Archive for June, 2017

$SNCR Confirms Receipt of Indication of Interest from Siris Capital Group

Synchronoss Technologies, Inc. (NASDAQ: SNCR) (the “Company”), the leader in mobile cloud innovation for mobile carriers, enterprises, retailers and OEMs around the world, today confirmed that it has received a non-binding indication of interest from Siris Capital Group, LLC (“Siris”) to acquire all of the outstanding shares of the Company’s common stock for $18.00 per share in cash, subject to certain conditions.

The Company’s Board of Directors, consistent with its fiduciary duties, will carefully review and consider Siris’s indication of interest and pursue the course of action that it believes is in the best interests of the Company and its shareholders. The Board cautions the Company’s shareholders and others considering trading in its securities that the Board just received the non-binding indication of interest from Siris and no decisions have been made with respect to the Company’s response to the indication of interest. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that this or any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to this or any other transaction, except as required under applicable law. The Company’s shareholders do not need to take any action at this time.

About Synchronoss Technologies, Inc.

Synchronoss (NASDAQ: SNCR) is an innovative software company that helps both service providers and enterprises realize and execute their goals for mobile transformation now. Our simple, powerful and flexible solutions serve millions of mobile subscribers and a large portion of the Fortune 500 worldwide today. For more information, visit us at www.synchronoss.com.

Forward-looking Statements

Certain statements contained in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions and other statements contained in this report that are not historical facts and statements identified by words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “outlook” or words of similar meanings. These statements are based on the Company’s current expectations and beliefs and various assumptions. There can be no assurance that the Company will realize these expectations or that these beliefs will prove correct. Numerous factors, many of which are beyond the Company’s control, could cause actual results to differ materially from those expressed as forward-looking statements. These factors include, but are not limited to, risks associated with the ongoing and uncompleted nature of the Company’s accounting review; fluctuations in the Company’s financial and operating results; integration of the Company’s Intralinks business and execution of the Company’s cost reduction plan; the Company’s substantial level of debt and related obligations, including interest payments, covenants and restrictions; uncertainty regarding increased business and renewals from existing customers; the dependence of the Company’s Intralinks business on the volume of financial and strategic business transactions; disruptions to the implementation of the Company’s strategic priorities and business plan caused by changes in the Company’s senior management team; customer renewal rates and attrition; customer concentration; the Company’s ability to maintain the security and integrity of the Company’s systems; foreign currency exchange rates; the financial and other impact of previous and future acquisitions; competition in the enterprise and mobile solutions markets; the Company’s ability to retain and motivate employees; technological developments; litigation and disputes and the costs related thereto; unanticipated changes in the Company’s effective tax rate; uncertainties surrounding domestic and global economic conditions; other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, which is on file with the SEC and available on the SEC’s website at www.sec.gov. Additional factors may be described in those sections of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, to be filed with the SEC as soon as practicable. The Company does not undertake any obligation to update any forward-looking statements contained in this report as a result of new information, future events or otherwise.

 

Investor and Media:
Synchronoss Technologies, Inc.
Daniel Ives, +1 908-524-1047
daniel.ives@synchronoss.com
or
Joele Frank, Wilkinson Brimmer Katcher
Matthew Sherman / Amy Feng / Greg Klassen
+1 212-355-4449

Friday, June 23rd, 2017 Uncategorized Comments Off on $SNCR Confirms Receipt of Indication of Interest from Siris Capital Group

$PTLA FDA Approves Bevyxxa

Company to hold conference call/webcast today at 4:30 p.m. ET

SOUTH SAN FRANCISCO, Calif., June 23, 2017 — Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced the U.S. Food and Drug Administration (FDA) has approved Bevyxxa (betrixaban), the first and only anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

Bevyxxa, an oral, once-daily Factor Xa inhibitor, was granted a Fast Track designation and approved by the FDA under Priority Review, which is a status given to drugs that may offer significant improvements in treatment or provide a treatment where no adequate therapy exists. Bevyxxa has been approved based on data from Portola’s pivotal Phase 3 APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide.

“Bevyxxa represents a major advance for the field of thrombosis. It is the first therapy to demonstrate a reduction in the incidence of VTE in these high-risk patients without a significant increase in major bleeding,” said C. Michael Gibson, M.D., APEX Executive Committee Member and Steering Committee Chairman, professor, Harvard Medical School and chairman of the PERFUSE Study Group. “With this approval, we are finally able to help protect these patients from this often fatal, yet preventable condition.”

“Our goal as a company is to bring to market important medicines for the benefit of patients,” said Bill Lis, Chief Executive Officer of Portola. Today’s approval is the ultimate milestone for Portola. We are grateful to the patients who participated in our trials, the FDA, our academic collaborators and investigators, and, importantly, our dedicated employees who have worked tirelessly to achieve this goal.”

Acutely ill medical patients are those hospitalized for serious medical conditions, including heart failure, stroke, infection and pulmonary disease. Because of their underlying disorder and immobilization, they are at increased risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE) blood clots.

In the G7 countries, an estimated 24 million acutely ill medical patients are hospitalized each year and are at risk of VTE, either while in the hospital or following discharge. More than one million VTE events and 150,000 VTE-related deaths occur annually in acutely ill medical patients in the G7 countries, despite the standard use of injectable enoxaparin and other heparins in the hospital. More than half of VTE events occur after patients are discharged from the hospital. No other anticoagulant, including enoxaparin or any of the marketed oral Factor Xa inhibitors, is approved for in-hospital and extended-duration VTE prophylaxis in acutely ill medical patients.

The APEX study evaluated oral betrixaban for 35 to 42 days compared with injectable enoxaparin for 6 to 14 days followed by placebo in assessing the prevention of VTE in high-risk acutely ill medical patients. As detailed in the prescribing information, Bevyxxa efficacy was measured in the modified Intent-to-Treat (mITT) analysis, which includes 7,441 patients assessed by a composite outcome score comprising either the occurrence of asymptomatic proximal DVT or symptomatic DVT, non-fatal PE or VTE-related death. Bevyxxa reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo (4.4 percent vs. 6.0 percent; relative risk 0.75, 95 percent CI: 0.61, 0.91) with no significant increase in major bleeding (0.67 percent vs. 0.57 percent). The most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4 percent and 1.2 percent for betrixaban and enoxaparin, respectively.

Results from the APEX Study have been peer-reviewed and published in The New England Journal of Medicine, Circulation and the American Heart Journal.1

“For the first time, physicians will have a therapy to help reduce VTE in acutely ill medical patients during their transition from hospital to home, which may ultimately help reduce morbidity,” said Alexander (Ander) T. Cohen, M.B.B.S., M.Sc., M.D., FRACP, APEX Co-Principal Investigator and Co-Chairman of the APEX Executive Committee and Consultant Physician at Guy’s and St Thomas’ NHS Foundation.

The timeline on which Portola expects to launch Bevyxxa is between August and November 2017. During this period, Portola will complete salesforce hiring and training, drug manufacturing validation and inventory buildup. For more information regarding the availability of Bevyxxa, please go to www.bevyxxa.com.

In the EU, the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) is reviewing the Marketing Authorization Application for betrixaban under its standard review period.

CONFERENCE CALL
The Portola management team will host a conference call and webcast today, June 23, 2017, to provide more information about Bevyxxa. The live call can be accessed by phone by calling (844) 452-6828 (domestic) or (765) 507-2588 (international) and specifying conference call ID 45842131. The webcast can be accessed live on the Investor Relations section of the Company’s website at http://investors.portola.com. It will be archived for 30 days following the call.

BEVYXXA INDICATION AND USE
Bevyxxa (betrixaban) is indicated for the prophylaxis of VTE in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.

The recommended dose of Bevyxxa is an initial single dose of 160 mg starting on day 1, followed by 80 mg once daily taken for 35 to 42 days at the same time each day with food.

Limitations of Use
The safety and effectiveness of Bevyxxa have not been established in patients with prosthetic heart valves because this population has not been studied.

IMPORTANT SAFETY INFORMATION FOR BEVYXXA

Warning: Spinal / Epidural Hematoma
Epidural or spinal hematomas may occur in patients treated with betrixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. The risk of these events may be increased by the use of in-dwelling epidural catheters or the concomitant use of medical products affecting hemostasis. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.  

CONTRAINDICATIONS
Active pathological bleeding; severe hypersensitivity reaction to Bevyxxa.

WARNINGS AND PRECAUTIONS

Risk of Bleeding
Bevyxxa increases the risk of bleeding and can cause serious and potentially fatal bleeding; concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs).

Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue Bevyxxa in patients with active pathological bleeding. There is no established way to reverse the anticoagulant effect of betrixaban, which can be expected to persist for at least 72 hours after the last dose.

Spinal/Epidural Anesthesia or Puncture
When neuraxial anesthesia (spinal/epidural anesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. An epidural catheter should not be removed earlier than 72 hours after the last administration of Bevyxxa. The next Bevyxxa dose is not to be administered earlier than 5 hours after the removal of the catheter. If traumatic puncture occurs, delay the administration of Bevyxxa for 7 hours. Monitor patients frequently for signs and symptoms of neurological impairment (e.g., numbness or weakness of the legs, bowel or bladder dysfunction).  If neurological compromise is noted, urgent diagnosis and treatment is necessary.

