(ARCI) Signs New Utility Contracts in Five States

ARCA Recycling, Inc., a wholly owned subsidiary of Appliance Recycling Centers of America, Inc. (NASDAQ:ARCI), recently signed contracts to manage turnkey appliance recycling programs for multiple utilities in five states: Delaware, Georgia, New Mexico, Maryland and Virginia.

These contracts vary in length and will take effect during the second quarter of 2016, beginning in early April. Some contracts resulted from ARCA Recycling’s work assisting utilities impacted by the suspension of programs managed by a former competitor. In many cases, ARCA Recycling was awarded long-term contracts after helping bridge the short-term service gap.

“We’re pleased to help utilities and their customers who were inconvenienced by disruptions to their programs,” said Edward R. (Jack) Cameron, ARCA Recycling’s President. “Since late last year we have been experiencing strong momentum and interest from utilities.”

As announced earlier this month, ARCA Recycling has been negotiating utility contracts that reflect the recycling industry’s changing landscape, notably the sharp decline in scrap metal prices the past two years.

Cameron concluded, “These new contract wins in five states, combined with our pricing adjustments, give us optimism for financial improvements in fiscal 2016.”

ARCA is a recognized leader in appliance recycling programs, supported by regional processing centers across the U.S. and utilizing state-of-the-art technology that removes environmentally damaging substances and produces byproducts for recycling.

About ARCA
ARCA’s three business components are uniquely positioned in the industry to work together to provide a full array of appliance-related services. ARCA Advanced Processing, LLC employs advanced technology to refine traditional appliance recycling techniques to achieve optimal revenue-generating and environmental benefits. ARCA (www.ARCAInc.com) is also the exclusive North American distributor for UNTHA Recycling Technology (URT), one of the world’s leading manufacturers of technologically advanced refrigerator recycling systems and recycling facilities for electrical household appliances and electronic scrap.

ARCA’s regional centers process appliances at end of life to remove environmentally damaging substances and produce material byproducts for recycling for utilities in the U.S. and Canada. Eighteen company-owned stores under the name ApplianceSmart, Inc.^® (www.ApplianceSmart.com) sell new appliances directly to consumers and provide affordable ENERGY STAR^® options for energy efficiency appliance replacement programs.

This press release contains statements that are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, including statements regarding ARCA’s future success. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made, including the risks associated with general economic conditions, competition in the retail and recycling industries and regulatory risks. Other factors that could cause operating and financial results to differ are described in ARCA’s periodic reports filed with the Securities and Exchange Commission. Other risks may be detailed from time to time in reports to be filed with the SEC.

ARCA Recycling, Inc.
Edward R. (Jack) Cameron, 952-930-9000

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(INO) Monoclonal Antibody, DNA Vaccine Provide 100% Protection in Chikungunya

Ability of unique dMAb and DNA vaccine combination to induce rapid short-term and long-term protection has broad implications for infectious disease prevention and control

PLYMOUTH MEETING, Pa., March 22, 2016  — Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that its novel dMAb antibody and DNA vaccine targeting the chikungunya virus (CHIKV) provided 100% protection against a lethal virus challenge in mice. This breakthrough data was published in the latest issue of The Journal of Infectious Diseases in a paper, “Rapid and long-term immunity elicited by DNA encoded antibody prophylaxis and DNA vaccination against Chikungunya virus,” prepared by Inovio authors and their academic collaborators. While conventional vaccine and marketed monoclonal antibody technologies have shown limited ability to provide an effective solution to CHIKV to date, Inovio’s DNA vaccine and dMAb products show potential, separately and in combination, to offer immediate and long term protection to large populations from CHIKV infection.

Over the years, CHIKV outbreaks have occurred in Africa, Asia, Europe, and throughout the Indian and Pacific Oceans, with local transmission in over 43 countries infecting millions of people. In late 2013, CHIKV was found for the first time in the Americas on islands in the Caribbean and spreading to other parts of the western hemisphere, including the United States. Along with a dramatic increase in cases and geographic spread of CHIKV infection and disease there has been a reported increase in morbidity and mortality, suggesting increased virulence. The concern for even greater potential global outbreaks underscores the need for targeted anti-viral interventions.

Inovio previously published that its SynCon^® DNA vaccine for CHIKV provided durable 100% protection in mice. In this study, a single intramuscular injection of a DNA plasmid encoding a monoclonal antibody targeting CHIKV protected mice from a lethal dose of the virus. The protection expressed by these dMAb antibodies was very rapid, with 100% survival in mice challenged with lethal enhanced CHIKV disease as early as two days after dMAb product administration. In comparison, vaccine-driven protection can take weeks to months to reach peak efficacy levels, but providing better long term protection compared to a dMAb product. Inovio’s study demonstrates that its CHIKV dMAb antibody and DNA vaccine could be used as an ideal combination to provide both rapid short-term as well as long-term protection.

Dr. J. Joseph Kim, Inovio’s President & CEO, said, “This study is significant for two reasons. First, this is our third published study (two previous in HIV and dengue) demonstrating the protective efficacy of our dMAb products. Inovio is rapidly building its dMAb product development program targeting cancer and infectious diseases. Notably, DARPA is providing us over $56 million to specifically develop dMAb products against influenza, antibiotic-resistant bacteria, and Ebola.

“Second, this study demonstrates that Inovio’s dMAb products and DNA vaccines could be a powerful combination to provide robust immediate and long term protection not only for CHIKV but also other infectious diseases. Inovio is the only organization to report such results in any disease by using a DNA-based monoclonal antibody, with published preclinical data in dengue as well, and we now are creating Zika, MERS, and Ebola dMAb products. Our MERS and Ebola vaccines are in phase I clinical studies and we will advance our Zika vaccine to phase I before year end. We also aim to test further combinations.”

Chikungunya does not often result in death, but the symptoms can be severe and disabling and include extreme pain, headache, muscle pain, joint swelling, or rash. The chikungunya virus is carried by the same mosquito species which carry Zika, dengue and West Nile virus (WNV). Inovio previously published robust immunogenicity and challenge protection data for its SynCon^® CHIKV, dengue, and WNV vaccine candidates. Inovio’s chikungunya program builds on its extensive preclinical development experience with various mosquito-borne viruses.

Paper Abstract

Background: Vaccination and passive antibody therapies are critical for controlling infectious diseases. Passive antibody administration has limitations including the necessity for purification and the delivery of multiple injections required for efficacy. Vaccination is associated with a lag phase before generation of immunity. Novel approaches reported here utilize the benefits of both methods for the rapid generation of effective immunity.
Methods: An antibody-based prophylaxis/therapy entailing the electroporation-mediated delivery of synthetic plasmids, encoding biologically active anti-Chikungunya virus envelope mAb (designated dMAb), was designed and evaluated for anti-viral efficacy as well as for the ability to overcome shortcomings inherent with conventional active vaccination by a novel passive immune-based strategy.
Results: One intramuscular injection of the CHIKV-dMAb produced antibodies in vivo more rapidly than active vaccination with a CHIKV-DNA vaccine. This dMAb neutralized diverse CHIKV clinical isolates and protected mice from viral challenge. Combinations of both afford rapid as well as long-lived protection.
Conclusions: We report that a DNA based dMAb strategy induces rapid protection against an emerging viral infection, which can be combined with DNA vaccination providing a uniquely both short term and long-term protection against this emerging infectious disease. These studies have implications for pathogen treatment and control strategies.

About Inovio’s dMAb Technology

Unlike conventional monoclonal technology, which involves constructing protein-based antibodies and manufacturing them in cell culture in a complex and costly process, Inovio’s patent-protected DNA-based monoclonal antibody technology encodes the DNA sequence for a specific monoclonal antibody in a highly optimized plasmid, which would be delivered directly into a subject’s arm using electroporation. Cells in the body would then produce the encoded monoclonal antibody molecules, with intended functional activity including high antigen-binding and neutralization capabilities against the targeted disease. Monoclonal antibodies offer the benefit of inducing a rapid onset of the immune response. The current monoclonal antibody product market is well over $50 billion. Overall, Inovio’s dMAb technology may provide clear advantages over conventional monoclonal antibody technology, including faster development, easier product manufacturing, and more favorable pharmacokinetics.

About Inovio Pharmaceuticals, Inc.

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Roche, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100 and INO-3112, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, our ability to advance our portfolio of immune-oncology products independently, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, our ability to enter into partnerships in conjunction with our research and development programs, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company’s technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2015, and other regulatory filings from time to time. There can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.

CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com

(UPIP) UK High Court Issues Second Judgment In Favor of Unwired Planet

Unwired Planet, Inc. (NASDAQ:UPIP) today announced the UK High Court once again ruled that cell phone manufacturers Samsung and Huawei infringe a valid standards-essential patent (SEP) held by Unwired Planet. The trial on this patent was held in February 2016.

Mr. Justice Colin Birss ruled that Unwired Planet’s patent EP (UK) 1 230 818 is valid and is infringed by wireless telecommunication networks which operate in accordance with the relevant GSM standards, 3GPP TS 45.008 release 5 (dated April 2006), and release 8 (dated September 2011). The court specifically held that the patent is essential to these standards.

This ruling adds to Unwired Planet’s four previous court wins in the UK and Germany in November 2015 and January 2016. Now the company holds two patents confirmed by the UK High Court as valid, infringed and essential to cellular standards and three patents confirmed by the Düsseldorf District Court in Germany as infringed and essential to cellular standards.

“Once again, we are very pleased by this result,” said Unwired Planet CEO Boris Teksler. “The courts continue to provide the much needed clarity that our patents are in fact standards-essential and therefore valuable and important. We have presented our cases in a public and transparent manner, holding ourselves to an objective standard of what it means to negotiate and pay for ‘fair’ and ‘reasonable’ licenses to cellular standards-essential patents.”

“With several favorable judgments in hand, it is no longer a question of whether licensees need take a license, but rather what is the appropriate price for the license,” said Unwired Planet’s general counsel Noah D. Mesel. “We have offered the defendants the opportunity to take a license, arbitrate or continue to litigate the remaining financial dispute, and believe those who continue to avoid substantive negotiations could be deemed recalcitrant licensees. FRAND is a two-way street, and we will continue to hold the industry accountable.”

Unwired Planet will be entitled to reimbursement of a substantial portion of its legal expenses incurred in trying the most recent case. The amount of that reimbursement will be determined at a future hearing. In the UK the practice is for the court to grant – or for the parties to negotiate – reimbursement of a large portion of the reimbursement in an initial payment, with the rest to be decided at a later date. Unwired Planet received approximately $1.9 million in initial reimbursements as a result of prevailing in the first case and paid approximately $3.1 million due to a ruling for the defendants in the second case. The amount of reimbursement in this case is not yet known.

Further, whether the defendants will ask the court for, or be granted, permission to appeal is also unknown at this time.

As previously announced by Unwired Planet, this is the third of five UK patent infringement trials scheduled to continue into the summer of 2016. The next UK trial is scheduled to begin the week of May 2, 2016.

A sixth trial is scheduled for October 2016 in which the court will consider commercial law questions, including the question of how to apply “fair, reasonable and non-discriminatory,” or “FRAND,” licensing principles to the standards-essential patents at issue in this series of cases. The outcome of the commercial case will establish the measure of damages to be awarded.

The claimants in the UK case, Unwired Planet International, Limited and Unwired Planet, LLC, were represented in the case by a team led by Gary Moss, Robert Lundie-Smith, Carissa Kendall-Windless and Jerome Spaargaren of EIP Legal, and by barristers Adrian Speck QC, Mark Chacksfield, and Tom Jones.

About Unwired Planet, Inc.

Unwired Planet, Inc. (NASDAQ:UPIP) is the inventor of the Mobile Internet and a premier intellectual property company focused exclusively on the mobile industry. The company’s patent portfolio of approximately 2,500 issued and pending US and foreign patents, includes technologies that allow mobile devices to connect to the Internet and enable mobile communications. The portfolio spans 2G, 3G, and 4G technologies, as well as cloud-based mobile applications and services. Unwired Planet’s portfolio includes patents related to key mobile technologies, including baseband mobile communications, mobile browsers, mobile advertising, push notification technology, maps and location based services, mobile application stores, social networking, mobile gaming, and mobile search. Unwired Planet is headquartered in Los Altos, California. References in this release to Unwired Planet may be to Unwired Planet, Inc. or its subsidiaries.

(APDNW) DNAnet(R) Discount Program Now Available to 2.7 Million AAA Members

Investor contact:
Debbie Bailey
631-240-8817
Email contact

Media contact:
Susan Forman
Dian Griesel Int’l.
212-825-3210
Email contact


Program contact:
Michael Nizich
631-240-8850
Email contact

(MYOS) Announces Corporate Name Change to MYOS RENS Technology Inc.

(ARQL) & Daiichi Sankyo Continue Phase 3 Cancer Study of Tivantinib

Independent Data Monitoring Committee (DMC) Conducts Interim Assessment

BURLINGTON, Mass. and PARSIPPANY, N.J., March 22, 2016  — ArQule, Inc. (Nasdaq:ARQL) and Daiichi Sankyo today announced that the independent data monitoring committee (DMC) of the METIV-HCC study conducted the planned interim assessment and it was determined the trial will continue to its final analysis.

METIV-HCC is a biomarker-selected, double-blind, placebo-controlled, pivotal phase 3 study evaluating tivantinib (2:1) versus best supportive care in previously systemically-treated patients with MET-high, inoperable HCC, with overall survival as the primary endpoint.

The interim analysis was triggered when at least 60 percent of the target number of events occurred. The final analysis will take place when 100 percent of the target number of events occurs. The METIV-HCC trial completed patient accrual in December 2015 with more than 300 patients with MET-high HCC enrolled.

