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$DARE trading on The NASDAQ Capital Market under the symbol “DARE”

Company focused on the development and commercialization of women’s reproductive health products
Daré to Host Conference Call on Monday, July 24, 2017, at
4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to Discuss Business Opportunity

SAN DIEGO, July 20, 2017 — Daré Bioscience, Inc. (NASDAQ:DARE) (formerly known as Cerulean Pharma Inc., and formerly traded under NASDAQ:CERU) announced today the outcomes of three important transactions: (i) approval by Cerulean stockholders of the purchase of all of the outstanding common shares and options of Daré Bioscience (which has been renamed Daré Bioscience Operations, Inc. to avoid confusion with the renamed Cerulean), (ii) approval by Cerulean stockholders of the sale of all rights related to the Dynamic Tumor Targeting™ Platform to Novartis for $6 million in cash, and (iii) approval by Cerulean stockholders and authorization by the Cerulean board of directors of a 10 to 1 reverse stock split. As a result of these transactions, the stockholders of pre-closing Daré have become owners of approximately 51% of the issued and outstanding shares of the combined company, while the stockholders of pre-closing Cerulean will continue to own approximately 49% of the issued and outstanding shares of the combined company, which represents the maximum ownership possible for the pre-closing Cerulean stockholders under the stock purchase agreement entered into between the companies on March 19, 2017.

Following the closing of the transaction, Sabrina Martucci Johnson, President and CEO of Daré, became the President and CEO of Cerulean and joined its board of directors and Lisa Walters-Hoffert, CFO of Daré, became Cerulean’s CFO.  The operations of Daré and Cerulean are being combined, with the combined company operating under the name “Daré Bioscience, Inc.” and led solely by Daré’s management team.

“Daré’s transition to the public market represents a significant milestone for us,” stated Sabrina Martucci Johnson, President and CEO of Daré. “We are grateful for the support of the Cerulean stockholders. Daré is committed to building a strong company in women’s reproductive health, beginning with our first clinical candidate, Ovaprene®. We believe Daré represents an attractive business with considerable product candidate opportunities and market potential.”

Conference Call and Webcast
Daré will hold a conference call on Monday, July 24, 2017, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to provide an overview and business update. Interested parties may access the conference call by dialing (844) 831-3031 from the U.S. and (443) 637-1284 from outside the U.S. and should request the Daré Call, conference ID 58451998. The conference call also will be webcast live over the Internet and can be accessed at http://edge.media-server.com/m/p/mmj5wibt.

About Daré Bioscience, Inc. (formerly Cerulean Pharma Inc.)

Daré is a healthcare company committed to the development and commercialization of innovative products in women’s reproductive health. We have identified areas within this market segment that remain underserved and believe they offer opportunities to generate value for both investors and women.

The problem isn’t early innovation. The global donor community of foundations and governments has invested tens of millions of dollars in early-stage and clinical-stage research to expand options, improve outcomes and advance global women’s reproductive health. In addition, independent private innovators have developed new approaches to address unmet needs. Yet, promising candidates often fail to advance for reasons unrelated to results, but rather because of shifting strategic priorities or a lack of dedicated funding.

The problem isn’t commercialization. Large and medium-size pharmaceutical companies with established sales and marketing franchises in women’s health exist.  However, many of these companies prefer to get involved in later stages of development, e.g., in pivotal trials or following an application for regulatory approval.

The problem is the gap. We believe that this gap between innovation and commercialization in women’s reproductive health creates an opportunity for Daré. Our business model is to license the rights to promising product candidates (many with clinical proof-of-concept data), advance their clinical development, and if successful, implement a comprehensive global commercialization strategy in combination with established pharmaceutical partners and regional distributors. We believe this approach is efficient in both its use of time and financial resources.

The contraceptive market in particular represents an interesting segment for Daré. Since the approval of the birth control pill by the FDA in 1960, most contraception innovation has focused on the use of hormones. Little innovation has occurred to create new non-hormonal options, leaving a void in the method mix and creating a potential opportunity.  Today’s non-hormonal alternatives include condoms, diaphragms, and spermicides, all of which require intervention at the time of intercourse and most of which have marginal efficacy.  There is a need for something better.

First product candidate, Ovaprene®

Ovaprene® is a clinical stage, non-hormonal contraceptive ring intended to provide protection over multiple weeks of use, require no intervention at the time of intercourse, and fill a void in today’s contraception method mix.

  • Research has shown that as many as 40% of women using contraception say they are not satisfied with their current method, reporting difficulty of use, problems with side effects, and concerns about effectiveness and reduced sexual pleasure.
  • A convenient, easy-to-use and effective non-hormonal option could appeal to a portion of the 22% of women currently using one of today’s non-hormonal methods.
  • Ovaprene® would represent a new category of birth control and expand options.

A contraceptive ring, whose use is initiated and controlled by a woman, has numerous attributes that women find appealing. Published surveys revealed the following:

  • A vaginal ring has most of the features they deemed extremely important,
  • 85% of women surveyed reported they would prefer a monthly option with a lower hormone dose than the pill, and
  • 80% currently use a non-coital dependent method, meaning there is no intervention at the time of intercourse.

The only contraceptive ring on the market today is NuvaRing®, a hormonal contraceptive ring with 2016 sales of $777 million.  Our goal for Ovaprene® is to provide similar monthly convenience and protection but without the use of hormones.

Ovaprene® has a custom intravaginal ring design, with a permeable mesh in the center of the ring that creates a partial barrier to sperm, and a mechanism to release locally acting spermiostatic agents through the ring.  The unique combination of these two complementary approaches seeks to produce attractive contraceptive efficacy outcomes that are consistent with the most effective barrier option, the diaphragm, and short-acting hormonal options (oral pill, patches and vaginal ring) that provide 88-91% effectiveness in typical use.  Typical use refers to effectiveness experienced among all couples who use the method, including inconsistent and incorrect use.

In a pilot postcoital test (“PCT”) clinical trial conducted in 21 women and published in the Journal of Reproductive Medicine in 2009, Ovaprene® demonstrated the following:

  • Ability to immobilize sperm and prevent their progression into the cervical mucus,
  • Acceptability of the device to both partners, and
  • No serious adverse events were reported.

While the original pilot PCT clinical trial was not designed to be utilized as part of a regulatory submission, its data provide preliminary proof-of-concept contraceptive efficacy. PCT clinical trials have been used to assess the preliminary efficacy of other contraception methods that work by preventing or blocking the progression of sperm into the cervical mucus.

Our stockholders can expect the following benefits from the combination of Daré (formerly Cerulean) and Daré Operations:

  • Daré intends to commence a PCT clinical trial of Ovaprene® with CONRAD, a non-profit organization that oversaw the successful development and FDA approval of the Caya® diaphragm, the most recently approved barrier contraceptive device in combination with a locally-acting spermiostatic agent.
  • Based on our current projections and the cash from the transaction, we believe Daré will be adequately funded to advance Ovaprene® through the completion of the PCT clinical trial within the next two years. A successful PCT clinical trial outcome would represent a meaningful milestone and should allow Daré to proceed directly to a pivotal contraceptive efficacy trial in the United States.
  • Daré is currently in discussions regarding other product candidates that meet our selection criteria. We are also exploring co-development opportunities with non-profit partners and foundations as a way to leverage their tremendous investment capacity and breadth of product candidates.

In addition to contraception, women’s reproductive health encompasses a broad spectrum of categories, including vaginal health, fertility and pain, among others.  Daré is committed to identifying, licensing and developing candidates that expand options, improve outcomes, and enhance safety for women across the broad spectrum.  We look forward to advancing the Ovaprene® development program while evaluating other clinical stage opportunities that meet our objectives.

Forward Looking Statements

This press release contains “forward-looking statements” regarding matters that are not historical facts, including statements relating to Daré’s expectations regarding the timing and availability of results from its clinical trials, the timing of commencement of manufacturing its products, the safety and effectiveness of its products and the continued ability of Daré to develop and market Ovaprene® under its license with ADVA-Tec. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether cash resources will be sufficient to fund the operations of Daré it will undertake; the uncertainties inherent in the initiation and completion of clinical trials; availability and timing of data from ongoing and future clinical trials and the results of such trials; whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials; whether the company will maintain its NASDAQ listing, expectations for regulatory approvals; claims of infringement and other risks relating to Daré’s owned and licensed intellectual property rights; and other factors discussed in the “Risk Factors” section of Daré’s Quarterly Report on Form 10-Q filed with the SEC on May 12, 2017, and in other filings that Daré made with the SEC, including the definitive proxy statement relating to the transaction with Daré Operations filed with the SEC on June 19, 2017. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. Daré and Daré Operations specifically disclaim any obligation to update any forward-looking statements included in this press release.

For more information on Daré, please visit www.darebioscience.com

Daré Bioscience, Inc.
11119 North Torrey Pines Road
Suite 200
La Jolla, CA 92037

Telephone: 858-769-9145
innovations@darebioscience.com
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$SRAX Releases People-Based Advertising Guide

SRAX guide unlocks how to turbo-charge ad targeting strategy through cross-device targeting precision

LOS ANGELES, July 20, 2017  — SRAX (NASDAQ: SRAX), an advertising technology company providing the tools to automate digital marketers and content owners’ campaigns across digital channels, today announced the release of a new guide: People-Based Advertising: How to Get Bigger Results by Targeting the Most Precise Audience. The guide is available to download by signing up at: http://go.srax.com/people-ad-guide.

SRAX’s guide provides the knowledge and information to invest in people-based advertising, which leverages a range of customer and user data to identify and reach people in the advertising ecosystem.

“Connecting with each consumer individually, across devices, platforms and publishers is critically important in today’s digital advertising marketplace,” said SRAX’s CEO and Chairman Christopher Miglino. “Our People-Based Advertising guide is designed to inform and inspire brands and agencies to unlock the ultimate level of cross-device targeting precision.”

SRAX’s People-Based Advertising guide covers the following for digital marketers and content owners:

  • Why people-based advertising should be part of your strategy
  • 5 ways people-based advertising will boost your business and your brand
  • How people-based advertising with first-party data works
  • What you’ll need to turnaround your targeting strategy

To download SRAX’s People-Based advertising guide, visit and sign-up at: http://go.srax.com/people-ad-guide.

ABOUT SRAX 

SRAX (NASDAQ: SRAX) is an advertising technology company providing the tools to automate digital marketers and content owners’ campaigns across digital channels. SRAX’s tools amplify performance and maximize profits for brands in the healthcare, CPG, automotive, wellness and lifestyle verticals through an omnichannel approach that integrates all aspects of the marketing experience into one platform. The company’s machine-learning technology identifies brands’ core consumers and their characteristics discovering new and measurable opportunities to target, reach and monetize audiences driving online and offline sales lift. For more information on how SRAX delivers a digital competitive advantage to surpass today’s marketing challenges, visit www.srax.com.

Safe Harbor Statement

This press release contains certain forward-looking statements that are based upon current expectations and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words or expressions such as “anticipate,” “plan,” “will,” “intend,” “believe” or “expect'” or variations of such words and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control and difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including, without limitation, statements made with respect to expectations of our ability to increase our revenues, satisfy our obligations as they become due, report profitable operations and other risks and uncertainties, all as set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, many of which are generally outside the control of Social Reality and are difficult to predict. Social Reality undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Steve Stratz
Relevanz Public Relations for SRAX
206.300.9134
steve@relevanzpr.com

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$NETE PayOnline Expands Payments Module to Include Prominent InSales Platform

InSales facilitates integration with PayOnline, provides access to over 4,000 new merchants

MIAMI, FL–(Jul 20, 2017) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a global financial technology and value-added solutions group that supports electronic payments acceptance in an omni-channel environment spanning across point-of-sale (POS), e-commerce and mobile devices, today announces that its PayOnline subsidiary has expanded its payments module for electronic commerce and Content Managements System (“CMS”) to include InSales (www.insales.com), a popular omni-channel commerce and CMS platform for small- to medium-sized businesses.

The new free PayOnline module for InSales allows merchants to accept payments for the most popular bankcards, including Visa, Visa Electron, MasterCard, Maestro and MIR. The PayOnline module also supports key world currencies, including U.S. dollars, euros, rubles, tenge, soms, shekels, and over 110 other currencies. All payment interfaces of PayOnline module are available in both English and Russian languages.

With this newest addition, PayOnline gains access to over 4,000 new merchants in Russia and Kazakhstan which translates into significant revenue potential for Net Element. PayOnline’s payment module is now available on 23 of the most popular ecommerce and CMS platforms, and the list of supported platforms continues to grow.

About Net Element
Net Element, Inc. (NASDAQ: NETE) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US it aims to grow transactional revenue by innovating SME productivity services such as its cloud based, restaurant and retail point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Net Element was named in 2016 by South Florida Business Journal as one of the fastest growing technology companies. 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 the expanded payments module which includes InSales will generate additional revenues or will be beneficial to the Company, 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.

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

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$ALIM Positive Results Accelerate ILUVIEN Development Timetable

Positive consistent results spur move to cap study at 550 patients
Enrollment complete as of January 2017

ATLANTA, July 19, 2017 — Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the commercialization, research and development of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has given final approval to reduce the size of its ILUVIEN Registry Safety Study (IRISS).

A post-marketing study, IRISS was originally designed to follow 800 ILUVIEN patients over five years. However, consistently positive real-world safety data from IRISS and other post-marketing studies led Alimera to seek a smaller sample size. Alimera enrolled the 550th patient in January of this year, making the anticipated last patient, last visit date January 2020.

“We are very pleased to receive final approval from MHRA to complete enrollment in IRISS as it stands today,” said Dan Myers, CEO of Alimera. “Since the beginning, the results we’ve seen in our post-marketing studies have mirrored, and often exceeded, the results in our FAME™ clinical trials. From this, we concluded that we could potentially reduce the IRISS sample size without compromising on the study objective, and MHRA agreed. In addition to cost and time savings, our ability to produce data sets on safety, efficacy and disease burden reduction earlier than expected allows us to share this data with our customers.”

About ILUVIEN

www.ILUVIEN.com.

ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in the E.U. to treat vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each ILUVIEN implant with its continuous microdosing is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months, enabling the physician to treat the disease consistently every day.

About Diabetic Macular Edema (DME)

DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.

About Alimera Sciences, Inc.

www.alimerasciences.com

Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization, research, and development of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. For more information, please visit www.alimerasciences.com.

Forward Looking Statements

This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, the results of our post-marketing studies of ILUVIEN, the expected timing of the last patient visit for IRISS and the benefits to be realized from the reduced patient enrollment in IRISS. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the ability of the reduced enrollment in IRISS to yield results consistent with the FAME™ clinical trials, our ability to capture the anticipated cost savings from the smaller sample size and our ability to accelerate the completion of IRISS, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Alimera’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, to be filed in the third quarter of 2017 with the SEC. In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

For press inquiries:
Katie Brazel
for Alimera Sciences 
404-317-8361
kbrazel@bellsouth.net

For investor inquiries:
CG Capital
for Alimera Sciences
877-889-1972
investorrelations@cg.capital
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$AKCA Announces Closing of Initial Public Offering

CAMBRIDGE, Mass., July 19, 2017  — Akcea Therapeutics, Inc. today announced the closing of its initial public offering of 17,968,750 shares common stock at a public offering price of $8.00 per share, including 2,343,750 shares of common stock issued upon full exercise by the underwriters of their option to purchase additional shares.  The gross proceeds from the offering were $143.8 million before deducting underwriting discounts and commissions and offering expenses to be paid by Akcea.  Akcea’s common stock is listed on the NASDAQ Global Select Market under the symbol “AKCA.”

In addition, Novartis Pharma AG purchased $50.0 million of Akcea’s common stock in a separate private placement concurrent with the completion of Akcea’s initial public offering at a price per share equal to the initial public offering price.

Cowen, Stifel and Wells Fargo Securities acted as joint book running managers for the offering.  BMO Capital Markets acted as lead manager for the offering.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission and became effective on July 13, 2017.  Copies of the registration statement can be accessed by visiting the U.S. Securities and Exchange Commission website at www.sec.gov.

The offering was made only by means of a prospectus.  A copy of the final prospectus relating to the offering was filed with the U.S. Securities and Exchange Commission and may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 274-2806; or from Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at syndprospectus@stifel.com; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, NY 10152, or by telephone at (800) 326-5897, or by email at cmclientsupport@wellsfargo.com.

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

ABOUT AKCEA THERAPEUTICS
Akcea Therapeutics is a late-stage pharmaceutical company focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders. Akcea is advancing a mature pipeline of four novel drugs with the potential to treat multiple diseases, including volanesorsen, AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx and AKCEA-APOCIII-LRx, which are all based on antisense technology developed by Ionis Pharmaceuticals, Inc. The most advanced drug in its pipeline, volanesorsen, has successfully completed a Phase 3 clinical program for the treatment of familial chylomicronemia syndrome, or FCS, and is currently in Phase 3 clinical development for the treatment of familial partial lipodystrophy, or FPL. Akcea is assembling the infrastructure to commercialize its drugs globally with a focus on lipid specialists as the primary call point. Akcea is a subsidiary of Ionis Pharmaceuticals, Inc. and is located in Cambridge, Massachusetts.

In this press release, unless the context requires otherwise, “Ionis”, “Akcea,” “Company,” “Companies” “we,” “our,” and “us” refers to Akcea Therapeutics and/or Ionis Pharmaceuticals.