Use in Patients with Severe Renal Impairment
Patients with severe renal impairment (CrCl ≥ 15 to < 30 mL/min computed by Cockcroft-Gault) taking Bevyxxa may have an increased risk of bleeding events. Reduce dose of Bevyxxa, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients.

Use in Patients on Concomitant P-glycoprotein (P-gp) Inhibitors
Patients on concomitant P-gp inhibitors with Bevyxxa may have an increased risk of bleeding. Reduce dose of Bevyxxa, monitor patients closely, and promptly evaluate any signs or symptoms of blood loss in these patients. Avoid use of Bevyxxa in patients with severe renal impairment receiving concomitant P‑gp inhibitors.

ADVERSE REACTIONS
The most common adverse reactions with Bevyxxa were related to bleeding (> 5 percent).

USE IN SPECIFIC POPULATIONS
Hepatic Impairment
Bevyxxa has not been evaluated in patients with hepatic impairment, because these patients may have intrinsic coagulation abnormalities. Bevyxxa is not recommended in patients with hepatic impairment.

For additional information and full Prescribing Information for Bevyxxa, please visit http://www.bevyxxa.com

About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first commercial product, Bevyxxa (betrixaban), an oral, once-daily Factor Xa inhibitor anticoagulant, is approved in the United States. Portola is advancing the clinical development of two other compounds, including AndexXa® (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor, and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola’s partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma.

Forward-looking Statements
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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding results that may be achieved after treatment with Bevyxxa and the timing of the availability of Bevyxxa to physicians and their patients in the United States. Risks that contribute to the uncertain nature of the forward-looking statements include our manufacturers’ ability to manufacture Bevyxxa on a commercial scale or scale to increased production and our overall ability to effectively commercialize Bevyxxa. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q, which was filed on May 8, 2017. All forward-looking statements contained in this press release speak only as of the date on which they were made. 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.

1 Cohen, Alexander T., Robert A. Harrington, Samuel Z. Goldhaber, Russell D. Hull, Brian L. Wiens, Alex Gold, Adrian F. Hernandez, and C. Michael Gibson. “Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients.” New England Journal of Medicine 375.6 (2016)

 

Investor Contact: 
Ana Kapor
Portola Pharmaceuticals
ir@portola.com

Media Contact:
Julie Normart
W2O Group
jnormart@purecommunications.com
Friday, June 23rd, 2017 Uncategorized Comments Off on $PTLA FDA Approves Bevyxxa

$AVEO Announces Positive CHMP Opinion for Tivozanib

AVEO Oncology (NASDAQ:AVEO) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has recommended FOTIVDA™ (tivozanib) for approval as a treatment for patients with advanced renal cell carcinoma (RCC). The CHMP’s recommendation is now referred to the European Commission (EC). The EC, which typically adheres to the recommendation of the CHMP, but is not obligated to do so, is expected to make its final decision in about 67 days. If approved by the EC, marketing authorization for tivozanib will be granted in all 28 countries of the European Union, Norway, Iceland and Liechtenstein. EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, is the European licensee for tivozanib.

“A positive opinion from the CHMP is a critical step in our goal of obtaining regulatory approval of tivozanib as a treatment for RCC,” said Michael Bailey, president and chief executive officer of AVEO. “Tivozanib’s unique tolerability profile together with the longest progression free survival reported in a Phase 3 first line RCC study, have the potential to fill an unmet patient need for better tolerated treatment in this disease. Further, we believe this tolerability profile could enable immune-oncology combinations such as those in the Phase 1/2 TiNivo study, which combines the PD-1 inhibitor Opdivo® (nivolumab) with tivozanib and recently advanced to Phase 2.”

Mr. Bailey concluded: “If the European Commission grants marketing approval for tivozanib, it would trigger a $4 million research and development reimbursement payment from EUSA, and AVEO will also be eligible for up to $12 million in additional milestones from EUSA based on member state reimbursement and regulatory approvals. These payments would add significant resources to our balance sheet as we work toward the anticipated readout of our U.S. pivotal trial in third-line RCC, the TIVO-3 trial, in the first quarter of 2018.”

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $394 million in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. Thirty percent of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee in Europe. In the United States, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

RCC is the most common form of kidney cancer,i which accounts for an estimated 49,000 deaths in Europe each year.ii It is expected to be one of the fastest increasing cancers over the next ten years.iii Tyrosine Kinase Inhibitor (TKI) vascular endothelial growth factor (VEGF) inhibitors are the standard of care treatment for advanced RCC in Europe, however, patients on current treatments can often experience significant side effects.iv,v If approved for use in the European Union, tivozanib would be indicated for use in adult patients with advanced RCC who are VEGFR and mTOR pathway inhibitor-naïve and are either untreated or who have failed prior therapy with interferon-alpha (IFN-α) or interleukin-2 (IL-2).

About Tivozanib

Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer, cachexia (wasting syndrome) and Pulmonary Arterial Hypertension (PAH). For more information, please visit the company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “could,” “should,” “would,” “will,” “seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about the potential for tivozanib to be approved by the EC as a treatment for RCC; the potential benefits of tivozanib both as a stand-alone agent and in combination with other therapies; AVEO’s expectations regarding the receipt of payments under its agreement with EUSA and the potential for such payments, if received, to favorably impact its financial condition; AVEO’s and its collaborators’ future discovery, development and commercialization plans and efforts, including without limitation with respect to tivozanib, ficlatuzumab and AVEO’s other programs and platforms; and AVEO’s strategy, prospects, plans and objectives. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to AVEO’s ability to enter into and maintain its third party collaboration agreements, and its ability, and the ability of its licensees and other partners, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates, including without limitation risks relating to the ability of EUSA to successfully obtain approval of tivozanib from the EC. AVEO faces other risks relating to its business as well, including risks relating to its ability to successfully enroll and complete clinical trials, including the TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s Annual Report on Form 10-K for the year ended December 31, 2016, its quarterly reports on Form 10-Q and in other filings that AVEO may make with the SEC in the future. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

i Cancer Research UK. Kidney Cancer, Types and Grades. Available at: http://www.cancerresearchuk.org/about-cancer/kidney-cancer/stages-types-grades/types-grades. Last accessed May 2017.
ii Cancer Research UK. Kidney Cancer Statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/mortality#heading-Five. Last accessed May 2017.
iii Cancer Research UK. Kidney cancer rates are increasing, so what’s fuelling the surge? Available at: http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/. Last accessed May 2017.
iv Motzer R.J; Nosov D et al. Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial. Journal of Clinical Oncology. Volume 31. 2013: 30:3791
v Wong MKK, Mohamed AF et al. Selecting renal cell carcinoma therapy: Ranking of patient perspective on toxicities. J Clin Oncol 30: 303s, 2012 (suppl; abstr 4608)

 

AVEO:
Argot Partners
David Pitts, 212-600-1902
aveo@argotpartners.com

Friday, June 23rd, 2017 Uncategorized Comments Off on $AVEO Announces Positive CHMP Opinion for Tivozanib

Net Element, Inc. (NASDAQ: NETE)

Net Element is a global technology company delivering a range of electronic payment solutions that enable merchants of all sizes to process transactions through various integrated platforms. Ranked as one of South Florida Business Journal’s Top 25 Fastest-Growing Technology Companies, Net Element bases its products around a set of innovations that enables it to compete in select, competitive market segments.

Florida-based Net Element owns and operates a global mobile payments and transactional processing provider TOT Group, Inc., parent company to: Unified Payments, which was recognized by Inc. Magazine as the #1 Fastest Growing Company in America in 2012; Aptito, a next generation cloud-based point-of-sale (“POS”) payments platform; Restoactive, a seamless digital add-ons for legacy POS systems; Digital Provider, a leading provider of SMS messaging and mobile billing solutions; and Payonline, a fully integrated processor agnostic electronic commerce platform.

Revenues are primarily driven by transaction fees, and the company continues to see increased acceptance and adoption of mobile and online payments. In 2015 alone, the company processed 51.2 million bankcard transactions in North America. The same year, Net Element processed 90 million transactions in CIS and the Russian Federation in 2015, as well as 19.5 million mobile transactions in emerging markets.

Net Element’s domestic strategy is to grow transactional revenue through the innovation of SME productivity services such as its signature POS solution, Aptito. The broader North America market strategy is to expand distribution while exploring new products, services, and value-added offerings.

Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions. With a growing physical presence in Central Asia, Net Element has a portfolio of international clients that includes Nokia, Samsonite, Papa Johns, Microsoft, Norton by Symantec, Alawar Entertainment and many others.

Laying the groundwork for sustained growth, Net Element continues to focus on improvement and investments in its core technology and new product offerings. The company allocates its resources, along with the extensive experience of its management team, to foster growth in payment processing and the worldwide mobile payment industry, which is forecast to surpass $1 trillion in 2019.