About Hepatocellular Carcinoma (HCC)

Liver cancer is the sixth most common cancer globally with 782,000 new cases in 2012 and is the second most common cause of cancer-related death with 745,000 deaths in 2012.¹ HCC accounts for about 90 percent of primary liver cancers.² Cirrhosis, chronic hepatitis B and C and smoking are recognized worldwide as factors increasing the risk of HCC.²

About MET and Tivantinib (ARQ 197)

Tivantinib is an oral MET inhibitor, currently in phase 2 and phase 3 clinical trials. In healthy adult cells, MET can be present in normal levels to support natural cellular function, but in cancer cells, MET can be inappropriately and continuously activated. When abnormally activated, MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The activation of certain cell signaling pathways, including MET, has also been associated with the development of resistance to anti-EGFR (epidermal growth factor receptor) antibodies such as cetuximab and panitumumab.

In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in a number of tumors studied. Tivantinib has not yet been approved for any indication in any country.

In December 2008, ArQule and Daiichi Sankyo signed a licensing, co-development and co-commercialization agreement for tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.

In November 2015, ArQule exercised its co-commercialization option for tivantinib in the U.S. A co-commercialization agreement is expected to be finalized in 2016.

About ArQule

ArQule is a biopharmaceutical company engaged in the research and development of targeted therapeutics to treat cancers and rare diseases. Our mission is to discover, develop and commercialize novel small molecule drugs in areas of high unmet need that will dramatically extend and improve the lives of our patients. Our prioritized clinical-stage pipeline consists of four drug candidates, all of which are in targeted, biomarker-defined patient populations, making ArQule a potential early leader in precision medicine. ArQule’s lead product, in phase 3 clinical development, is tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase, for second-line treatment of hepatocellular carcinoma in partnership with Daiichi Sankyo in the West and Kyowa Hakko Kirin in Asia. ArQule’s proprietary pipeline includes: ARQ 092, designed to inhibit the AKT serine/threonine kinase, in phase 1 for multiple oncology indications as well as ultra-rare Proteus syndrome, in partnership with the National Institutes of Health (NIH); ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family, in phase 2 for iCCA and in phase 1b for multiple oncology indications; and ARQ 761, a β-lapachone analog being evaluated as a promoter of NQO1-mediated programmed cancer cell necrosis, in phase 1/2 in multiple oncology indications in partnership with the University of Texas Southwestern Medical Center. ArQule’s current discovery efforts are focused on the identification and development of novel kinase inhibitors, leveraging the Company’s proprietary library of compounds.

About Daiichi Sankyo Oncology

Daiichi Sankyo is focused on the discovery and development of novel oncology agents with the goal of delivering first-in-class and best-in-class treatments that address unmet medical needs. The oncology pipeline of Daiichi Sankyo continues to grow and currently includes both small molecules and monoclonal antibodies with novel targets in both solid and hematological cancers.

Daiichi Sankyo currently has four compounds in phase 3 clinical development, each with a unique mechanism of action, with three focusing on rare or orphan indications. These investigational   compounds include quizartinib, an oral FLT3 inhibitor, for relapsed or refractory FLT3-ITD-positive acute myeloid leukemia (AML); pexidartinib (PLX3397), an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT) being developed with Plexxikon, a member of the Daiichi Sankyo Group; tivantinib, an oral MET inhibitor, for second-line treatment of hepatocellular carcinoma in partnership with ArQule, Inc.; and patritumab, a HER3 monoclonal antibody, for non-small cell lung cancer.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group’s research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com.

This press release contains forward-looking statements regarding the Company’s clinical trials with tivantinib (ARQ 197). These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, tivantinib may not demonstrate promising therapeutic effect or appropriate safety profiles in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise prior to the initiation of planned clinical trials, during clinical trials or in the course of developing, testing or manufacturing that could lead the Company or its partners and collaborators to fail to initiate or to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials for tivantinib is subject to the ability of the Company as well as Daiichi Sankyo, Inc., our development partner for tivantinib, and Kyowa Hakko Kirin, a licensee of tivantinib, to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome technical hurdles and other issues related to the conduct of the trials for which each of them is responsible. There is a risk that these issues may not be successfully resolved. In addition, we and our partners are utilizing companion diagnostic tests to identify MET-high patients in the METIV-HCC, JET-HCC and other trials. We may encounter difficulties in developing and obtaining approval for companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility, or clinical validation. Any delay or failure by our collaborators or us to develop or obtain regulatory approval of the companion diagnostics could delay or prevent approval of our product candidates. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Positive pre-clinical data may not be supported in later stages of development. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future.  Moreover, with respect to partnered programs, even if certain compounds show initial promise, Daiichi Sankyo or Kyowa Hakko Kirin may decide not to license or continue to develop them, as the case may be. In addition, Daiichi Sankyo and Kyowa Hakko Kirin have certain rights to unilaterally terminate their agreements with ArQule. If either company were to do so, the Company might not be able to complete development and commercialization of the applicable licensed products on its own. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.

Contact:
Dawn Schottlandt
Sr. Director, Investor Relations/ Corp. Communications
ArQule, Inc.
+1 781 994 0300
dschottlandt@arqule.com
www.arqule.com

Jennifer Brennan
Daiichi Sankyo, Inc.
+1 973 944 2393 (office)
+1 201 709 9309 (mobile)
jbrennan2@dsi.com

References:
¹ Ferlay J, et al. Int. J. Cancer. 2015;136:E359-E386.
2 Llovet JM, et al. J Hepatol. 2012;56(4):908-43.

(OGES) Announces Start of Operations at New Manufacturing Facility

Company begins shipping orders from first-of-kind facility in US

MELBOURNE, FL /  March 22, 2016 / Oakridge Global Energy Solutions, Inc. (OTCQB: OGES), a leading supplier and manufacturer of lithium-ion batteries for military, civilian and medical applications, has today announced the opening of its $40 million, 70,000-square-foot state-of-the-art manufacturing facility in Palm Bay, Florida. This new facility will immediately begin full commercial production fulfilling orders.

This marks the completion of the Company’s transition–begun in July 2014 and continued through December 2015–from a primarily Research & Development company to a full-fledged battery manufacturing company. With over $40 million invested in research and product development since mid 2013 the opening and operation of the manufacturing facility confirms the commercial viability of Oakridge’s innovations and represents the most significant step forward in the Company’s history.

Recent highlights:

– Forecasted revenues for Q1 2016–the first for the Company–to exceed $250,000
– First customer orders for its Pro Series batteries include numerous golf courses, golf cart retailers and manufacturers of unmanned maritime vehicles
– Recent sale of assets adding $20 million to balance sheet
– $2 million debt payoff–eliminating all current company debt
– Strategic deal with Sojitz Machinery Corporation of Tokyo, Japan to supply and finance raw materials
– Existing pipeline orders of $24 million
– $30 million in recent State and local tax credits
– Significant additional new capital equipment on order

“We started 2016 with full commercial production and customer focus,” said Oakridge CEO, Steve Barber. “We are excited to announce that we have now begun regularly shipping our groundbreaking lithium-ion batteries to the golf cart and motorcycle markets, as well as a number of significant custom and semi-custom markets. This signifies the first time Oakridge is on permanent, routine commercial production footing,” Barber continued. “With the domestic US market representing over 35% of global demand, we are uniquely capable of leveraging our position as the only domestic manufacturer of lithium-ion batteries.”

Conference Call

Oakridge CEO Steve Barber will conduct a conference call to discuss Company updates on Tuesday, March 22, 2016, at 2:00 p.m. EDT. The conference call can be heard by dialing +1-712-775-7035 then referencing the Conference ID 684304#.

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc. leads in the innovation, development, manufacturing and marketing of disruptive energy storage technology for military, civilian and medical uses. The company’s research & development has led to some of the world’s longest-lasting rechargeable power sources currently available, with a battery life up to 3 times greater than its foreign-manufactured counterparts. Located in Palm Bay, Florida, the Company operates the only lithium-ion battery manufacturing facility in the United States. For more information visit: www.oakridgeglobalenergy.com

Forward-Looking Statements Disclaimer:

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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Contact:

Oakridge Global Energy Solutions, Inc.
Name: Suzanna Barber
Phone: (321) 610-7959
Email: IR@oakg.net

(CTRV) Initiates Phase 1/2a Study of CMX157 in HepB

Begins Screening Patients to Assess Safety and Tolerability of Multiple Ascending Doses of CMX157

EDISON, N.J., March 21, 2016  — ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that it has commenced screening healthy volunteers for enrollment into the Phase 1 portion of the Company’s Phase 1/2a multiple ascending dose clinical study of CMX157, ContraVir’s novel, highly potent lipid conjugate of tenofovir for treating hepatitis B virus (HBV) infection.  In order to facilitate enrollment, the study is being conducted by several leading academic medical centers in Thailand, a country in which the incidence of HBV is very high.

The Phase 1 portion of the study will enroll 50 healthy volunteers assigned to one of five sequential, ascending CMX157 dosing cohorts.  Participants will receive two weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157 or placebo; eight per cohort receiving CMX157 and two per cohort receiving placebo. The objectives of the study are to evaluate the safety, tolerability and pharmacokinetic profile of CMX157.  Initiation of each higher dose cohort will proceed following review of the data from the previous cohort. An independent review will be conducted by a data safety and monitoring board (DSMB) between the 25 mg and 50 mg cohorts (the midpoint of the Phase 1 portion of the study).

Following this DSMB review, ContraVir will initiate the Phase 2a portion of the study in parallel with the continuing Phase 1 portion.  The Phase 2a will enroll 60 treatment-naïve patients with chronic HBV infection to compare CMX157 to tenofovir DF (TDF, marketed by Gilead Sciences as Viread^®).  This portion of the study will also consist of a sequential dose escalation, with 10 patients per cohort receiving four weeks of a once-daily dose of either 5, 10, 25, 50 or 100 mg of CMX157, and two patients per cohort receiving 300 mg of TDF, the standard dose of Viread^®.  As in the Phase 1 portion of the study, initiation of each higher dose cohort will follow review of the data from the previous cohort and there will be a DSMB review between the 25 mg and 50 mg CMX157 cohorts.

James Sapirstein, CEO of ContraVir, stated, “Our Phase 1/2a clinical trial of CMX157 will allow ContraVir to continue building the safety database for CMX157, which was shown to be safe and well tolerated in a completed Phase 1 study, as well as evaluate its antiviral activity compared to Viread at clearing HBV infection in our first head-to-head, proof-of-concept clinical study.  The high potency of CMX157 against HBV in vitro suggests its potential to provide better efficacy and improved safety at a lower dose than Viread^®.  We expect the first healthy volunteer to be dosed in the current Phase 1 portion in the coming weeks, followed by initiation of the Phase 2a portion of the study in the second quarter 2016.”

About ContraVir Pharmaceuticals

ContraVir is a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir’s lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development.  In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study.  ContraVir is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir for the Hepatitis B virus.  CMX157’s novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal and bone side effects.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on ContraVir’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. ContraVir does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in ContraVir’s Form 10-K for the year ended June 30, 2015, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Tiberend Strategic Advisors, Inc.
Josh Drumm (investors)
jdrumm@tiberend.com; (212) 375-2664

Claire Sojda (media)
csojda@tiberend.com; (212) 375-2686

(ADXS) Survival Results with Advaxis HER2 Targeted Immunotherapy Published

Data Shows Reduction in Metastatic Disease and Increased Survival

PRINCETON, N.J., March 21, 2016  — Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, today announced that data from a dose-escalation study of ADXS-HER2 in canine osteosarcoma (OSA) was published online March 18, 2016 in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR).

The study by Nicola Mason, PhD, BVetMed, Associate Professor of Medicine at the University of Pennsylvania School of Veterinary Medicine, evaluated the immunogenicity, safety, and impact of attenuated, recombinant Listeria monocytogenes (Lm) transformed with a HER2/Neu fusion protein (ADXS-HER2) on survival in 18 dogs with surgically treated osteosarcoma. The research is part of Advaxis’ ongoing ADXS-HER2 clinical program.

“This is promising and important research both for dogs and humans,” said Dr. Mason. “We were able to use the Advaxis Lm Technology to induce an antigen-specific T-cell response against HER2/Neu which is expressed in both canine and pediatric osteosarcoma, with only low-grade, transient side-effects. I am very excited about these results and the potential this technology holds for treatment of cancer patients of either species.”

In the study, 18 dogs received either 2×10⁸, 5×10⁸, 1×10⁹ or 3.3×10⁹ CFU of ADXS–HER2 post-completion of surgery and adjuvant chemotherapy with 15 dogs showing an induced antigen-specific response within 6 months of immunotherapy administration. Additionally, treatment with ADXS-HER2 reduced the incidence of metastatic disease and prolonged survival relative to a historical control group. The median survival time for the ADXS-HER2 treated dogs was 956 days which was significantly longer than the 423 day median survival time of the historical control group (p=0.014, HR 0.33; 95% CI 0.136-0.802).

Osteosarcoma is the most common primary bone tumor in dogs, with more than 10,000 dogs annually diagnosed. Osteosarcoma is also the most common bone cancer in children and teens. It is the third most common cancer in teens after lymphomas and brain tumors. HER2 is expressed in approximately 40 to 60 percent of pediatric and canine osteosarcomas and in pulmonary metastatic disease, providing strong rationale for HER2 targeted immunotherapy in these cancers.

About ADXS-HER2

ADXS-HER2 is an Lm Technology™ immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 to Aratana Therapeutics, Inc. for animal health therapeutics. Aratana expects to receive a conditional USDA license by the end of 2016 to market and sell ADXS-HER2 for dogs with canine osteosarcoma.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The Lm Technology™, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’ lead Lm Technology™ immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.

