including NASH Cirrhosis –

– Detailed Data to be Presented in Late-Breaker Poster at EASL Meeting –

SAN DIEGO, March 26, 2015  — Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced top-line results from the company’s Phase 2 double-blind, placebo-controlled clinical trial of emricasan, a first-in-class, orally active pan-caspase protease inhibitor, in 38 patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with nonalcoholic steatohepatitis (NASH). The trial met its primary endpoint, showing a statistically significant (p<0.05) reduction in alanine amino transferase (ALT) in patients treated for 28 days with emricasan at 25 mg twice per day dosing compared to patients in the placebo control group. Reductions from baseline in ALT at Day 28 of approximately 39% in the emricasan treatment arm and approximately 14% in the placebo arm were similar to results observed in previous trials. Elevated baseline levels of three key serum biomarkers – caspase-cleaved cytokeratin 18 (cCK18), full length cytokeratin 18, and caspase 3/7 – also showed statistically significant reductions from baseline in emricasan-treated patients at Day 28. The baseline elevation in cCK18 confirmed that the underlying targets of emricasan’s mechanism, apoptosis and inflammation, which are believed to drive liver disease progression, were engaged in the NAFLD/NASH patients in this trial. A reduction from baseline in cCK18 at Day 28 of approximately 30% in the emricasan treatment arm and an increase from baseline of approximately 4% in the placebo arm were similar to results observed in previous trials. The reduction in serum cCK18 levels demonstrated that emricasan can effectively reduce inflammation and elevated levels of apoptosis in NAFLD/NASH patients. These results were consistent with data obtained from the company’s previous clinical trials in other liver disease patient populations.

Emricasan was safe and well tolerated in the NAFLD/NASH trial, with no dose-limiting toxicities and no drug-related serious adverse events. Treatment with emricasan also had no adverse effects on lipid levels or insulin sensitivity, important safety assessments in NAFLD/NASH patients who are at risk for cardiovascular disease. Detailed results from the NAFLD/NASH trial will be presented in a late-breaker poster at The International Liver Congress™ 2015, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 22-26, 2015.

“With these results from the NAFLD/NASH trial, we have confirmed that the optimal dose of emricasan is consistent across different etiologies,” said Conatus co-founder, President and Chief Executive Officer, Steven J. Mento, Ph.D., “and strengthened our belief that inhibiting excessive apoptosis and inflammation will be therapeutic in patients whose liver damage is associated with NASH.”

“Our focus is on developing emricasan initially as a treatment in patients with liver cirrhosis,” said David T. Hagerty, M.D., Executive Vice President of Clinical Development at Conatus. “The data from the NAFLD/NASH trial, along with the data from our three organ impairment dosing trials, support the conduct of efficacy trials in patients with liver cirrhosis due to NASH. In addition, the recently published proceedings of a 2013 NASH endpoints workshop sponsored by the American Association for the Study of Liver Diseases (AASLD) and U.S. Food and Drug Administration (FDA) provided important insights regarding validated surrogate clinical endpoints that could be useful for accelerated approval pathways in patients with NASH-driven liver cirrhosis. With this comprehensive information package, we are prepared for planned discussions with regulatory authorities to seek guidance on the appropriate use and analysis of these endpoints in registrational trials including patients with NASH cirrhosis.”

About Emricasan Clinical Development

To date, emricasan has been studied in over 550 subjects in fourteen clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and apoptosis that are implicated in the severity and progression of liver disease. Importantly, these key biomarkers are known to be elevated and to have prognostic value in multiple hepatic indications that Conatus is currently pursuing.