Investment Considerations

  • Positioned to benefit from adoption of mobile and online payments worldwide
  • Proven ability to execute an established growth strategy in the U.S. and abroad
  • Innovative solutions and disruptive product offerings create sustainable growth potential


Friday, June 23rd, 2017 Uncategorized Comments Off on Net Element, Inc. (NASDAQ: NETE)

Moxian, Inc. (NASDAQ: MOXC)

Moxian, Inc. is a leading offline-to-online (O2O) integrated platform operator committed to providing high-quality social marketing and promotion platforms to end-users and merchants interested in promoting their business via social media.

The company’s proprietary Social Customer Relationship Management (Social CRM) system is at the foundation of its multi-channel social commerce platform, and was developed to foster enhanced consumer/merchant interaction. By integrating social media, entertainment and business intelligence, Moxian’s system is especially suitable for SMB, integrated entertainment, commerce, shopping and customer loyalty rewards providers.

Through its big data analytics system, Moxian has a clear picture of its targeted customers, their demands and payment data. End-user data generated from the platform helps Moxian’s merchant clients achieve optimal marketing strategies.

Leveraging these assets, Moxian has two primary core products: Moxian User App and Moxian Business App.

The structure of Moxian User APP is for consumers to collect loyalty points from issuing merchants. Virtual currency (MO-Coin and MO-Points) is earned playing games and can be redeemed globally with any merchant in Moxian eco-system. This model drives registered consumers to Moxian and its merchant clients while providing merchants the opportunity to advertise, run marketing campaigns, and learn about their customers through Moxian’s platform. The app also provides consumers a set of social networking features to set up a personalized multimedia profile and participate in traditional social media functions such as friend search, interest groups, topics and content sharing.

Moxian Business App is similar in that it is also based on loyalty points, but is geared toward the merchant. This app provides merchants the tool kits to covert customers into members and fans, issue loyalty points and redeem rewards, and respond to customer inquiries via instant messaging. Users can also conduct targeted marketing campaigns to members of Moxian community in the form of ads and games, list products online, as well as process orders. Moxian Business also provides business reports and analytical insights for merchants.

Led by a management team with more than a century of combined experience, Moxian’s technologies supplement the company’s broader corporate mission to create and lead a personalized social network platform best suited for modern users and businesses.

Investment Considerations

  • Proprietary technology is transforming today’s mobile, online and offline commerce capabilities
  • Social media marketing and promotion platforms help merchants accelerate and advertise business growth
  • Management team has 100+ years of combined experience in relevant technology, payment processing, finance and marketing
  • Board of experienced directors supplements management team, providing additional momentum to corporate initiatives

 


Friday, June 23rd, 2017 Uncategorized Comments Off on Moxian, Inc. (NASDAQ: MOXC)

$IDRA FDA Orphan Drug Designation for IMO-2125 for the Treatment of Melanoma

CAMBRIDGE, Mass. and EXTON, Pa., June 22, 2017 — Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for IMO-2125, an agonist of endosomal Toll-like receptor (TLR) 9 for the treatment of melanoma Stages IIb to IV.

Idera is currently conducting the Phase 2 portion of the ipilimumab combination arm of a Phase 1/2 clinical trial of intratumoral IMO-2125 in patients with anti-PD-1 refractory metastatic melanoma.  The objectives of the current trial are to evaluate IMO-2125’s safety, tolerability and clinical activity. The company expects to complete enrollment of the Phase 2 multicenter trial in the second half of 2017 with overall response rate (ORR) data available in the first quarter of 2018.  The company has submitted an abstract to provide an update of clinical data from the ongoing trial at the European Society of Medical Oncology (ESMO) Congress being held in September, in Spain.

“The Orphan Drug Designation bestowed by the FDA today, represents another important step in the development of IMO-2125,” stated Joanna Horobin, M.B. Ch.B., Idera’s Chief Medical Officer.  “A substantial proportion of patients with metastatic melanoma do not benefit from anti-PD-1 therapy.  For these patients, with PD-1 refractory melanoma, ipilimumab offers a modest benefit with an overall response rate of 10-13%1,2.  Our goal is to significantly improve on this through the combination of IMO-2125 with ipilimumab.  We are increasingly encouraged with the data seen to date and look forward to providing our next clinical data update.”

Idera is also enrolling a second arm in the Phase 1/2 clinical trial in patients with PD-1 refractory melanoma to study the combination of IMO-2125 and pembrolizumab which is currently in the dose escalation phase.

In addition to the above mentioned clinical trial, the company recently initiated a trial of IMO-2125 monotherapy in refractory solid tumors, including PD-1 refractory melanoma.

Orphan Drug Designation is granted by the FDA Office of Orphan Products Development to drugs intended for the treatment of a rare disease or condition that affects fewer than 200,000 people in the United States. This designation provides certain incentives, including eligibility for federal grants, research and development tax credits, waiver of PDUFA filing fees and a seven-year marketing exclusivity period, once the product is approved and as long as orphan drug designation is maintained.

The approval of an orphan drug designation request does not alter the standard regulatory requirements and processes for obtaining marketing approval of an investigational drug. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.

About the Phase 1/2 trial of IMO-2125 in PD-1 Refractory Melanoma
The Phase 1/2 trial of intratumoral IMO-2125 in combination with ipilimumab or pembrolizumab is being conducted in patients who are refractory to anti-PD-1 therapy.  The phase 1 portion of the trial was conducted at MD Anderson Cancer Center and the phase 2 portion of the trial is being conducted at multiple clinical sites.  In the Phase 1 arms of the trial, four dose levels of IMO-2125 (4, 8, 16 and 32 mg) have been administered intratumorally in one selected lesion at weeks 1, 2, 3, 5, 8 and 11, in combination with the standard dosing regimens of ipilimumab or pembrolizumab, beginning on week 2.  The Phase 2 expansion portion of the trial utilizes a Simon two-stage design. If at least 2 of the first 10 patients treated at the Phase 2 dose experience confirmed response the futility hurdle has been met and the trial may continue to enroll. Phase 2 will evaluate 21 patients at the phase 2 dose. Tumor biopsies have been collected pre- and post-24 hours of the first dose of IMO-2125, as well as at 8 and 13 weeks to evaluate multiple immune markers.  Clinical activity has been evaluated by the RECIST v1.1 criteria.  Clinical data from this study has been presented at SITC 2017, ASCO-SITC 2017 and AACR 2017, and can be found also on Idera’s corporate website at http://www.iderapharma.com/our-approach/key-publications/.

About IMO-2125
Toll-like receptors (TLRs) play a central role in the innate immune system, the body’s first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, intratumoral TLR9 agonist administration may increase the tumor-infiltrating lymphocytes (TILs), and thereby potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor as well as systemically.

IMO-2125, Idera’s TLR9 agonist, has been created using the company’s proprietary chemistry-based discovery platform.  IMO-2125 has been shown in various scientific presentations and publications to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile.  In previously completed clinical trials, subcutaneous administration of IMO-2125 was very well tolerated in about 114 patients with hepatitis C.  Idera has conducted further preclinical and clinical research evaluating the potential of IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data has been presented at several scientific and medical conferences during the past few years.  The posters from these presentations can be found at http://www.iderapharma.com/our-approach/key-publications.

About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes.  As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as by through the lymphatic system (metastatic disease).  Melanoma accounts for only one percent of skin cancer cases, but causes a large majority of skin cancer deaths.  The American Cancer Society estimates that in 2017, there will be 87,110 new cases of melanoma in the U.S., and about 9,730 will die of this disease.  Based on proprietary Idera research, the company anticipates by the year 2025, there will be roughly 13,000 anti-PD-1 refractory metastatic melanoma patients.

About Idera Pharmaceuticals           
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel nucleic acid-based therapies for the treatment of certain cancers and rare diseases. Idera’s proprietary technology involves designing synthetic oligonucleotide-based drug candidates to modulate the activity of specific TLRs. In addition to its TLR programs, Idera has used its proprietary knowledge to create a third generation antisense technology platform which inhibits the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company’s strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. There are a number of important factors that could cause Idera’s actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether interim results from a clinical trial, such as preliminary results reported in this release, will be predictive of the final results of the trial, whether results obtained in preclinical studies and clinical trials such as the preclinical data described in this release will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera’s technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company’s products receive approval, they will be successfully distributed and marketed; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s Annual Report and on Form 10-Q for the period ended March 31, 2017. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

References 

  1. Bowyer S, Prithviraj P, Lorigan P, et al. Efficacy and toxicity of treatment with the anti-CTLA-4 antibody ipilimumab in patients with metastatic melanoma after prior anti-PD-1 therapy. Br J Cancer. 2016;114:1084-9.
  2. Long GV, et al. Outcomes in patients treated with Ipilimumab after pembrolizumab in KEYNOTE-006.  Soc Mel Res, 2016.