For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements

This media statement contains forward-looking statements, including, but not limited to: statements regarding Advaxis’ ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’ proprietary immunotherapies. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’ SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2015, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

CONTACTS:

Company:
Advaxis, Inc.
Greg Mayes, Executive Vice President and COO
mayes@advaxis.com
609.250.7515

Media Contact:
JPA Health Communications
Catherine Brady
Catherine@jpa.com
617.945.9316

(MRKT) & (IHS) to Merge into Critical Information, Analytics and Solutions Juggernaut

IHS (NYSE: IHS) and Markit (NASDAQ: MRKT) today announced the signing of a definitive agreement under which the companies will combine in an all-share merger of equals to create a global leader in critical information, analytics and solutions. Based on the closing prices of IHS and Markit common stock on March 18, 2016, the implied equity value of the transaction is more than $13 billion. The transaction has been unanimously approved by the Board of Directors of each company.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160321005378/en/

Upon completion of the merger, the combined company will be renamed IHS Markit and will be headquartered in London and have certain key operations based in Englewood, Colorado. IHS shareholders will own approximately 57 percent and Markit shareholders will own approximately 43 percent of the combined company on a fully diluted basis. IHS shareholders will receive 3.5566 common shares of IHS Markit for each share of IHS common stock, which based upon the IHS closing price of $110.71 on March 18, 2016, implies a per share price of Markit common shares of $31.13.

IHS Markit will be a leader in critical information, analytics and solutions, and will have non-overlapping customers and products, a strong financial profile and a world-class management team. The company will also deliver next-generation information and analytics products to help customers improve decision making. IHS Markit will have more than 50,000 key customers, including 75 percent of the Fortune Global 500, creating significant cross-selling opportunities across multiple commercial industries and governments.

The combined company’s reported results for fiscal year 2015 include approximately: $3.3 billion in revenue, $1.2 billion in adjusted earnings before interest, taxes depreciation and amortization (EBITDA), and $800 million in free cash flow.

Jerre Stead, IHS Chairman and Chief Executive Officer, said, “This transformational merger brings together two information-rich companies to create a powerful provider of unique business intelligence, data and analytics to a broad and complementary customer base. IHS Markit and its shareholders will benefit from enhanced product innovation to deliver strong returns across economic cycles. Importantly, the two companies are values-based organizations that have a strong cultural fit which focuses on customer satisfaction and colleague success.”

Lance Uggla, Chairman and Chief Executive Officer of Markit, said, “This is an exciting transaction for customers, employees and shareholders of IHS and Markit. Together, we will create a global information powerhouse and a platform for innovation that drives future revenue. At the heart of our shared vision is the opportunity to offer our customers a broader and richer content set through both existing and new products that will support their critical decision making and manage regulatory change. The combination will enhance cash flow and enable stronger returns of capital to shareholders.”

Compelling Strategic and Financial Rationale

• Creates a global information platform across industries with leading positions in energy, financial services and transportation. The combined company will create a platform for innovation and new product development to drive future revenue growth.
• Combination of commercial, operational and structural synergies will result in approximately 20 percent adjusted diluted EPS growth in 2017. The transaction is expected to be immediately accretive to adjusted diluted EPS, with mid-teens accretion in 2018. The new company expects to realize cost synergies of $125 million by year-end 2019. Cost synergies are expected to be driven by integrating corporate functions, reducing technology spend by optimizing IT infrastructure, using centers of excellence in cost-competitive locations, and optimizing real estate and other costs. IHS Markit anticipates an adjusted effective tax rate in the low- to mid-20 percent range.
• Strong balance sheet with financial flexibility and meaningful capital returns. IHS Markit will have a capital policy with a target leverage ratio of 2.0 to 3.0 times. The new company will execute $1 billion of share repurchases in each of 2017 and 2018.
• High recurring revenue generation drives new product investments. IHS Markit anticipates the combination will deliver approximately $100 million of run rate revenue opportunities by fiscal year 2019. IHS Markit’s subscription-based model will generate approximately 85 percent in recurring revenues, providing predictability and stability.
• Complementary and broad customer base leads to the opportunity to cross sell. IHS and Markit have deep, non-overlapping senior relationships across corporate, government, financial services and consumer customers. There will be significant opportunities to offer a more diverse product set to a broader combined customer base.
• World-class management team with track record of driving value creation through successful M&A integration. IHS and Markit each have a proven track record in mergers and acquisitions and integration and have started developing plans to ensure seamless integration of the two companies.

Governance

The combination will be a merger of equals. Mr. Stead will assume the role of Chairman of the Board of Directors and Chief Executive Officer of IHS Markit. Mr. Uggla will be President and a member of the Board of Directors.

Mr. Uggla will assume the role of Chairman of the Board of Directors and Chief Executive Officer of IHS Markit upon Mr. Stead’s retirement on December 31, 2017.

The Board of Directors of the combined company will be comprised of 11 members, with IHS designating six members (including the chairman) and Markit designating five members (including the lead director) from their current boards.

Transaction Details

• Headquarters: IHS Markit will be headquartered in London and have certain key operations based in Englewood, Colorado.
• Closing and Approvals: The transaction is expected to close in the second half of 2016, subject to customary closing conditions, including regulatory approvals and approval by both IHS and Markit shareholders. This will be a fully taxable transaction for IHS U.S. shareholders which will allow the ability to offset capital losses against capital gains.
• Advisors: IHS legal advisor is Weil, Gotshal & Manges LLP and its lead financial advisor is M. Klein and Company and its other financial advisor is Goldman, Sachs & Co. Markit’s legal advisor is Davis Polk & Wardwell LLP and its financial advisor is J.P. Morgan Securities LLC.

Conference Call and Webcast Information

IHS and Markit senior management will conduct a conference call and webcast to discuss this news release today, March 21, 2016 at 8:00 a.m. Eastern Daylight Time as part of the IHS first quarter 2016 earnings call. To hear the live event, visit the IHS or Markit websites at http://investor.ihs.com/ and http://www.markit.com/Company/Investors and log in at least 15 minutes prior to the start of the webcast.

A replay of the webcast will be available approximately two hours after the conclusion of the live event on March 21. To access the webcast recording, visit the same website links above.

A copy of the investor presentation will be made available on both companies’ investor relations websites.

About IHS (www.ihs.com)

IHS (NYSE: IHS) is the leading source of insight, analytics and expertise in critical areas that shape today’s business landscape. Businesses and governments in more than 140 countries around the globe rely on the comprehensive content, expert independent analysis and flexible delivery methods of IHS to make high-impact decisions and develop strategies with speed and confidence. IHS has been in business since 1959 and became a publicly traded company on the New York Stock Exchange in 2005. Headquartered in Englewood, Colorado, USA, IHS is committed to sustainable, profitable growth and employs nearly 9,000 people in 32 countries around the world.

IHS is a registered trademark of IHS Inc. All other company and product names may be trademarks of their respective owners. © 2016 IHS Inc. All rights reserved.

About Markit (www.markit.com)

Markit is a leading global provider of financial information services. We provide products that enhance transparency, reduce risk and improve operational efficiency. Our customers include banks, hedge funds, asset managers, central banks, regulators, auditors, fund administrators and insurance companies. Founded in 2003, we employ over 4,200 people in 13 countries. Markit shares are listed on NASDAQ under the symbol MRKT. For more information, please see www.markit.com.

Important Information About the Transaction and Where to Find It

In connection with the proposed transaction, Markit will file with the Securities and Exchange Commission (“SEC”) a registration statement on Form F-4 that will include a joint proxy statement of IHS and Markit. IHS and Markit may also file other documents with the SEC regarding the proposed transaction. This document is not a substitute for the joint proxy statement/prospectus or registration statement or any other document which IHS or Markit may file with the SEC. INVESTORS AND SECURITY HOLDERS OF IHS AND MARKIT ARE URGED TO READ THE REGISTRATION STATEMENT, THE JOINT PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and security holders may obtain free copies of the registration statement and the joint proxy statement/prospectus (when available) and other documents filed with the SEC by IHS and Markit through the web site maintained by the SEC at www.sec.gov or by contacting the investor relations department of IHS or Markit at the following:

Participants in the Solicitation

IHS, Markit, and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information regarding IHS’s directors and executive officers, and their direct or indirect interests in the transaction, by security holdings or otherwise, is contained in IHS’s Form 10-K for the year ended November 30, 2015, and its proxy statement filed on February 24, 2016, which are filed with the SEC. Information regarding the directors and executive officers of Markit, and their direct or indirect interests in the transaction, by security holdings or otherwise, is contained in Markit’s 20-F for the year ended December 31, 2015, and Markit’s proxy statement filed on Form 6-K on March 27, 2015, which are filed with the SEC. A more complete description will be available in the registration statement on Form F-4 and the joint proxy statement/prospectus.

No Offer or Solicitation

This communication is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote of approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In this context, forward-looking statements often address expected future business and financial performance and financial condition, and often contain words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “see,” “will,” “would,” “target,” similar expressions, and variations or negatives of these words. Forward-looking statements by their nature address matters that are, to different degrees, uncertain, such as statements about the consummation of the proposed transaction and the anticipated benefits thereof. These and other forward-looking statements, including the failure to consummate the proposed transaction or to make or take any filing or other action required to consummate such transaction on a timely matter or at all, are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially from those expressed in any forward-looking statements. Important risk factors that may cause such a difference include, but are not limited to, (i) the completion of the proposed transaction on anticipated terms and timing, including obtaining shareholder or stockholder (as applicable) and regulatory approvals, anticipated tax treatment, unforeseen liabilities, future capital expenditures, revenues, expenses, earnings, synergies, economic performance, indebtedness, financial condition, losses, future prospects, business and management strategies for the management, expansion and growth of the combined company’s operations and other conditions to the completion of the merger, (ii) the ability of IHS and Markit to integrate the business successfully and to achieve anticipated synergies, risks and costs, (iii) potential litigation relating to the proposed transaction that could be instituted against IHS, Markit or their respective directors, (iv) the risk that disruptions from the proposed transaction will harm IHS’s and Markit’s business, including current plans and operations, (v) the ability of IHS or Markit to retain and hire key personnel, (vi) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger, (vii) continued availability of capital and financing and rating agency actions, (viii) legislative, regulatory and economic developments, (ix) potential business uncertainty, including changes to existing business relationships, during the pendency of the merger that could affect IHS’s and/or Markit’s financial performance, (x) certain restrictions during the pendency of the merger that may impact IHS’s or Markit’s ability to pursue certain business opportunities or strategic transactions, and (xi) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism or outbreak of war or hostilities, as well as management’s response to any of the aforementioned factors. These risks, as well as other risks associated with the proposed merger, will be more fully discussed in the joint proxy statement/prospectus that will be included in the registration statement on Form F-4 that will be filed with the SEC in connection with the proposed merger. While the list of factors presented here is, and the list of factors to be presented in the registration statement on Form F-4 are, considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward looking statements. Consequences of material differences in results as compared with those anticipated in the forward-looking statements could include, among other things, business disruption, operational problems, financial loss, legal liability to third parties and similar risks, any of which could have a material adverse effect on IHS’s or Markit’s consolidated financial condition, results of operations, credit rating or liquidity. Neither IHS nor Markit assumes any obligation to publicly provide revisions or updates to any forward looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by securities and other applicable laws.

Note on GAAP and IFRS Reporting Standards

The financial information of IHS included herein was prepared in accordance with U.S. generally accepted accounting principles, or GAAP, while the financial information of Markit was prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board. As a result, the financial information of IHS and Markit may not be directly comparable. In addition, the combined company information has been prepared based on a simple arithmetic sum of the results of IHS and Markit, and was not prepared in accordance with Regulation S-X of the SEC’s rules for pro forma financial information, and you should therefore not place undue reliance on this information

Note on Non-GAAP and Non-IFRS Financial Measures

Non-GAAP and non-IFRS results are presented only as a supplement to IHS’s and Markit’s financial statements based on GAAP and IFRS, respectively. Non-GAAP and non-IFRS financial information is provided to enhance understanding of IHS’s and Markit’s financial performance, but none of these non-GAAP and non-IFRS financial measures are recognized terms under IFRS or GAAP and non-GAAP and non-IFRS measures should not be considered in isolation from, or as a substitute analysis for, IHS’s or Markit’s results of operations as determined in accordance with GAAP and IFRS, respectively. Definitions and reconciliations of non-GAAP and non-IFRS measures to the most directly comparable GAAP or IFRS measures are provided within the schedules attached to this release.

IHS and Markit use non-GAAP and non-IFRS measures in their respective operational and financial decision making, and believe that it is useful to exclude certain items in order to focus on what they regard to be a more reliable indicator of the underlying operating performance of the business. As a result, internal management reports feature non-GAAP and non-IFRS measures which are also used to prepare strategic plans and annual budgets and review management compensation. IHS and Markit also believe that investors may find non-GAAP and non-IFRS financial measures useful for the same reasons, although investors are cautioned that non-GAAP and non-IFRS financial measures are not a substitute for GAAP and IFRS disclosures.

Non-GAAP and non-IFRS measures are frequently used by securities analysts, investors and other interested parties in their evaluation of companies comparable to IHS and Markit, many of which present non-GAAP and non-IFRS measures when reporting their results. Non-GAAP and non-IFRS measures have limitations as an analytical tool. They are not presentations made in accordance with GAAP or IFRS, are not measures of financial condition or liquidity and should not be considered as an alternative to profit or loss for the period determined in accordance with GAAP or IFRS or operating cash flows determined in accordance with GAAP or IFRS. Non-GAAP and non-IFRS measures are not necessarily comparable to similarly titled measures used by other companies. As a result, you should not consider such performance measures in isolation from, or as a substitute analysis for, IHS’s and Markit’s respective results of operations as determined in accordance with GAAP and IFRS, respectively.