About Conatus Pharmaceuticals

Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. For additional information, please visit www.conatuspharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding: the belief that inhibiting apoptosis and inflammation will be therapeutic in patients with NASH; the appropriateness of surrogate clinical endpoints for accelerated approval pathways; the company’s ability to secure regulatory guidance on the appropriate use and analysis of surrogate clinical endpoints in registration trials including patients with NASH cirrhosis; and emricasan’s therapeutic potential in patients with NASH cirrhosis and other forms of liver disease. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including:  Conatus’ ability to initiate and successfully complete current and future clinical trials; Conatus’ dependence on its ability to obtain regulatory approval for, and then successfully commercialize emricasan, which is Conatus’ only drug candidate; Conatus’ reliance on third parties to conduct its clinical trials, enroll subjects, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; the potential that earlier clinical trials may not be predictive of future results; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; results of future clinical trials of emricasan; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the FDA’s and other regulatory agencies’ approval processes and other regulatory requirements; Conatus’ ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; Conatus’ limited operating history and its ability to operate successfully as a public company; Conatus’ ability to obtain additional financing in order to complete the development and commercialization of emricasan; and those risks described in Conatus’ prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in Conatus’ forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

CONTACT: MEDIA: David Schull
         Russo Partners, LLC
         (858) 717-2310
         David.Schull@RussoPartnersLLC.com

         INVESTORS: Alan Engbring
         Conatus Pharmaceuticals Inc.
         (858) 376-2637
         aengbring@conatuspharma.com
Thursday, March 26th, 2015 Uncategorized Comments Off on (CNAT) Announces Successful Top-Line Results From NAFLD/NASH Clinical Trial of Emricasan

(NETE) SeeThruEquity Issues Company Update Highlighting PayOnline Acquisition

NEW YORK, NY / March 26, 2015 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced that it has issued a company update on Net Element, Inc. (NASDAQ: NETE).

The note is available here: NETE Update Note. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack’s. The report will also be available on these platforms. We also contribute our estimates to Thomson Estimates, the leading estimates platform on Wall Street.

“We see the acquisition of PayOnline as strategic for Net Elements, as the company already has a strong presence in Russia, CIS, Europe and Asia and all representing attractive markets with significant growth potential for online and mobile payments. Russia, for example, is the 6th largest global market for online payments, according to McKinsey & Company, accounting for $50Bn in payments annually. The country has several attractive growth characteristics, with ecommerce growing at a 22% annual rate and a long runway for potential growth, with only 43% of the Russian population using the Internet. We are reiterating our raising our 12 month price target on NETE of $5.17 per share,” stated Ajay Tandon, CEO of SeeThruEquity.

Additional highlights of the note are as follows:

PayOnline acquisition a strategic move for Net Element

– The acquisition of PayOnline is a strategic move that significantly expands Net Element’s scale, product offerings and international presence. PayOnline operates a proprietary integrated platform of payment solutions that supports over 10mn active consumers and thousands of merchants in the Russian Federation, Commonwealth of Independent States (CIS), Europe and Asia. PayOnline is an online payment leader in Russia, which McKinsey & Company estimates is the 6th largest payments market globally, accounting for $50Bn in payments. PayOnline is estimated to hold a 30% share of the online payments segment, and appears to be an attractive addition to the company’s TOT Money and Unified Payments businesses, allowing a best in class solution that covers all methods of online and mobile payment in Russia. We estimate PayOnline processes approximately $100mn in online payments per year, generating roughly $3.5mn in revenue, with positive net income.

PayOnline acquisition adds to momentum in Russian Federation, Europe and Asia

– The PayOnline acquisition is the latest in a series of positive announcements for Net Element’s TOT Group subsidiary in the region. TOT Money, a TOT Group company, is an industry leader in the growing mobile payments market in Russia, where it has achieved 10% market share and has been one of the top three mobile payments provider for the last two years, according to research from Russian leading mobile operator Vimpelcom. The company has relationships with the top three mobile operators in Russia and reached a crucial milestone by exceeding 1mn recurring mobile payment subscribers in January. In fact TOT Money achieved 10% market share in Russia while generating double-digit, quarter-over-quarter subscriber throughout 2014.

– We believe Net Element is rightly investing its resources in this strategic market where robust growth is expected for the foreseeable future and the company commands a strong competitive position. Net Element further increased the resources available to TOT Money in November, by entering into a financing agreement with Bank Otkritie Financial Corp, one of Russia’s largest private banks, to provide approximately $4mn in accounts receivable financing.