Investor and Media Contact
Robert Doody
Vice President, Investor Relations and Corporate Communications
Office: 617-679-5515
Mobile: 484‐639‐7235
rdoody@iderapharma.com
Thursday, June 22nd, 2017 Uncategorized Comments Off on $IDRA FDA Orphan Drug Designation for IMO-2125 for the Treatment of Melanoma

$DMPI Receives Institutional Review Board Approval for Pivotal Phase 3

VANCOUVER, British Columbia and MENLO PARK, Calif., June 22, 2017 — DelMar Pharmaceuticals (Nasdaq: DMPI) (“DelMar” and “the Company”), a biopharmaceutical company focused on the development of new cancer therapies, today announced it has received Institutional Review Board (IRB) approval to conduct its pivotal Phase 3 Study in Temozolomide-Avastin (bevacizumab) Recurrent GBM (STAR-3).

“IRB approval is an essential step in initiating patient enrollment in our Phase 3 trial,” stated Jeffrey Bacha DelMar’s chairman & CEO.  “We are pleased to remain on track to open enrollment in this trial at leading centers in the United States.  Based on our research, we believe that VAL-083 offers significant potential as a new therapy for GBM patients who currently have no viable treatment options.”

Under FDA regulations, Institutions Review Boards (IRBs) are required to review all human subject research to ensure that the rights and welfare of human subjects are protected at all times. To accomplish this purpose, IRBs are comprised of physicians and research administrators with the authority to approve, require modifications to, or disapprove research.  The VAL-083 STAR-3 GBM trial and all pertinent study related materials were critically examined by Schulman IRB, the leading independent institutional review board, and approved without any modifications.

About the VAL-083 STAR-3 GBM Trial

DelMar’s VAL-083 STAR-3 GBM trial is an adaptive design, randomized, controlled pivotal Phase 3 clinical trial in patients with glioblastoma multiforme (GBM) whose disease has progressed following prior treatment with temozolomide and bevacizumab.

A total of up to 180 eligible patients will be randomized at approximately 25 centers in the United States to receive either the investigational drug (VAL-083) or “investigator’s choice salvage therapy” as a contemporaneous control, in a 2:1 fashion. Up to 120 eligible patients will be randomized to receive intravenous VAL-083 at 40 mg/m2 on days 1, 2, and 3 of a 21-day treatment cycle, for up to 12, 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation. Up to 60 patients will be randomized to “investigator’s choice” control, limited to temozolomide, lomustine, or carboplatin, until they fulfill one of the criteria for study discontinuation.

In both study arms, interval medical histories, targeted physical exams, neurologic evaluations, complete blood counts, and other laboratory and safety assessments will be performed approximately every 21 days while receiving treatment. Tumor assessments are to be performed approximately every 42 ± 7 days while remaining on study. The study is estimated to last less than two years from initiation.

The primary endpoint of the trial is overall survival.  The statistical design between the two arms of the study is 90% power, and is proposed to include an interim analysis at 50% events for futility with O’Brien-Fleming superiority boundary and non-binding, gamma (-5) futility boundary.

About VAL-083

VAL-083 (dianhydrogalactitol) is a “first-in-class”, DNA-targeting agent that introduces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes.

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

DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT in vitro.  Further details regarding these studies can be found at http://www.delmarpharma.com/scientific-publications.html.

DelMar’s recent outcomes in Phase 1-2 clinical trials suggested that VAL-083 may offer a clinically meaningful survival benefit for patients with recurrent GBM following treatment with both TMZ and bevacizumab.  A well-tolerated dosing regimen of 40mg/m2/day on days 1, 2, and 3 of a 21-day cycle was selected for study in subsequent GBM clinical trials.

DelMar has embarked human clinical trials for VAL-083 across multiple lines of GBM therapy. These trials include, i) an ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab, improves overall survival, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962);  ii) a pivotal, controlled Phase 3 study in temozolomide-Avastin Recurrent GBM (“STAR-3”) to evaluate overall survival versus salvage chemotherapy (clinicaltrials.gov identifier: NCT03149575);   iii) a single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels (clinicaltrials.gov identifier: NCT03050736). The results of these studies may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM.

About Glioblastoma Multiforme (GBM)

Glioblastoma (GBM) is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ), however nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for O6-methylguanine-DNA-methyltransferase (MGMT); a validated biomarker for TMZ-resistance. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%.

About DelMar Pharmaceuticals, Inc.

DelMar Pharmaceuticals, Inc. was founded in 2010, driven by the passion of its initiators to develop and commercialize unique new cancer therapies that save and improve lives in indications where patients are failing or have become intolerable to modern targeted or biologic treatments. DelMar’s lead product candidate VAL-083 is currently undergoing clinical trials in the U.S. as a potential new therapy for GBM. VAL-083 has been extensively studied by the U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients.

Connect with the Company on Twitter, LinkedIn, Facebook, and Google+.

Thursday, June 22nd, 2017 Uncategorized Comments Off on $DMPI Receives Institutional Review Board Approval for Pivotal Phase 3

$ENOC Enters Into an Agreement to be Acquired by the Enel Group for over $300M

BOSTON, June 22, 2017  — EnerNOC, Inc. (Nasdaq:ENOC), a leading provider of demand response solutions and energy intelligence software, announced today that it has entered into an agreement to be acquired by the Enel Group (“Enel”), a multinational power utility and leading integrated electricity and gas operator present in over 30 countries across five continents with a managed capacity of approximately 85 GW and more than 65 million business and household customers worldwide.

Under the terms of the agreement, the Enel Group, through its subsidiary Enel Green Power North America, Inc. (“EGPNA”), will purchase EnerNOC for $7.67 per share in an all-cash transaction valuing the Company at over $300M, including EnerNOC’s net debt. EGPNA will commence a tender offer to acquire all of EnerNOC’s shares of common stock for $7.67 per share, representing an approximate 42% premium to the Company’s closing stock price on June 21, 2017 and a 38% premium to the 30-day volume-weighted average price.  EGPNA’s obligation to purchase the shares of EnerNOC’s common stock tendered in the tender offer is subject to certain conditions, including that holders of a majority of the shares are tendered during the tender offer period and receipt of antitrust clearance in the United States. Following completion of the tender offer, the remaining shares will be acquired in a second step merger at the same cash price per share as paid in the tender offer.

“After a comprehensive review of strategic options, during which we evaluated a wide range of paths to maximize shareholder value, we are excited to enter into this agreement with the Enel Group. The transaction provides our stockholders with significant and immediate cash value, and unites us with one of the most innovative, global energy companies that shares our vision to change the way the world uses energy. In combining forces with the Enel Group, we look forward to accelerating the growth of our core businesses and to delivering ever more value to our customers as we lead the transition to a more sustainable, distributed energy future,” said Tim Healy, Chairman and CEO of EnerNOC.

This transaction has been unanimously approved by the Board of Directors of EnerNOC.  The closing of the transaction is subject to the satisfaction of customary conditions and is expected to close in the third quarter of 2017.

Morgan Stanley and Greentech Capital Advisors are serving as financial advisors and Cooley LLP is acting as legal counsel.

About EnerNOC

EnerNOC is a leading provider of demand response solutions and energy intelligence software (EIS). With capabilities to better address budgets and procurement, utility bill management, facility analysis and optimization, sustainability and reporting, project tracking, and demand management, EnerNOC’s SaaS platform helps enterprises control energy costs, mitigate risk, and streamline compliance and sustainability reporting. EnerNOC also offers access to more demand response programs worldwide than any other provider, offering enterprises a valuable payment stream to further enhance bottom line results and utilities and grid operators a reliable, cost-effective demand-side resource. For more information, visit www.enernoc.com and follow @EnerNOC on Twitter.

Safe Harbor Statement

Statements in this press release regarding the sale of EnerNOC, including, without limitation, statements relating to the ability of EnerNOC and the Enel Group to complete the transactions contemplated by the merger agreement and the timing of the expected closing, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements can be identified by terminology such as “anticipate,” “believe,” “could,” “could increase the likelihood,” “estimate,” “expect,” “intend,” “is planned,” “may,” “should,” “will,” “will enable,” “would be expected,” “look forward,” “may provide,” “would” or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including the risks impacting the timing of the tender offer and subsequent merger, risks relating to satisfying closing conditions, risks to the business relating to the announcement and pendency of the transaction, and those risks, uncertainties and factors referred to under the section “Risk Factors” in EnerNOC’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as well as other documents that may be filed by EnerNOC from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. EnerNOC is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Notice to Investors

The tender offer described herein has not yet been commenced. The description contained in this press release is neither an offer to purchase nor a solicitation of an offer to sell securities of EnerNOC. At the time the tender offer is commenced, the Enel Group and its wholly owned subsidiary intend to file a Tender Offer Statement on Schedule TO containing an offer to purchase, forms of letters of transmittal and other documents relating to the tender offer, and the Company intends to file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Investors and stockholders of EnerNOC are strongly advised to read the Tender Offer Statement on Schedule TO, including the offer to purchase, form of letter of transmittal and other documents related to the tender offer, and the Solicitation/Recommendation Statement on schedule 14D-9 that will be filed by EnerNOC, and other relevant materials when they become available, because these materials contain important information regarding the tender offer. Stockholders of EnerNOC will be able to obtain a free copy of these documents (when they become available) and other documents filed by EnerNOC or the Enel Group with the SEC at the website maintained by the SEC at www.sec.gov. In addition, the Schedule TO and related exhibits, including the offer to purchase, forms of letters of transmittal, and other related tender offer documents may be obtained (when available) for free by contacting the EnerNOC at One Marina Park Drive, Suite 400, Boston, MA 02210.