This release also includes certain forward-looking non-IFRS or non-GAAP financial measures, such as combined free cash flow for fiscal 2017. We are unable to present a quantitative reconciliation of this forward-looking non-IFRS or non-GAAP financial information because management cannot reliably predict all of the necessary components of such measures. Accordingly, investors are cautioned not to place undue reliance on this information.

Finally, IHS operates under a fiscal year that ends on November 30th of each year, while Markit operates under a fiscal year that ends on December 31st of each year. The combined information in this press release is based on the results of IHS and Markit for each of their respective fiscal years, without any adjustment for the fact that the companies have different fiscal year ends.

Reconciliation to Non-GAAP and Non-IFRS Financial Measures

Adjusted EBITDA for IHS

Adjusted EBITDA is equal to EBITDA, which is defined as net income plus or minus net interest, plus provision for income taxes, depreciation, and amortization, and further excludes primarily non-cash items and other items that we do not consider to be useful in assessing our operating performance (e.g., stock-based compensation expense, restructuring charges, acquisition-related costs, asset impairment charges, gain or loss on sale of assets, gain or loss on debt extinguishment, pension mark-to-market and settlement expense, and income or loss from discontinued operations).

The following table reconciles IHS profit for the period from continuing operations to our Adjusted EBITDA for the periods presented:

Adjusted EBITDA for Markit

Adjusted EBITDA is defined as profit for the period from continuing operations before income taxes, net finance costs, depreciation and amortisation on fixed assets and intangible assets (including acquisition related intangible assets), acquisition related items, exceptional items, share based compensation and related items, net other gains or losses, including Adjusted EBITDA attributable to joint ventures and excluding Adjusted EBITDA attributable to non-controlling interests.

The following table reconciles Markit’s profit for the period from continuing operations to our Adjusted EBITDA for the period presented:

Free Cash Flow for IHS

Free cash flow is defined as net cash provided by operating activities less capital expenditures.

The following table reconciles IHS net cash generated by or used in operating activities to free cash flow.

Free Cash Flow for Markit

Free cash flow is defined as net cash generated by or used in operating activities, less capital expenditure, purchases of property, plant and equipment and intangible assets. The following table reconciles Markit’s net cash generated by or used in operating activities to free cash flow.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160321005378/en/

(PETX) Granted First FDA Approval

Galliprant for the Control of Pain and Inflammation Associated with Osteoarthritis in Dogs

KANSAS CITY, Kan., March 21, 2016  — Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, today announced the Food and Drug Administration’s Center for Veterinary Medicine (CVM) approved GALLIPRANT^® (grapiprant tablets) for the control of pain and inflammation associated with osteoarthritis in dogs. Galliprant is expected to be available to veterinarians in fall 2016.

“As the first approved product in the new piprant class, Galliprant offers veterinarians a needed therapeutic option for the millions of dogs treated each year for osteoarthritis,” explains Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics. “Clinical studies have shown Galliprant offers proven efficacy when compared to placebo and is well-tolerated in dogs.”

Galliprant is a prostaglandin E2 (PGE2) EP4 receptor antagonist (PRA), a non-cyclooxygenase inhibiting, non-steroidal and anti-inflammatory drug. Galliprant blocks PGE2-elicited pain and inflammation.

Important Safety Information
GALLIPRANT® (grapiprant tablets) is for use in dogs only. Do not use in dogs younger than 9 months of age and less than 8 lbs (3.6 kg), dogs used for breeding, or in pregnant or lactating dogs. Adverse reactions in dogs may include mild gastrointestinal effects including, vomiting, diarrhea and decreased appetite. Should not be used in dogs that have a hypersensitivity to grapiprant. Avoid use with COX-inhibiting NSAIDs or corticosteroids.

About Aratana Therapeutics
Aratana Therapeutics is a pet therapeutics company focused on licensing, developing and commercializing innovative pharmaceutical products for dogs and cats. Aratana believes that it can leverage the investment in the human pharmaceutical industry to bring therapeutics to pets in a capital and time efficient manner. The Company has multiple products approved by the Food and Drug Administration’s Center for Veterinary Medicine or licensed by the United States Department of Agriculture. The Company’s pipeline includes therapeutic candidates targeting pain, inappetence, cancer, viral diseases, allergy and other serious, unmet or underserved medical needs.  Aratana believes providing innovative options to veterinarians and pet owners will help manage pets’ medical needs safely and effectively, result in longer and improved quality of life for pets. For more information, please visit www.aratana.com.

Forward-Looking Statements Disclaimer
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, including without limitation statements with respect to our ability to bring several innovative products to market; expectations regarding the timing or scope of commercialization of Galliprant; and the Company’s plans and opportunities, including without limitation offering innovative therapeutics.

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 our 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 following: our history of operating losses and expectations of losses for the foreseeable future; failure to obtain sufficient capital to fund our operations; risks relating to the impairment of intangible assets AT-004, AT-005, AT-007 and AT-011; effects of unstable market and economic conditions; restrictions placed on our operating and financial flexibility by the terms of our credit facility; our substantial dependence on the success of certain of our product candidates; our dependence on novel technologies and compliance with complex regulatory requirements; our inability to obtain regulatory approval for our existing or future product candidates; the lack of commercial success of our current or future product candidates; our inability to realize all of the anticipated benefits of our acquisitions and difficulty integrating acquired businesses; the uncertainty of outcomes of the development of pet therapeutics, which is a lengthy and expensive process; effects of competition; our inability to identify, license, develop and commercialize additional product candidates; our failure to attract and keep senior management and key scientific personnel; our reliance on third-party manufacturers, suppliers, and partners; regulatory restrictions on the marketing of our product candidates; unanticipated difficulties or challenges in the relatively new field of biologics development and manufacturing;  our small commercial organization; difficulties managing the growth of our organization; our significant costs of operating as a public company; risks related to the restatement of our financial statements for the year ended December 31, 2013 and the identification of a material weakness in our internal control over financial reporting; changes in distribution channels for pet therapeutics; consolidation of our customers; limitations on our ability to use our net operating carryforwards; impact of generic products; unanticipated safety or efficacy concerns; our limited patents and patent rights; our failure to comply with our intellectual property license obligations; our infringement of third party patents and challenges to our patents or rights; litigation resulting from the misuse of our confidential information; the uncertainty of the regulatory approval process; our failure to comply with regulatory requirements or obtain foreign regulatory approvals; our failure to report adverse medical events related to our products; legislative or regulatory changes; the volatility of our stock price; our status as an “emerging growth company,” as defined in the JOBS Act; the potential for dilution if we sell shares of our common stock in future financings; the influence of significant stockholders over our business; and effects of anti-takeover provisions in our charter documents and under Delaware law. These and other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 15, 2016, along with our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts
For investor inquires:
Craig Tooman
ctooman@aratana.com
(913) 353-1026

For media inquiries:
Rachel Reiff
rreiff@aratana.com
(913) 353-1050

(HTGM) IVD Development and Supply Agreement with (TMO)

TUCSON, Ariz., March 21, 2016  — HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM), a provider of instruments and reagents for molecular profiling applications, today announced that it has entered into a long-term agreement with Thermo Fisher Scientific under which HTG will have the right to develop a number of in-vitro diagnostic (IVD) tests for use with Thermo Fisher’s next-generation sequencing Ion PGM Dx System.

“We believe the combination of HTG EdgeSeq chemistry and automation platform with the Ion Torrent next-generation sequencing (NGS) platform is a great solution for clinical sequencing workflows in molecular diagnostic laboratories,” stated TJ Johnson, HTG’s CEO.  “We believe this agreement will provide us important options for our planned diagnostic menu.”

About HTG Molecular Diagnostics:

Headquartered in Tucson, Arizona, HTG’s mission is to empower precision medicine at the local level. In 2013 the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry. HTG’s product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing. Additional information is available at www.htgmolecular.com.

Safe Harbor Statement:

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with our business, capabilities of our technology and the benefits of our agreement with Thermo Fisher Scientific (specifically its wholly owned subsidiary Life Technologies Corporation). Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks associated with our ability to successfully develop, manufacture and commercialize diagnostic products; difficulties that may be encountered with combining HTG EdgeSeq chemistry and automation platform with Life Technologies’ sequencing technology; and our ability to successfully improve customer workflows. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Quarterly Report on Form 10-Q for the Quarter ended September 30, 2015. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:

Westwicke Partners
Jamar Ismail
Phone: 415-513-1282
Email: jamar.ismail@westwicke.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: tjjohnson@htgmolecular.com

(OGES) Revenue Guidance Q1 FY2016 First Commercial Revenues in the Company’s History

Oakridge Global Energy Solutions: A New Era In Battery Manufacturing

Oakridge Global Energy Solutions:
A New Era In Battery Manufacturing

Revenue Guidance Q1 FY2016
First Commercial Revenues in the Company’s History

FOR IMMEDIATE RELEASE

Oakridge Corporate Headquarters

March 21, 2016 Palm Bay, Florida – Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is excited, in this revenue guidance announcement for Q1, FY2016, to announce the first ever commerical revenues in the history of the Company.

Oakridge Global Energy Solutions has fully completed its transition, begun in July 1, 2014 and continued through to December 31, 2015, from a Research and Development company to a fully-fledged “Made in USA”, lithium ion battery manufacturing company.  After spending more than $40M USD in research, product development and corporate restructuring since the Company’s major shareholder, Precept Fund Management SPC took control of the company in mid-2013, Oakridge kicked off 2016 in full commercial production ramp up mode.

Completing the restructure of the Company into a fully commercial manufacturing and production enterprise from a zero base has not been without the usual production start-up hurdles, but the Company is now pleased to offer revenue guidance for the first quarter of fiscal year 2016, with forecast revenue for Q1, 2016 of USD$250,000.  Oakridge utilizes the standard calendar year as its fiscal year and the first quarter for Oakridge runs from January 1 to March 31.

While the Q1, 2016 revenues will still see a net loss for that quarter, the fact that the Company is now in full commercial production ramp up to meet customer demand for its carefully thought through product offerings, means that this announcement of the first ever commercial production and revenues by the Company is one of the most significant steps forward in the entire history of OGES since its inception almost 20 years ago, and the Company forecasts to be in a break even financial position by the end of Q2, 2016, as the commercial production ramp up and shipping of product to customers continues from now on.

“We started 2016 as a new year with a full commercial production and customer focus,” said Oakridge Executive Chairman and CEO, Steve Barber. “We are excited to announce that we have now begun routinely shipping our ground breaking lithium ion batteries to the golf car market, the motorcycle market, and a number of very significant custom or semi-custom markets.  These results are nothing short of game-changing for the Company, which has never previously, in all its past history, shipped commercial product of any kind, and the entire team is working together as a highly-focused production machine, with the company now on a permanent, routine commercial production footing.  We are very proud of every member of the excellent team which we have assembled during the preparation for this move towards permanent commercial production.

“We would also like to thank the city of Palm Bay, the Space Coast Economic Development Committee, and the Florida Governor’s office for all their support and encouragement while we completed the difficult transition from research to production.  Gregory Wiener and his team at the Space Coast EDC, Palm Bay Mayor Capote, County Commissioner and Director Economic Development and External Affairs for City of Palm Bay Andy Anderson, and Bayfront Community Redevelopment Agency Administrator James Marshal have all been very encouraging and supportive as we worked through the final issues on the way to this groundbreaking commercial production basis and routine shipping of commercial product to customers.”

“Oakridge currently employs 57 full time and 6 part time employees.  The company is starting up the second shift operation on April 4, 2016 to continue to keep pace with the customer requirements.  The company is also currently finalizing orders for significant additional new capital equipment for manufacturing of its range of lithium batteries to meet customer demand.

“We now are in the gratifying position, based on all the hard planning work we have done, of having a growing range of excellent customers and a solid backlog of orders – we have lots of work remaining to fill those orders and are adding new customers to our list on a weekly basis, but this quarter is truly transformative for the Company.

We will have further exciting news as we move into Q2 as the Company is now on a very significant growth curve in the lithium battery space from this point onwards and we will not be looking back.”

http://www.globenewswire.com/NewsRoom/AttachmentNg/3eef33a1-1bf8-4a91-a589-aa8456ce942a  http://www.globenewswire.com/NewsRoom/AttachmentNg/d444a80c-6b35-4750-9e18-a5dba215feb9   http://www.globenewswire.com/NewsRoom/AttachmentNg/1b868cc3-67f3-4ea7-9041-0c9c42943513

The first shipment of Oakridge Pro Series batteries ready for the customer – a major milestone!

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com

Forward-Looking Statements Disclaimer: 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Contact:
Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net

Investor Inquiries:

Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com

And:

Mike King
Princeton Research
www.princetonresearch.com
702.650.3000
mike@princetonresearch.com

(CLNE) CEO Strongly Supports Senator Inhofe letter to EPA

Clean Energy Fuels Corp., (NASDAQ: CLNE) CEO Andrew J. Littlefair today gave his strong support to Senator Jim Inhofe (R-OK) and the letter he delivered to EPA Administrator Gina McCarthy, detailing how the EPA should incorporate natural gas vehicles into remediation efforts when investigating the Volkswagen diesel emissions issue.

“Senator Inhofe has given the EPA a proven path to significantly remediate the excess diesel emissions caused by Volkswagen. Natural gas vehicles with the new ‘Near Zero’ engine, available on the market today, lower nitrogen oxide emissions by 90 percent or more over their diesel counterparts, and provide a cost-effective real-world answer to this challenge. Only a comprehensive solution including both light duty electric vehicles, and natural gas vehicles in the medium and heavy-duty trucking markets, will be able to correct the damage caused to our environment.”