Please review important disclosures on our website at www.seethruequity.com.

About Net Element, Inc.

Net Element, Inc. (NASDAQ: NETE) is a global financial technology-driven company specializing in mobile payments and transactional services in emerging countries and in the U.S. The company operates its business through its global mobile payments and transaction processing provider, TOT Group. TOT Group companies include Unified Payments, recognized by Inc. Magazine as the #1 Fastest Growing Private Company in America in 2012; Aptito, a next generation cloud-based point of sale payments platform; and TOT Money, which has a leading position in Russia and has been ranked as the #1 SMS content provider by Beeline, Russia’s second largest telecommunications operator. NETE has global development centers and high-level business relationships in the U.S., Russia and Commonwealth of Independent States.

For more information, visit www.netelement.com.

About SeeThruEquity

SeeThruEquity is an equity research and corporate access firm focused on companies with less than $1 billion in market capitalization. The research is not paid for and is unbiased. We do not conduct any investment banking or commission based business. We are approved to contribute our research to Thomson One Analytics (First Call), Capital IQ, FactSet, Zacks and distribute our research to our database of opt-in investors. We also contribute our estimates to Thomson Estimates, the leading estimates platform on Wall Street.

For more information visit www.seethruequity.com.

Contact:

Ajay Tandon
SeeThruEquity
info@seethruequity.com

Thursday, March 26th, 2015 Uncategorized Comments Off on (NETE) SeeThruEquity Issues Company Update Highlighting PayOnline Acquisition

(VCEL) Three-Year Follow-Up Results, Phase 3 SUMMIT Extension Study of MACI(TM) Implant

Poster Presentation at AAOS Annual Meeting Shows Continued Benefit Over Microfracture Bone Marrow Stimulation Procedure

CAMBRIDGE, Mass., March 25, 2015  — Vericel Corporation (Nasdaq:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today reported that positive results from the three-year extension of the Phase 3 SUMMIT study with MACI™ (matrix-applied characterized autologous cultured chondrocytes) were presented at the annual meeting of the American Association of Orthopedic Surgeons in Las Vegas. In a poster presentation (number P169) entitled “SUMMIT Trial: Matrix-induced Autologous Chondrocyte Implant versus Microfracture at 3 Years,” Professor Mats Brittberg, Cartilage Research Unit, University of Gothenburg, Sweden, and colleagues reported that patients followed for three years following treatment with MACI had consistent results as those reported previously in the two-year SUMMIT trial.

In the open-label, multi-center Phase 3 SUMMIT study, 144 patients with symptomatic articular cartilage defects in the knee were randomized to receive treatment with MACI implant or microfracture bone marrow stimulation (MFX) and followed for two years. The study found that treatment with MACI was clinically and statistically significantly better than MFX, with similar structural repair tissue and safety. The SUMMIT study concluded that “MACI offers a more efficacious alternative than MFX with a similar safety profile for the treatment of symptomatic articular cartilage defects of the knee.”1

In the SUMMIT Extension trial, 128 patients (men and women aged 18 to 55) from the original SUMMIT study continue to be followed. The co-primary endpoints of the extension study are change in knee injury and osteoarthritis outcome (KOOS) pain and function scores at year 3, the same primary endpoint from the two-year SUMMIT trial. Patients treated with MACI versus MFX continue to show a statistically significant improvement from baseline in the co-primary endpoint of KOOS pain and function at year 3 (p = 0.046) with higher responder rates in the MACI group (81.5%) than in the MFX group (66.7%). Patients treated with MACI versus MFX also showed significant improvement in knee-related quality of life and other measures. The authors concluded that “the co-primary endpoints of pain and function showed significant improvement with MACI, which was statistically significantly better than with MFX.” The incidences of treatment emergent adverse events and serious adverse events were similar between treatment groups at year 3 and no unexpected safety findings were reported.