EnerNOC Media Relations: 		
Sarah McAuley
617.532.8195
news@enernoc.com 

EnerNOC Investor Relations:
ir@enernoc.com
Thursday, June 22nd, 2017 Uncategorized Comments Off on $ENOC Enters Into an Agreement to be Acquired by the Enel Group for over $300M

$TROV Agreement with Global Biopharmaceutical Company to Utilize Trovera

SAN DIEGO, June 22, 2017 — Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced it has entered into an agreement with a worldwide, premier biopharmaceutical company to provide Trovera® urine circulating tumor DNA (ctDNA) biomarker tests and services.

The Trovera® urine and blood liquid biopsy tests will be used to assess and monitor mutation status in clinical trials of potential first-in-class or best-in-class oncology therapeutics in development.

“We’re pleased to have our liquid biopsy tests included in the clinical trials with a leading biopharmaceutical company and to participate in their development of transformative therapies to improve the lives of cancer patients worldwide,” said Bill Welch, Chief Executive Officer of Trovagene.  “This agreement follows a separate, recent announcement of our collaboration with AstraZeneca and demonstrates the value of our Trovera® biomarker technology.”

Trovagene performs CLIA laboratory testing services for other biopharmaceutical companies and clinical research third parties.  This expertise is supportive of the development of biomarkers for Trovagene’s internal drug development program for PCM-075, a polo-like kinase 1 (PLK1) inhibitor. Trovagene plans to use an acute myeloid leukemia (AML) genetic panel to assess patient response to PCM-075 in its phase 1/2 trial.

About Trovagene, Inc.

Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics.  Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies.  Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics.  For more information, please visit www.trovagene.com.

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 words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’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, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations.  There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene’s strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes.  Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission.  While the list of factors presented here is 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.  Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Trovagene Contact:

Vicki Kelemen
VP, Corporate Communications
858-952-7652
vkelemen@trovagene.com

Thursday, June 22nd, 2017 Uncategorized Comments Off on $TROV Agreement with Global Biopharmaceutical Company to Utilize Trovera

$DRYS Reports Updated Key Financial Information Post Reverse Stock Split

ATHENS, GREECE–(Jun 22, 2017) – DryShips Inc. (NASDAQ: DRYS), or DryShips or the Company, a diversified owner of ocean going cargo vessels, today reports its updated key financial information giving effect to the reverse stock split on June 22, 2017:

Key Financial Information as of June 22, 2017, post reverse stock split:

  • Cash and cash equivalents: approximately $113.1 million (or $20.01 per share)
  • Book value of vessels, net: approximately $529.1 million (or $93.61 per share)
  • Debt outstanding balance: approximately $200.0 million
  • Equity, book value: approximately $442.2 million (or $78.23 per share)
  • Number of Shares Outstanding: 5,652,257

About DryShips Inc.

The Company is a diversified owner of ocean going cargo vessels that operate worldwide. The Company owns a fleet of (i) 13 Panamax drybulk vessels; (ii) 4 Newcastlemax drybulk vessels, 3 of which are expected to be delivered in the second quarter of 2017; (iii) 5 Kamsarmax drybulk vessels; (iv) 1 Very Large Crude Carrier; (v) 2 Aframax tankers; (vi) 1 Suezmax tanker; (vii) 4 Very Large Gas Carriers which are expected to be delivered in June, September October and December of 2017; and (viii) 6 offshore support vessels, comprising 2 platform supply and 4 oil spill recovery vessels.

DryShips’ common stock is listed on the NASDAQ Capital Market where it trades under the symbol “DRYS.”

Visit the Company’s website at www.dryships.com

Forward-Looking Statement

Matters discussed in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with such safe harbor legislation.

Forward-looking statements reflect the Company’s current views with respect to future events and financial performance and may include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.

The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in the Company’s records and other data available from third parties. Although the Company believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond the Company’s control, the Company cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.

Important factors that, in the Company’s view, could cause actual results to differ materially from those discussed in the forward-looking statements include the factors related to the strength of world economies and currencies, general market conditions, including changes in charter rates, utilization of vessels and vessel values, failure of a seller or shipyard to deliver one or more vessels, failure of a buyer to accept delivery of a vessel, the Company’s inability to procure acquisition financing, default by one or more charterers of the Company’s ships, changes in demand for drybulk or LPG commodities, changes in demand that may affect attitudes of time charterers, scheduled and unscheduled drydockings, changes in the Company’s voyage and operating expenses, including bunker prices, dry-docking and insurance costs, changes in governmental rules and regulations, changes in the Company’s relationships with the lenders under its debt agreements, potential liability from pending or future litigation, domestic and international political conditions, potential disruption of shipping routes due to accidents, international hostilities and political events or acts by terrorists.

Risks and uncertainties are further described in reports filed by DryShips Inc. with the Securities and Exchange Commission, including the Company’s most recently filed Annual Report on Form 20-F. The Company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. If one or more forward-looking statements are updated, no inference should be drawn that additional updates will be made.

Investor Relations / Media:
Nicolas Bornozis
Capital Link, Inc. (New York)
Tel. 212-661-7566
E-mail: dryships@capitallink.com

Thursday, June 22nd, 2017 Uncategorized Comments Off on $DRYS Reports Updated Key Financial Information Post Reverse Stock Split

$MDGL Announces $35 Million Private Placement Offering

WEST CONSHOHOCKEN, Pa., June 21, 2017  — Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced that it has entered into a definitive securities purchase agreement with a group of institutional accredited investors for the private placement offering of approximately 328,300 shares of its common stock and approximately 1.97 million shares of its Series A Convertible Preferred Stock.  The institutional investors participating in the private placement consist of a core group of existing, non-controlling stockholders of Madrigal.

For each share of common stock and each share of Series A Convertible Preferred Stock, the investors agreed to pay a negotiated purchase price of $15.23, resulting in gross proceeds to Madrigal, before deducting estimated offering expenses, of approximately $35 million. The private placement is expected to close on or about June 23, 2017, subject to customary closing conditions.

Madrigal expects to use the proceeds from the offering primarily to support the ongoing clinical development of its lead compound, MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor (THR) β-selective agonist.  MGL-3196 is being developed as a treatment for patients with non-alcoholic steatohepatitis (NASH) and heterozygous familial hypercholesterolemia (HeFH). Madrigal recently reported that, following a prescheduled Data Safety Monitoring Board (DSMB) meeting to review data from Madrigal’s Phase 2 NASH clinical trial, the DSMB issued a positive recommendation for the continuation of the clinical trial with no changes to the protocol. Madrigal expects top-line results from two Phase 2 proof-of-concept trials by year-end.

“This additional capital and expanded support from our institutional shareholders reinforces our belief that MGL-3196 has the potential to safely and effectively address the serious unmet medical needs of patients with NASH as well as those with HeFH,” stated Paul A. Friedman, M.D., Chief Executive Officer of Madrigal. “Further, with the Phase 2 data expected by year-end, we are well-positioned to move MGL-3196 forward in an appropriate and expeditious manner.”

The Series A Convertible Preferred Stock is non-voting. Each share of Series A Convertible Preferred Stock is convertible into one share of Madrigal’s common stock, provided that conversion will be prohibited if, as a result, the holder and its affiliates would beneficially own more than 4.99% of the total number of shares of Madrigal’s common stock or any other class of any equity security (other than an exempted security) that is registered pursuant to Section 12 of the Securities Exchange Act of 1934, as amended, which may be increased or decreased to any other percentage at the holder’s election on 61 days’ notice delivered to Madrigal.

The securities offered and to be sold by Madrigal in this private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from registration requirements. Madrigal has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issued in the private placement.

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

About Madrigal Pharmaceuticals

Madrigal Pharmaceuticals, Inc. (Nasdaq:MGDL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. The company’s lead candidate, MGL-3196, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) ß-selective agonist that is currently in Phase 2 development for NASH and HeFH. For more information, visit www.madrigalpharma.com.

Forward-Looking Statements

This communication contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company’s clinical development of MGL-3196, the timing and outcomes of clinical studies of MGL-3196, and the uncertainties inherent in clinical testing. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s filings with the U.S. Securities and Exchange Commission for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.