Natural gas fuel costs less per gallon than gasoline or diesel, depending on local market conditions. The use of natural gas fuel not only reduces operating costs for vehicles, but also reduces greenhouse gas emissions up to 30% in light-duty vehicles and 23% in medium to heavy-duty vehicles. In addition, nearly all natural gas consumed in North America is produced domestically.

About Clean Energy

Clean Energy Fuels Corp. (Nasdaq: CLNE) is the leading provider of natural gas fuel for transportation in North America. We build and operate compressed natural gas (CNG) and liquefied natural gas (LNG) fueling stations; manufacture CNG and LNG equipment and technologies for ourselves and other companies; develop renewable natural gas (RNG) production facilities; and deliver more CNG, LNG and Redeem™ RNG fuel than any other company in the U.S. For more information, visit www.cleanenergyfuels.com.

Clean Energy Media Contact:
Jason A. Johnston
949-437-1411
jason.johnston@cleanenergyfuels.com
or
Clean Energy Investor Contact:
Tony Kritzer
949-437-1403
tkritzer@cleanenergyfuels.com

(ICBK) Announces Merger Approval by Fox River Valley Bancorp

MANITOWOC, Wis., March 18, 2016  — County Bancorp, Inc. (Nasdaq:ICBK) (“County”), the holding company for Investors Community Bank, announced that shareholders of Fox River Valley Bancorp, Inc. (“Fox River”), the holding company for The Business Bank, have approved the merger of Fox River with and into County at a shareholder meeting held on March 17, 2016.  Approval of the merger by County shareholders is not required.

County and Fox River announced they had entered into a merger agreement on November 20, 2015 under which County will acquire Fox River. The merger is subject to customary closing conditions, one of which was approval by Fox River’s shareholders.  The companies also must obtain regulatory approvals.

Upon completion of the transaction, The Business Bank will be merged into Investors Community Bank. The combined institution will have more than $1 billion in assets, and County will be the sixth largest exchange traded bank holding company headquartered in the State of Wisconsin. The merger will add to Investors Community Bank’s business banking platform and expand its reach into contiguous markets with the addition of The Business Bank’s Appleton and Green Bay branches to complement Investors Community bank’s two current branch offices (Manitowoc and Stevens Point) and four loan production offices (Sheboygan, Darlington, Eau Claire and Fond du lac).

Timothy J. Schneider, President of County and CEO of Investors Community Bank, stated, “This merger with Fox River represents a strategic opportunity for us to achieve our objective of expanding our commercial lending and business banking platform. Fox River has built a solid business banking franchise in two distinct markets that are logical geographical fits and areas we have been targeting for expansion.”

“The combination of our organizations also diversifies the mix of our loan portfolio, creating the opportunity to continue to grow both commercial and agricultural lending in the future. We see this transaction as a perfect opportunity to optimally utilize the capital we recently raised, and position us for growth in the short and long-term.”

County and Fox River expect the merger to close in the second quarter of 2016.

County has scheduled its annual shareholder meeting for June 21, 2016, 6 PM at Silver Lake College’s Franciscan Center for Music Education and Performance.

About County Bancorp, Inc.

County Bancorp, Inc., a Wisconsin corporation and registered bank holding company founded in May 1996, and our wholly-owned subsidiary Investors Community Bank, a Wisconsin-chartered bank, are headquartered in Manitowoc, Wisconsin.  The state of Wisconsin is often referred to as “America’s Dairyland,” and one of the niches we have developed is providing financial services to agricultural businesses statewide, with a primary focus on dairy-related lending.  We also serve business and retail customers throughout Wisconsin, with a focus on northeastern and central Wisconsin. Our customers are served from our full-service locations in Manitowoc and Stevens Point, and our loan production offices in Darlington, Eau Claire, Sheboygan and Fond du Lac.

Investor Relations Contact
Timothy J. Schneider
CEO, Investors Community Bank
Phone: (920) 686-5604
Email: tschneider@investorscommunitybank.com

(SHLD) Enters Into Plan Protection Arrangement With PBGC

HOFFMAN ESTATES, Ill., March 18, 2016  — Sears Holdings Corporation (the “Company”) (NASDAQ: SHLD) today announced that it has entered into a five-year pension plan protection and forbearance agreement (the “Definitive Agreement”) with the Pension Benefit Guaranty Corporation (“PBGC”) implementing the terms of the previously announced term sheet, dated as of September 4, 2015, entered into by the Company and PBGC.  Pursuant to the Definitive Agreement, the Company will continue (as it has since at least 2006) to protect, or “ring-fence,” pursuant to customary covenants, the assets of certain special purpose subsidiaries (the “Relevant Subsidiaries”) holding real estate and/or intellectual property assets.

Also under the Definitive Agreement, the Relevant Subsidiaries have granted PBGC a springing lien on the ring-fenced assets, which lien will be triggered only by (a) failure to make required contributions to the Company’s pension plan (the “Plan”), (b) prohibited transfers of ownership interests in the Relevant Subsidiaries, (c) termination events with respect to the Plan, and (d) bankruptcy events with respect to the Company or certain of its material subsidiaries.

The Company will continue to make required contributions to the Plan, the scheduled amounts of which are not affected by the Definitive Agreement.  The Company has consistently managed its business such that it is able to meet its obligations to the Plan despite the historically unprecedented low interest rate environment.  Although the Company believes that no basis exists under ERISA for an involuntary or distress termination of the Plan, PBGC has further agreed to forbear from initiating an involuntary termination of the Plan, except upon the occurrence of specified conditions.

“Concluding this agreement is another positive step forward for the Company; it preserves the Company’s operational and financial flexibility to continue with the transformation and provides meaningful protections to the PBGC,” said Edward S. Lampert, Sears Holdings’ Chairman and Chief Executive Officer.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the Definitive Agreement with the PBGC.  The Company cautions that these forward-looking statements are subject to risks, uncertainties and assumptions, many of which are beyond its control, that may cause actual results to differ materially from those indicated in the forward-looking statements.  Additional information concerning other factors is contained in the Company’s annual report on Form 10-K for the fiscal year ended January 30, 2016 and subsequent filings with the SEC.  The Company intends the forward-looking statements to speak only as of the time made and, except as required by law, do not undertake to update or revise them as more information becomes available.

About Sears Holdings Corporation

Sears Holdings Corporation (NASDAQ: SHLD) is a leading integrated retailer focused on seamlessly connecting the digital and physical shopping experiences to serve our members – wherever, whenever and however they want to shop. Sears Holdings is home to Shop Your Way^®, a social shopping platform offering members rewards for shopping at Sears and Kmart as well as with other retail partners across categories important to them. The Company operates through its subsidiaries, including Sears, Roebuck and Co. and Kmart Corporation, with full-line and specialty retail stores across the United States. For more information, visit www.searsholdings.com.

NEWS MEDIA CONTACT:
Sears Holdings Public Relations
(847) 286-8371

(WDC) Proposed Offerings Of $1.5 Billion Of Senior Secured Notes

IRVINE, Calif., March 18, 2016  — Western Digital Corporation (NASDAQ: WDC) (“Western Digital” or the “Company”) today announced proposed offerings of $1.5 billion aggregate principal amount of senior secured notes due 2023 (the “Secured Notes”) and $4.1 billion aggregate principal amount of senior unsecured notes due 2024 (together with the Secured Notes, the “Notes”) to qualified institutional buyers in the United States pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), and to certain non-United States persons in transactions outside the United States pursuant to Regulation S under the Securities Act.

The timing of pricing and terms of the Notes are subject to market conditions and other factors. Western Digital intends to use the proceeds from the proposed offerings, together with the proceeds from other financing transactions, to finance the previously announced proposed merger with SanDisk Corporation (“SanDisk”), refinance indebtedness of Western Digital and SanDisk and pay related fees and expenses. The Notes are expected to be issued by Western Digital, and guaranteed, jointly and severally on a senior basis, by certain of Western Digital’s subsidiaries.

The Notes and related guarantees have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States or to, or for the benefit of, U.S. persons absent registration under, or an applicable exemption from, the registration requirements of the Securities Act.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other security and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which, or to any persons to whom, such an offer, solicitation or sale would be unlawful. Any offers of the Notes will be made only by means of a private offering memorandum.

About Western Digital

Western Digital Corporation (NASDAQ: WDC) is an industry-leading developer and manufacturer of storage solutions that enable people to create, leverage, experience and preserve data. The company addresses ever-changing market needs by providing a full portfolio of compelling, high-quality storage solutions with effective technology deployment, high efficiency, flexibility and speed. Our products are marketed under the HGST and WD brands to OEMs, distributors, resellers, cloud infrastructure providers and consumers.

Forward-Looking Statements

This document contains forward-looking statements within the meaning of the federal securities laws. These forward-looking statements include, but are not limited to, statements regarding Western Digital’s proposed merger with SanDisk (including financing of the proposed transaction and the benefits, results, effects and timing of a transaction), all statements regarding Western Digital’s (and Western Digital’s and SanDisk’s combined) expected future financial position, results of operations, cash flows, dividends, financing plans, business strategy, budgets, capital expenditures, competitive positions, growth opportunities, plans and objectives of management, and statements containing the use of forward-looking words, such as “may,” “will,” “could,” “would,” “should,” “project,” “believe,” “anticipate,” “expect,” “estimate,” “continue,” “potential,” “plan,” “forecast,” “approximate,” “intend,” “upside,” and the like, or the use of future tense. Statements contained herein concerning the business outlook or future economic performance, anticipated profitability, revenues, expenses, dividends or other financial items, and product or services line growth of Western Digital (and the combined businesses of Western Digital and SanDisk), together with other statements that are not historical facts, are forward-looking statements that are estimates reflecting the best judgment of Western Digital based upon currently available information. Statements concerning current conditions may also be forward-looking if they imply a continuation of current conditions.

Such forward-looking statements are inherently uncertain, and shareholders and other potential investors must recognize that actual results may differ materially from Western Digital’s expectations as a result of a variety of factors, including, without limitation, those discussed below. These forward-looking statements are based upon management’s current expectations and include known and unknown risks, uncertainties and other factors, many of which Western Digital is unable to predict or control, that may cause actual results, performance or plans to differ materially from those expressed or implied by such forward-looking statements, including: volatility in global economic conditions; business conditions and growth in the storage ecosystem; pricing trends and fluctuations in average selling prices; the availability and cost of commodity materials and specialized product components; actions by competitors; unexpected advances in competing technologies; the development and introduction of products based on new technologies and expansion into new data storage markets; and other risks and uncertainties listed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including Western Digital’s most recent Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. You should not place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Western Digital undertakes no obligation to update these forward-looking statements to reflect new information or events.

Risks and uncertainties related to the proposed merger include, but are not limited to, potential adverse reactions or changes to business relationships resulting from the announcement, pendency or completion of the merger, uncertainties as to the timing of the merger, the possibility that the closing conditions to the proposed merger may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant a necessary approval, adverse effects on Western Digital’s stock price resulting from the announcement or completion of the merger, competitive responses to the announcement or completion of the merger, costs and difficulties related to the integration of SanDisk’s businesses and operations with Western Digital’s businesses and operations, the inability to obtain, or delays in obtaining, cost savings and synergies from the merger, uncertainties as to whether the completion of the merger or any transaction will have the accretive effect on Western Digital’s earnings or cash flows that it expects, unexpected costs, liabilities, charges or expenses resulting from the merger, litigation relating to the merger, the inability to retain key personnel, and any changes in general economic and/or industry-specific conditions. In addition to the factors set forth above, other factors that may affect Western Digital’s or SanDisk’s plans, results or stock price are set forth in Western Digital’s and SanDisk’s respective filings with the SEC, including Western Digital’s and SanDisk’s most recent Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and Western Digital’s most recent registration statement on Form S-4 referenced below. Many of these factors are beyond Western Digital’s and SanDisk’s control. Western Digital and SanDisk caution investors that any forward-looking statements made by Western Digital or SanDisk are not guarantees of future performance. Neither Western Digital nor SanDisk intend, or undertake any obligation, to publish revised forward-looking statements to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events.

Important Additional Information and Where to Find It

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities. In connection with the proposed merger, Western Digital filed a registration statement on Form S-4 with the SEC on Dec. 11, 2015, as amended by Amendment No. 1, dated Jan. 27, 2016 and by Amendment No. 2, dated Feb. 5, 2016, which was declared effective by the SEC on Feb. 5, 2016, and Western Digital filed the definitive proxy statement/prospectus on Feb. 5, 2016. Western Digital and SanDisk began to mail the definitive joint proxy statement/prospectus to their respective shareholders on Feb. 5, 2016. This material is not a substitute for the joint proxy statement/prospectus or registration statement or for any other document that Western Digital or SanDisk may file with the SEC and send to Western Digital’s and/or SanDisk’s shareholders in connection with the proposed merger. INVESTORS AND SECURITY HOLDERS OF WESTERN DIGITAL AND SANDISK ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE JOINT PROXY STATEMENT/PROSPECTUS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER. Investors and security holders will be able to obtain copies of the joint proxy statement/prospectus as well as other filings containing information about Western Digital and SanDisk, without charge, at the SEC’s website, http://www.sec.gov.

(DNAI) Appoints Jeffrey H. Cooper and Tran Nguyen to its Board of Directors

– Company opens San Francisco area office –

VANCOUVER, March 18, 2016  – ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases, today announced the appointments of Mr. Jeffrey H. Cooper and Mr. Tran Nguyen to its Board of Directors, effective today. ProNAi also announced that it has opened an office in the San Francisco area, where ProNAi’s development team led by Dr. Barb Klencke is primarily located.