Akcea Therapeutics™ is a trademark of Ionis Pharmaceuticals, Inc. Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc.

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$SRPT & Clinigen Launch a Managed Access Program for DMD Patients

The MAP will be available to a limited number of patients who meet pre-specified medical criteria and can secure funding

CAMBRIDGE, Mass., July 19, 2017  — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a U.S. biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases, and Clinigen Group plc’s (AIM:CLIN) (‘Clinigen’) Idis Managed Access division, have initiated a Managed Access Program (MAP) for eteplirsen in certain geographies to treat eligible Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping. This MAP (also known as an early / expanded access, or named patient program) provides a mechanism through which physicians can legally and ethically prescribe eteplirsen to patients who meet pre-specified medical criteria and where funding can be secured.

Initially, the program is being launched in select countries within Europe, North America and South America for certain patients where eteplirsen is not currently approved. Sarepta plans to expand the program to include more countries over time.

The program will be administered by Clinigen Group plc’s Idis Managed Access division. Clinigen is the trusted global leader in access to unlicensed medicines delivering over 220 MAPs to thousands of patients, helping physicians access medicines when no other treatment options are available.

All requests must be submitted by the treating physician on behalf of the patient. Healthcare providers can obtain details about the EXONDYS 51® (eteplirsen) Managed Access Program by calling a Clinigen representative at +44 1283 494 340, or emailing medicine.access@clinigengroup.com.

For more information on the MAP, including the countries where the program is currently available to patients, please visit www.sarepta.com/community/managed-access-program.

About Eteplirsen

Eteplirsen uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 51 of the dystrophin gene. Eteplirsen is designed to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. Data from clinical studies of eteplirsen in a small number of DMD patients have demonstrated a consistent safety and tolerability profile. The pivotal trials were not designed to evaluate long-term safety and a clinical benefit of eteplirsen has not been established.

About Duchenne Muscular Dystrophy

DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500 – 5,000 males worldwide. A devastating and incurable muscle-wasting disease, DMD is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas of the body. The condition is universally fatal, and death usually occurs before the age of 30 generally due to respiratory or cardiac failure.

About Sarepta Therapeutics

Sarepta Therapeutics is a U.S. commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying Duchenne muscular dystrophy (DMD) drug candidates. For more information, please visit www.sarepta.com.

About Clinigen Group

Clinigen Group plc (AIM:CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

Forward-Looking Statement

This press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements about the MAP being a mechanism through which physicians can legally and ethically prescribe eteplirsen to eligible patients who meet pre-specified medical criteria and where funding can be secured; and Sarepta’s plan to expand the Managed Access Program it initiated with Clinigen to include more countries over time.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Known risk factors include, among others: Sarepta, in partnership with Clinigen, may not be able to establish and successfully conduct a Managed Access Program in one or more countries, and even if such program(s) are successfully conducted in each country targeted, Sarepta may not achieve any significant revenues from sales of eteplirsen under the MAP in one or more of the countries in which the MAP is launched; and Sarepta may not be able to commercialize eteplirsen in MAP countries even if the product has been available on a named patient basis. Any of the foregoing risks could adversely affect Sarepta’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review Sarepta’s 2016 Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Internet Posting of Information

We routinely post information that may be important to investors in the ‘For Investors’ section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Source: Sarepta Therapeutics, Inc.

Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com 
or
W2O Group
Brian Reid, 212-257-6725
breid@w2ogroup.com 
or
Clinigen Group plc
Shaun Chilton / Martin Abell, +44 1283 495 010
or
Instinctif Partners (Clinigen Media Relations)
Melanie Toyne-Sewell / Alex Shaw / Deborah Bell, +44 2074 572 020
clinigen@instinctif.com
Wednesday, July 19th, 2017 Uncategorized Comments Off on $SRPT & Clinigen Launch a Managed Access Program for DMD Patients

$DWCH Elects Colin Mahony to Board of Directors

Hewlett Packard Enterprise Executive has Wealth of Big Data Experience

BEDFORD, Mass., July 19, 2017 — Datawatch Corporation (NASDAQ-CM: DWCH), a leading global provider of self-service data preparation and fast analytics solutions, today announced that Colin Mahony has been appointed to the Board of Directors effective immediately. His appointment expands the board to nine members.

Mr. Mahony, a recognized expert in Big Data, is Senior Vice President and General Manager of the Hewlett Packard Enterprise (HPE) Big Data Platform business group, which focuses on helping organizations of all sizes leverage their data to improve business outcomes. He joined HPE through its acquisition of Vertica, where his technical knowledge and market intelligence helped guide the company’s customer relationships and strategic partnerships to achieve significant growth. Prior to joining Vertica, he held leadership roles at two venture capital firms, focused on investments in enterprise software, telecommunications and digital media, first at Lazard Technology Partners and later at Bessemer Venture Partners. Mr. Mahony also served as a Senior Industry Analyst at Yankee Group, where he helped build the firm’s ERP and Internet Computing Strategies practice.  He holds a B.S. degree in Economics with a minor in Computer Science from Georgetown University and an M.B.A. degree from the Harvard Business School.  He is an active volunteer with Big Brothers Big Sisters of Massachusetts Bay and the Joey Fund for Cystic Fibrosis as well as a mentor and board member of Year Up Boston.

Richard de J. Osborne, Chairman of the Board of Directors of Datawatch, said, “We are very pleased to add Colin to our board of directors. He brings a wealth of industry expertise, technology acumen and understanding of the markets in which we compete, from a customer, partner and analyst perspective. We are confident that his insights about our product and business strategy will contribute significantly to our effectiveness in capitalizing on the opportunities we see for self-service analytics in the market today.”

Mr. Mahony added, “I’ve been familiar with Datawatch’s technology for many years, and the opportunity to contribute to the company’s continued development and success is an exciting one for me. I look forward to working closely with the board and management to further Datawatch’s growth within the evolving self-service data preparation and analytics marketplace.”

About Datawatch Corporation

Datawatch Corporation (NASDAQ-CM: DWCH) enables ordinary users to deliver extraordinary results with all their data.  Only Datawatch can unlock data from the widest variety of sources and prepare it for use with visualization tools or other business processes.  When real-time visibility to rapidly changing data is critical, Datawatch enables you to visualize streaming data for the most demanding business environments such as capital markets. Organizations of all sizes in more than 100 countries worldwide use Datawatch products including 93 of the Fortune 100. Datawatch is headquartered in Bedford, Massachusetts with offices in New York, London, Frankfurt, Stockholm, Singapore, and Manila.  To learn more about Datawatch or download a free version of its enterprise software, please visit: www.datawatch.com.

© 2017 Datawatch Corporation. Datawatch and the Datawatch logo are trademarks or registered trademarks of Datawatch Corporation in the United States and/or other countries. All other names are trademarks or registered trademarks of their respective companies.

Source: Datawatch

Investor Contact: 
Datawatch Investor Relations
investor@datawatch.com
Phone: (978) 441-2200 ext. 8323

Media Contact:
Frank Moreno
Datawatch Corporation
Frank_Moreno@datawatch.com
Phone: (978) 441-2200 ext. 8322
Twitter: @datawatch
Wednesday, July 19th, 2017 Uncategorized Comments Off on $DWCH Elects Colin Mahony to Board of Directors

$MYSZ White Label RealSize Apparel Measurement App at the Apple App Store

MySize’s customizable, online apparel measurement technology now available to all retailers

AIRPORT CITY, Israel, July 19, 2017  —

MySize Inc. (the “Company”) (NASDAQ: MYSZ; TASE: MYSZ), developer of proprietary, measurement technologies using smartphones, announced today the launch of RealSize at the Apple app store. The RealSize application will make its debut on the Trucco website in the very near future and will be available immediately thereafter to Trucco’s customers in Spain.

Please click here to watch a video demonstrating how RealSize works and how easy it is to use.

RealSize is a white label, apparel measurement application developed by MySize based on the Company’s customizable TrueSize technology. With the formal launch of RealSize, TrueSize is now available to any retailer interested in personalizing their customer service, reducing online sales returns and increasing user conversion.

“Online clothing shoppers now have the power to choose the right size garment every time, based on the measurements that they take with their TrueSize or associated white label product app. No more wasting time or money with incorrect size selections and returns. It’s a win-win situation for both retailer and customer,” said Ms. Billy Pardo, Chief of Product at MySize Inc.

RealSize recommends the appropriate size of the garment of choice on the Trucco website based on the measurements calculated by analyzing an article of clothing from the customer’s own wardrobe. For example: you just love a shirt you saw on the Trucco website. You want to buy one in the size that will match, as closely as possible, with your favorite and best fitting shirt. To achieve this, customers first download the RealSize app on their mobile phone. Then, they follow the instructions and use the app to measure their favorite shirt from their closet. The calculations are then processed and the customer is sent the recommended size of the new shirt to choose. It’s that simple.

Mr. Ronen Luzon, CEO of MySize Inc., said, “Today marks a major milestone for MySize in online retail. We very much appreciate Trucco’s valuable partnership, from the testing phase through to today’s launch on the Apple app store, and their clear understanding of the enormous benefit RealSize will bring to their store and customers. For example, MySize’s technology not only has a high level of accuracy but, it also increases conversion from shopper to buyer.  Moreover, the app seamlessly integrates into a retailer’s website.  We look forward to continuing our strong relationship with Trucco as well as helping other retailers worldwide to benefit from the many deliverables of MySize’s technology.”

About MySize Inc.

MySize Inc. (TASE: MYSZ) (NASDAQ: MYSZ) has developed a unique measurement technology based on sophisticated algorithms and cutting edge technology with broad applications including the apparel, e-commerce DIY, shipping and parcel delivery industries.  This proprietary technology is driven by several patent-pending algorithms which are able to calculate and record measurements in a variety of novel ways. To learn more about MySize, please visit our website. http://www.mysizeid.com.

Follow us on Facebook, LinkedIn and Twitter.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of the words “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” and similar expressions that are intended to identify forward-looking statements.  All forward-looking statements speak only as of the date of this press release. You should not place undue reliance on these forward-looking statements. Although we believe that our plans, objectives, expectations and intentions reflected in or suggested by the forward-looking statements are reasonable, we can give no assurance that these plans, objectives, expectations or intentions will be achieved.  Forward-looking statements involve significant risks and uncertainties (some of which are beyond our control) and assumptions that could cause actual results to differ materially from historical experience and present expectations or projections.  Known material factors that could cause actual results to differ materially from those in the forward-looking statements include: an active trading market for our common stock may not develop on NASDAQ; the trading price for our common stock may fluctuate significantly; and the Company will continue to be a “controlled company,” as defined under NASDAQ rules, and the interests of our controlling stockholder may differ from those of our public stockholders.  Forward-looking statements also are affected by the risk factors described in the Company’s filings with the U.S. Securities and Exchange Commission.  Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.

Press Contact
Marjie Hadad
MH Communications
marjierhadad@gmail.com
+972-54-536-5220

Wednesday, July 19th, 2017 Uncategorized Comments Off on $MYSZ White Label RealSize Apparel Measurement App at the Apple App Store

$HRMNW MOU with Port of Cork to Develop FSRU & LNG Import Terminal Infrastructure

Parties Commit to Exclusive Collaboration for Delivery of up to 3 Million Tons of LNG per year into the Irish Gas Grid

NextDecade, LLC (“NextDecade”), a liquefied natural gas (“LNG”) development company focused on LNG export projects in the State of Texas, announced it has signed a Memorandum of Understanding (“MOU”) with the Port of Cork Company (“Port of Cork”) to advance a joint business development opportunity in Ireland for a new Floating Storage and Regasification Unit (“FSRU”) and associated LNG import terminal infrastructure.

NextDecade and the Port of Cork are planning a joint public event at the Port of Cork on August 2, 2017, to highlight the MOU and its potential benefits for Ireland and its regional partners. NextDecade CEO Kathleen Eisbrenner and Flex LNG CEO Jonathan Cook will meet with port officials and discuss the opportunity with local industry and political leaders.

Under the terms of the MOU, the potential development at the Port of Cork would receive LNG from NextDecade’s planned Rio Grande LNG (“RGLNG”) project in South Texas. The development would provide competitively priced energy solutions to Ireland and its regional partners under long-term contracts. If constructed, the project would substantially increase and diversify Ireland’s supply of natural gas.

The MOU commits the parties to undertake exclusive negotiations to develop the LNG import project. A key seaport in the south of Ireland, the Port of Cork is a sheltered, natural deepwater harbor capable of handling large liquids and cargo ships of all sizes.

NextDecade’s RGLNG project is optimally located in close proximity to associated and stranded gas resources in the Permian Basin and Eagle Ford Shale. RGLNG and its associated Rio Bravo Pipeline, originating in the Agua Dulce market area, are well-positioned among the second wave of U.S. LNG projects. NextDecade believes the Port of Cork facility could support imports of up to 3 mtpa from RGLNG.

In December 2016, NextDecade announced it had signed a Heads of Agreement with FSRU provider FLEX LNG (Oslo Børs: FLNG) for the joint development of a full value chain infrastructure solution utilizing FSRU and dockside regasification import technology. FLEX LNG will be supporting NextDecade to provide a fully integrated regas import solution for the proposed LNG terminal at the Port of Cork. NextDecade is in discussions with European energy companies to enter into long-term purchase contracts for delivery of LNG at the Port of Cork. Additionally, NextDecade will manage shipping from its proposed RGLNG export facility at the Port of Brownsville in South Texas to the Port of Cork.

On June 29, 2017, Harmony Merger Corp. (NASDAQ: HRMN) (“Harmony”) filed a definitive proxy statement with the U.S. Securities and Exchange Commission (“SEC”). The definitive proxy statement provides detailed information regarding Harmony’s planned merger with NextDecade, which is subject to approval of Harmony’s stockholders at a special meeting on July 24, 2017. If approved by Harmony’s stockholders, following consummation of the merger, NextDecade will be a publicly listed company (NASDAQ: NEXT).

# # #

About NextDecade, LLC

NextDecade, based in The Woodlands, Texas, is a developer of LNG projects and associated pipelines in the State of Texas. NextDecade is focused on providing customers around the world with flexible solutions for low-cost, reliable LNG across the full value chain. Founded in 2010, NextDecade has a team of industry leaders with extensive experience in signing major LNG off-take deals, and developing and managing LNG, FLNG, and FSRU projects, as well as associated natural gas and electricity infrastructure around the world. Any development of its projects remains contingent upon completing required commercial agreements; acquiring all necessary permits and approvals; securing all financing commitments and potential tax incentives; achieving other customary conditions; and making a final investment decision to proceed. For more information, please visit www.next-decade.com.

About Harmony Merger Corp.

Harmony Merger Corp. (NASDAQ: HRMN) was incorporated in Delaware on May 21, 2014 as a blank check company whose objective is to acquire, through a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination, one or more businesses or entities. On March 27, 2015, Harmony consummated its initial public offering (“IPO”) of 11,500,000 units, each unit consisting of one share of common stock and one warrant to purchase one common share, and a simultaneous private placement of units to certain initial stockholders and Cantor Fitzgerald & Co., the representative of the underwriters in the IPO. Pursuant to a definitive merger agreement with NextDecade, as well as subsequent proxy materials filed with the SEC, Harmony expects to consummate a merger with NextDecade following a stockholder vote scheduled for July 24, 2017. For more information, please visit www.harmonymergercorp.com.

CAUTIONARY INFORMATION ABOUT FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of U.S. federal securities laws. The words “believe”, “expect”, “intend”, “plan”, “potential”, and similar expressions are intended to identify forward-looking statements, and these statements may relate to the merger transaction. These statements involve a number of known and unknown risks, which may cause actual results to differ materially from expectations expressed or implied in the forward-looking statements. THESE RISKS INCLUDE THE FACT THAT THE MOU IS NON-BINDING ON THE PARTIES AND NEXTDECADE’S DISCUSSIONS WITH THE PORT OF CORK DOES NOT IMPOSE ANY LEGAL OBLIGATIONS UPON EITHER OF THEM; the ability of NextDecade and the Port of Cork to obtain necessary legal and regulatory approvals to establish an FSRU in Ireland; the ability of the parties to enter into long-term contracts on terms acceptable to the parties or at all to deliver the LNG at the Port of Cork if the FSRU is established; uncertainties about NextDecade’s ability to complete the merger with Harmony; the development of the Rio Grande LNG export project following completion of the merger; and other matters discussed in the “Risk Factors” section of Harmony’s Definitive Proxy Statement (the “Proxy Statement”) related to the proposed merger filed with the Securities and Exchange Commission (the “SEC”) on June 29, 2017, and any updates thereto in subsequent reports filed with the SEC. The forward-looking statements in this press release speak as of the date of this release. Although NextDecade and/or Harmony may from time to time voluntarily update prior forward-looking statements, they disclaim any commitment to do so except as required by securities laws.

IMPORTANT INFORMATION FOR STOCKHOLDERS

This communication does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. In connection with Harmony’s proposed business combination, Harmony filed and mailed to stockholders of Harmony the Proxy Statement on June 29, 2017. HARMONY STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS) AND ANY OTHER MATERIALS THAT MAY BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED BUSINESS COMBINATION.

Harmony stockholders will be able to obtain free copies of these documents (if and when available) and other documents containing important information about Harmony and NextDecade, once such documents are filed with the SEC, through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Harmony will be available free of charge on Harmony’s internet website at www.harmonymergercorp.com or by contacting Harmony using the contact information below.