David Recker, M.D., Vericel’s chief medical officer, stated: “These findings appear to support the positive risk-benefit profile of MACI implantation in patients who require knee cartilage repair surgery that was first demonstrated in the pivotal Phase 3 SUMMIT study. We are extremely encouraged by the favorable clinical and efficacy of MACI compared to MFX after 3 years of follow-up.”

1 D. Saris et al., “Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture; Two-Year Follow-up of a Prospective Randomized Trial,” The American Journal of Sports Medicine, Vol. 42, No. 6, April 2014

About MACI

MACI is a third-generation autologous chondrocyte implantation (ACI) product for the treatment of focal chondral cartilage defects in the knee. MACI has been approved but is not currently marketed in Europe and is a Phase 3 product candidate in the United States. The pivotal clinical trial supporting MACI registration in Europe (Superiority of MACI Implant to Microfracture Treatment, or SUMMIT) demonstrated a statistically significant and clinically meaningful improvement in the co-primary endpoint of pain and function for those patients treated with a MACI implant compared to microfracture, the previous standard of care.  MACI has the potential advantages of a shorter, less-invasive surgical procedure and faster recovery period than current biological treatments for knee cartilage repair. Vericel plans to meet with the FDA this year to discuss the requirements for registration of MACI in the United States.

About Vericel Corporation

Vericel Corporation (formerly Aastrom Biosciences, Inc.) is a leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions.  The company markets two autologous cell therapy products in the U.S.: Carticel® (autologous cultured chondrocytes), an autologous chondrocyte implant for the treatment of cartilage defects in the knee, and Epicel® (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep-dermal or full-thickness burns comprising greater than or equal to 30% of total body surface area. Vericel is also developing MACI™, a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy. For more information, please visit the company’s website at www.vcel.com.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, intended product development, clinical activity timing, integration of the acquired business, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, integration of the acquired business, clinical trial and product development activities, regulatory approval requirements, the availability and allocation of resources among different potential uses, estimating the commercial potential of our products and product candidates and growth in revenues, market demand for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Aastrom’s Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2014, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Aastrom does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law. 

CONTACT: Chad Rubin
         The Trout Group
         crubin@troutgroup.com
         (646) 378-2947

         Lee Stern
         The Trout Group
         lstern@troutgroup.com
         (646) 378-2922
Wednesday, March 25th, 2015 Uncategorized Comments Off on (VCEL) Three-Year Follow-Up Results, Phase 3 SUMMIT Extension Study of MACI(TM) Implant

(EXFO) Renews Normal Course Issuer Bid

QUEBEC CITY, March 25, 2015  – EXFO Inc. (NASDAQ: EXFO; TSX: EXF) announced today that its Board of Directors has authorized the renewal of its share repurchase program, by way of a normal course issuer bid (“NCIB”) on the open market, of up to 10% (1,397,598 subordinate voting shares) of the public float (13,975,983 subordinate voting shares as of March 20, 2015) as defined by the Toronto Stock Exchange (“TSX”).

EXFO had 22,221,590 subordinate voting shares outstanding on March 20, 2015. As of March 20, 2015, EXFO had repurchased in the course of the previous renewal of its NCIB a total of 450,956 shares, being 139,986 shares on the TSX at a weighted average amount of CA$ 4.35 and 310,970 shares on the NASDAQ at a weighted average amount of US$ 3.96 (of which were repurchased in the last 12 months: 78,056 shares on the TSX at a weighted average amount of CA$ 4.03 and 158,430 shares on the NASDAQ at a weighted average amount of US$ 3.60, for a total of 236,486 shares). The previous renewal of the NCIB had been effective since January 13, 2013 and expired on January 12, 2014.

The TSX has accepted a notice filed by EXFO of its intention to renew its NCIB. EXFO may use cash, short-term investments and future cash flows from operations to fund the repurchase of shares. Repurchases under the bid will be made on the open market, through the facilities of the TSX and NASDAQ Global Market, at the prevailing market price. The timing of such repurchases, if any, will depend on price, market conditions and applicable regulatory requirements.