Investor Contact:

Marc Schneebaum, Madrigal Pharmaceuticals, Inc.
IR@madrigalpharma.com

Media Contact:

Mike Beyer, Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
Wednesday, June 21st, 2017 Uncategorized Comments Off on $MDGL Announces $35 Million Private Placement Offering

$CA Introduces Microservices Solution

Enhanced Management, Security and Monitoring Increases Business Agility for Competitive Advantage in one of the Industry’s Leading API Management Portfolios

CA Technologies (NASDAQ:CA) today announced new solutions and capabilities within its API Management portfolio to help developers, enterprise architects and digital leaders create and deploy microservices—and manage the APIs that connect and orchestrate microservices to build modern application architectures. The latest innovations include:

  • Expanded capabilities of CA Live API Creator to quickly, effectively and independently create, deploy and run microservices.
  • Docker® container deployment options across many products within the API Management portfolio for end-to-end support in microservices architectures.
  • Expanded API Management portfolio integrations to address management, security and advanced monitoring of APIs for modern architectures in any enterprise or cloud environment.

“Successful digital businesses require a modern application architecture to accelerate development, open new business opportunities and innovate faster,” said Rahim Bhatia, general manager, CA Technologies Developer Products. “CA provides one of the broadest portfolio of microservices and API management solutions – from design and development to deployment and management – supporting application agility and scale for competitive advantage.”

New Capabilities for Microservices Creation and Management

The ability to create and manage microservices deployed using container-based technology is required in today’s modern application architecture. CA supports Docker® container-based deployment of CA Live API Creator and CA API Gateway for microservices creation, security and management. CA also has expanded its powerful, yet easy point-and-click solution, CA Live API Creator, to quickly produce comprehensive microservices incorporating data, logic and robust APIs. In addition, the new CA Microgateway, currently available in beta, helps enforce local policies for microservices, such as service discovery, routing, last mile security and rate limiting.

Beachbody, a leading provider of fitness, nutrition and weight-loss programs, used CA’s products and services to help transform its IT architecture. “We recently went through a three-year project to modernize a wide range of infrastructure and applications to give us the agility to meet rapidly changing market conditions,” said Michael Lee, Technology vice president at Beachbody. “We chose a cloud-first and API-driven approach to continue leveraging existing business critical systems while developing the architecture to quickly create modern applications using microservices.”

Expanded Full Lifecycle API Management Capabilities Support Modern Application Architectures

CA’s newly architected CA API Developer Portal gives organizations the flexibility to manage APIs wherever and however they want – on-premises, hybrid or cloud – with the ability to switch among them seamlessly. The containerized, API-first architecture eases deployment and migration to the cloud, and simplifies management, policy configuration and integration with existing analytics and content management system investments.

New capabilities and integration between CA Mobile API Gateway and CA Advanced Authentication accelerate the development of mobile security while delivering risk-based security from the mobile app to the API. A new, unified mobile SDK helps developers easily integrate authentication requirements while maintaining a streamlined experience for end users. In addition, CA APM integration with CA API Management provides visibility into API and app performance metrics with transaction tracing for precise triangulation and resolution of performance issues.

“Agility and time-to-market for new and compelling apps are essential to compete in the market. CA API Management has demonstrated it can help take ideas and turn them into viable solutions quickly,” said Joe Farrell, Chief Product Officer and co-founder of BiTE Interactive, a mobile product studio. “For example, working with CA API Management we were able to complete the single sign-on feature for an app in just one sprint. When we built this feature without CA API Management for a large financial client, it required four sprints.”

Resources

  • Learn from the API Academy Experts: The API Academy provides expert counsel on microservices and API strategy and design. The API Academy team has also contributed open-source software to help organizations sketch and brainstorm ideas for microservices in a disposable fashion for faster iteration, innovation and inspiration.
  • API Academy Book: Microservice Architecture: Aligning Principles, Practices, and Culture
  • developer.ca.com: Find the right tools and resources for your next project, whether you are interested in microservices and APIs, secure and reliable mobile apps or want to add a whole new level of visibility with app analytics.

Join the API Academy, CA API and microservices technologists and CA customers for a virtual summit, Modernizing Application Architectures with Microservices and APIs, on July 11, 2017, at 12 p.m. ET to learn how to get started with, or advance, microservices initiatives within your organization.

About CA Technologies

CA Technologies (NASDAQ:CA) creates software that fuels transformation for companies and enables them to seize the opportunities of the application economy. Software is at the heart of every business in every industry. From planning, to development, to management and security, CA is working with companies worldwide to change the way we live, transact, and communicate – across mobile, private and public cloud, distributed and mainframe environments. Learn more at www.ca.com.

Follow CA Technologies

Twitter

Social Media Page

Press Releases

Blogs

Legal Notices

Copyright © 2017 CA, Inc. All Rights Reserved. All trademarks, trade names, service marks, and logos referenced herein belong to their respective companies.

 

Press
CA Technologies
Leanne Agurkis
Mobile: (407) 620-2136
leanne.agurkis@ca.com

Wednesday, June 21st, 2017 Uncategorized Comments Off on $CA Introduces Microservices Solution

$CXRX Provides Update on Development of Long-Term Growth Strategy

OAKVILLE, ON, June 21, 2017  – Concordia International Corp. (the “Company”) (NASDAQ: CXRX) (TSX: CXR), an international specialty pharmaceutical company focused on generic and legacy pharmaceutical products, today announced an update on the development of its long-term growth strategy.

Further to previous communications, the Company’s development of a long-term growth strategy is nearing completion. Once finalized, the Company intends to communicate its details with stakeholders in the second half of 2017.

To support the development and execution of this strategy, the Company has engaged Perella Weinberg Partners LP to provide financial advisory services. These services may include, but are not limited to, helping the Company explore and evaluate potential transactional alternatives, including initiatives to optimize its capital structure.

There can be no assurance that this process will result in any transaction, or that any transaction, if pursued, will be consummated. The Company does not expect to comment further unless and until a specific transaction is approved by its Board of Directors or the Company otherwise decides further disclosure is appropriate or required.

“We have made significant progress on our long-term growth strategy and we are looking forward to working with Perella Weinberg Partners to support the Company in finalizing and executing on that strategy,” said Allan Oberman, Chief Executive Officer of Concordia International Corp.

About Concordia
Concordia is a diverse, international specialty pharmaceutical company focused on generic and legacy pharmaceutical products. Concordia has an international footprint with sales in more than 90 countries, and has a diversified portfolio of more than 200 established, off-patent products. Concordia also markets Photofrin® for the treatment of certain rare forms of cancer.

The Company operates out of facilities in Oakville, Ontario and, through its subsidiaries, operates out of facilities in Bridgetown, Barbados; London, England and Mumbai, India.