PARTICIPANTS IN SOLICITATION

Harmony and its directors, executive officers and other members of its management and employees may be deemed to be participants in the solicitation of proxies from Harmony’s stockholders in connection with the business combination. Stockholders are urged to carefully read the definitive proxy statement, and any other related materials that may be filed with the SEC when they become available, because they will contain important information. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Harmony’s stockholders in connection with the business combination is set forth in the definitive proxy statement. Information about Harmony’s executive officers and directors is set forth in the definitive proxy statement relating to the business combination and stockholders are encouraged to read any amendments or supplements to the definitive proxy statement and other related materials filed with the SEC. You can obtain free copies of these and other documents containing relevant information at the SEC’s web site at www.sec.gov or by directing a request to the address or phone number set forth below.

 

INVESTORS
Height for NextDecade
Patrick Hughes, + 1 (202) 629 0004
phughes@heightllc.com
or
Harmony Merger Corp.
David Sgro, + 1 (212) 319 7676
ds@harmonymergercorp.com
or
MEDIA
Ward for NextDecade
Molly LeCronier, +1 (713) 869 0707
MLeCronier@wardcc.com

Wednesday, July 19th, 2017 Uncategorized Comments Off on $HRMNW MOU with Port of Cork to Develop FSRU & LNG Import Terminal Infrastructure

$TTOO CE Mark for T2Bacteria Panel

New Diagnostic Test Panel Expands Platform Menu Providing Comprehensive T2Sepsis Solution™ for Hospitals

LEXINGTON, Mass., July 18, 2017  — T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, announced today that it has received a CE Mark for its T2Bacteria Panel, allowing for the sale and distribution of the product within the European Union and those countries accepting the CE Mark. The T2Bacteria Panel runs on the Company’s proprietary T2Dx® Instrument and provides highly accurate species-specific test results of targeted bacterial infections direct from whole blood in as fast as about 3.5 hours, and without the need for a time-consuming blood culture. The T2Bacteria Panel is currently available in the United States for Research Use Only (RUO) and the Company is in the final stages of completing the FDA pivotal trial, after which a 510(k) application will be submitted to the FDA. Patient enrollment in the trial is currently 92% complete and the company is very pleased with the product performance demonstrated to date, which for the prospective arm of the study is showing an average sensitivity of 96% and average specificity of 98%.

The T2Candida® Panel and the T2Dx Instrument were both CE-marked and FDA-cleared in 2014 and now, combined with the new T2Bacteria Panel, provide a comprehensive sepsis solution for hospitals in Europe. Consistent with previous guidance, the company believes it is on track to potentially receive FDA clearance of the T2Bacteria Panel by the end of 2017 enabling a US commercial launch in early 2018. Once the clinical trial is complete, the company will provide a full update on the product performance metrics submitted to the FDA.

“The CE Mark of our T2Bacteria Panel is a significant milestone in our mission to save lives and improve healthcare by empowering clinicians to more effectively treat patients with sepsis faster than ever before,” said John McDonough, president and chief executive officer. “Our T2Sepsis Solution now includes T2Candida and T2Bacteria, creating a significant opportunity to expand our target hospitals and positioning T2 Biosystems for accelerated commercial growth.”

CE Mark confirms that the product meets the Essential Requirements of the European Directive on In Vitro Diagnostic Medical Devices. The T2Bacteria Panel will be commercially available as part of the T2Sepsis Solution in Europe in the third quarter 2017.

The T2Bacteria Panel identifies six of the most deadly and prevalent bacteria species that are often not covered by empiric therapy. The prevalence of bacterial infections is high in hospitals across the world and the T2Bacteria Panel identifies approximately 90% of all gram-negative infections coming in through the emergency department and approximately 70% of community-acquired infections in the emergency department. Current broad spectrum antimicrobial therapy regimens only cover 60% of all bloodstream infections. Test results generated from the T2Candida Panel and T2Bacteria Panel, when coupled with current empiric therapy practices, may empower healthcare teams to effectively treat up to 95% of all bloodstream infections presenting in hospitals within the first 4 hours.

Additionally, the company is seeing significant interest from new and existing customers in working with the T2Bacteria RUO Panel under a Research Use Only program where customers can begin early validation testing to accelerate adoption post FDA clearance.

“We are pleased to be close to finalizing the submission of our T2Bacteria Panel to the FDA,” said Tom Lowery, chief scientific officer. “Even more encouraging are the early responses we have been receiving from hospitals taking advantage of the T2Bacteria Panel under the RUO program.  We believe the RUO program will provide independent data for hospitals to present at conferences and for publications later this year and into 2018.”

T2 Biosystems will provide an additional, more comprehensive update on its upcoming second quarter 2017 financial update call and at this time is reiterating its prior financial guidance.

About T2 Biosystems
T2 Biosystems is dedicated to developing innovative diagnostic products to improve patient health. With the FDA-cleared T2Dx Instrument and T2Candida Panel targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance technology, or T2MR®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of patient sample types, including whole blood. For more information, please visit www.t2biosystems.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the performance of the Company’s diagnostic products and the ability to bring such products to market. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. For more information on risk factors for T2 Biosystems, Inc.’s business, please refer to the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 15, 2017, under the heading “Risk Factors,” and other filings the Company makes with the Securities and Exchange Commission from time to time. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Company Contact: 
Darlene Deptula-Hicks, T2 Biosystems 
SVP & Chief Financial Officer 
ddeptula@t2biosystems.com 
603-553-5803

Media Contact: 
Matthew McKillip, T2 Biosystems 
mmckillip@t2biosystems.com 
518-577-3466

Investor Contact: 
Chris Brinzey, Westwicke Partners  
chris.brinzey@westwicke.com 
339-970-2843
Tuesday, July 18th, 2017 Uncategorized Comments Off on $TTOO CE Mark for T2Bacteria Panel

$AEZS NDA for Macrilen™ for the Evaluation of Growth Hormone Deficiency

Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZS) (the “Company”) today announced that it has been notified by the U.S. Food and Drug Administration (“FDA”), that the Company’s New Drug Application (“NDA”) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (“AGHD”) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.

David A. Dodd, President and Chief Executive Officer of the Company stated, “We are pleased that the FDA has formally accepted our resubmitted NDA and that it is under active review with an end-of-year PDUFA date. We remain confident that the FDA will approve our NDA and, therefore, we are moving forward with our preparations to launch the product in the first quarter of 2018.”

The Company also announces that Mr. Kenneth Newport is no longer a member of the Board of Directors effective as of July 12, 2017.

About MacrilenTM (macimorelin)

Macimorelin, a ghrelin agonist, is an orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this patented compound and has significant patent protection left. The Company’s U.S. composition of matter patent expires in 2022 and its U.S. utility patent runs through 2027. The Company proposes, subject to FDA approval, to market macimorelin under the tradename Macrilen™.

About AGHD

AGHD affects approximately 75,000 adults across the U.S., Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel pharmaceutical therapies. We are engaged in drug development activities and in the promotion of products for others. We recently completed Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in non-U.S. territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known risks and uncertainties, many of which are discussed under the caption “Key Information – Risk Factors” in our most recent Annual Report on Form 20-F filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission (“SEC”). Such statements include, but are not limited to, statements about the progress of our research, development and clinical trials and the timing of, and prospects for, regulatory approval and commercialization of our product candidates, the timing of expected results of our studies, anticipated results of these studies, statements about the status of our efforts to establish a commercial operation and to obtain the right to promote or sell products that we did not develop and estimates regarding our capital requirements and our needs for, and our ability to obtain, additional financing. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue our research and development projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the rejection or non-acceptance of any new drug application by one or more regulatory authorities and, more generally, uncertainties related to the regulatory process (including whether or not the regulatory authorities will definitively accept the Company’s conclusions regarding Macrilen™ and approve its registration following the Company’s re-submission of an NDA for the product as described elsewhere in this press release), the ability of the Company to efficiently commercialize one or more of its products or product candidates, the degree of market acceptance once our products are approved for commercialization, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company’s quarterly and annual filings with the Canadian securities commissions and the SEC for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

 

Aeterna Zentaris Inc.
Philip A. Theodore, 843-900-3211
Senior Vice President
ir@aezsinc.com

Tuesday, July 18th, 2017 Uncategorized Comments Off on $AEZS NDA for Macrilen™ for the Evaluation of Growth Hormone Deficiency

$MBRX Signs Agreement with MD Anderson Cancer Center for Leukemia Drug, Annamycin

HOUSTON, TX–(July 18, 2017) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has signed a new technology license agreement with MD Anderson Cancer Center based on new patent applications it intends to file relating to its drug Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML).

“In anticipation of beginning our planned clinical trials for Annamycin,” commented Walter Klemp, CEO of Moleculin, “one of our priorities has been to ensure the best possible protection for our intellectual property. Some key patent applications had yet to be filed and signing a new license agreement with MD Anderson clears the way for those patents.”

Mr. Klemp continued: “we have benefitted greatly from our collaboration with MD Anderson, and this license helps ensure that collaboration continues.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Our lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two preclinical small molecule portfolios, one of which is focused on the modulation of hard-to-target tumor cell signaling mechanisms and the recruitment of the patient’s own immune system. The other portfolio targets the metabolism of tumors.

For more information about the Company, please visit http://www.moleculin.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company’s IND being filed and permitted, the potential for Moleculin to expand its planned Annamycin clinical trial to Poland, the potential for sites in Poland to increase access to AML patients, accelerate enrollment in and completion of the Annamycin clinical trial, and the ability of Annamycin to demonstrate activity in the treatment of AML. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Contacts
PCG Advisory Group
Investors:
Kirin M. Smith
Chief Operating Officer
D: 646.863.6519
E: ksmith@pcgadvisory.com

Tuesday, July 18th, 2017 Uncategorized Comments Off on $MBRX Signs Agreement with MD Anderson Cancer Center for Leukemia Drug, Annamycin

$VRTX Positive Phase 1 & Phase 2 Data in F508del Cystic Fibrosis

-Phase 2 data showed mean absolute improvements in ppFEV1 of 9.7 and 12.0 percentage points for VX-152 and VX-440, respectively, in triple combination with tezacaftor and ivacaftor in F508del/Min patients; Initial data from Phase 1 study showed mean absolute improvement in ppFEV1 of 9.6 percentage points with VX-659 triple combination in F508del/Min patients-

-First data to demonstrate the potential to treat the underlying cause of CF in people with F508del/Min mutations, a severe and difficult-to-treat type of the disease-

-Initial Phase 2 data also showed mean absolute improvements in ppFEV1 of 7.3 and 9.5 percentage points when VX-152 or VX-440 was added in people with two copies of the F508del mutation (F508del/F508del), who were already receiving tezacaftor and ivacaftor-

-All 3 triple combination regimens were generally well tolerated across the studies-

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced positive data from Phase 1 and Phase 2 studies of three different triple combination regimens in people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min). These are the first data to demonstrate the potential to treat the underlying cause of CF in these patients, who have a severe and difficult-to-treat type of the disease. Data from the Phase 2 studies in these patients showed mean absolute improvements in percent predicted forced expiratory volume in one second (ppFEV1) of 9.7 and 12.0 percentage points from baseline for the triple combination regimens with VX-152 (200mg q12h) or VX-440 (600mg q12h), respectively. Initial data from a Phase 1 study showed a mean absolute improvement in ppFEV1 of 9.6 percentage points from baseline for the triple combination regimen of VX-659, tezacaftor and ivacaftor in people with one F508del mutation and one minimal function mutation. The company also announced today initial data showing improvements in mean absolute ppFEV1 of 7.3 and 9.5 percentage points when VX-152 or VX-440 was added in people with two copies of the F508del mutation, who were already receiving tezacaftor and ivacaftor. Vertex will host a conference call for investors today, July 18, 2017 at 5:00 p.m. EDT, to discuss these results.

The triple combination regimens were generally well tolerated across all three studies, and the majority of adverse events were mild to moderate in severity. Across the studies, the discontinuation rate due to adverse events was low.

“These safety and efficacy data are clear and compelling, indicating significant potential benefit for people with CF from each of these three different triple combination regimens,” said Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical Officer at Vertex. “We will be collecting and evaluating additional data from these and other studies and will make a decision on which regimen(s) to take forward into pivotal program(s), which we expect to begin in the first half of 2018.”

Vertex has established a Steering Committee of global CF experts and clinical trial investigators to support the design, conduct and execution of the triple combination pivotal study program. This committee is co-chaired by Steven M. Rowe, M.D., M.S.P.H., Professor of Medicine, Pediatrics, and Cell, Developmental and Integrative Biology, Director of the Gregory Fleming James Cystic Fibrosis Research Center, Nancy and Eugene Gwaltney Endowed Chair for Medical Research, University of Alabama at Birmingham, and Jennifer Taylor-Cousar, M.D., Associate Professor, Departments of Medicine and Pediatrics, Pulmonary Divisions, Medical Director of Clinical Research Services and Co-Director and Director of the CF Therapeutics Development Network, Adult CF Program, National Jewish Health, Colorado.

“Patients with minimal function mutations have been waiting for a medicine to treat the underlying cause of their disease, which makes these data showing pronounced improvements in lung function particularly important,” said Dr. Rowe. “It’s also encouraging to see that the addition of a next-generation corrector may lead to substantial additional benefits for patients with two copies of the F508del mutation, who were already receiving tezacaftor and ivacaftor.”

Next Steps

Vertex has advanced four next-generation correctors in parallel with the goal of developing the best triple combination regimen or regimens for people living with CF.

Vertex has accelerated the development programs for VX-445 and VX-659. A VX-445 Phase 2 study is underway and a VX-659 Phase 2 study will begin in early August. VX-445 and VX-659 will be evaluated in triple combination with tezacaftor and ivacaftor in people with one F508del mutation and one minimal function mutation and will be evaluated in people with two copies of the F508del mutation who are already receiving tezacaftor and ivacaftor. Data from both of these Phase 2 studies are expected in early 2018.

Pending additional data from these Phase 2 studies and the ongoing studies of VX-152 and VX-440 and discussions with regulatory agencies and the Steering Committee, Vertex plans to initiate pivotal development of one or more triple combination regimens in the first half of 2018.

About the VX-440 Phase 2 Study

This randomized, double-blind Phase 2 study is evaluating VX-440 (200mg and 600mg q12h) in combination with tezacaftor and ivacaftor in two different groups of people with CF ages 18 and older – those who have one F508del mutation and one minimal function mutation, and in those who have two copies of the F508del mutation. Minimal function mutations are those that result in little-to-no functioning CFTR protein and are not responsive to ivacaftor, tezacaftor or the combination of ivacaftor and tezacaftor. The primary objectives for the study are safety, tolerability and efficacy as assessed by mean absolute change in ppFEV1 from baseline. Secondary endpoints include change in sweat chloride and Cystic Fibrosis Questionnaire-Revised (CFQ-R).

Overall Safety Data: In the study, the triple combination regimen was generally well tolerated. The majority of adverse events were mild or moderate. The most common adverse events (>10%), regardless of treatment group, were infective pulmonary exacerbation, cough, sputum increased and diarrhea. There was one discontinuation due to an adverse event in the triple combination treatment groups (elevated liver enzymes >5x upper limit of normal in the VX-440 600mg group) and one in the control groups (respiration abnormal and sputum increased). One additional patient treated with the triple combination had elevated liver enzymes (>8x upper limit of normal in the VX-440 600mg group), which were observed on the final day of dosing. In both patients, the elevated liver enzymes returned to normal after treatment discontinuation or completion.

4-Week Efficacy Data in F508del/Min Patients: Part 1 of the study evaluated the triple combination for four weeks in 47 patients who have one F508del mutation and one minimal function mutation (11 in placebo, 18 in VX-440 200mg and 18 in VX-440 600mg). A summary of the within-group lung function and sweat chloride data is provided below:

VX-440 in F508del/Min Patients
Mean Absolute Within-Group Change From Baseline Through Day 29* Mean Absolute Within-Group Change in ppFEV1 (percentage points) Mean Absolute Within-Group Change in Sweat Chloride (mmol/L)
Triple placebo +1.4(p=0.4908) +1.6(p=0.6800)
VX-440 (200mg q12h) + tezacaftor (50mg q12h or 100mg QD) + ivacaftor (150mg q12h) +10.0(p<0.0001) -20.7(p<0.0001)
VX-440 (600mg q12h) + tezacaftor (50mg q12h) + ivacaftor (300mg q12h) +12.0(p<0.0001) -33.1(p<0.0001)
* all p-values are within group p-values based on mixed effect models; values expressed as ‘Through Day 29’ are the average of Day 15 and Day 29 measures

A secondary endpoint in the study measured mean absolute change in the respiratory domain of CFQ-R, a validated patient-reported outcome tool, at Day 29. In this study, the mean absolute improvements for patients with a minimal function mutation who received the triple combination were 18.3 points (VX-440 200mg) and 20.7 points (VX-440 600mg). The improvement for those who received placebo was 2.2 points.