The NCIB will become effective on March 27, 2015 and end on March 26, 2015 or on an earlier date if EXFO repurchases the maximum number of shares permitted. The average daily trading volume (ADTV) of EXFO’s subordinate voting shares was 17,331 on the TSX and 29,248 on the NASDAQ over the last six months preceding March 20, 2015. Accordingly, EXFO is entitled to repurchase up to 25% of the ADTV on any trading day (being 4,332 subordinate voting shares on the TSX and 7,312 subordinate voting shares on the NASDAQ) or pursuant to the applicable rules of the TSX. The program does not require the company to repurchase a minimum number of shares and it may be modified, suspended or terminated at any time without prior notice. All shares acquired by EXFO under the bid will be cancelled.

EXFO believes that the repurchase of some of its subordinate voting shares is an appropriate and desirable use of its available cash. Consequently, EXFO believes that the offer is made in the best interests of the company and its shareholders.

About EXFO
Listed on the NASDAQ and TSX stock exchanges, EXFO is a leading provider of next-generation test, service assurance and end-to-end quality of experience solutions for mobile and fixed network operators and equipment manufacturers in the global telecommunications industry. EXFO’s intelligent solutions with contextually relevant analytics improve end-user quality of experience, enhance network performance and drive operational efficiencies throughout the network and service delivery lifecycle. Key technologies supported include 3G, 4G/LTE, VoLTE, IMS, video, Ethernet/IP, SNMP, OTN, FTTx, xDSL and various optical technologies accounting for more than 38% of the global portable fiber-optic test market. EXFO has a staff of approximately 1600 people in 25 countries, supporting more than 2000 customers worldwide. For more information, visit www.EXFO.com and follow us on the EXFO Blog, Twitter, LinkedIn, Facebook, Google+ and YouTube.

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

Wednesday, March 25th, 2015 Uncategorized Comments Off on (EXFO) Renews Normal Course Issuer Bid

(VICL) Expands Infectious Disease Portfolio With Novel Antifungal From Astellas

  • Development and potential commercial synergies with existing CMV program
  • Targeting Phase 1 initiation in first half of 2016
  • 2015 cash burn guidance remains unchanged

SAN DIEGO, March 25, 2015  — Vical Incorporated (Nasdaq:VICL) today announced that it has expanded its infectious disease portfolio with the addition of a novel antifungal, ASP2397, in-licensed from Astellas Pharma Inc. (TOKYO:4503) (“Astellas”). ASP2397 represents a potential new class of antifungal compounds to address invasive Aspergillus infections, which are major causes of morbidity and mortality in immunocompromised patients, including transplant recipients. ASP2397 is differentiated by a new mechanism of action and has a low propensity for P450 drug-drug interactions. In preclinical studies to date, it has demonstrated faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. As part of the agreement, Astellas, which is also Vical’s partner for the ASP0113 CMV vaccine program in transplant recipients, will become a shareholder in Vical.

“It is exciting to see a novel antifungal with preclinical data showing potent and rapid fungicidal activity, and low potential for drug-drug interactions. Such a drug could become a treatment of choice for front-line therapy of invasive fungal infections,” said John R. Perfect, M.D., Chief of Division of Infectious Diseases at Duke University Medical Center.

Under the terms and conditions of the license agreement, Astellas granted Vical an exclusive worldwide license to develop and commercialize ASP2397. Astellas will receive Vical common stock equivalent to approximately 1% of outstanding shares and $250 thousand in cash. Astellas will also be eligible for up to $100 million in aggregate milestone payments, the vast majority of which are commercial and sales milestones, and single-digit royalties on net sales. The above agreement does not impact Vical’s cash burn guidance, which remains at between $12 million and $15 million for 2015.