“Mr. Cooper and Mr. Nguyen both have extensive and relevant experiences in guiding the financial functions of public healthcare companies. Each gentleman brings a commitment to the important role of sound financial management in governing an emerging public company,” said Donald Parfet, Chairman of the Board of Directors of ProNAi. Dr. Nick Glover, President and CEO of ProNAi added: “We appreciate the commitments Jeff and Tran are making to advancing ProNAi and look forward to their contributions. We also thank the outgoing directors, Mr. Alvin Vitangcol who is resigning today and Dr. Albert Cha who will be stepping down after the 2016 annual stockholders meeting, for their guidance and support through ProNAi’s growth and successful transition into a public company.”

Mr. Cooper has served as an independent consultant for life science companies since January 2014. Previously, Mr. Cooper served at KaloBios Pharmaceuticals, Inc., a biotechnology company, as a senior advisor from November 2013 until December 2013 and as the Chief Financial Officer from July 2012 until October 2013. Prior to joining KaloBios, Mr. Cooper served in positions of increasing responsibility at BioMarin Pharmaceutical, Inc., a pharmaceutical company, beginning as Vice President, Controller, to his most recent position as Senior Vice President and Chief Financial Officer from 2007 to May 2012. He has also served as Vice President of Finance at Matrix Pharmaceutical, Inc. and held numerous finance-related positions within the health care and pharmaceutical industries, including Corporate Controller at Foundation Health Systems and Director of Business Analysis at Syntex Corporation. He also currently serves on the board of directors of Tobira Therapeutics, Inc. Mr. Cooper received a BA from the University of California, Los Angeles and an MBA from Santa Clara University.

Mr. Nguyen has served as the Chief Financial Officer of Prothena Corporation plc, a biotechnology company, since March 2013. Previously, Mr. Nguyen served at Somaxon Pharmaceuticals, Inc. as Vice President, Chief Financial Officer from 2010 to 2011 and Senior Vice President, Chief Financial Officer from 2011 until its sale in 2013. He has also served as Vice President, Chief Financial Officer at Metabasis Therapeutics, Inc., as a Vice President in the Healthcare Investment Banking group at Citi Global Markets, Inc. and in various capacities as a healthcare investment banker at Lehman Brothers, Inc. Mr. Nguyen received a BA from Claremont McKenna College and an MBA from the Anderson School of Management at the University of California, Los Angeles.

ProNAi’s new San Francisco area office will be located at 1000 Marina Blvd., Suite 450, Brisbane, California 94005. ProNAi maintains its headquarters in Vancouver, Canada and operates a research facility at the Michigan Life Science and Innovation Center, Plymouth, Michigan.

About ProNAi Therapeutics

ProNAi Therapeutics is a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases. ProNAi’s lead product candidate, PNT2258, is based on the company’s pioneering and proprietary DNAi technology platform. PNT2258 is designed to target cancers that overexpress BCL2, an important and validated oncogene known to be dysregulated in many types of cancer. ProNAi is pursuing a multi-faceted clinical development strategy designed to efficiently achieve regulatory approval and maximize the commercial opportunity of PNT2258. ProNAi is actively enrolling patients in “Wolverine”, a Phase 2 trial evaluating PNT2258 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and in “Brighton”, a Phase 2 trial evaluating PNT2258 for the treatment of Richter’s transformation. For more information, please visit www.pronai.com.

Cautionary Note on 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, including, but not limited to, statements regarding ProNAi’s anticipated clinical development and potential business development strategies. 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. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that ProNAi may be unable to successfully develop and commercialize PNT2258 or any other future product candidates, PNT2258 may fail to demonstrate safety and efficacy or may not otherwise produce positive results, ProNAi may experience delays in clinical trials, including due to difficulties enrolling patients, ProNAi’s third-party manufacturers may cause its supply of materials to become limited or interrupted or fail to be of satisfactory quantity or quality, ProNAi’s cash resources may be insufficient to fund its current operating plans and it may be unable to raise additional capital when needed, ProNAi may be unable to obtain and enforce intellectual property protection for its technologies and product candidates and the other factors described under the heading “Risk Factors” set forth in ProNAi’s filings with the Securities and Exchange Commission from time to time, including the Company’s reports filed with the Securities and Exchange Commission. ProNAi undertakes 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.

(RLYP) Announces New Employment Inducement Grants

REDWOOD CITY, Calif., March 17, 2016  — Relypsa, Inc. (Nasdaq:RLYP), a biopharmaceutical company, today announced that on Mar. 15, 2016, the compensation committee of the company’s board of directors granted 4 new employees options to purchase an aggregate of 10,400 shares of the company’s common stock with a per share exercise price of $12.94, the closing trading price on the grant date, and 5,200 restricted stock units.  The stock options and restricted stock units were granted pursuant to the Relypsa, Inc. 2014 Employment Commencement Incentive Plan, which was approved by the company’s board of directors in June 2014 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the company.

About Relypsa, Inc.

Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company’s first medicine, Veltassa^® (patiromer) for oral suspension, was developed based on Relypsa’s rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.

Contact:
Charlotte Arnold
Vice President, Corporate Communications
650.421.9352
IR@relypsa.com

(ESES) Signs Field Management Diagnostics Contract

(MESO) New Tech Shows Potential to Induce Durable Reversal of Type 1 Diabetes

Mesoblast Exclusively Licenses Technology to Enhance Natural Homing Properties of Cells to Sites of Inflammation

NEW YORK and MELBOURNE, Australia, March 17, 2016  — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that the Company has exclusively licensed patented technology developed at Harvard Medical School which can modify mesenchymal lineage adult stem cells (MLCs) to enhance their natural homing properties to sites of excessive inflammation.

MLCs modified using this proprietary cell targeting technology, called ex vivo fucosylation, have successfully induced durable reversal of Type 1 diabetes in a preclinical study. The study results were published in the peer reviewed journal Stem Cells (2015; 33:1523-1531).

The results showed that the cell targeting technology increased by three-fold the numbers of MLCs reaching the inflamed pancreas in autoimmune diabetic mice following intravenous infusion, compared with unmodified MLCs. This resulted in a markedly increased number of mice who reverted to having normal blood glucose, and in durable reversal of Type 1 diabetes.

The study’s lead investigator, Robert Sackstein, MD, PhD, Professor of Medicine at Harvard Medical School, said: “The hypothesis was that inflammation that destroys pancreatic islet cells could be controlled by selectively targeting the pancreas with anti-inflammatory mesenchymal lineage cells. The realization was that this new clinical approach essentially cured mice of Type 1 diabetes.”

Results of a placebo-controlled, randomized, dose-escalating Phase 2 clinical trial of Mesoblast’s product candidate MPC-300-IV in patients with Type 2 diabetes were published in the peer-reviewed journal Diabetes Care (2015; 38:1742-1749). By enhancing targeting of the cells to the inflamed pancreas, the ex vivo fucosylation technology has the potential to further augment the glucose lowering properties of MPC-300-IV, and to extend its use to patients with Type 1 diabetes.

Type 1 diabetes remains a disease with significant morbidity and mortality despite use of insulin and other glucose-lowering agents. The prevalence of Type 1 diabetes continues to increase in people under age 20, making innovative new treatments a major strategic focus for the pharmaceutical industry.

About Ex Vivo Fucosylation Technology
The new technology licensed by Mesoblast involves a patented process that results in ex vivo fucosylation (exofucosylation) of, or addition of fucose to, cell surface receptors on stem cells. This process modifies these receptors by adding carbohydrate or sugar sequences which allows them to be recognized by and bound to their ligands present on endothelial cells lining blood vessels in inflamed tissues. The licensed technology is supported by United States Patent Office granted patents including US7,875,585, US8,084,236, US8,728,810 and US8,852,935. Latest patent expiry dates are through 2027, with potential for further patent term adjustments and/or extensions.

About Diabetes
Type 1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables glucose to enter cells and thereby allows people to get energy from food. It occurs when the body’s immune system attacks and destroys the insulin-producing cells in the islets of the pancreas, called beta cells. Each year the disease contributes to the death of more than 230,000 individuals in the United States. The American Diabetes Association estimates that the total annual cost associated with diagnosed diabetes, which affects nearly 26 million people in the United States alone, is currently $174 billion.

About Mesoblast
Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions.

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

For further information, please contact:
Julie Meldrum
Global Head of Corporate Communications
Mesoblast Limited
T: +61 3 9639 6036
E: julie.meldrum@mesoblast.com

(CBAY) Positive Results, Pilot Phase 2 of MBX-8025 in HoFH

NEWARK, Calif., March 17, 2016  — CymaBay Therapeutics, Inc. (NASDAQ:CBAY) today announced top line results from its pilot Phase 2 clinical study of MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH).  The study demonstrated that the range of responses to MBX-8025 was broad, but that MBX-8025 provided a clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) for a subset of patients. This is the first study to demonstrate the potential utility of a PPARδ agonist in HoFH.

“This pilot study provides the first evidence that MBX-8025 has potential utility for the treatment of HoFH, an ultra-orphan disease in which patients remain in need of additional LDL-C lowering,” said Harold Van Wart, Chief Executive Officer of CymaBay.

Study objectives and design

This was an open label, dose escalation study of 12 weeks duration conducted at five centers in Europe and Canada. Thirteen patients were enrolled, all of whom had genetically confirmed HoFH, including two subjects who had functionally negative mutations in their LDL receptor (LDL-R) genes. All of the subjects were taking ezetimibe and were on maximum statin therapy. None of the study participants received lomitapide, mipomersen or a PCSK9 inhibitor. Eight patients were undergoing concomitant apheresis on a weekly or biweekly schedule. Despite being on maximal conventional therapy, the average baseline LDL-C was 368 mg/dL. Subjects received once daily treatment with 50 mg of MBX-8025 for 4 weeks, after which the dose was escalated to 100 and 200 mg in successive 4-week periods. The goals of the study were to evaluate the effect on LDL-C as well as a spectrum of other lipid-related parameters, including PCSK9 levels, and to collect safety information.

Results

Two per-protocol analyses were performed on 12 subjects. The data for one subject was excluded because of multiple missed apheresis visits throughout the study which caused marked fluctuations in LDL-C levels. A responder analysis was carried out which reflects the largest decrease in LDL-C observed during treatment for each subject. Three subjects (25%) exhibited a greater than or equal to 30% decrease. Five subjects (42%) had a greater than or equal to 20% decrease, including one patient that was receptor negative, and 7 (58%) had a greater than or equal to 15% decrease. Five subjects (42%) had a less than 15% decrease. The average maximum decrease in the study was 19%. Because of the high baseline LDL-C levels in these individuals, these percentage decreases correspond to significant absolute decreases in LDL-C (mean decrease of 109 mg/dL for the subjects with a greater than or equal to 15% decrease). Although reductions in LDL-C tended to be greater at the higher doses, no clear dose response was observed.

In a second analysis, the mean change in LDL-C for each subject was calculated by averaging values across all doses and dosing periods while on treatment. The overall mean change for all 12 subjects was a decrease of 10%. Eight of these subjects had a mean decrease in LDL-C of 16%, including 3 with a greater than 20% decrease. This included one patient that was receptor negative. This was offset by 4 patients who showed a mean increase of 4%.

Mean PCSK9 was elevated at baseline (544 +/- 133 ng/mL), as anticipated for patients with HoFH, and increased significantly during treatment by a mean of 43%. During the study, decreases in the mean levels of alkaline phosphatase (30%), gamma glutamyl transferase (27%) and total bilirubin (22%), which are markers of cholestasis, were also observed. There were three SAEs, none drug related, and three treatment discontinuations for AEs possibly related to MBX-8025.

“Despite the availability of new therapies, including PCSK9 inhibitors, most patients with HoFH remain far from their LDL-C targets and there is still a need for new therapeutic approaches,” said Dr. Evan Stein, Director Emeritus of the Medpace Metabolic and Atherosclerosis Research Center. “The finding that MBX-8025 lowers LDL-C, despite the unexpected increase in PCSK9, suggests that studies on top of PCSK9 inhibitors may be warranted to further assess the potential of MBX-8025 treatment in patients with HoFH.”

“We are encouraged by the meaningful response in LDL-C reductions observed in a number of patients in the study and plan to evaluate the feasibility of conducting a pilot study of MBX-8025 in combination with a PCSK9 inhibitor,” said Harold Van Wart.

Conference Call

CymaBay will host a conference call today, March 17, 2016, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of this pilot Phase 2 study. The call can be accessed by dialing 877-407-0784 (domestic) and 201-689-8560 (international) five minutes prior to the start of the call. A slide presentation to be used in connection with the call entitled “MBX-8025 Pilot Study in HoFH Top Line Data” has been posted on CymaBay’s website and can be accessed at http://ir.cymabay.com/presentations. A live audio webcast of the call can be accessed under the Investors section of CymaBay’s website at http://ir.cymabay.com/events and will be available for 14 days following the call.

About MBX-8025

MBX-8025 is a potent and selective agonist of PPARδ, a nuclear receptor important for lipid transport, storage and metabolism in liver and muscle. MBX-8025 has shown favorable effects on lipid and other metabolic parameters in a Phase 2 study in patients with mixed dyslipidemia. Treatment effects observed include lowering of LDL-C with selective depletion of pro-atherogenic dense LDL particles, decreases in triglycerides and increases in HDL, as well as decreases in hsCRP, a biomarker of cardiovascular and systemic inflammation. MBX-8025 also decreased levels of alkaline phosphatase and gamma glutamyl transferase, which are markers of cholestasis. The U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for MBX-8025 as a treatment for HoFH and Fredrickson types I and V hyperlipoproteinemia. CymaBay has also initiated a Phase 2 study of MBX-8025 in patients with primary biliary cholangitis.