4-Week Efficacy Data in F508del/F508del Patients: Part 2 of the study is ongoing to evaluate the addition of VX-440 for four weeks in 26 patients who have two copies of the F508del mutation, who were already receiving the combination of tezacaftor and ivacaftor (6 in placebo and 20 in VX-440 600mg). In this part of the study, all participants received four weeks of treatment with tezacaftor and ivacaftor and were then randomized to the addition of VX-440 or placebo for four additional weeks. A summary of the within-group lung function and sweat chloride data for the triple combination treatment period, from baseline (end of the 4-week tezacaftor/ivacaftor run-in period), is provided below:

VX-440 in F508del/F508del Patients
Mean Absolute Within-Group Change From Baseline Through Day 29* Mean Absolute Within-Group Change in ppFEV1 (percentage points) Mean Absolute Within-Group Change in Sweat Chloride (mmol/L)
Placebo + tezacaftor (100mg QD) + ivacaftor (150mg q12h) -2.5(p=0.2755) +2.1(p=0.7385)
VX-440 (600mg q12h) + tezacaftor (50mg q12h) + ivacaftor (300mg q12h) +9.5(p<0.0001) -31.3(p<0.0001)
* all p-values are within group p-values based on mixed effect models; values expressed as ‘Through Day 29’ are the average of Day 15 and Day 29 measures

The safety follow-up portion of the study in patients with two copies of the F508del mutation is ongoing.

About the VX-152 Phase 2 Study

This ongoing Phase 2 randomized, double-blind study is evaluating VX-152 (100mg, 200mg and 300mg q12h) in combination with tezacaftor and ivacaftor in people with CF ages 18 and older who have one F508del mutation and one minimal function mutation and in people who have two copies of the F508del mutation. The primary objective is safety and tolerability. Secondary endpoints include mean absolute change in ppFEV1 and change in sweat chloride. Data reported today are from the 100mg and 200mg arms of the study in people who have one F508del mutation and one minimal function mutation and from the 200mg arm in people who have two copies of the F508del mutation.

Overall Safety Data: In the study, the triple combination regimen was generally well tolerated. The majority of adverse events were mild or moderate. The most common adverse events (>10%), regardless of treatment group, were cough, sputum increased, infective pulmonary exacerbation, productive cough, diarrhea and fatigue. There was one discontinuation due to an adverse event in the triple combination treatment groups (pneumonia in the VX-152 200mg group) and none in the control groups.

2-Week Initial Efficacy Data in F508del/Min Patients: In Part 1 of the study, the triple combination was evaluated for two weeks in 21 patients ages 18 and older who have one F508del mutation and one minimal function mutation (5 in combined placebo, 6 in VX-152 100mg and 10 in VX-152 200mg). A summary of the initial within-group lung function and sweat chloride data (secondary endpoints) from the VX-152 100mg and 200mg dose groups is provided below:

VX-152 in F508del/Min Patients
Observed Mean Absolute Within-Group Change from Baseline at Day 15* Observed Mean Absolute Within-Group Change in ppFEV1 (percentage points) Observed Mean Absolute Within-Group Change in Sweat Chloride (mmol/L)
Triple placebo -0.9(p=0.6245) +1.0(p=0.5659)
VX-152 (100mg q12h) + tezacaftor (100mg QD) + ivacaftor (150mg q12h) +5.6(p=0.0135) -19.6(p=0.0004)
VX-152 (200mg q12h) + tezacaftor (100mg QD) + ivacaftor (150mg q12h) +9.7(p=0.0017) -14.1(p=0.0219)
* p-values presented are within-group p-values based on 1 sample t-test; an efficacy analysis using mixed effect models will be conducted following completion of an additional cohort of patients currently being treated in the study

This part of the study is ongoing to evaluate the triple combination of VX-152 (300mg q12h), tezacaftor and ivacaftor in patients with one F508del mutation and one minimal function mutation. These data are expected later in 2017.

2-Week Initial Efficacy Data in F508del/F508del Patients: Part 2 of the study is ongoing to evaluate the addition of VX-152 for two weeks in 14 patients ages 18 and older who have two copies of the F508del mutation, who were already receiving the combination of tezacaftor and ivacaftor (4 in placebo and 10 in VX-152 200mg). A summary of the initial within-group lung function and sweat chloride data (secondary endpoints) for the triple combination treatment period, from baseline (end of the 4-week tezacaftor/ivacaftor run-in period), is provided below:

VX-152 in F508del/F508del Patients
Observed Mean Absolute Within-Group Change from Baseline at Day 15* Observed Mean Absolute Within-Group Change in ppFEV1 (percentage points) Observed Mean Absolute Within-Group Change in Sweat Chloride (mmol/L)
Placebo + tezacaftor (100mg QD) + ivacaftor (150mg q12h) -1.4(p=0.2773) +3.4(p=0.1212)
VX-152 (200mg q12h) + tezacaftor (100mg QD) + ivacaftor (150mg q12h) +7.3(p=0.0354) -20.9(p=0.0010)
* p-values presented are within-group p-values based on 1 sample t-test; an efficacy analysis using mixed effect models will be conducted following completion of an additional cohort of patients currently being treated in the study

This part of the study is ongoing to evaluate the addition of VX-152 (300mg q12h) for four weeks in patients with two F508del mutations, who are already receiving the combination of tezacaftor and ivacaftor. These data are expected in early 2018.

About the VX-659 Phase 1 Study

This Phase 1 randomized, double-blind, placebo-controlled study evaluated the safety and tolerability of single and multiple ascending doses of VX-659 alone and in triple combination with tezacaftor and ivacaftor in healthy volunteers. It also evaluated the safety and tolerability of VX-659 as part of a triple combination for two weeks in 12 people with CF ages 18 and older who have one F508del mutation and one minimal function mutation (3 in placebo and 9 in VX-659 120mg). In this part of the study, sweat chloride was evaluated as an additional endpoint, and the absolute change in ppFEV1 was evaluated as part of the safety analysis.

In CF patients, VX-659 was generally well tolerated in triple combination with tezacaftor and ivacaftor. The majority of adverse events were mild or moderate. The most common adverse events (>10%), regardless of treatment group, were cough, infective pulmonary exacerbation and productive cough. There were no discontinuations due to adverse events in either group.

At Day 15, there was a mean absolute improvement in ppFEV1 of +9.6 percentage points from baseline in those receiving the triple combination regimen of VX-659 (120mg q12h), tezacaftor and ivacaftor and a mean decrease in sweat chloride of -41.6 mmol/L. For those receiving placebo, there was a mean absolute decrease in ppFEV1 of -0.4 percentage points and a mean decrease in sweat chloride of -11.0 mmol/L.

Preclinical Toxicology Data

In the Phase 2 study of VX-440, women of childbearing potential were required to use pre-specified, non-hormonal methods of contraception based on results from previous preclinical reproductive toxicology studies. Preclinical reproductive toxicology studies of VX-152, VX-659 and VX-445 are complete with no adverse findings of note.

About CF

CF is a rare, life-shortening genetic disease affecting approximately 75,000 people in North America, Europe and Australia.

CF is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working or too few CFTR proteins at the cell surface. The defective function or absence of CFTR protein results in poor flow of salt and water into and out of the cell in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the mid-to-late 20s.

About Vertex

Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For seven years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com.

Collaborative History with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT)

Vertex initiated its CF research program in 2000 as part of a collaboration with CFFT, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. KALYDECO® (ivacaftor), ORKAMBI® (lumacaftor/ivacaftor), tezacaftor, VX-440, VX-152, VX-659 and VX-445 were discovered by Vertex as part of this collaboration.

Special Note Regarding Forward-looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, Dr. Chodakewitz’s statements in the third paragraph, and the information provided regarding Vertex’s plans to initiate pivotal development of one or more triple combination regimens in the first half of 2018. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release, and there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, (i) that Vertex could experience unforeseen delays in conducting its development programs relating to triple combination treatments and in submitting related regulatory filings, (ii) that the initial results set forth in this press release may differ from the final results from these ongoing studies, (iii) that regulatory authorities may not approve, or approve on a timely basis, triple combination treatments due to safety, efficacy or other reasons, and (iv) and other risks listed under Risk Factors in Vertex’s annual report and quarterly reports filed with the Securities and Exchange Commission and available through the company’s website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Conference Call and Webcast

The company will host a conference call and webcast today at 5:00 p.m. EDT to discuss these results. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International). The conference call will be webcast live, and a link to the webcast may be accessed through Vertex’s website at www.vrtx.com in the “Investors” section under “Events and Presentations.” To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

 

Vertex Pharmaceuticals Incorporated
Investors:
Michael Partridge, +1 617-341-6108
or
Eric Rojas, +1 617-961-7205
or
Zach Barber, +1 617-341-6470
or
Media:
Megan Goulart
Heather Nichols
mediainfo@vrtx.com
or
North America: +1 617 961 5093
or
Europe & Australia: +44 20 3204 5275

Tuesday, July 18th, 2017 Uncategorized Comments Off on $VRTX Positive Phase 1 & Phase 2 Data in F508del Cystic Fibrosis

$CAPR Rare Pediatric Disease Designation from FDA for CAP-1002 in DMD

LOS ANGELES, July 18, 2017 — Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing biological therapies for Duchenne muscular dystrophy and other rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to CAP-1002, Capricor’s development candidate for the treatment of Duchenne muscular dystrophy, a debilitating genetic disorder characterized by progressive weakness and chronic inflammation of skeletal, heart, and respiratory muscles. The Rare Pediatric Disease Designation, as well as the Orphan Drug Designation previously granted to CAP-1002 by the FDA, covers the broad treatment of DMD. Upon receiving market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher.

“The Rare Pediatric Disease Designation adds to our previous Orphan Drug Designation for CAP-1002 for the treatment of Duchenne muscular dystrophy, which together underscore the urgent need for treatment options for this devastating rare disease as well as provide Capricor with certain incentives for their development,” said Linda Marbán, Ph.D., Capricor’s president and chief executive officer. “We believe CAP-1002 has the potential to provide meaningful clinical benefit to patients. We look forward to commencing our next clinical trial in DMD, for which design will be relevant to the overall registration plan for this candidate.”

In April 2017, Capricor announced positive results from its Phase I/II HOPE clinical trial of CAP-1002 in DMD patients with advanced disease. The company recently met with the FDA to discuss potential product registration strategies for this indication, and Capricor plans to commence a randomized, double-blind, placebo-controlled clinical trial of intravenous, repeat-dose CAP-1002 in boys and young men with Duchenne in the second half of this year, subject to regulatory approval.

Capricor expects to report 12-month results from the HOPE Trial in the fourth quarter of 2017.

The HOPE Trial is funded in part by the California Institute for Regenerative Medicine.

About Rare Pediatric Disease Designation

The FDA defines a “rare pediatric disease” as a serious or life-threatening disease affecting individuals primarily aged from birth to 18 years and that affects fewer than 200,000 individuals in the U.S. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, upon the approval of a qualifying new drug application (NDA) or biologics license application (BLA) for the treatment of a rare pediatric disease, the sponsor of such application would be eligible for a Rare Pediatric Disease Priority Review Voucher that can be used to obtain priority review for a subsequent NDA or BLA. The Priority Review Voucher may be sold or transferred an unlimited number of times.

About CAP-1002

CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a type of progenitor cell that has been shown to exert potent immuno-modulatory activity. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to approximately 140 human subjects across several clinical trials.

About Duchenne Muscular Dystrophy

DMD is a genetic disorder characterized by progressive muscle degeneration and weakness. It is caused by an abnormality in the dystrophin complex, a structural element that plays a critical role in muscle fiber integrity, which leads to chronic muscle damage. Patients with DMD typically die in their twenties, most commonly due to heart disease. The incidence of DMD is estimated to be one in every 3,600 live male births, and DMD is believed to afflict approximately 15,000 to 20,000 boys and young men in the U.S.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company developing first-in-class biological therapies. Capricor’s lead candidate, CAP-1002, is a cell-based candidate currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor is exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, visit www.capricor.com.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; the timing of regulatory approvals; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2016 as filed with the Securities and Exchange Commission on March 16, 2017, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with prospectus supplements thereto, and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, as filed with the Securities and Exchange Commission on May 15, 2017. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

CAP-1002 is an Investigational New Drug and is not approved for any indications. Capricor’s exosomes technology, including CAP-2003, has not yet been approved for clinical investigation.

For more information, please contact:

AJ Bergmann, Vice President of Finance
+1-310-358-3200
abergmann@capricor.com

Tuesday, July 18th, 2017 Uncategorized Comments Off on $CAPR Rare Pediatric Disease Designation from FDA for CAP-1002 in DMD

$AMRS Enters First Product Development and Production Agreement With Royal DSM

EMERYVILLE, Calif., July 17, 2017  — Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, today announces that it has entered into its first product development and production agreement with Koninklijke DSM N.V. (Royal DSM) (AEX:DSM.AS), the global science-based company active in health, nutrition and materials, to develop a food and nutrition molecule for which DSM is a major market provider.

As part of the previously announced equity investment DSM is making into Amyris, DSM and Amyris have agreed to focus on a number of short- to medium-term product development & production opportunities in vitamins and other nutritional ingredients. This agreement is the first of what is expected to be several of such development and production projects.

As part of the agreement, DSM will partner with Amyris and fund the development of the technology to produce the specific molecule that Amyris will scale and supply long term to deliver improved performance while growing its business. DSM will take the molecule to market utilizing its channel and market access and take advantage of Amyris’s biotechnology production, which provides a lower cost of production than currently available.

“We are very excited to partner with DSM on our first product development and production agreement,” said John Melo, Amyris President & CEO. “This is the first of what are expected to be several highly disruptive products addressing major markets where, together, we can leverage Amyris’s technology platform to reduce cost for products DSM then takes to market in a cost-advantaged position.”

About Amyris
Amyris is the integrated renewable products company that is enabling the world’s leading brands to achieve sustainable growth. Amyris applies its innovative bioscience solutions to convert plant sugars into hydrocarbon molecules and produce specialty ingredients and consumer products. The company is delivering its No Compromise® products across a number of markets, including specialty and performance chemicals, flavors and fragrances, cosmetics ingredients, pharmaceuticals, and nutraceuticals. More information about the company is available at www.amyris.com.

Forward-Looking Statements
This release contains forward-looking statements regarding Amyris, and any statements regarding Amyris other than statements of historical facts could be deemed to be forward-looking statements. These forward-looking statements include, among other things, statements regarding future events (such as expected future development and production projects between Amyris and DSM, Amyris’s anticipated cost of production for the molecule subject to the current development and production agreement with DSM, and Amyris’s expected future performance and business growth) that involve risks and uncertainties. These statements are based on management’s current expectations and actual results and future events may differ materially due to risks and uncertainties, including risks related to manufacturing capacity at Amyris’s Brotas facility, delays or failures in development, production and commercialization of products, liquidity and ability to fund capital expenditures, Amyris’s reliance on third parties to achieve its goals, and other risks detailed in the “Risk Factors” section of Amyris’s quarterly report on Form 10-Q filed on May 15, 2017. Amyris disclaims any obligation to update information contained in these forward-looking statements whether as a result of new information, future events, or otherwise.

Amyris, the Amyris logo and No Compromise are registered trademarks of Amyris, Inc. All other trademarks are trademarks of their respective owners.

Contact:

Peter DeNardo
Director, Investor Relations and Corporate Communications
Amyris, Inc. 
+1 (510) 740-7481
investor@Amyris.com
pr@Amyris.com
Monday, July 17th, 2017 Uncategorized Comments Off on $AMRS Enters First Product Development and Production Agreement With Royal DSM

$IPXL Announces FDA Approval of its AB Rated Generic Concerta®

HAYWARD, Calif., July 17, 2017 — Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration (“FDA”) approval on its Abbreviated New Drug Application (“ANDA”) for a generic version of Concerta® (methylphenidate hydrochloride) Extended-Release tablets USP CII, 18, 27, 36 and 54 mg.

“Approval of our AB-rated generic version of Concerta further demonstrates the capabilities of Impax’s R&D organization,” said Paul Bisaro, President and Chief Executive Officer of Impax. “We are preparing for launch including working to secure API quota and currently expect to launch by the end of this year. As a result, we don’t anticipate sales of generic Concerta to meaningfully impact our earnings in 2017.”

Methylphenidate hydrochloride extended-release tablets had U.S sales of approximately $1.8 billion, according to IMS Health for the 12 months ending May 2017.

Methylphenidate hydrochloride extended-release tablets, are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.

IMPORTANT SAFETY INFORMATION

WARNING: DRUG DEPENDENCE    
See full prescribing information for complete boxed warning.   
Methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior.

Methylphenidate hydrochloride extended-release tablets are not for use in patients:

  • With known hypersensitivity to the product
  • With marked anxiety, tension, or agitation
  • With glaucoma
  • With tics or a family history or diagnosis of Tourette’s syndrome
  • Currently using or within 2 weeks of using an MAO inhibitor

The following have been reported with use of methylphenidate HCl and other stimulant medicines:

Heart-related problems:

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Mental (Psychiatric) problems:
All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Painful and prolonged erections (priapism)
Painful and prolonged erections (priapism) have occurred with methylphenidate.

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:

  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue to red

Other serious side effects include:

  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision
  • blockage of the esophagus, stomach, small or large intestine in patients who already have a narrowing in any of these organs

The most common adverse reaction in double-blind clinical trials (>5%) in children and adolescents was abdominal pain upper. The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis. The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased.

For complete safety information and other important information about this product please see the Full Prescribing Information including the medication guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit FDA MedWatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.

About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of central nervous system disorder branded products. Impax markets its generic products through its Impax Generics division and markets its branded products through the Impax Specialty Pharma division. Additionally, where strategically appropriate, Impax develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams, and ointments.