Notice regarding forward-looking statements and information:
This press release includes forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of Canadian securities laws, regarding Concordia and its business, which may include, but are not limited to, statements with respect to consideration of transactional alternatives potentially available to the Company, the occurrence or consummation of any transaction, Perella Weinberg Partners LP’s ability to assist the Company to support the finalization and execution of the Company’s long-term growth strategy and help the Company with transactional alternatives that may be available to the Company, the development of a long-term growth strategy (and the timing thereof), the progress made on the Company’s long-term growth strategy, the communication of the Company’s long-term growth strategy to its stakeholders (and the timing thereof), the stabilization of Concordia’s business, the ability of Concordia to execute and deliver on business plans and growth strategies, the ability to drive long-term value or growth for the Company’s stakeholders, the Company taking actions to rebuild value for stakeholders (and the ability of Concordia to rebuild value for its stakeholders), Concordia’s ability to service its debt obligations and meet its other obligations in 2017 and beyond, optimism about Concordia’s future, the stability of Concordia’s business (including, without limitation, with respect to its business in certain jurisdictions), expected debt levels and leverage, free cash flows, Concordia’s debt structure (including its flexibility) and the ability to pay down debt, expected sources of funds (including expected levels of cash on hand and the ability to draw on the Company’s revolving facility), future growth of the Company (including, without limitation, the Company’s expansion globally), the ability to pay certain debt and other obligations of Concordia, the ability to use the Company’s expected cash flow and cash on hand to pay certain future obligations (including, without limitation, debt obligations), the Company’s cash on hand and cash flows being sufficient to meet the Company’s liquidity needs, the performance of Concordia’s products and segments, the revenue-generating capabilities and/or potential of Concordia’s assets, Concordia’s financial strength, the continued and/or expected profitability of Concordia’s products and/or services, the sales and/or demand for Concordia’s products, Concordia’s ability to evaluate growth opportunities on a global scale (and the availability of such opportunities) and other factors. Often, but not always, forward-looking statements and forward-looking information can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of Concordia’s management, and are based on assumptions and subject to risks and uncertainties. Although Concordia’s management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this press release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to Concordia’s inability to find transactional alternatives, Concordia’s inability to consummate a transaction, the inability of Perella Weinberg Partners LP to help the Company finalize and execute the Company’s long-term growth strategy or find and complete transactional alternatives that may be available to the Company, Concordia’s inability to stabilize its business, Concordia’s inability to develop a long-term growth strategy or being delayed in developing such plan, cash on hand and cash flows from operations being insufficient to meet Concordia’s liquidity needs, which could result in Concordia having to refinance or restructure its debt, sell assets or seek to raise additional capital, which may be at less favourable terms, the inability to implement Concordia’s objectives and priorities for 2017, which could result in financial strain on the Company and continued pressure on the Company’s business, Concordia’s securities, risks associated with developing new product indications, increased indebtedness and leverage, the inability to generate cash flows, revenues and/or stable margins, the inability to grow organically, the inability to repay debt and/or satisfy future obligations (including, without limitation, earn out obligations), risks associated with Concordia’s outstanding debt, risks associated with the geographic markets in which Concordia operates and/or distributes its products, risks associated with fluctuations in exchange rates (including, without limitation, fluctuations in currencies), risks associated with the use of Concordia’s products to treat certain diseases, the pharmaceutical industry and the regulation thereof, the failure to comply with applicable laws, risks relating to distribution arrangements, possible failure to realize the anticipated benefits of acquisitions and/or product launches, risks associated with the integration of assets and businesses into Concordia’s business, product launches (including, without limitation, unsuccessful product launches), the inability to launch products, the fact that historical and projected financial information may not be representative of Concordia’s future results, the failure to obtain regulatory approvals, economic factors, market conditions, acquisition opportunities, risks associated with the acquisition and/or launch of pharmaceutical products, risks relating to clinical trials and/or patient enrollment into clinical trials, the equity and debt markets generally, risks associated with growth and competition (including, without limitation, with respect to Concordia’s niche, hard-to-make products and Concordia’s key products in its International and North America segments), general economic and stock market conditions, risks associated with the United Kingdom’s exit from the European Union (including, without limitation, risks associated with regulatory changes in the pharmaceutical industry, changes in cross-border tariff and cost structures and the loss of access to the European Union global trade markets), risks associated with regulatory investigations (including investigations by competition authorities with respect to the Company’s operations), risks related to the introduction of new legislation, or amendments to existing legislation, in the jurisdictions in which Concordia carries on business, risks related to patent infringement actions, the loss of intellectual property rights, risks associated with class action litigation, risks associated with Concordia’s inability to defend itself in certain legal actions or being found to have violated certain laws (including, without limitation, the regulatory investigations and class actions which Concordia is currently subject to), which may require Concordia to make certain payments in respect of such legal matters or which may result in certain fines being levied against Concordia, risks and uncertainties detailed from time to time in Concordia’s filings with the Securities and Exchange Commission and the Canadian Securities Administrators and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and forward-looking information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or forward-looking information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and forward-looking information speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement or forward-looking information, whether as a result of new information, future events, or otherwise.

Wednesday, June 21st, 2017 Uncategorized Comments Off on $CXRX Provides Update on Development of Long-Term Growth Strategy

$MBRX Announces Significant Discovery with Potential to Treat Pancreatic Cancer

Metabolic Inhibitor Shows Greater Ability to Kill Pancreatic Cancer Cell Lines

HOUSTON, TX–(June 21, 2017) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced the discovery of a metabolic inhibitor with the potential to treat pancreatic cancer.

“We’ve received a lot of attention from the scientific community for our glucose decoy technology (WP1122 Portfolio, Moleculin Presents Preclinical Data of Novel Inhibitor of Glycolysis at 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, December 13, 2016) as a potential means to starve tumors to death by exploiting their hyper-dependence on glycolysis for energy production,” commented Walter Klemp, Chairman and CEO of Moleculin, “and now we have identified possible new properties of our compound WP1234, a modification to WP1122. In pre-clinical testing, WP1234 has shown improved drug characteristics when compared with WP1122 and a 20 to 50-fold greater ability to kill pancreatic cancer cell lines when compared with traditional inhibitors of glycolysis. We know that pancreatic cancer thrives even in a reduced oxygen environment, which indicates it may be highly dependent on glycolysis to survive. This discovery now makes WP1234 a promising drug candidate to be studied for the treatment of pancreatic cancer.”

Mr. Klemp continued: “Pancreatic cancer is still considered largely untreatable, so even modest gains in treating this disease could represent a significant clinical benefit. WP1234 improves on known inhibitors for glycolysis by increasing drug circulation time, which should increase the potential for drug uptake by and destruction of tumor cells. We are excited about the potential to pursue development opportunities with WP1234 for the treatment of pancreatic cancer. We are also pleased to report that this discovery was the direct result of our ongoing collaboration with M.D. Anderson Cancer Center and the science team there will be presenting detailed findings to the scientific community in the near future.”

About Moleculin Biotech, Inc.

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

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

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of WP1234 to become a safe and effective drug for pancreatic cancer in humans and the potential for that to translate into a significant clinical benefit. These statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (“SEC”) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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

Wednesday, June 21st, 2017 Uncategorized Comments Off on $MBRX Announces Significant Discovery with Potential to Treat Pancreatic Cancer

$NETE PayOnline Announces Partnership with Payvision in Europe

New partnership expands payment acceptance to 120+ currencies globally

MIAMI, FL–(Jun 21, 2017) –  Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a global financial technology and value-added solutions group that supports electronic payments acceptance in an omni-channel environment spanning across point-of-sale (POS), e-commerce and mobile devices, today announces that its PayOnline subsidiary expanded its list of integrations and partnerships in Europe through an addition of Payvision to its network of partners and access to 120+ currencies globally.

Cooperation with Payvision has broadened the scope of PayOnline customers’ capabilities. Thanks to this partnership, PayOnline has an additional channel to route payments in Europe, as well as manage 3D level security in payments. This allows merchants to ensure they get the sale regardless of how the customer chooses to pay, thus achieving a high conversion rate in successful payments. One example is Intui Travel (https://en.intui.travel), a website for searching and booking airport, port and train transportation online. Working together with Payvision, PayOnline was able to reach an 89% conversion rate for Intui Travel.

“Intui Travel facilitates international business. We work with customers and suppliers from 190 countries. We needed payment solutions that offered optimal convenience for the payer and protected the company from fraud. With PayOnline we were able to offer optimal combinations of these factors in a cost-effective manner. We are satisfied with the constructive approach of PayOnline employees to the tasks that have arisen in the process of teamwork. We continue to cooperate and agree on development goals that can stimulate business growth for PayOnline and Intui Travel,” commented Ilya Balakhnichev, Managing Director of Intui Travel.

In addition to 120+ currencies, merchants can withdraw funds in American, Canadian, Australian and New Zealand dollars, Swiss francs, Swedish kroner, Danish kroner, euro, British pound, Japanese yen, Norwegian krone, Polish zloty, and South African rand. The conversion takes place at the rate of Visa / Mastercard, which makes the financial terms profitable for the merchants.

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

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

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

Wednesday, June 21st, 2017 Uncategorized Comments Off on $NETE PayOnline Announces Partnership with Payvision in Europe

$OTIC to Host Key Opinion Leader Meeting for Investors on Ménière’s Disease

SAN DIEGO, June 20, 2017  — Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that it will host a Key Opinion Leader meeting on Ménière’s disease at 8:30 a.m. EDT (5:30 a.m. PDT) on June 27, 2017 in New York.

The meeting will feature presentations by key opinion leaders Paul R. Lambert, M.D., Professor and Chair, Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina, and Anthony A. Mikulec, M.D., MBA, Professor, Chief of Otology and Neurotology, Saint Louis University School of Medicine, who will discuss the significant disease burden and unmet medical needs in the treatment of Ménière’s disease, review the OTIVIDEX™ Phase 2b clinical trial results, and share their clinical trial experience using OTIVIDEX. Both physicians will be available to answer questions.

In addition, Kathie M. Bishop, Ph.D., Chief Scientific Officer of Otonomy will provide an updated analysis of the OTIVIDEX Phase 2b results based on the Phase 3 target patient population and review the program timeline.

A live audio webcast of the event and a replay will be available through the Events and Presentations page of the company’s website (www.otonomy.com).

About Otonomy

Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO® (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, an sNDA has been submitted to the FDA for acute otitis externa (AOE) and a successful Phase 2 trial has been completed in patients with acute otitis media with tympanostomy tubes (AOMT). OTIVIDEX™ (formerly OTO-104) is a steroid in development for the treatment of Ménière’s disease and other balance and hearing disorders. Two Phase 3 trials in Ménière’s disease patients are ongoing, AVERTS-1 in the United States and AVERTS-2 in Europe, with AVERTS-1 results expected in the third quarter of 2017 and AVERTS-2 results expected by the end of 2017. In addition, a Phase 2 trial of OTIVIDEX is underway in patients at risk for cisplatin-induced hearing loss. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that has completed a Phase 1 clinical safety trial with a Phase 2 trial expected to be initiated in the second half of 2017. A fourth program targeting sensorineural hearing loss including age-related hearing loss is in preclinical development. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, the timing of Phase 3 results for OTIVIDEX and the timing of a Phase 2 clinical trial for OTO-311. Otonomy’s expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy’s limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy’s ability to obtain additional financing; Otonomy’s dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTIVIDEX and OTO-311, and label expansion indications for OTIPRIO; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy’s ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy’s product candidates; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct nonclinical studies and clinical trials; the timing and outcome of hospital pharmacy and therapeutics reviews and other facility reviews; the impact of coverage and reimbursement decisions by third-party payors on the pricing and market acceptance of OTIPRIO; Otonomy’s dependence on third parties for the manufacture of OTIPRIO and product candidates; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to OTIPRIO and its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy’s ability to manage operating expenses; implementation of Otonomy’s business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Otonomy’s Annual Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 4, 2017, and Otonomy’s future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.