About HoFH

HoFH is a rare, life-threatening, autosomal genetic disease characterized by loss-of-function mutations in both alleles of the LDL receptor (LDL-R) gene. The accompanying loss of LDL-R activity results in marked elevations in the plasma levels of LDL cholesterol (LDL-C), causing premature cardiovascular disease that often presents during the first decades of life and which can result in myocardial infarction, ischemic stroke and premature death.

About CymaBay

CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company developing therapies to treat metabolic diseases with high unmet medical need, including serious rare and orphan disorders. MBX-8025 is a potent, selective, orally active PPARδ agonist. A Phase 2 study of MBX-8025 in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile. CymaBay has completed a pilot Phase 2 study of MBX-8025 in patients with homozygous familial hypercholesterolemia and has an ongoing Phase 2 study in patients with primary biliary cholangitis. Arhalofenate, CymaBay’s other product candidate, is a potential Urate-Lowering Anti-Flare Therapy that has completed five Phase 2 studies in gout patients. Arhalofenate has been found to reduce painful flares in joints while at the same time promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia.

Cautionary Statements

The statements in this press release, including those statements regarding the structure and conduct of clinical trials, future performance of CymaBay’s product candidates, the potential of MBX-8025 to treat homozygous familial hypercholesterolemia or primary biliary cholangitis, the therapeutic and commercial potential of MBX-8025, and any of the targeted indications for the potential future development or commercialization of MBX-8025 are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of MBX-8025 could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay’s product development activities, including clinical trials of MBX-8025; effects observed in trials to date which may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay’s product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay’s filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

For additional information about CymaBay visit www.cymabay.com.

Contacts:

Sujal Shah
CymaBay Therapeutics, Inc.
(510) 293-8800
sshah@cymabay.com

or

Hans Vitzthum
LifeSci Advisors, LLC
212-915-2568
Hans@LifeSciAdvisors.com

(VTAE) What Do the Clinical Results Mean for This Biotech

FORT WASHINGTON, PA / March 17, 2016 / Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company, yesterday announced positive top-line results from its Phase 2a proof-of-concept clinical trial of VTP-43742 in psoriatic patients. VTP-43742 is Vitae’s wholly owned, first-in-class, orally active RORγt inhibitor with the potential to transform the treatment of multiple autoimmune disorders, including psoriasis, through the potent inhibition of IL-17 secretion from Th17 cells and blocking the action of IL-23.

Get the full report here: http://broadstreetalerts.com/vitae-pharma-vtae/.

About Broad Street Alerts

We make the connection between sophisticated investors and high quality micro and small cap companies. An issuer of reports that provide a straightforward assessment of the profiled company. They include stocks traded in the NYSE, NASDAQ, and OTCBB exchanges.

Safe Harbor Statement

This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to anticipated revenues, expenses, earnings, operating cash flows, the outlook for markets and the demand for products. Forward-looking statements are no guarantees of future performance and are inherently subject to uncertainties and other factors which could cause actual results to differ materially from the forward-looking statements. Such statements are based upon, among other things, assumptions made by, and information currently available to, management, including management’s own knowledge and assessment of the Company’s industry and competition. The Company refers interested persons to its most recent Annual Report on Form 10-K and its other SEC filings for a description of additional uncertainties and factors, which may affect forward-looking statements. The company assumes no duty to update its forward-looking statements.

Compliance Procedure

Content is researched, written and reviewed on a best-effort basis by a 3rd party analyst. However, we are only human and may make mistakes. If you notice any errors or omissions, please notify us. This report was prepared for informational purposes only. A full disclaimer can be found by viewing the full analyst report. We do not hold any positions and have not been compensated in any form for this press release and coinciding reports. For more information and services provided beyond this press release please use contact information provided below.

Contact: editor@broadstreetalerts.com

(OGES) Q1 Investor Press Conference Call

Oakridge Global Energy Solutions Investor Conference Call – Tuesday March 22

Oakridge Global Energy Solutions, Inc.
Info@oakg.net

Oakridge Global Energy Solutions:
A New Era In Battery Manufacturing

Q1 Investor Press Conference

 Oakridge Executive Chairman Steve Barber

Palm Bay, Florida, March 17, 2016  — Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is pleased to announce an upcoming Investors Conference Call on Tuesday March 22, 2016 at 2:00PM EST (11:00AM PST).

The Call-In Number is +1 712-775-7035

The Access Code for the Press Conference is 684304#

Oakridge Global Energy Solutions’ Executive Chairman and CEO Steve Barber will be expanding upon the Company’s recent press announcements. Steve will share more details of the recently announced Sojitz agreement and its significance and its enormous significance for the Company. He will explain what the new Sojitz agreement means to Oakridge and its shareholders and how the company will benefit. In addition, he will give information and updates on revenue forecasts for Q1, on the electric interstate truck project; the Daytona Beach Bike Fest and the release of the Liberty Series motorcycle battery, as well as updates on shipments of Company’s Pro Series golf car batteries.

“We started 2016 in full manufacturing mode and have continued to ramp up as the first quarter has progressed,” said Oakridge Executive Chairman and CEO, Steve Barber. “We are currently shipping production product in the golf car and low speed electric vehicle markets; the radio controlled unmanned vehicles and drones markets; the motorcycle starter motor markets; and a number of very special custom applications.  It is a very exciting time at Oakridge!”

Oakridge has partnered with Benchmark Advisory (www.bmarkadvisory.com) Investor Relations team, SmallCapNetwork (www.smallcapnetwork.com),Princeton Research (www.princetonresearch.com ), and New-To-The-Street (www.newtothestreet.com) public relations firms.

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com

Forward-Looking Statements Disclaimer: 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Contact:
Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net

Investor Inquiries:

Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com

And:

Mike King
Princeton Research
www.princetonresearch.com
702.650.3000
mike@princetonresearch.com

(CBAK) Signs Purchase Contract with Sysgration

DALIAN, China, March 16, 2016  –China BAK Battery, Inc. (NASDAQ: CBAK) (“China BAK”, or the “Company”), the world’s leading lithium battery manufacturer and electric energy solution provider, announced today that it has reached a purchase contract with Sysgration (Zhenjiang) Co., Ltd. (“Sysgration”), a leading manufacturer of automotive electronics products and smart home devices. Under the contract, Sysgration undertakes to purchase from China BAK for no less than 6 million units of 26650 high power lithium batteries in calendar year 2016, for use in Sysgration’s battery packs supplied to electric vehicles manufacturers. China BAK will supply the batteries through its wholly-owned operating subsidiary, Dalian BAK Power Battery Co., Ltd., a specialized high power battery provider in Dalian.

The 26650 high power lithium battery is one of China BAK’s most popular self-developed products. It has outstanding performance, such as high capacity, stability and safety, which has been used in various kinds of electric vehicles and gets good reputations from electric vehicle customers. China BAK has been dedicated to the research and development and commercial use of high power lithium batteries for many years. Apart from the 26650 lithium battery, China BAK has also developed several other lithium batteries, such as 26700HC, 26700HE, 26650HC and 26650HE, etc.

“We are glad to enter into the large-quantity purchase contract with Sysgration, which reflects the market recognition of our high power battery products for use in electric vehicles. It encourages us to continue investment on the R&D of high power lithium batteries and expansion of high power lithium battery production lines. It is a good beginning for year 2016, and with the surging electric vehicle markets, we believe we will enter into more lithium battery agreements with customers,” commented Mr. Yunfei Li, the CEO of China BAK.

About Sysgration (Zhenjiang) Co., Ltd

Sysgration (Zhenjiang) Co., Ltd., established in 2013, is one of the China mainland subsidiaries of Sysgration Ltd, which was founded in Taiwan in 1977 as a supplier of automotive electronics products, peripheral, and power solution. In 1996, Sysgration Ltd. is listed in the Taiwan Stock Exchange (TWSE) under the symbol of 5309. In its first 20 years, Sysgration has supported global partners as their trusted commitment OEM development and manufacturing. Sysgration has built its reputation by supporting advanced OEM peripheral for branded company. In the recent decade, Sysgration has positioned as manufacturer of IoV(Internet of Vehicle) automotive electronics products and IoT(Internet of Things) smart home devices.

About China BAK Battery, Inc.

China BAK Battery, Inc. (NASDAQ: CBAK) is a global leading high-tech enterprise engaged in the R&D, manufacture, and sales of high power lithium batteries. The application of its products and solutions covers such areas as electric vehicles, light electric vehicles, electric tools, transportation and energy storage. As the first lithium battery company in China to get listed in the U.S. in January 2005, CBAK possesses China’s first production base specially engaged in power battery, and has its wholly-owned subsidiary – Dalian BAK Power Battery Co., Ltd., and a large-scale R&D and production base in Dalian. For more information, please visit www.cbak.com.cn.

Safe Harbor Statement

This press release contains forward-looking statements, which are subject to change. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All “forward-looking statements” relating to the business of China BAK Battery, Inc. and its subsidiary companies, which can be identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties which could cause actual results to differ. These factors include but are not limited to: the ability of the Company to meet its contract obligations; the uncertain market for the Company’s high-power lithium and other battery cells; business, macroeconomic, technological, regulatory, or other factors affecting the profitability of battery cells designed for electric vehicles; and risks related to China BAK’s business and risks related to operating in China. Please refer to China BAK’s Annual Report on Form 10-K for the fiscal year ended September 30, 2015, as well as other SEC reports that have been filed since the date of such annual report, for specific details on risk factors. Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. China BAK’s actual results could differ materially from those contained in the forward-looking statements. China BAK undertakes no obligation to revise or update its forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.

(QIWI) Announces Extraordinary General Meeting of Shareholders

NICOSIA, Cyprus, March 16, 2016  — QIWI plc (Nasdaq:QIWI) (MOEX:QIWI) (“QIWI” or the “Company”) today announced that it will hold an extraordinary general meeting of shareholders (“EGM”) on Friday April 29, 2016, at 10:00a.m. (Cyprus Time) at QIWI’s office located at 12 Kennedy Avenue, Kennedy Business Centre, 2nd floor, 1087, Nicosia, Cyprus.

Only shareholders of record at the close of business on March 10, 2016 are entitled to receive notice, attend and vote at the EGM and any adjourned meeting thereof. Holders of the Company’s American Depositary Shares (“ADS”) who wish to exercise their voting rights for the underlying shares must act through the depositary of the Company’s ADS program, The Bank of New York Mellon. Shareholders are cordially invited to attend the EGM.

At the EGM, the following item will be submitted for shareholders’ approval:

1. approval of amendments to the Articles of Association.

Further details on the agenda and procedural matters related to the EGM will be made available to the Company’s shareholders by the Company and the Company’s ADS holders through The Bank of New York Mellon.

About QIWI plc.

QIWI is a leading provider of next generation payment services in Russia and the CIS. It has an integrated proprietary network that enables payment services across physical, online and mobile channels. It has deployed over 16.1 million virtual wallets, over 172,000 kiosks and terminals, and enabled merchants to accept over RUB 70 billion cash and electronic payments monthly from over 67 million consumers using its network at least once a month. QIWI’s consumers can use cash, stored value and other electronic payment methods to order and pay for goods and services across physical or online environments interchangeably.

Contact

Yakov Barinskiy 
Head of M&A and Investor Relations 
+357.25028091
ir@qiwi.com

Varvara Kiseleva
Investor Relations
+357.25028091
ir@qiwi.com

(VTAE) Proof-of-Concept, First-in-Class RORyt Psoriasis Inhibitor

VTP-43742 demonstrated statistically significant efficacy and was well tolerated             

Company plans to move VTP-43742 forward into 16-week study

Conference call to discuss results at 5:00 p.m. ET, March 16, 2016

James Krueger, M.D., Ph.D., Head of the Laboratory for Investigative Dermatology at Rockefeller University, to join call

FORT WASHINGTON, Pa., March 16, 2016  — Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, today announced positive top-line results from its Phase 2a proof-of-concept clinical trial of VTP-43742 in psoriatic patients. VTP-43742 is Vitae’s wholly owned, first-in-class, orally active RORγt inhibitor with the potential to transform the treatment of multiple autoimmune disorders, including psoriasis, through the potent inhibition of IL-17 secretion from Th17 cells and blocking the action of IL-23.

This randomized, double-blind, placebo-controlled trial assessed the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of VTP-43742 in patients with moderate to severe psoriasis over a four-week period. VTP-43742 demonstrated a clear signal of efficacy, with patients in the 350 mg dose group achieving a 24 percent reduction in the Psoriasis Area Severity Index (PASI) score relative to placebo. In the 700 mg dose group, patients achieved a 30 percent placebo-adjusted PASI score reduction. For both doses, we observed clinically relevant and statistically significant reductions (p<0.015) relative to baseline values.

Between weeks zero and two, there was a modest onset of PASI reduction, and for the last weeks of the study, and particularly between weeks three and four, there was an acceleration of the rate of reduction in PASI score in both the 350 mg and 700 mg dose groups, suggesting the potential for greater reductions in PASI scores with longer duration of treatment. While full efficacy in psoriasis is not generally seen until at least 12 weeks of continuous therapy, the PASI score reductions observed for VTP-43742 at four weeks, and the acceleration of rate of PASI reduction between weeks three and four, are consistent with the potential to achieve greater oral efficacy in the treatment of psoriasis. VTP-43742 was shown to be generally well tolerated at all dose levels tested, with no serious adverse events reported. No drug-related electrocardiogram (ECG) abnormalities were observed. In the 700 mg dose group, reversible transaminase elevations were observed in four patients. Pharmacokinetics were consistent with once-a-day dosing.