For more information, please visit the Company’s Web site at: www.impaxlabs.com.

“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical; these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance, or achievements to differ significantly from the results, performance, or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: fluctuations in the Company’s operating results and financial condition; the volatility of the market price of the Company’s common stock; the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner; the impact of competition; the effect of any manufacturing or quality control problems;  the Company’s ability to manage its growth; risks related to acquisitions of or investments in technologies, products or businesses; risks relating to goodwill and intangibles; the reduction or loss of business with any significant customer; the substantial portion of the Company’s total revenues derived from sales of a limited number of products; the impact of consolidation of the Company’s customer base; the Company’s ability to sustain profitability and positive cash flows; the impact of any valuation allowance on the Company’s deferred tax assets; the restrictions imposed by the Company’s credit facility and indenture; the Company’s level of indebtedness and liabilities and the potential impact on cash flow available for operations; the availability of additional funds in the future; any delays or unanticipated expenses in connection with the operation of the Company’s manufacturing facilities; the effect of foreign economic, political, legal and other risks on the Company’s operations abroad; the uncertainty of patent litigation and other legal proceedings; the increased government scrutiny on the Company’s agreements to settle patent litigations, product development risks and the difficulty of predicting FDA filings and approvals; consumer acceptance and demand for new pharmaceutical products; the impact of market perceptions of the Company and the safety and quality of the Company’s products; the Company’s determinations to discontinue the manufacture and distribution of certain products; the Company’s ability to achieve returns on its investments in research and development activities; changes to FDA approval requirements; the Company’s ability to successfully conduct clinical trials; the Company’s reliance on third parties to conduct clinical trials and testing; the Company’s lack of a license partner for commercialization of Numient® (IPX066) outside of the United States; impact of illegal distribution and sale by third parties of counterfeits or stolen products; the availability of raw materials and impact of interruptions in the Company’s supply chain; the Company’s policies regarding returns, rebates, allowances and chargebacks; the use of controlled substances in the Company’s products; the effect of current economic conditions on the Company’s industry, business, results of operations and financial condition; disruptions or failures in the Company’s information technology systems and network infrastructure caused by third party breaches or other events; the Company’s reliance on alliance and collaboration agreements; the Company’s reliance on licenses to proprietary technologies; the Company’s dependence on certain employees; the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry; the regulatory environment; the effect of certain provisions in the Company’s government contracts; the Company’s ability to protect its intellectual property; exposure to product liability claims; changes in tax regulations; uncertainties involved in the preparation of the Company’s financial statements; the Company’s ability to maintain an effective system of internal control over financial reporting; the effect of terrorist attacks on the Company’s business; the location of the Company’s manufacturing and research and development facilities near earthquake fault lines; expansion of social media platforms and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission.  Forward-looking statements speak only as to the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

Contact:
Mark Donohue
Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com

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$IDSY Announces Closing of Underwritten Public Offering

WOODCLIFF LAKE, N.J., July 17, 2017 — I.D. Systems, Inc. (NASDAQ:IDSY) (“I.D. Systems” or the “Company”) today announced the closing of its previously announced underwritten public offering consisting of 2,608,695 shares of common stock at a price per share of $5.75. In addition, the underwriters of the public offering have exercised in full their option to purchase an additional 391,304 shares of common stock. Including this option exercise, the aggregate gross proceeds from the offering of a total of 2,999,999 shares of common stock, before deducting discounts and commissions and offering expenses, were approximately $17.25 million.  The Company intends to use the net proceeds from the offering to fund its pending acquisition of assets of Keytroller, LLC and for general corporate purposes.

B. Riley & Co., LLC acted as the sole book-runner in the offering, and Lake Street Capital Markets, LLC acted as co-manager in the offering.

The shares of common stock were issued by I.D. Systems pursuant to a shelf registration statement on Form S-3 that was previously filed with, and declared effective by, the Securities and Exchange Commission (“SEC”).  A final prospectus supplement was filed with the SEC on July 12, 2017.  Copies of the final prospectus supplement and the accompanying base prospectus related to the offering may be obtained from B. Riley & Co., LLC, 11100 Santa Monica Blvd., Suite 800, Los Angeles, California 90025, or by telephone at (888) 295-0155, or by email at capitalmarkets@brileyco.com.  An electronic copy of the final prospectus supplement and accompanying base prospectus relating to the offering are available on the SEC’s website at www.sec.gov.

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

About I.D. Systems

Headquartered in Woodcliff Lake, New Jersey, with subsidiaries in Texas, Germany, and the United Kingdom, I.D. Systems is a leading global provider of wireless M2M solutions for securing, controlling, tracking, and managing high-value enterprise assets, including rental cars, industrial vehicles, trailers, containers, and cargo.  The Company’s patented technologies address the needs of organizations to monitor and analyze their assets to increase efficiency and productivity, reduce costs, and improve profitability. For more information, please visit www.id-systems.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward looking statements within the meaning of federal securities laws. Forward-looking statements include statements with respect to I.D. Systems’ beliefs, plans, goals, objectives, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond I.D. Systems’ control, and which may cause its actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. For example, forward-looking statements include statements regarding: prospects for additional customers; potential contract values; market forecasts; projections of earnings, revenues, synergies, accretion or other financial information; emerging new products; and plans, strategies and objectives of management for future operations, including growing revenue, controlling operating costs, increasing production volumes, and expanding business with core customers. The risks and uncertainties referred to above include, but are not limited to, future economic and business conditions, the loss of key customers or reduction in the purchase of products by any such customers, the failure of the market for I.D. Systems’ products to continue to develop, the possibility that I.D. Systems may not be able to integrate successfully the business, operations and employees of acquired businesses, the inability to protect I.D. Systems’ intellectual property, the inability to manage growth, the effects of competition from a variety of local, regional, national and other providers of wireless solutions, and other risks detailed from time to time in I.D. Systems’ filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2016. These risks could cause actual results to differ materially from those expressed in any forward-looking statements made by, or on behalf of, I.D. Systems. Unless otherwise required by applicable law, I.D. Systems assumes no obligation to update the information contained in this press release, and expressly disclaims any obligation to do so, whether as a result of new information, future events or otherwise.

 

I.D. Systems Contacts
Ned Mavrommatis, CFO
ned@id-systems.com
201-996-9000

Liolios Group, Inc.
Matt Glover
IDSY@liolios.com
949-574-3860
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$RIBT Shareholder Update Conference Call

Company to discuss the $18.3 million sale of its Healthy Natural subsidiary and strategic plan to build shareholder value through its proprietary ingredient business

SACRAMENTO, California, July 17, 2017 —

RiceBran Technologies (NASDAQ: RIBT; NASDAQ: RIBTW) (“RBT” or “Company”), a global leader in the production and marketing of value-added products derived from rice bran, today that Dr. Robert Smith – Chief Executive Officer & President of RBT, Brent Rystrom – Chief Financial Officer, and Michael Goose – President of Ingredient Sales will host a conference call today at 4:30 p.m. EDT to discuss the Company’s recent sale of its Healthy Natural subsidiary and the strategic plan to build shareholder value through its proprietary ingredient business.

The call information is as follows:

  • Date:   July 17, 2017
  • Time:  4:30 p.m. Eastern Daylight Savings Time
  • Direct Dial-in number for US/Canada: (201) 493-6780
  • Toll Free Dial-in number for US/Canada: (877) 407-3982
  • Dial-In number for international callers: (201) 493-6780
  • Participants will ask for the RiceBran Technologies Shareholder Update Call

This call is being webcast by ViaVid and can be accessed at http://public.viavid.com/index.php?id=125547.

The call will also be available for replay by accessing http://public.viavid.com/index.php?id=125547.

About RiceBran Technologies

RiceBran Technologies is a food, animal nutrition, and specialty ingredient company focused on the procurement, bio-refining and marketing of numerous products derived from rice bran. RiceBran Technologies has proprietary and patented intellectual property that allows us to convert rice bran, one of the world’s most underutilized food sources, into a number of highly nutritious food, animal nutrition and specialty ingredient products. Our global target markets are food and animal nutrition manufacturers and retailers, as well as specialty food, functional food and nutritional supplement manufacturers and retailers. More information can be found in the Company’s filings with the SEC and by visiting our website at http://www.ricebrantech.com.

Investor Contact:
Ascendant Partners, LLC
Richard Galterio
+1-(732)-410-9810
rich@ascendantpartnersllc.com

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$QDEL Announces Definitive Agreement to Acquire Alere Triage® Assets

Combination creates an expanded, less seasonal portfolio of rapid diagnostic capabilities in critical care settings

Transaction Highlights:

  • Acquiring the assets of the Triage® MeterPro cardiovascular and toxicology business, and the Triage BNP business from Alere Inc.
  • Diversifies Quidel’s overall business by seasonality, geography, while strengthening its position in the point-of-care (“POC”) market
  • Triage® MeterPro installed base of cardiovascular and toxicology instruments is complementary to Quidel’s Sofia® installed base of instruments, providing a beachhead into new, fast growing areas of POC testing
  • Accretive transactions extend Quidel’s market leadership and position it for future growth

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has entered into definitive agreements to acquire the Triage® MeterPro cardiovascular (CV) and toxicology assets (“Triage business”) and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers (“BNP business”) from Alere Inc. These products are being divested in order to obtain antitrust approvals required for Abbott’s pending acquisition of Alere. The sale transactions are subject to the completion of Abbott’s acquisition of Alere, as well as antitrust approvals and other customary closing conditions.

Quidel will distribute the Triage® MeterPro products and BNP assays through a combination of direct sales force and distributors. Triage® MeterPro revenues were $146 million in 2016, while estimated revenues for the BNP business as structured under the transaction were $51 million for the same period. Total actual and estimated revenues for the acquired businesses in 2016 were $197 million. The transactions will be funded through a combination of cash on hand and committed financing. Quidel expects the transactions to close by September 30, 2017.

“We’ve been looking at acquisition opportunities in high-growth segments of the POC diagnostics market, such as cardiovascular, for several years, and believe that this strategic acquisition extends Quidel’s market leadership, adding an extensive cardiovascular and toxicology POC offering to our innovative medical diagnostics portfolio. The Triage acquisition significantly stabilizes our quarterly revenue profile and enhances our geographic and product diversity, with substantial expansion opportunities in new markets. Further, while the installed base of Triage® MeterPro instruments in the U.S. nicely complements the installed base of our Sofia and Solana platforms in the hospital segment, there will be new call points that our U.S. commercial organization can leverage as well. And internationally, the Triage® MeterPro system gives us access to the rapidly evolving cardiac biomarker segment, one of the faster growing segments in the IVD market,” stated Douglas Bryant, president and chief executive officer of Quidel Corporation. “We believe there are substantial benefits to be realized as we bring these strong organizations together, further establishing Quidel’s platform for growth and shareholder value creation opportunities.”

Summary Terms of Agreement and Financing

Quidel will acquire the Triage business, including real estate for the San Diego Triage facilities, and the BNP business for a total consideration of $400 million plus $40 million in contingent consideration.

To support the acquisitions, the transactions are to be financed with cash plus committed financing from Bank of America Merrill Lynch and J.P. Morgan Chase Bank.

The transaction is subject to customary and other terms and conditions set forth in the acquisition agreement, which Quidel will file shortly with the SEC on Form 8-K.

Advisors

Perella Weinberg Partners LP acted as exclusive financial advisor to Quidel in this transaction. Gibson, Dunn & Crutcher LLP acted as legal advisor.

Conference Call

Quidel will host a conference call beginning at 7:30 AM EDT / 4:30 AM PDT on July 17, 2017. The conference call may be accessed by dialing (877) 930-5791 from the U.S. or (253) 336-7286 if dialing internationally, and using the required pass code 5641-3525. The live conference call can also be accessed by logging into the company’s investor relations website at http://ir.quidel.com/. Interested parties are invited to listen to the webcast. In addition, a presentation will be posted on Quidel’s website and referred to during the conference call. A replay of the webcast will be available on the company’s website immediately following the conclusion of the call by dialing (855) 859-2056 from the U.S., or by dialing (404) 537-3406 for international callers, and entering pass code 5641-3525.

About Quidel Corporation

Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit quidel.com.

Forward-Looking Statements

This press release contains certain forward-looking statements. These matters are subject to risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. These risks and uncertainties include: the ability to successfully consummate the transactions contemplated by the Triage Purchase Agreement and the BNP Purchase Agreement on a timely basis, if at all, including receipt of required regulatory approvals; the satisfaction of the closing conditions of the transactions (including consummation of the Abbott/Seller merger); the conditions of the credit markets and the Company’s ability to fund the transactions on acceptable terms; the risk that disruptions will occur from the transactions that will harm the Company’s business, the Triage Business or the BNP Business; if the transactions are consummated, the Company’s ability to retain the distributors, suppliers, customers and employees of the Triage Business and the BNP Business; and the Company’s ability to successfully integrate the acquired businesses into the Company’s operations, and the ability to achieve the expected synergies. Forward-looking statements are based on management’s expectations as well as estimates and assumptions prepared by management that, although they believe to be reasonable, are inherently uncertain. The Company is subject to additional risks and uncertainties described in the Company’s annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis and expectations only as of the date of this Form 8-K. We undertake no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.

 

Quidel Corporation
Randy Steward
Chief Financial Officer
(858) 552-7931
or
Ruben Argueta
(858) 646-8023
rargueta@quidel.com

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$SEV Signs Definitive Agreement to be Acquired by BorgWarner

SOUTHBOROUGH, Mass., July 17, 2017 — Sevcon, Inc. (“Sevcon” or the “Company”) (Nasdaq:SEV), a world leader in the design and manufacture of controls and battery chargers for zero emission electric and hybrid vehicles, today announced that it has entered into a definitive merger agreement with BorgWarner Inc. that provides for BorgWarner to acquire all of the outstanding shares of Sevcon’s common stock for $22.00 per share in cash and all of the outstanding shares of Sevcon’s Series A Convertible Preferred Stock for a price per share on an as-converted basis equal to the common stock, together with payment of any accrued and unpaid dividends.  The total transaction value, including the assumption of indebtedness, is expected to be approximately $200 million at the closing of the transaction.

The transaction price of $22.00 per share represents a 61% premium to the closing sale price of common stock of the Company on Friday, July 14, 2017 and a 64% premium to the 30-day volume weighted average price of common stock of the Company.

“The proposed merger with BorgWarner provides substantial value to our stockholders and the chance for Sevcon to maximize previous growth investments and capitalize on greater opportunities as a part of a much larger organization with significant market presence,” said Sevcon President and CEO Matt Boyle.

The Sevcon Board of Directors has unanimously approved the merger agreement and has recommended approval of the merger by Sevcon’s stockholders. The transaction is expected to close in the fourth calendar quarter of 2017 and is contingent on the approval of Sevcon’s stockholders, and is subject to the satisfaction or waiver of certain other closing conditions. The transaction is not subject to a financing condition.

Rothschild Inc. is acting as financial advisor to Sevcon, with Skadden, Arps, Slate, Meagher & Flom LLP and Locke Lord LLP acting as legal advisors.

About Sevcon

Sevcon is a global supplier of control and power solutions for zero-emission, electric and hybrid vehicles. Its products control on- and off-road vehicle speed and movement, integrate specialized functions, optimize energy consumption and help reduce air pollution. Sevcon’s Bassi Division produces battery chargers for electric vehicles; power management and uninterrupted power source systems for industrial, medical and telecom applications; and electronic instrumentation for battery laboratories. The company supplies customers from its operations in the U.S., U.K., France, Germany, Italy, China and the Asia Pacific region, as well as through an international dealer network. Learn more about Sevcon at www.sevcon.com.

About BorgWarner

BorgWarner Inc. (NYSE:BWA) is a global product leader in clean and efficient technology solutions for combustion, hybrid and electric vehicles. With manufacturing and technical facilities in 62 locations in 17 countries, the company employs approximately 27,000 worldwide. For more information, please visit borgwarner.com.

Contact:
Matt Boyle
President and CEO
+1 (508) 733 3655 (US)
+44 7802260706 (ROW)
matt.boyle@sevcon.com
Matt Goldfarb
Chairman
+1 (917) 664-0051
mgoldfarb@southportmidstream.com


Cautionary Statement Regarding Forward Looking Statements

This document includes “forward-looking statements” within the meaning of the securities laws. The words “will,” “expect,” “believe,” “future” and similar expressions are intended to identify information that is not historical in nature.

This document contains forward-looking statements relating to the proposed transaction between Sevcon and BorgWarner. All statements, other than historical facts, including statements regarding the expected timing of the closing of the transaction; the ability of the parties to complete the transaction considering the various closing conditions; the competitive ability and position of BorgWarner following completion of the proposed transaction; and any assumptions underlying any of the foregoing, are forward-looking statements. Such statements are based upon current plans, estimates and expectations that are subject to risks, uncertainties and assumptions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. The inclusion of such statements should not be regarded as a representation that such plans, estimates or expectations will be achieved. You should not place undue reliance on such statements. Important factors that could cause actual results to differ materially from such plans, estimates or expectations include, among others, that (1) one or more closing conditions to the transaction may not be satisfied or waived, on a timely basis or at all, including that the required approval by the shareholders of Sevcon may not be obtained; (2) there may be a material adverse change of Sevcon or the business of Sevcon may suffer as a result of uncertainty surrounding the transaction; (3) the transaction may involve unexpected costs, liabilities or delays; (4) legal proceedings may be initiated related to the transaction; (5) changes in economic conditions, political conditions, changes in federal or state laws or regulation may occur; and (6) other risk factors as detailed from time to time in Sevcon’s reports filed with the Securities and Exchange Commission (the “SEC”), including Sevcon’s Annual Report on Form 10-K for the year ended September 30, 2016 and subsequent Quarterly Reports on Form 10-Q which are available on the SEC’s web site (www.sec.gov). There can be no assurance that the merger will be completed, or if it is completed, that it will close within the anticipated time period or that the expected benefits of the merger will be realized.