“ASP2397 is an exciting opportunity that has arisen out of the relationship we have built with Astellas,” said Vijay B. Samant, Vical’s President and CEO. “While advancing our CMV and HSV-2 programs remains the top priority at Vical, this novel candidate adds depth to our pipeline and strengthens Vical’s position as an infectious disease company.”

“ASP2397 is a unique antifungal discovered at Astellas, and we are pleased to partner it with Vical, who we believe has the right capabilities to develop this compound and bring it to market,” said Naoki Okamura, Corporate Vice President and Global Head of Business Development at Astellas.

ASP2397 is a novel natural product discovered by Astellas from leaf litter fungus collected in a Malaysian national park. In vitro and in vivo data were featured in two posters presented during the ICAAC 2014 meeting last September. Most of the IND-enabling preclinical studies have been completed by Astellas, and Vical is targeting initiation of a Phase 1 trial in the first half of 2016.

Vical consulted an expert team of advisors during the evaluation of ASP2397 and is forming a Clinical Advisory Board (CAB) to help direct the development program. Initial members of the CAB include:

  • John R. Perfect, M.D., Chief of Division of Infectious Diseases, Duke University Medical Center
  • Dennis Schmatz, Ph.D., consultant, 30-year veteran of Merck and team leader for Cancidas (caspofungin)
  • Michael R. Hodges, M.D., consultant, 17-year veteran of Pfizer and team leader for Vfend (voriconazole)

Vical intends to develop ASP2397 as a front-line therapy for invasive aspergillosis and as part of combination regimen for preemptive treatment of fungal infections, which may represent a meaningful commercial opportunity within the $4 billion global market for systemic antifungals. Current treatment options have limited efficacy, as approximately 50-60% of allogeneic hematopoietic stem cell transplant recipients with invasive aspergillosis infections die within 12 weeks. Over the past 30 years, only one new class of antifungal drugs (echinocandins) has been introduced.

Conference Call

Vical will conduct a conference call and webcast tomorrow, March 26, at 8:30 a.m. Eastern Time. Listeners may access the accompanying slide presentation through the webcast at www.vical.com. The call and webcast will be open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 325-2308 (preferred), or (888) 312-3048 (toll-free), and reference confirmation code 2695093. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 2695093. The webcast portion of the call will be available live and archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at (858) 646-1127 or by e-mail at ir@vical.com.

About Vical

Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.

Forward-Looking Statements

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include cash burn guidance, the potential benefits of ASP2397, Vical’s capabilities to develop ASP2397, Vical’s development plans and timelines for ASP2397, the potential market opportunity for ASP2397, and potential payments under the license agreement with Astellas. Risks and uncertainties include whether Vical or others will continue development of ASP2397, whether planned clinical development of ASP2397 will begin when expected, or at all, whether the results of future preclinical or clinical studies will be consistent with prior preclinical studies or will otherwise merit further development; whether Vical will achieve levels of revenues and control expenses to meet its financial projections; whether Vical or its collaborative partners will seek or gain approval to market any product candidates, including ASP2397; whether pending legislation related to the development or drug candidates such as ASP2397 will be enacted in its current form or at all, and the ultimate impact of any such legislation; and additional risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

CONTACT: Andrew Hopkins
         (858) 646-1127
         Website: www.vical.com
Wednesday, March 25th, 2015 Uncategorized Comments Off on (VICL) Expands Infectious Disease Portfolio With Novel Antifungal From Astellas

(VBLT) Topline Results, Phase 2 Clinical Trial of VB-111 in Recurrent Glioblastoma

— Interim Data Demonstrate Statistically Significant Improvement in Overall Survival in Patients Treated With VB-111 in Combination With Bevacizumab (Avastin(R)) —

TEL AVIV, Israel, March 25, 2015  — VBL Therapeutics (Nasdaq:VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced top-line interim results from its ongoing Phase 2 study of VB-111 in patients with recurrent glioblastoma (rGBM), which demonstrated a statistically significant improvement in overall survival in patients treated with VB-111 followed by VB-111 in combination with bevacizumab (Avastin®) upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone upon disease progression (p=0.05). Study results will be presented in conjunction with the American Society of Cancer Oncology (ASCO) Annual Meeting, May 29th-June 2nd, 2015 in Chicago, Illinois.