“We believe these data validate RORγt as an exciting and novel therapeutic target for the treatment of psoriasis and other autoimmune disorders,” said Jeff Hatfield, President and Chief Executive Officer of Vitae. “While the autoimmune market is currently dominated by injectable antibody therapy, we believe VTP-43742 has the potential to expand utilization of oral therapy in a variety of autoimmune disorders, such as psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease with an effective, safe and well tolerated, once-a-day agent.”

In biomarker assays measuring plasma IL-17A and IL-17F, the 350 mg and 700 mg doses of VTP-43742 were shown to decrease both plasma cytokines by up to 75 percent, and these decreases were statistically significant (p<0.02), consistent with the change in PASI score from baseline.

“We plan to advance VTP-43742 into a larger scale 16 week trial in the second half of 2016 to continue to assess the efficacy, safety and tolerability of our first-in-class drug candidate,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae. “We look forward to presenting the complete results of this Phase 2a trial at future medical meetings.”

Conference Call

Vitae’s management team will host a conference call and webcast today, March 16, 2016 at 5:00 p.m. ET to discuss these top-line proof-of-concept results and next steps for VTP-43742. Presentation slides will be available via the webcast link. A question and answer session with the Vitae management team and James Krueger, M.D., Ph.D., Head of the Laboratory for Investigative Dermatology at Rockefeller University, will follow Vitae’s remarks. To participate on the live call, please dial 844-423-9893 (domestic) or +1-716-247-5808 (international), and provide the conference ID 73110204, approximately five to 10 minutes ahead of the start of the call.

A live audio webcast of the call will be available via the “Investor Relations” page of the Vitae website, www.vitaepharma.com. Please log on through Vitae’s website approximately 10 minutes prior to the scheduled start time. A replay of the webcast will be archived on Vitae’s website for 90 days following the call.

About Psoriasis

Psoriasis, which affects approximately 7.5 million people in the U.S., is a chronic autoimmune disorder affecting the skin. It causes cells to rapidly multiply and build up on the skin’s surface, resulting in red scaly patches that are often itchy and painful. Increased activity of a class of lymphocytes called Th17 cells, and the subsequent excess production of pro-inflammatory cytokines, including IL-17A and IL-17F, by those cells are critical parts of the pathophysiology of psoriasis. RORγt is a nuclear hormone receptor that is essential for the formation and function of Th17 cells. Vitae believes that inhibiting RORγt activity in immune cells will be beneficial for the treatment of psoriasis, and potentially other autoimmune disorders.

About VTP-43742

VTP-43742 is Vitae’s wholly owned, orally active RORγt inhibitor with the potential to transform the treatment of multiple autoimmune disorders, including psoriasis, through the potent inhibition of IL-17 secretion from Th17 cells and blocking the action of IL-23. In preclinical studies, VTP-43742 has been observed to inhibit RORγt activity, is highly selective versus other ROR isotypes, and has a human oral dosing schedule of once-a-day. The efficacy potential of VTP-43742 was demonstrated in an animal model of multiple sclerosis where it was observed to be superior in direct comparison to an IL-17A monoclonal antibody. In September 2015 and November 2015, Vitae announced top-line results from a Phase 1 single ascending dose clinical trial and a Phase 1 multiple ascending dose trail, respectively, in healthy human volunteers. In March 2016, Vitae announced top-line results from a Phase 2a randomized, double-blind, placebo-controlled clinical trial in patients with moderate to severe psoriasis.

About Vitae Pharmaceuticals

Vitae Pharmaceuticals is a clinical-stage biotechnology company developing first-in-class product candidates with potential to transform the treatment paradigm for patients with significant unmet medical needs. Initial indications being pursued include psoriasis, other autoimmune disorders, and atopic dermatitis. Vitae’s lead clinical assets include VTP-43742, an oral RORgt inhibitor currently being studied in patients with moderate to severe psoriasis, and VTP-38543, an LXRβ selective agonist being studied in patients with mild to moderate atopic dermatitis.

For additional information, please visit the company’s website at www.vitaepharma.com.

Safe Harbor Statement

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements related to pharmaceutical development of VTP-43742 and future prospects. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations. These risks include, but are not limited to those that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vitae’s Annual Report on Form 10-K for the year ended December 31, 2015, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.

In addition to the risks described above and in Vitae’s other filings with the SEC, other unknown or unpredictable factors also could affect Vitae’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vitae undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

INVESTORS:
Vitae Pharmaceuticals, Inc.
Richard S. Morris, CPA
Chief Financial Officer
(215) 461-2000
rmorris@vitaerx.com

Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com

MEDIA:
6 Degrees PR
Tony Plohoros 
(908) 591-2839
tplohoros@6degreespr.com

(ORPN) Positive Final Results from HOPEMD Phase 2

NEW HAVEN, Conn., March 16, 2016  — BioBlast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company, announced positive results from its HOPEMD Phase 2 six-month open-label clinical study in patients with oculopharyngeal muscular dystrophy (OPMD), a rare progressive muscle-wasting disease characterized by swallowing difficulties (dysphagia), leading to the risk of aspiration of food into the lungs, weight loss, and generalized progressive muscle weakness.  These results will be presented today by Prof. Zohar Argov M.D., Senior Medical Advisor to BioBlast, during the plenary session at Myology 2016, a leading muscle conference in Lyon, France, and, in April, 2016, during two general sessions at the American Academy of Neurology in Vancouver, Canada.  See information in this release regarding these scientific symposia.

The primary objective of the HOPEMD Phase 2 open-label study was to assess the safety and tolerability of trehalose 90mg/mL IV solution.  Although not powered for efficacy, secondary endpoints were included to explore if trehalose 90mg/mL IV solution could improve or prevent worsening of OPMD disease markers. The study enrolled 25 patients with clinical dysphagia and muscle weakness at two centers in Canada and Israel. All patients have now completed 24 weeks of weekly treatment with trehalose 90mg/mL IV solution and these are the data presented today.

Trehalose 90mg/mL IV solution was observed to be safe and well-tolerated with no drug-related serious adverse events.  Improvements versus baseline were observed in multiple secondary efficacy endpoints related to dysphagia and muscle strength and function as further discussed below.

“The final study results are consistent with the interim data previously reported and continue to look promising,” stated Bernard Brais, MD, M.Phil., PhD, FRCP(C), Professor, Departments of Neurology and Neurosurgery and Human Genetics, Faculty of Medicine, McGill University, Co-director Rare Neurological Diseases Group at the Montreal Neurological Institute, and Principal Investigator in the study.  “With no pharmacotherapy available to treat OPMD, trehalose 90mg/mL IV solution may be a step forward in caring for these patients.  We look forward to confirming these results in the planned Phase 2b double blind placebo controlled study.”

HOPEMD Phase 2 Open-Label Clinical Study – Results

Safety and Tolerability – Trehalose 90mg/mL IV solution was observed to be safe and well tolerated with no drug-related serious adverse events reported. There were no significant changes in lab safety data including chemistry, hematology, and ECG tests.  There was one death due to aspiration pneumonia that was not considered drug-related but instead, related to the underlying disease. No patients chose to discontinue the study for reasons related to safety or side effects.

Dysphagia Tests (swallowing difficulties) – The dysphagia endpoints were the timed cold water drinking test (80mL) for all sites, the nectar (80mL) and honey (80mL) timed drinking tests at the Canadian site and the Penetration Aspiration Score as measured by video fluoroscopy (VFS-PAS), a radiographic technique to determine the severity of swallowing difficulties and risk of aspiration.   A patient reported swallowing quality of life questionnaire (SWAL-QOL) specifically developed for patients suffering from swallowing problems was employed to assess the degree to which patients felt that their swallowing capability improved with treatment.

There was a mean reduction in time to complete the cold water drinking test of 31.8% versus baseline (n=23). In the nectar and honey timed drinking tests, time to complete was reduced by 43.8% and 46.6% respectively (n=11).  Out of the 11 patients in Canada whose scores were evaluated in the per protocol analysis of the VFS-PAS, six patients improved (54.5%), two patients showed stabilization (18.2%), and three patients deteriorated (27.2%).  As previously reported, due to deviations from protocol and deficient radiological procedures, the VFS-PAS tests from the Israel cohort were excluded from the final analysis. With respect to the SWAL-QOL questionnaire, there was a 12.7% (n=24) improvement versus baseline with the mean total symptom severity score increasing from 43.2 to 48.7.

Muscle Strength Tests – As measured quantitatively by a digital hand-held dynamometer, there was a mean increase in lower body muscle strength compared to baseline in knee extension of 15.0% (n=22) and foot dorsiflexion of 22.4% (n=22). Hip flexion did not materially change (1.3% deterioration, n=21).  For the upper extremity strength tests, arm (bicep) flexion increased on average 17.9% (n=22), and shoulder abduction by 11.4% (n=22).

Muscle Function Tests – The 30 second arm-lift test showed a 16.0% increase in the number of completed tasks (n=20) at 24 weeks of treatment versus baseline while the 30 second sit-to-stand test showed a 16.6% increase (n=21).  The standard 4-stair climbing test did not materially change (1.5% deterioration, n=21).

“We are encouraged by the safety profile observed and the early efficacy signals noted in this relatively small study of OPMD patients.  With this knowledge, we can proceed to develop our double blind placebo controlled study to confirm these results and progress our clinical program to registration,” stated Warren Wasiewski M.D., Chief Medical Officer of BioBlast.

“These positive safety and efficacy signals give us confidence to continue the development of trehalose 90mg/mL IV solution in OPMD,” said Colin Foster, President and Chief Executive Officer of BioBlast.  “We look forward to the possibility of significantly helping patients afflicted with this disease.”

HOPEMD Phase 2 Open-Label Clinical Study – Design

The HOPEMD study was designed as an initial proof-of-concept open-label clinical study in 74 patients for 24 weeks, following which it was intended that all patients would be randomized into a treatment arm or non-treatment control group, and followed for an additional 12 months in a separate continuation study. The study was conducted at two centers – Montreal Neurological Institute at McGill University in Montreal, Canada, and Hadassah-Hebrew University Medical Center in Jerusalem, Israel.  The primary objective was to assess the safety and tolerability of trehalose 90mg/mL IV solution in patients suffering from OPMD. Although not powered for efficacy, secondary endpoints were included to explore if trehalose 90mg/mL IV solution could improve or prevent worsening of OPMD disease markers, notably those related to dysphagia (difficulty in swallowing) and upper and lower muscle weakness. As previously reported, based on the interim efficacy signals seen in the first 25 patients enrolled in Canada (11 patients) and Israel (14 patients), recruitment was terminated in mid-2015.   Now that all patients have received at least 24 weeks of treatment, BioBlast intends to discontinue the ongoing continuation study and offer patients access to the drug in an expanded access program.

Scientific Symposia Information

Final results of the HOPEMD Phase 2 open-label study will be presented at two upcoming scientific neurology conferences:

About Trehalose 90mg/mL IV Solution

Trehalose 90mg/mL IV solution is a chemical chaperone that protects against pathological processes in cells.  It has been shown to reduce pathological aggregation of proteins within cells in several diseases associated with abnormal cellular-protein aggregation as well as acting as an autophagy enhancer.  Trehalose 90mg/mL IV solution has been documented as demonstrating significant promise in preclinical animal models of OPMD and other PolyA/PolyQ diseases.

In OPMD, trehalose 90mg/mL IV solution is being developed to prevent the aggregation of the pathological protein (PABPN1) in muscle cells, the hallmark of the disease, by stabilizing the protein, reducing the formation of protein aggregations, and promoting their clearance from cells through autophagy, thus preventing muscle cell death.

About Oculopharyngeal Muscular Dystrophy (OPMD)

OPMD is an inherited myopathy characterized by dysphagia (difficulty in swallowing), eyelid drooping (ptosis), the loss of muscle strength, and weakness in multiple muscles of the body.  Symptoms generally appear in mid-life and get worse over time.  As the dysphagia becomes more severe, patients become malnourished, lose significant weight, and may suffer from repeated incidents of aspiration pneumonia.  Aspiration pneumonia and severe emaciation may result in death.  The disease is caused by a genetic mutation responsible for the creation of a mutant protein (PABPN1) with an expanded polyalanine domain that aggregates within patient muscle cells.  There is currently no approved pharmacologic treatment for OPMD.

About BioBlast Pharma Ltd.

BioBlast Pharma is a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases. The Company has a portfolio of product candidates with the potential to address unmet medical needs for incurable diseases. The BioBlast platforms are based on a deep understanding of disease-causing biological processes, and potentially offer solutions for several diseases that share the same biological pathology.  BioBlast was founded in 2012 and is traded on the NASDAQ under the symbol “ORPN”. For more information, please visit the Company’s website, www.bioblast-pharma.com, the content of which is not incorporated herein by reference.

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 and other Federal securities laws. For example, the Company is using forward looking statements when it discusses, confirming results of its HOPEMD clinical study in a future clinical study, if such study is commenced and concluded at all, and the design thereof, future efforts and plans to develop trehalose 90mg/mL IV solution, potential uses of its product candidates for various indications, building a diverse portfolio of product candidates with the potential to address unmet medical needs for incurable diseases, or that BioBlast’s platforms potentially offer solutions for several diseases that share the same biological pathology. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions or those historic results referred to in this press release would not be interpreted differently in light of additional research and clinical and preclinical trial results. Because such statements deal with future events and are based on BioBlast Pharma Ltd.’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of BioBlast Pharma could differ materially from those described in or implied by the statements in this press release, including those discussed under the heading “Risk Factors” in BioBlast Pharma’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 31, 2015, and in any subsequent filings with the SEC. Except as otherwise required by law, BioBlast Pharma disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

INVESTOR CONTACT: 
Matthew P. Duffy
Managing Director
LifeSci Advisors, LLC
Telephone:  +1 212.915.0685 direct