Neither Sevcon nor BorgWarner undertakes any obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.

Additional Information and Where to Find It

In connection with the proposed merger transaction, Sevcon intends to file relevant materials with the SEC, including a preliminary proxy statement on Schedule 14A. Following the filing of the definitive proxy statement with the SEC, Sevcon will mail the definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed merger. INVESTORS ARE URGED TO READ THE PROXY STATEMENT WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION. Investors will be able to obtain the proxy statement, as well as other filings containing information about Sevcon, free of charge, from the SEC’s web site (www.sec.gov). Investors may also obtain Sevcon’s SEC filings in connection with the transaction, free of charge, from Sevcon’s web site (www.sevcon.com) under the link “Investors” and then under the tab “SEC Filings,” or by directing a request to Sevcon, Matt Boyle, President and CEO.

Participants in the Merger Solicitation

The directors, executive officers and employees of Sevcon and other persons may be deemed to be participants in the solicitation of proxies in respect of the transaction. Information regarding Sevcon’s directors and executive officers is available in its definitive proxy statement for its 2017 annual meeting of stockholders filed with the SEC on January 11, 2017. This document can be obtained free of charge from the sources indicated above. Other information regarding the interests of the participants in the proxy solicitation will be included in the proxy statement when it becomes available.

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$RIBT Shits Focus to Ingredients Business, Sells Healthy Natural Subsidiary for $18.3M

Proceeds will eliminate all USA segment debt, and significantly improve cash and shareholders’ equity positions

SACRAMENTO, California, July 14, 2017  —

RiceBran Technologies (NASDAQ: RIBT)(NASDAQ: RIBTW) (“RBT” or “Company”), a global leader in the production and marketing of value-added products derived from rice bran, today announced that  the Company has sold its contract manufacturing and packaging subsidiary, Healthy Natural, Inc., to an affiliate of Rosewood Private Investments.

“We are pleased to have completed the sale of Healthy Natural as part of our plan to improve shareholder value creation by focusing on RBT’s ingredients business,” said Robert Smith, Chief Executive Officer of RBT.  “We were also pleased to sell the business to an established and successful industry participant like Rosewood, whose success in this segment should well serve the Healthy Natural customer base.”

RBT was paid $18.3 million for the Healthy Natural business.  RBT will use a portion of the sale proceeds to eliminate senior debt and subordinated notes with face value totaling $12.5 million, to pay transaction-related costs, and to increase cash and cash equivalents (RBT had cash and cash equivalents of $3.4 million as of March 31, 2017).  The gain on the sale will also increase shareholders’ equity, which totaled $7.9 million on March 31, 2017.  Allegiance Capital Corporation of Dallas, Texas, was engaged to advise RiceBran Technologies in this sale.

“By eliminating our senior debt and subordinated notes and improving liquidity and our equity funding,” Brent Rystrom, RBT Chief Financial Officer added, “we believe we are now positioned to increase our efforts in the markets for stabilized rice bran and derivative products ingredients, and we are excited for the opportunities awaiting us.  We view this as an important step in our plans to create improved shareholder value and look forward to updating our progress on these efforts in the future.”

About RiceBran Technologies

RiceBran Technologies is a food and animal feed ingredient company focused on the procurement, bio-refining and marketing of numerous products derived from rice bran. RiceBran Technologies has proprietary and patented intellectual property that allows us to convert rice bran, one of the world’s most underutilized food sources, into a number of highly nutritious food and feed ingredient products. Our global target markets are food and feed manufacturers and retailers, as well as specialty food, functional food and nutritional supplement manufacturers and retailers. More information can be found in the Company’s filings with the SEC and by visiting our website at http://www.ricebrantech.com.

About Rosewood Private Investments

Rosewood Private Investments is the private equity arm of The Rosewood Corporation, a family-backed yet institutional firm with diverse worldwide operations and investments.  Rosewood is wholly owned by the Caroline Hunt Trust Estate, which was established in 1935 by H.L. Hunt and built upon over generations by developing and acquiring businesses that are leaders in their respective industries.  Rosewood’s structure and history enable the firm to be a unique resource and flexible investment partner. As an evergreen entity, Rosewood is continually seeking to invest capital in companies that share a commitment to entrepreneurism, integrity and sound business principles.  While a generalist investor, Rosewood has a particular focus in the nutrition and wellness, aerospace, manufacturing technologies and environmental services sectors.

About Allegiance Capital Corporation

Allegiance Capital Corporation, headquartered in Dallas, is a premier, private investment bank focused on M&A, financings and other financial advisory services for leading North American companies. (http://www.allcapcorp.com)

Forward-Looking Statements-portion of additional disclosure

This release contains forward-looking statements, including, but not limited to, statements about RiceBran Technologies’ expectations regarding growth and building future value. These statements are made based upon current expectations that are subject to known and unknown risks and uncertainties, including the risk that if RBT determines to complete a reverse stock split in the future, RBT’s shareholders may not provide the requisite approval. RiceBran Technologies does not undertake to update forward-looking statements in this news release to reflect actual results, changes in assumptions or changes in other factors affecting such forward-looking information. Assumptions and other information that could cause results to differ from those set forth in the forward-looking information can be found in this press release and in RiceBran Technologies’ filings with the Securities and Exchange Commission, including its most recent periodic reports.

Investor Contact:
Ascendant Partners, LLC
Richard Galterio
+1-732-410-9810
rich@ascendantpartnersllc.com

Friday, July 14th, 2017 Uncategorized Comments Off on $RIBT Shits Focus to Ingredients Business, Sells Healthy Natural Subsidiary for $18.3M

$HEES to Acquire $NEFF to Create Leading Equipment Rental Company

H&E Equipment Services, Inc. (NASDAQ: HEES) and Neff Corporation (NYSE: NEFF) today announced that they have entered into a definitive merger agreement under which H&E Equipment Services (“H&E”) will acquire Neff Corporation (“Neff”). Under the terms of the agreement, which has been unanimously approved by the boards of directors of both companies, H&E will pay $21.07 in cash per share of Neff common stock, for a total enterprise value of approximately $1.2 billion, including approximately $690 million of net debt. The per share merger consideration payable to Neff stockholders is subject to certain downward adjustments, not to exceed $0.44 per share, in the event that H&E incurs certain increased financing costs due to the transaction not being consummated on or prior to January 14, 2018. The transaction is expected to close in the late third quarter or early fourth quarter of 2017, and is subject to customary closing conditions including Hart-Scott-Rodino Act clearance.

John Engquist, H&E’s Chief Executive Officer, said, “This agreement accelerates our stated strategy to expand our footprint across the United States as we seek to penetrate and grow our business in strategic business segments. Further, this transaction will bring together what we believe to be two highly complementary businesses that share a commitment to addressing the increasingly complex equipment needs of our customers. Our broader geographic footprint and enhanced capabilities in strategic markets, coupled with complementary expertise across equipment categories, are expected to help us to achieve our growth goals. We look forward to welcoming Neff’s talented employee base to the H&E family, and to offering more coverage and capabilities to support our combined customer base.”

Graham Hood, Chief Executive Officer of Neff, commented, “We are looking forward to joining an industry leader who shares our core values, including our commitment to providing customers with best-in-class equipment services and solutions. Neff offers H&E a talented, experienced and knowledgeable employee base that we expect will continue to maintain and develop relationships with key customers and contribute to the combined company’s growth. I would like to thank our 1,160 employees across the country, who are the driving force behind our business. Today’s announcement is a testament to the value that they have helped to create for our stakeholders.”

Strategic Rationale

  • Scale – The acquisition will nearly double the number of H&E branches, from 78 to 147, within H&E’s existing footprint in the strategically important Gulf Coast, Mid-Atlantic, Southeast and West Coast regions. Both H&E’s and Neff’s customers will benefit from best-in-class practices and a wide range of equipment in more locations.
  • Fleet – As of March 31, 2017, the companies’ combined fleet totaled $2.2 billion based on original equipment cost (OEC) and consisted of 43,749 units. The addition of Neff’s fleet will be highly complementary to H&E’s concentration in aerial work platform equipment and the combined company will possess one of the largest earthmoving rental fleets in the industry. As of March 31, 2017, the earthmoving fleet of H&E and Neff on a combined OEC basis totaled $727 million and consisted of 8,736 units. The increased geographic expansion and density is expected to allow H&E to better position fleet to regional pockets of higher demand and improve overall utilization.
  • Increased Non-Residential Construction Penetration and End-User Market Diversification – The transaction is expected to increase H&E’s penetration in the non-residential construction market. With a significantly larger earthmoving fleet, we believe H&E will be well-positioned to gain from any future governmental infrastructure spending initiatives and will also have a broader exposure to new regional and local customers in the construction markets generally. H&E believes that the earthmoving segment is an under-penetrated segment that may afford enhanced growth opportunities.
  • Employees and Culture – Neff employees will bring significant industry expertise to H&E, where they will have the opportunity for further career development and advancement in the significantly larger combined company. Both companies share the same best-in-class commitment to customer service and safety.

Transaction Highlights

  • H&E estimates the acquisition will create $25 to $30 million of synergies annually related to corporate overhead, systems and operational efficiencies, as well as scale benefits for equipment purchases.
  • The acquisition of Neff is expected to generate in excess of $800 million of gross tax assets for H&E arising from a step-up in the basis of certain of Neff’s assets.
  • Wells Fargo Bank and affiliated entities have agreed to provide committed financing for the transaction, subject to customary conditions. The transaction is not subject to a financing condition.
  • Private investment funds managed by Wayzata Investment Partners LLC holding approximately 62.7% of the outstanding common shares of Neff have executed a written consent to approve the transaction, thereby providing the required stockholder approval for the transaction.
  • The merger agreement includes a “go-shop” period which runs through August 20, 2017 during which the special committee of Neff’s board of directors, with the assistance of its financial and legal advisors, may solicit alternative proposals to acquire Neff. There can be no assurance that this process will result in receipt of a superior offer or that any other transactions will be approved or consummated.

Conference Call

H&E’s management will hold a conference call to discuss the Neff acquisition on Tuesday, July 18, 2017. Specific details regarding the meeting will be provided in advance of the conference call.

Wells Fargo Securities, LLC acted as financial advisor to H&E and Dechert LLP acted as H&E’s legal advisor. Deutsche Bank Securities Inc. and Akin Gump Strauss Hauer & Feld LLP served as advisors to the special committee of Neff’s board of directors.

About H&E Equipment Services, Inc.

H&E is one of the largest integrated equipment services companies in the United States with 78 full-service facilities throughout the West Coast, Intermountain, Southwest, Gulf Coast, Mid-Atlantic and Southeast regions. H&E is focused on heavy construction and industrial equipment and rents, sells and provides parts and services support for four core categories of specialized equipment: (1) hi-lift or aerial platform equipment; (2) cranes; (3) earthmoving equipment; and (4) industrial lift trucks. By providing a multitude of services including equipment rental, sales, on-site parts and repair and maintenance, H&E is a one-stop provider for its customers’ varied equipment needs. This full service approach provides H&E with multiple points of customer contact, enabling it to maintain a high quality rental fleet, as well as an effective distribution channel for fleet disposal and provides cross-selling opportunities among its new and used equipment sales, rental, parts sales and services operations.

About Neff Corporation

Neff is a leading regional equipment rental company in the United States, focused on the fast growing Sunbelt States. Based in Miami, FL, the company offers a broad array of equipment rental solutions for its more than 15,000 customers, focusing on key end user markets including infrastructure, non-residential construction, energy and municipal and residential construction. Neff has 69 branches, approximately 1,160 employees and a broad fleet of equipment, including earthmoving, material handling, aerial and other rental equipment to meet specific customer needs.

Forward-Looking Statements

Statements contained in this press release that are not historical facts, including statements about H&E’s or Neff’s beliefs and expectations, are forward-looking statements within the meaning of the federal securities laws. Forward-looking statements include statements preceded by, followed by or that include the words “may”, “could”, “would”, “should”, “believe”, “expect”, “anticipate”, “plan”, “estimate”, “target”, “project”, “intend”, “foresee” and similar expressions, as well as other statements, including statements about the anticipated benefits to H&E and Neff from the merger, H&E’s and Neff’s anticipated financial and operating results, the impact of the merger on H&E’s earnings and capital structure and H&E’s and Neff’s respective plans, objectives and intentions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause the actual results, performance and achievements of H&E and Neff to differ materially from the anticipated results expressed or implied by any forward-looking statements. These risks, uncertainties and other factors include, among others: (1) the risk that the savings and synergies anticipated from the merger are not realized or take longer than anticipated to be realized; (2) disruption or reputational harm as a result of the merger with H&E’s or Neff’s customers, suppliers, employees or others business partner relationships; (3) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement, the failure of the closing conditions included in the merger agreement to be satisfied (or any material delay in satisfying such conditions), or any other failure to consummate the transactions contemplated thereby, including in circumstances in which one party would be obligated to pay the other a termination fee or other damages or expenses; (4) the risk of unsuccessful integration of H&E’s and Neff’s businesses, or that such integration will be materially delayed or will be more costly or difficult than anticipated; (5) the amount of the costs, fees, expenses and charges related to the merger; (6) the ability to obtain required governmental approvals of the proposed merger, including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976; (7) any additional costs related to the merger or the other transactions contemplated thereby as a result of unexpected factors or events; (8) the significant indebtedness of the combined company, including the indebtedness incurred in the proposed financing of the merger; (9) any negative effects of this announcement or the consummation of the merger, the proposed financing thereof or any of the other transactions contemplated thereby on the market price of H&E’s or Neff’s common stock or other securities; (10) the diversion of management time on transaction-related issues; (11) other business effects, including the effects of general industry, market, economic, political or regulatory conditions, future exchange or interest rates or changes in tax laws, regulations, rates and policies, including the uncertainty regarding rules and regulations with respect to the foregoing that may be affected by the United States Congress and Trump administration; and (12) the expected business outlook, anticipated financial and operating results generally. For a more detailed discussion of some of the foregoing risks and uncertainties, see H&E’s and Neff’s respective Annual Reports on Form 10-K and other reports and other documents filed with the U.S. Securities and Exchange Commission. Forward-looking statements are only predictions and are not guarantees of performance. These statements are based on the current beliefs and assumptions of H&E’s and Neff’s management, which in turn are based on currently available information and important, underlying assumptions. H&E and Neff are under no obligation to publicly update or revise any forward-looking statements after this press release, whether as a result of any new information, future events or otherwise. Investors, potential investors, security holders and other readers are urged to consider the above mentioned factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. Although H&E and Neff believe that the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee future results or performance, including the consummation of the transactions contemplated by the merger agreement or the proposed financing thereof or any anticipated effects of the merger.

Additional Information and Where to Find It

In connection with the proposed acquisition, Neff intends to prepare an information statement in preliminary and definitive form for its stockholders containing the information with respect to the proposed merger specified in Schedule 14C promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and describing the proposed merger. Neff’s stockholders are urged to carefully read the information statement regarding the proposed merger and any other relevant documents in their entirety when they become available because they will contain important information about the proposed acquisition. You may obtain copies of all documents filed with the SEC regarding the proposed merger, free of charge, at the SEC’s website, http://www.sec.gov, or on the Investor Relations section of Neff’s website (www.neffrental.com), or by directing a request to Neff by mail or telephone as set forth above. Investors are also urged to read the current reports on Form 8-K to be filed by each of H&E and Neff regarding the proposed merger, which will also contain important information.

 

H&E Equipment Services, Inc.
Leslie S. Magee, 225-298-5261
Chief Financial Officer
lmagee@he-equipment.com
or
Kevin S. Inda, 225-298-5318
Vice President of Investor Relations
kinda@he-equipment.com
or
For Investors:
Neff Corporation
Mark Irion, Chief Financial Officer
Brian Coolidge, Director of Financial Reporting
305-513-3350
InvestorRelations@neffcorp.com
or
For Media:
FTI Consulting
Brian Shiver and Grace Altman
212-850-5683 and 212-850-5602
Brian.Shiver@fticonsulting.com and Grace.Altman@fticonsulting.com

Friday, July 14th, 2017 Uncategorized Comments Off on $HEES to Acquire $NEFF to Create Leading Equipment Rental Company

$TEUM Granted Extension by NYSE MKT for Compliance with Listing Requirements

NEW YORK, July 14, 2017  — Pareteum Corporation (NYSE MKT: TEUM) (“Pareteum” or the “Company”), a leading communications technology provider to global Mobile, MVNO, Enterprise and IoT markets, today announced that the NYSE MKT LLC has granted the Company an extension for compliance with its listing requirements through November 27, 2017.