“We are extremely pleased by these interim results and are particularly excited to see a statistically significant improvement in overall survival in this needy patient population. We believe VB-111’s ability to curb disease progression in this devastating illness further reinforces its broad potential as a gene therapy for a range of solid tumor indications,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We continue to work to bring VB-111 forward as a potential new treatment option, and look forward to initiating a pivotal Phase 3 trial in recurrent glioblastoma later this year.”

These interim Phase 2 data include 46 patients with rGBM. VB-111 monotherapy was discontinued upon progression in 22 patients who were then treated with bevacizumab alone. The remaining 24 patients, upon disease progression on VB-111 monotherapy, could elect to receive further treatment with VB-111 in combination with bevacizumab. 23 have received combined therapy; one patient is still stable on VB-111 monotherapy at 424 days. VB-111 in combination with bevacizumab demonstrated a statistically significant improvement in overall survival, with median overall survival of 414 days, compared to 235 days in patients on VB-111 followed by bevacizumab alone (p=0.05).

VBL’s pivotal Phase 3 clinical trial will be led by Dr. Timothy Cloughesy, MD, Professor of Clinical Neurology and Director of the Neuro-Oncology Program, UCLA School of Medicine and is expected to initiate in mid-2015 under a special protocol assessment granted by the FDA.

Study Details:

The Phase 1/2 trial is a multi-center, two stage, dose-escalation study designed to determine the safety, tolerability and efficacy of VB-111 in patients with rGBM. In the first stage of the study, patients were treated with VB-111 alone. Upon disease progression — defined according to the Response Assessment in Neuro-Oncology (RANO) criteria as a worsening of the patient’s cancer with an increase of at least 25% in the overall mass of measurable tumors, the appearance of new tumors, the worsening of non-measurable tumors since the beginning of treatment, a need for increased dose of corticosteroids, or clinical deterioration — patients entered the second stage in which they received either bevacizumab alone or bevacizumab in combination with VB-111, in two sequential cohorts.

About VB-111:

VB-111 is a novel, intravenously-administered, anti-angiogenic agent that utilizes VBL’s proprietary Vascular Targeting System (VTS™) to target endothelial cells in the tumor vasculature for cancer therapy. VB-111 continues a non-replicating adenovector, a proprietary modified murine pre-proendothelin promoter (PPE-1-3x) and a Fas-Chimera transgene to angiogenic tumor blood vessels, leading to their apoptosis. VB-111 is the first agent based on transcriptional targeting of tumor endothelium to be assessed in a clinical trial.

VB-111 completed a Phase 1/2 “all-comers” clinical trial, which demonstrated multiple cases of objective tumor response and disease control and excellent safety and tolerability. VB-111 has Fast Track Designation for recurrent glioblastoma in the US and organ drug status for glioblastoma in both the US and EU. VBL is conducting early phase II studies in thyroid and ovarian cancer.

About VBL:

Vascular Biogenics Ltd., operating as VBL Therapeutics, is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, VB-111, is a gene-based biologic that is initially being developed for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer. VB-111 has received orphan drug designation in both the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation. VBL Therapeutics expects to begin the pivotal Phase 3 clinical trial of VB-111 in rGBM in mid-2015, under a special protocol assessment agreement granted by the FDA.

Forward Looking Statements:

This press release contains forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our proposed pivotal Phase 3 clinical trial of VB-111 in rGBM may not support approval of VB-111 for marketing in the United States, notwithstanding the positive results seen in our current clinical trial. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACT: Hannah Deresiewicz
         Stern Investor Relations, Inc.
         212-362-1200, hannahd@sternir.com
Wednesday, March 25th, 2015 Uncategorized Comments Off on (VBLT) Topline Results, Phase 2 Clinical Trial of VB-111 in Recurrent Glioblastoma