On July 13, 2017, Pareteum Corporation (the “Company”) received a notice from the NYSE MKT LLC (the “Exchange”) indicating that the Company is not currently in compliance with the Exchange’s continued listing standards as set forth in Section 1003(a)(i), Section 1003(a)(ii), Section 1003(a)(iii), and Section 1003(a)(iv) of the NYSE MKT Company Guide (the “Company Guide”). The Company is now in compliance with Section 1003(f)(v). The Exchange has reviewed the Company’s most recent updates and determined to extend the plan period for the Company to regain compliance with Section 1003(a)(iv) through November 27, 2017. The compliance date for Section 1003(a)(i), Section 1003(a)(ii), and Section 1003(a)(iii) remain November 27, 2017, as we previously stated in the exchange’s notice dated January 5, 2017.

“We are pleased to receive the NYSE MKT’s extension through November 27, 2017. Having completed our restructuring in 2016, Pareteum is proving its value and potential in the market through our $60 million contracted backlog, which we expect will convert into growing quarterly revenues. Combined with our cost cutting measures, we are positioned to meet our listing requirement obligations,” stated Hal Turner, Executive Chairman of Pareteum.

About Pareteum Corporation:
Pareteum Corporation and its subsidiaries provide a complete mobility cloud platform, utilizing messaging and security capabilities for the global Mobile, MVNO, Enterprise, Software-as-a-Service and IoT markets. The Company’s software solutions allow any organization to harness the power of a wirelessly connected world by delivering seamless connectivity and subscriber management capabilities that provide end-to-end control of millions of connected devices. Mobile Network Operator (MNO) customers include Vodafone, the world’s second largest mobile operator by customer count, Zain, one of the largest mobile operators in the Middle East, as well as MVNO customers such as Lebara and Lowi. For more information please visit: www.pareteum.com.

Forward-Looking Statements:
Certain statements contained herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Pareteum’s plans and objectives, projections, expectations and intentions. These forward-looking statements are based on current expectations, estimates and projections about Pareteum’s industry, management’s beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Pareteum may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Pareteum also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Pareteum’s filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Pareteum.

Pareteum Investor Relations Contact:
Ted O’Donnell
Chief Financial Officer
(212) 984-1096
InvestorRelations@pareteum.com

Friday, July 14th, 2017 Uncategorized Comments Off on $TEUM Granted Extension by NYSE MKT for Compliance with Listing Requirements

$HPJ Enters Smart Vacuum Market with Two New Partnerships

SAN DIEGO and SHENZHEN, China, July 14, 2017  — Highpower International, Inc. (NASDAQ: HPJ) (“Highpower” or the “Company”), a developer, manufacturer, and marketer of lithium ion and nickel-metal hydride (Ni-MH) rechargeable batteries, battery management systems, and a provider of battery recycling, today announced that it has reached strategic partnership agreements with industry-leading appliance brands from Europe and the U.S. to develop and supply power solutions for high-end smart vacuum robots.

Mr. George Pan, Chairman and CEO of Highpower International, commented, “Under the swift development of smart home, people are relying more and more on smart appliances such as vacuum robots with greater power and endurance as well as compact and sleek design. With our deep knowledge of power solution design and strong base of household-name customers during the past 16 years, we are well positioned to serve customers in the smart vacuum industry. Highpower pays close attention to the end user as well as developing trends and work jointly with our industry-leading clients to provide quality products and services. These two partnerships will further strengthen our market share in smart home application and Highpower will continue to supply convenience and style to our consumers.”

The two agreements are expected to provide Highpower with top-line revenues of $4 million in 2017 and $15 million in 2018, with which Highpower has been involved in designing power solutions for three new models of smart vacuums, which are expected to be launched in 2018.

About Market information

According to Euromonitor International, the world leader in strategy research for consumer markets, the whole smart vacuum market reached $1.7 billion in 2015 and is expected to reach $2.4 billion in 2020. GFK SE, Germany’s largest market research institute and the fourth largest market research organization in the world, estimates that by 2020, the global smart furniture market will surpass $58 billion with demand driven by Europe, the U.S., and Asia.

About Highpower International, Inc.

Highpower International was founded in 2001 and produces high-quality Nickel-Metal Hydride (Ni-MH) and lithium-based rechargeable batteries used in a wide range of applications such as electric buses, bikes, energy storage systems, power tools, medical equipment, digital and electronic devices, personal care products, and lighting, etc. Highpower’s target customers are Fortune 500 companies and top 20 companies in each vertical segment. With advanced manufacturing facilities located in Shenzhen, Huizhou, and Ganzhou of China, Highpower is committed to clean technology, not only in the products it makes, but also in the processes of production. The majority of Highpower International’s products are distributed to worldwide markets mainly in the United States, Europe, China and Southeast Asia.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995 that are not historical facts. These statements can be identified by the use of forward-looking terminology such as “believe,” “expect,” “may,” “will,” “should,” “project,” “plan,” “seek,” “intend,” or “anticipate” or the negative thereof or comparable terminology. Such statements involve known and unknown risks, uncertainties and other factors that could cause the Company’s actual results to differ materially from the results expressed or implied by such statements, including, without limitation, fluctuations in the cost of raw materials; our dependence on, or inability to attract additional, major customers for a significant portion of our net sales; our ability to increase manufacturing capabilities to satisfy orders from new customers; our ability to maintain increased margins; our dependence on the growth in demand for smart wearable devices and energy storage systems, and other digital products and the success of manufacturers of the end applications that use our battery products; our responsiveness to competitive market conditions; our ability to successfully manufacture our products in the time frame and amounts expected; the market acceptance of our battery solutions, including our lithium ion batteries; and our ability to continue R&D development to keep up with technological changes. For a discussion of these and other risks and uncertainties see “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s public filings with the SEC. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward-looking information contained in this press release.

CONTACT:

Highpower International, Inc.
Sunny Pan
Chief Financial Officer
Tel: +86-755-8968-6521
Email: ir@highpowertech.com

Yuanmei Ma
Investor Relations Manager
Tel: +1-909-214-2482
Email: ir@highpowertech.com

ICR, Inc.
Rose Zu
Tel: +1-646-931-0303
Email: ir@highpowertech.com

Friday, July 14th, 2017 Uncategorized Comments Off on $HPJ Enters Smart Vacuum Market with Two New Partnerships

$FSC $FSFR BDCs Management to be Assumed by $OAK

Transaction Provides Oaktree with BDC Platform with Scale

Oaktree Capital Group, LLC (NYSE: OAK) (“OCG”) today announced that Oaktree Capital Management, L.P. (“Oaktree”) has signed a definitive asset purchase agreement under which Oaktree will become the new investment adviser to two business development companies (“BDCs”): Fifth Street Finance Corp. (NASDAQ: FSC) (“FSC”) and Fifth Street Senior Floating Rate Corp. (NASDAQ: FSFR) (“FSFR”). Oaktree will pay $320 million in cash to Fifth Street Management LLC (“FSM”) upon the close of the transaction. The parties expect the transaction to be completed in the fourth quarter of 2017.

“We are excited about the opportunity to serve as the investment adviser for FSC and FSFR,” said Jay Wintrob, Chief Executive Officer of Oaktree. “These BDCs are a clear strategic fit with Oaktree’s direct lending expertise, and the completion of this transaction will create a BDC platform with scale that leverages our deep credit expertise, loan origination capabilities and underwriting skills. Importantly, Oaktree has the investment experience and acumen to manage these portfolios effectively and to pursue new investment opportunities to maximize value for BDC investors over time.”

Oaktree portfolio manager Edgar Lee is expected to serve as CEO of both BDCs, which together have approximately $2.5 billion of assets under management across first lien, second lien, uni-tranche and mezzanine credits. Following the transaction, FSC will change its name to Oaktree Specialty Lending Corporation, and will trade under the ticker symbol OCSL; FSFR will change its name to Oaktree Strategic Income Corporation, and will trade under the ticker symbol OCSI.

“Oaktree has a foundation built on deep expertise in credit and we have significant experience investing across market cycles. We will seek to apply our rigorous credit underwriting process for the benefit of the shareholders of the BDCs by helping stabilize and improve the performance of both BDC portfolios as well as leverage our broad, global credit platform to source quality investments,” said Edgar Lee.

Following the closing of the transaction, Oaktree will replace FSM as the investment adviser to the BDCs, and an Oaktree affiliate will become their administrator. Oaktree’s proposed investment advisory agreements are more aligned with BDC shareholders as the management fee rate for FSC will be reduced from 1.75% to 1.50%, and the incentive fee will be reduced from 20.0% to 17.5% with respect to both income and capital gains. The incentive fee for FSFR will also be reduced from 20.0% to 17.5% with respect to both income and capital gains. The current FSFR management fee rate of 1.0% will remain unchanged. OCG expects the transaction to be immediately accretive to its adjusted net income.

The new advisory agreements, which have been unanimously approved by the independent directors of the boards of directors of FSC and FSFR, are subject to approval by the stockholders of FSC and FSFR. The FSC and FSFR boards of directors unanimously recommended that the stockholders of each BDC vote in favor of the new investment advisory agreement with Oaktree and related corporate governance matters, including the election of new directors. Fifth Street Holdings L.P. and Leonard Tannenbaum, Chairman and Chief Executive Officer of Fifth Street Asset Management Inc., have agreed to vote their shares in favor of the proposed investment advisory agreements and the new director nominees.

Following the closing of the transaction, all current FSC board members except Richard P. Dutkiewicz, and all current FSFR board members except Richard W. Cohen, have agreed to resign. Each BDC board has nominated Marc H. Gamsin, Craig Jacobson, Richard G. Ruben and Bruce Zimmerman as new independent directors and John Frank, Vice Chairman of Oaktree, as a new interested director of the board, each of whom would take office upon approval of the stockholders and the closing of the transaction. Mr. Frank is expected to serve as Chairman of each BDC board. The executive officers of FSC and FSFR will resign and will be replaced with individuals affiliated with Oaktree at the closing of the transaction.

Consummation of the transaction contemplated by the asset purchase agreement is subject to FSAM stockholder approval, approval of the new investment advisory agreements and new director nominees by the stockholders of both BDCs, Hart-Scott-Rodino antitrust clearance and other customary closing conditions.

Bank of America Merrill Lynch is serving as financial advisor and Simpson Thacher & Bartlett LLP is serving as legal advisor to Oaktree.

About Oaktree

Oaktree is a leader among global investment managers specializing in alternative investments, with $100 billion in assets under management as of March 31, 2017. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in distressed debt, corporate debt (including high yield debt and senior loans), control investing, convertible securities, real estate and listed equities. Headquartered in Los Angeles, the firm has over 900 employees and offices in 18 cities worldwide. For additional information, please visit Oaktree’s website at oaktreecapital.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Exchange Act, which reflect the current views of OCG with respect to, among other things, its future results of operations and financial performance. In some cases, you can identify forward-looking statements by words such as “anticipate,” “approximately,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “outlook,” “plan,” “potential,” “predict,” “seek,” “should,” “will” and “would” or the negative version of these words or other comparable or similar words. These statements identify prospective information. Because forward-looking statements include risks and uncertainties, actual results may differ materially from those expressed or implied and include, but are not limited to, those discussed in OCG’s filings with the SEC (including the factors listed in the item captioned “Risk Factors” in OCG’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 1, 2017, which is accessible on the SEC’s website at www.sec.gov), and (i) the satisfaction of certain closing conditions specified in the definitive agreements relating to the proposed transaction, (ii) the parties’ ability to successfully close the proposed transaction and the timing of such closing, (iii) the impact of transaction expenses and potential litigation contingencies, (iv) that the proposed transaction may disrupt current plans and operations of the BDCs and (v) the possibility that competing offers or acquisition proposals related to the proposed transaction will be made.

Forward-looking statements speak only as of the date of this press release. Except as required by law, OCG does not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

 

Investor Relations:
Oaktree Capital Group, LLC
Andrea D. Williams, 213-830-6483
investorrelations@oaktreecapital.com
or
Media Relations:
Sard Verbinnen & Co
John Christiansen / David Millar
(415) 618-8750 / (212) 687-8080
mediainquiries@oaktreecapital.com

Friday, July 14th, 2017 Uncategorized Comments Off on $FSC $FSFR BDCs Management to be Assumed by $OAK

$IGC Announces Financial Results for Fiscal Year Ended March 31, 2017

Core Operations Transitioned to Phytocannabinoid-Based Therapy Development Targeting Large Market Indications

BETHESDA, Md., July 14, 2017  — India Globalization Capital, Inc. (NYSE MKT:IGC) announces financial results for the fiscal year ended March 31, 2017.

“In fiscal 2017, our major accomplishments include the advancement of our phytocannabinoid patent filing portfolio to large market indications. And in order to keep this focus on the medical cannabis industry, we disposed of our low-margin iron ore and electronic trading businesses, and retired about 10% of our outstanding common stock; thus reducing revenue, PP&E, and stockholder’s equity.  We firmly believe that this planned strategic move positions our Company for growth in one of the fastest growing industries in America,” said Ram Mukunda, CEO.

Total revenue was approximately $0.58 million for FYE 2017, as compared to approximately $6.37 million for the FYE 2016.  Exiting the electronic business contributed to the decrease in revenue.

As a result of our decision to exit the iron ore business segment, our FYE 2017 Property, Plant and Equipment, net of depreciation decreased by approximately $6.1 million to approximately $0.95 million, and that also largely led to the decrease in stockholder’s equity to about $7.3 million from about $13.9 million in fiscal 2016.

Selling, general and administrative expenses were about $1.88 million for fiscal 2017, inclusive of one time expenses associated with the disposition of businesses lines, and non-cash expenses, as compared to about $2.70 million for fiscal 2016, an improvement of 30.6%.  Fiscal 2017 reflects a steep cut in expenses associated with a further aligning of resources to focus on phytocannabinoid therapies.

Loss from operations was approximately $2.05 million in fiscal year 2017, as compared to approximately $2.91 million in fiscal year 2016. The improvement in operating loss year over year is mostly attributed to lower SG&A.  At the end of fiscal year 2017, the Company has approximately $0.54 million in cash and cash equivalents and working capital of approximately $2.30 million.

Financial Tables to Follow

INDIA GLOBALIZATION CAPITAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Audited)
(All amounts in USD, except number of shares and per share amounts)
31-March-17 31-March-16
(audited) (audited)
ASSETS
Current assets:
Cash and cash equivalents $ 538,029 $ 1,490,693
Accounts receivable, net of allowances 752,926 962,658
Inventories 162,091
Prepaid expenses and other current assets 410,408 1,226,507
Short-term investments 1,880,000
Total current assets $ 3,581,363 $ 3,841,949
Goodwill 198,169 1,180,951
Intangible Assets 113,321
Property, plant and equipment, net 953,936 7,074,437
Investments in affiliates 773,111 609,148
Investments-others 5,238,003 5,175,392
Deferred Income taxes 356,684
Other non-current assets 539,720 507,300
 Total long-term assets $ 7,702,939 $ 15,017,233
Total assets $ 11,284,302 $ 18,859,182
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Short -term borrowings 27,762
Trade payables 416,532 330,631
Accrued expenses 181,465 300,111
Loans – others 189,680
Notes payable 1,800,000
Other current liabilities 691,714 550,877
Total current liabilities $ 1,289,711 $ 3,199,061
Long -term borrowings 452,080 801,467
Loans – others 392,226
Notes payable 1,800,000
Other non-current liabilities 910,583
Total long-term liabilities $ 2,644,306 $ 1,712,050
 Total liabilities $ 3,934,017 $ 4,911,111
Stockholders’ equity:
Common stock — $.0001 par value; 150,000,000 shares authorized; 23,265,531 issued and outstanding as of March 31, 2016 and 28,272,667 issued and outstanding as of March 31, 2017. $ 2,827 $ 2,327
Additional paid-in capital 61,413,533 65,885,243
Accumulated other comprehensive income (2,047,780 ) (2,269,357 )
Retained earnings (Deficit) (52,009,459 ) (50,142,199 )
Total equity attributable to Parent $ 7,359,121 $ 13,476,014
 Non-controlling interest $ (8,836 ) $ 472,057
Total stockholders’ equity $ 7,350,285 $ 13,948,071
Total liabilities and stockholders’ equity $ 11,284,302 $ 18,859,182

These financial statements should be read in connection with the accompanying notes on Form 10-K for fiscal 2017
filed with the SEC on July 13, 2017.

INDIA GLOBALIZATION CAPITAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Audited)
(All amounts in USD, except number of shares and per share amounts)
Year ended March 31,
2017 2016
Revenues $ 580,372 $ 6,366,550
Cost of revenues (excluding depreciation) (362,135 ) (5,523,256 )
Selling, general and administrative expenses (1,875,344 ) (2,702,753 )
Depreciation (396,346 ) (728,741 )
Loss on investments / associates /joint ventures (932 ) (317,510 )
 Operating income (loss) $ (2,054,385 ) $ (2,905,710 )
Interest expense (223,464 ) (213,928 )
Interest income 1,744 2,085
 Profit on investments/associates and Joint Ventures 317,742
Other income, net 119,933 284,186
Income before income taxes and minority interest attributable to non-controlling interest $ (1,838,430 ) $ (2,833,367 )
Income taxes benefit/ (expense) (14,431 ) (579 )
Net income/(loss) $ (1,852,861 ) $ (2,833,946 )
Non-controlling interests in earnings of subsidiaries 14,399 (25,702 )
 Net income / (loss) attributable to common stockholders $ (1,867,260 ) $ (2,808,244 )
Earnings/(loss) per share attributable to common stockholders:
Basic $ (0.07 ) $ (0.17 )
Diluted $ (0.07 ) $ (0.17 )
Weighted-average number of shares used in computing earnings per share amounts:
Basic 25,658,544 16,387,290
Diluted 25,658,544 16,387,290

These financial statements should be read in connection with the accompanying notes on Form 10-K for fiscal 2017
filed with the SEC on July 13, 2017.

About IGC

India Globalization Capital is engaged in the development of cannabis-based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in humans, dogs and cats.  In support of this effort, IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Bethesda, Maryland.

For more information visit www.igcinc.us

Follow us on Twitter @IGCIR and Facebook.com/IGCIR/

Forward-looking Statements         

Please see forward-looking statements as discussed in detail in IGC’s Form 10-K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.

Contact Info:
Claudia Grimaldi
301-983-0998
Friday, July 14th, 2017 Uncategorized Comments Off on $IGC Announces Financial Results for Fiscal Year Ended March 31, 2017

$CTIC EMA Validation of Pacritinib Marketing Authorization Application in Myelofibrosis

SEATTLE, July 13, 2017 — CTI BioPharma Corp. (NASDAQ and MTA: CTIC) today announced that European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microliter). Validation confirms that the submission is complete and initiates the centralized review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).  The CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU authorization within three months. If authorized, pacritinib would be granted a marketing license valid in all 28 EU member states.

“The MAA validation is a significant milestone for CTI BioPharma as we seek to bring pacritinib to patients with myelofibrosis who have thrombocytopenia that could benefit from its unique profile,” said Adam R. Craig, M.D., Ph.D., President and CEO of CTI BioPharma. “We look forward to working with the CHMP/EMA during their review of this application.”

The MAA is primarily supported by data from two randomized Phase 3 clinical trials, PERSIST-1 and PERSIST-2, that evaluated pacritinib in patients with myelofibrosis.

About Pacritinib 

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia, or AML, myelodysplastic syndrome, or MDS, chronic myelomonocytic leukemia, or CMML, and chronic lymphocytic leukemia, or CLL, due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

Pacritinib was evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis, with one trial in a broad set of patients without limitations on platelet counts, the PERSIST-1 trial; and the other in patients with low platelet counts, the PERSIST-2 trial. The PERSIST-1 trial met its primary endpoint of spleen volume reduction (35 percent or greater from baseline to Week 24 by MRI/CT scan). The PERSIST-2 trial met one of its co-primary endpoints, that of spleen volume reduction. The co-primary endpoint of reduction of Total Symptom Score (TSS) was not achieved but trended toward improvement in TSS.

Clinical studies under the investigational new drug (IND) for pacritinib were subject to a full clinical hold issued by the FDA in February 2016. In January 2017, the FDA removed the full clinical hold and stated that clinical trials may resume. CTI BioPharma is initiating a Phase 2 dose exploration study that was a condition of the clinical hold being removed.

About Myelofibrosis and Myeloproliferative Neoplasms

Myelofibrosis is one of three main types of myeloproliferative neoplasms (MPN), which are a closely related group of progressive blood cancers. The three main types of MPNs are primary myelofibrosis (PMF), polycethemia vera (PV) and essential thrombocythemia (ET).1

Myelofibrosis is a serious and life-threatening bone marrow disorder caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response and scars the bone marrow. The replacement of bone marrow with scar tissue limits its ability to produce red blood cells, prompting the spleen and liver to take over this function. Symptoms that arise from this disease include enlargement of the spleen, anemia, extreme fatigue and pain.

The estimated prevalence of MPNs suggest there are approximately 300,000 people living with the disease in the U.S., of which myelofibrosis accounts for approximately 18,000 patients.2 In Europe, there is a wide variation of prevalence observed across data sources. Myelofibrosis has a median age of 64 at the time of diagnosis3 and is a progressive disease with approximately 20 percent of patients eventually developing acute myeloid leukemia (AML).4 The median survival for high-risk myelofibrosis patients is less than 1.5 years, while the median survival for patients with myelofibrosis overall is approximately 6 years.4

About CTI BioPharma Corp.

CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.

Forward-Looking Statements

This press release includes forward-looking statements, which are within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding expectations with respect to the potential therapeutic utility of pacritinib, including pacritinib’s potential to achieve treatment goals across patients with myelofibrosis, and expectations with respect to our ability to be able to interpret clinical trial data and results despite not satisfying the pre-specified minimum evaluable patient goal for the PERSIST-2 clinical trial and expectations with respect to the potential therapeutic utility of pacritinib. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the issuers’ securities, including risks related to the satisfaction of regulatory and other requirements; the actions of regulatory bodies and other governmental authorities; other clinical trial results; changes in laws and regulations; product quality, product efficacy, study protocol, data integrity or patient safety issues; product development risks; and other risks identified in each of the issuer’s most recent filings on Forms 10-K and 10-Q and other Securities and Exchange Commission filings.

  1. MPN Research Foundation. Accessed June 2017. Available at www.mpnresearchfoundation.org.
  2. Based on Mesa R, ASH 2012 poster.
  3. Cervantes F, et al., New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009; 113:2895-2901.
  4. Vannucchi, A. Management of Myelofibrosis. ASH Education Book. 2011; 1:222-230.

CTI BioPharma Contacts:

Ed Bell
+1 206-272-4345
ebell@ctibiopharma.com

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$BLFS CryoStor First Approved Cell and Gene Therapy for Osteoarthritis

Korean Approval Received by Kolon Life Science, TissueGene’s Exclusive Licensee

BOTHELL, Wash., July 13, 2017  — BioLife Solutions, Inc. (NASDAQ: BLFS), the leading supplier of pre-formulated, clinical grade cell and tissue hypothermic storage and cryopreservation freeze media (“BioLife”), today announced that Kolon Life Science, TissueGene’s exclusive licensee for Asia, including Korea, has received marketing approval for Invossa-K Inj., the world’s first cell and gene therapy for degenerative arthritis from the Korea Ministry of Food and Drug Safety (MFDS).

The manufactured Invossa cell and gene therapy will be frozen and shipped in BioLife’s CryoStor cell freeze media to extend the shelf life until arrival at the clinic for injection into the patient.

Invossa is a first-in-class cell and gene therapy drug designed to conveniently and effectively treat osteoarthritis of the knee through a single intra-articular injection.  Clinical trials completed in Korea and on-going in the US have demonstrated pain relief, increased mobility, and potentially game-changing improvements in joint structure – offering substantial relief and convenience for osteoarthritis patients who would otherwise be in need of surgery.

In December 2016, BioLife executed a ten year supply agreement with TissueGene to supply clinical grade CryoStor for use in the Invossa manufacturing process. Kolon Life Science filed for a Biologics License Application (BLA) for Invossa-K Inj. with the MFDS in August 2016 based on efficacy results from its Phase III clinical trials conducted at 12 major university hospitals in Korea.

Mike Rice, BioLife CEO, commented, “This initial geographic approval of Invossa in Korea is a major accomplishment for TissueGene and Kolon. We are very pleased that our CryoStor cell freeze media is integrated into the storage and distribution protocol for this approved cell-mediated gene therapy.  This approval confirms the value of our regenerative medicine customer base and the enabling role our proprietary products play in helping to commercialize novel cell and tissue based therapies. Furthermore, we anticipate that additional customers will receive regulatory marketing approvals in the near future, which we anticipate will increase demand for our proprietary, clinical grade biopreservation media products.”

Worldwide, an estimated 150 million people suffer from knee osteoarthritis. BioLife estimates that just 1% of the worldwide addressable patient population represents at least $5 million in revenue.

In November last year, Kolon Life Science signed a license agreement with Mitsubishi Tanabe Pharmaceutical Corporation, and Mitsubishi Tanabe Pharma is proceeding with the preparation of clinical trials through its exclusive development and commercialization rights in Japan. Through its national US Phase III clinical trials, TissueGene will be using the results to seek a Disease Modifying Osteoarthritis Drug (DMOAD) designation for Invossa™ from the US Food and Drug Administration (FDA), potentially making Invossa™ the first and only cell and gene therapy for osteoarthritis of the knee.

About BioLife Solutions

BioLife Solutions develops, manufactures and markets biopreservation media products and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics for cells, tissues, and organs. The Company’s proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife’s biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. BioLife’s enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs.  For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

This press release contains forward-looking statements, including, but not limited to, statements, concerning the company’s anticipated business and operations, and expected revenue growth from customer regulatory approvals or approved therapies.  All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Media & Investor Relations
Roderick de Greef
Chief Financial Officer
(425) 686-6002
rdegreef@biolifesolutions.com

 

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$CLIR Receives Order from Supermajor Oil Company to Qualify Duplex™ Technology

First Step in Broad Adoption of Duplex™ Technology by Industry Leading Refiner

SEATTLE, July 13, 2017  — ClearSign Combustion Corporation (NASDAQ: CLIR), a leading provider of industrial combustion technologies that deliver unmatched reduction of pollutant emissions while improving operational costs, today announced that they have received a purchase order to qualify the company’s revolutionary Duplex™ combustion technology as a precursor to an installation at a super major oil refinery.

Qualification testing will occur at ClearSign’s facility in Seattle, WA and involves evaluating the company’s Duplex technology under a variety of fuel compositions and process conditions that mirror the customer’s operations. The global oil giant is funding the testing to determine Duplex’s suitability for a variety of refinery process heaters and conditions in a test expected to conclude later this year. The customer plans to continue testing at one of the oil giant’s refineries. Following this qualification, the customer has indicated interest in standardizing the Duplex technology to existing heaters within the US and abroad where the Duplex platform is suited for deployment.

ClearSign’s Chairman and CEO, Stephen Pirnat stated, “Our Duplex technology has been proven to the extent that a global supermajor refiner is willing to pay for qualification. This is substantial validation of the hard working scientists and engineers at ClearSign that have worked diligently to create game-changing technology that solves difficult air pollution problems in a cost-effective manner.”

About ClearSign Combustion Corporation
ClearSign Combustion Corporation designs and develops products and technologies for the purpose of improving key performance characteristics of combustion systems, including emissions and operational performance, energy efficiency and overall cost-effectiveness. Our patented Duplex™ and Electrodynamic Combustion Control™ platform technologies enhance the performance of combustion systems in a broad range of markets, including the energy (upstream oil production and down-stream refining), commercial/industrial boiler, chemical, petrochemical, and power industries. For more information, please visit www.clearsign.com.

Cautionary note on forward-looking statements
All statements in this press release that are not based on historical fact are “forward-looking statements.” While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, general business and economic conditions, the performance of management and our employees, our ability to obtain financing, competition, whether our technology will be accepted and other factors that are to be detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a competitive environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Thursday, July 13th, 2017 Uncategorized Comments Off on $CLIR Receives Order from Supermajor Oil Company to Qualify Duplex™ Technology

$ANY HVE Wins VDI Deployment Contract with University of North Alabama

HVE’s Datrium ready nodes and 3D GFX vGPU appliances, along with Datrium DVX NetShelf, come together to provide a predictable cost model and the ability to scale to 1000’s of users

SAN JOSE, Calif., July 13, 2017 — Sphere 3D Corp. (NASDAQ:ANY), a containerization, virtualization, and data management solutions provider, is pleased to announce that its HVE ConneXions has been awarded a contract with the University of North Alabama (UNA) to deploy next-generation desktop virtualization solutions.  UNA’s technology staff went through an eight-month process to evaluate multiple vendors, and ultimately chose HVE ConneXions as it provides the most robust, cost effective and proven solution to meet their requirements.

Howard Technologies, a partner for over three years, presented to UNA both the HVE technology and an overall architecture that included leading edge technology integrated with HVE’s VDI appliances to support their overall desktop virtualization footprint.  UNA implemented two HVE-202-Ds (Datrium Ready VDI Nodes for 200 Users) and two HVE-3DGFX vGPU VDI appliances, coupled with an OpenConverged Datrium DVX NetShelf solution.  This architecture will allow the UNA virtualization environment to scale from a few hundred to thousands of sessions while maintaining a predictable cost model and increase performance as the consumption grows.

HVE’s turnkey solution was implemented, and training completed, within a week at UNA.   Also, as part of the solution, HVE and Datrium are providing 24×7 proactive monitoring and support, which is a unique offering when compared to other providers, and  an additional deciding factor for UNA.

Stephen Putman, Chief Information Officer for UNA, said, “The decision to go with VDI at UNA had been debated for many years.  After deciding to pursue VDI initially for labs and classrooms, we quickly realized finding the right technology was a challenge. We contacted several technology providers and were overwhelmed with the number of available solutions. HVE ConneXions was presented to us by Howard Technologies and we quickly realized HVE was very knowledgable and had put much research and  development into providing a highly optimized VDI  solution.”

Putman added, “HVE coupled with Datrium provided the most comprehensive long-term solution with outstanding performance and overall viability. Also, their track record in education is excellent, and their responsiveness to quickly address any technology challenges in the implementation was impeccable. This purchase allows our staff and academic community to reap the benefits of VDI by delivering applications more rapidly than in the past and allows the ITS department to provide UNA  with predictable performance and a cost-effective model for expansion.”

Greg Horsleyl, Senior Account Executive for Datrium stated, “HVE and Datrium provide a best of breed solution through their purpose built compute and storage specifically designed for VDI that scales to meet any requirement.  Architected, implemented, and monitored by HVE ConneXions and Datrium, we are able to provide UNA white glove customer service from start to finish.”

Dave Harmon, VP of Virtualization for Sphere 3D said, “HVE, Howard and Datrium technology staff went through a comprehensive process of environment analysis, VDI infrastructure requirements, and onsite interviews with UNA staff to determine their goals and expectations of a desktop virtualization solution.We were told that other vendors were focused on meeting the budget and failed to address the unique requirements at hand for UNA.”

Harmon added, “We believe it was HVE’s overall end-to-end solution that encompasses all aspects of VDI, our high-level of customer satisfaction and virtualization competency, that set us apart for this win.  It’s a great partnership with UNA, Howard, Datrium and HVE that will prove to be beneficial for UNA‘s technology education objectives long-term.”

About University of North Alabama
University of North Alabama (UNA), located in Florence, Alabama is listed in “US News and World Report America’s Best Colleges” as an institution that offers a quality education at an affordable price. UNA is one of the oldest higher education institutions in the United States, founded in 1830. UNA offers fully-accredited programs in over 100 different undergraduate or graduate options in four different colleges.  For more information on UNA, visit www.una.edu.

About Howard Technologies
Howard Technology Solutions, a value-added reseller, based out of Ellisville, Mississippi, strives to bring to market cutting-edge, reliable, high-quality technology equipment at affordable prices. Visit www.howardcomputers.com/education for more information on Howard Technology solutions for education.

About Datrium
Datrium is the leader in Open Convergence for private clouds. Datrium converges storage and compute in a radical new way—modeled on public cloud IaaS versus traditional converged infrastructure or hyper-convergence—for vastly simpler performance and predictability. The company is led by the founders and early top architects of Data Domain and VMware. Datrium has been named to Gartner’s Cool Vendors in Storage Technologies, 2016. For more information, visit www.datrium.com and follow @datriumstorage on Twitter.

About HVE
HVE ConneXions, recently acquired by Sphere 3D, is a fast-growing technology provider of next generation converged and hyperconverged infrastructure. Its engineering philosophy is dedicated to creating Manageable, Scalable, Reproducible, and Predictable (MSRP) solutions based on proven virtualization technologies running on high-performance, next generation platforms. For more information and technical specifications on the HVE product line, visit www.hveconnexions.com.

About Sphere 3D
Sphere 3D Corp. (NASDAQ:ANY) delivers containerization, virtualization, and data management solutions via hybrid Cloud, Cloud and on-premises implementations through its global reseller network and professional services organization. Sphere 3D, along with its wholly owned subsidiaries Overland Storage, and Tandberg Data, has a strong portfolio of brands, including HVE ConneXions and UCX ConneXions, dedicated to helping customers achieve their IT goals. For more information, visit www.sphere3d.com. Follow us on Twitter @Sphere3D and @ovltb.

Safe Harbor Statement

This press release contains forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including the market adoption, actual performance and functionality of our products, both on a stand-alone and integrated basis; our inability to comply with the covenants in our credit facilities or to obtain additional debt or equity financing; any increase in our future cash needs; our ability to successfully integrate the UCX and HVE ConneXions business with Sphere 3D’s other businesses;  our ability to regain compliance with the NASDAQ minimum closing bid price requirement between now and July 31, 2017; our inability to take other actions to regain compliance with the NASDAQ minimum closing bid price requirement; our ability to maintain compliance with other NASDAQ Capital Market listing requirements; unforeseen changes in the course of Sphere 3D’s business or the business of its wholly-owned subsidiaries, including, without limitation, Overland Storage and Tandberg Data; the level of success of our collaborations and business partnerships; possible actions by customers, partners, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in Sphere 3D’s periodic reports contained in our Annual Information Form and other filings with Canadian securities regulators (www.sedar.com) and in prior periodic reports filed with the United States Securities and Exchange Commission (www.sec.gov). Sphere 3D undertakes no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Sphere 3D Press Contact:
Tina Brown
Tel: +1 408-283-4731
media.relations@sphere3d.com  

Sphere 3D Investor Contact:
The Blueshirt Group
Mike Bishop
Tel: +1 415-217-4968
mike@blueshirtgroup.com
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