Contacts:
Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior Vice President
619.849.5377
heidi@canalecomm.com

Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
Tuesday, June 20th, 2017 Uncategorized Comments Off on $OTIC to Host Key Opinion Leader Meeting for Investors on Ménière’s Disease

$NVIV Announces New Patient Enrollment into The INSPIRE Study

InVivo Therapeutics Holdings Corp. (NVIV) today announced that a new patient has been enrolled into The INSPIRE Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury) at Allegheny General Hospital in Pittsburgh, PA, part of the Allegheny Health Network (AHN). Drs. Dan Altman, Nestor Tomycz, and Terrence Julien successfully performed the surgery and implantation approximately 21 hours after the injury occurred.

Dr. Julien, System Co-Director of Minimally Invasive Spine Surgery and Principal Investigator, said, “We are all hoping for the best possible outcome for this and all patients enrolled in the study. This will certainly be a landmark study and once again demonstrates the AHN Neurosurgery Department’s commitment to world class research endeavors brought to the Pittsburgh region.”

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “The patient is stable and the implantation procedure was a success. We now have 16 patients in follow up, and with the reported increase in spinal cord injury incidence during the summer months, we remain on track to complete enrollment into INSPIRE during the third quarter of this year.”

For more information on the INSPIRE study, please visit the company’s ClinicalTrials.gov registration site: http://clinicaltrials.gov/ct2/show/study/NCT02138110.

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the progress of the clinical program and the timing of the completion of enrollment in the INSPIRE Study. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

 

InVivo Therapeutics
Investor Relations
Heather Hamel, 617-863-5530
Investor-relations@invivotherapeutics.com

Tuesday, June 20th, 2017 Uncategorized Comments Off on $NVIV Announces New Patient Enrollment into The INSPIRE Study

$SGOC Signed a contract with Hong Kong Aircraft Engineering

HONG KONG, June 20, 2017  — SGOCO Group, Ltd. (Nasdaq: SGOC) (“SGOCO” or the “Company”), a company focused on product design, distribution, and brand development in the display and computer product market in China as well as energy saving products and services worldwide, today announced that BOCA International Limited (“BOCA”), a wholly owned subsidiary of the Company, has signed a Performance Agreement (the “Agreement”) with Hong Kong Aircraft Engineering Company Limited (“HAECO”), a subsidiary of Swire Group. Pursuant to the Agreement, HAECO engaged BOCA to design, supply and install a new Ultra-High Efficiency BOCA Hybrid Power Chiller Plant (the “Project”) on a 10 years performance contract for HAECO’s facility at the Hong Kong International Airport.

Dr. Richard Chan, the Chief Technology Officer of BOCA estimated that the annual electricity running cost saving through the Project is approximately 30~40% of the existing chiller plant annual energy cost. Expect this can contribute a reduction of 4,212,000kg CARON EMISSION.

BOCA has successfully installed and operated BocaPCM- TES for a number of real estate projects worldwide, including in the United Kingdom, Italy, Australia, Malaysia and Hong Kong. Regarding this new project of BOCA which the Company acquired at the end of 2015, Mr. Shi-Bin Xie, Chief Executive Officer of SGOCO, commented, “We are pleased to see the initial results of the integration of Boca and Company grows the energy saving and environmental protection business. The Company will continue its efforts to further develop such new business and achieve our goals. ”

About SGOCO Group, Ltd.

SGOCO Group, Ltd. is focused on product design, brand development and distribution in the Chinese display and computer product market as well as energy saving products and services. SGOCO sells its products and services in the Chinese market and abroad. For more information about SGOCO, please visit our investor relations website:

http://www.sgocogroup.com

For investor and media inquiries, please contact:
SGOCO Group, Ltd.
Tony Zhong
Vice President of Finance
Tel: +852 3610 7777
Email: ir@sgoco.com

Safe Harbor and Informational Statement

This announcement contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, those with respect to the objectives, plans and strategies of the Company set forth herein and those preceded by or that include the words “believe,” “expect,” “anticipate,” “future,” “will,” “intend,” “plan,” “estimate” or similar expressions, are “forward-looking statements”. Forward-looking statements in this release include, without limitation, the effectiveness of the Company’s multiple-brand, multiple channel strategy and the transitioning of its product development and sales focus and to a “light-asset” model, Although the Company’s management believes that such forward-looking statements are reasonable, it cannot guarantee that such expectations are, or will be, correct. These forward looking statements involve a number of risks and uncertainties, which could cause the Company’s future results to differ materially from those anticipated. These forward-looking statements can change as a result of many possible events or factors not all of which are known to the Company, which may include, without limitation, our ability to have effective internal control over financial reporting; our success in designing and distributing products under brands licensed from others; management of sales trend and client mix; possibility of securing loans and other financing without efficient fixed assets as collaterals; changes in government policy in China; China’s overall economic conditions and local market economic conditions; our ability to expand through strategic acquisitions and establishment of new locations; compliance with government regulations; legislation or regulatory environments; geopolitical events, and other events and/or risks outlined in SGOCO’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F and other filings. All information provided in this press release and in the attachments is as of the date of the issuance, and SGOCO does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Tuesday, June 20th, 2017 Uncategorized Comments Off on $SGOC Signed a contract with Hong Kong Aircraft Engineering

$EVI Completes the Acquisition of Martin-Ray Laundry Systems, Inc.

EnviroStar, Inc. (NYSE MKT:EVI) announced today that it completed the previously announced acquisition of Martin-Ray Laundry Systems, Inc. The transaction is expected to be accretive to EVI’s earnings for its fiscal year ending June 30, 2018.

Founded in 1988 and based in Denver, Colorado, Martin-Ray is a distributor of commercial, industrial, and vended laundry products and provider of laundry installation and routine maintenance services. Consistent with EVI’s operating philosophy, Martin-Ray will operate as a subsidiary of EVI led by its existing management team, under its present name, and from its existing locations.

Henry M. Nahmad, EVI’s Chairman and CEO added: “We are pleased to have successfully completed the acquisition of Martin-Ray. We believe that our unique entrepreneurial culture and focus on growth, combined with our access to financial resources, will lead to additional opportunities to build our business and network beyond its current scope.”

About EnviroStar

EnviroStar, Inc. is a distributor of commercial laundry equipment, industrial boilers, and related parts, supplies, and technical services. Through its subsidiaries, EVI sells its products to over 7,500 customers across the United States, the Caribbean, and Latin America, including providing related technical services through its vast network of service technicians.

Forward-Looking Statements

Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results, trends, performance or achievements of EnviroStar, or industry trends and results, to differ from the future results, trends, performance or achievements expressed or implied by such forward-looking statements. These risks and uncertainties include, among others, that the acquisition of Martin-Ray may not be accretive to EnviroStar’s earnings or otherwise have a positive impact on EnviroStar’s operating results or financial condition to the extent anticipated or at all, integration risks, risks related to the business, operations and prospects of Martin-Ray and EnviroStar’s plans with respect thereto, and the risks related to EnviroStar’s operations, results, financial condition, financial resources, and growth strategy, including EnviroStar’s ability to find and complete other acquisition opportunities, and the impact of any such acquisitions on EnviroStar’s operations, results and financial condition. Reference is also made to other economic, competitive, governmental, technological and other risks and factors discussed in EnviroStar’s filings with the Securities and Exchange Commission, including, without limitation, those disclosed in the “Risk Factors” section of EnviroStar’s Annual Report on Form 10-K for the fiscal year ended June 30, 2016 filed with the SEC on September 20, 2016. Many of these risks and factors are beyond EnviroStar’s control. In addition, past performance and perceived trends may not be indicative of future results. EnviroStar cautions that the foregoing factors are not exclusive. The reader should not place undue reliance on any forward-looking statement, which speaks only as of the date made. EnviroStar does not undertake to, and specifically disclaims any obligation to, update or supplement any forward-looking statement, whether as a result of changes in circumstances, new information, subsequent events or otherwise, except as may be required by law.

EnviroStar, Inc.
Henry M. Nahmad, 305-754-8676
or
Rob Lazar, 305-754-8676

Tuesday, June 20th, 2017 Uncategorized Comments Off on $EVI Completes the Acquisition of Martin-Ray Laundry Systems, Inc.

$CA Positioned as a Leader in Gartner Magic Quadrant

CA Security Portfolio Recognized for Ability to Execute and Completeness of Vision in Access Management Market

Gartner, Inc. has named CA Technologies (NASDAQ:CA) a Leader in the Gartner Magic Quadrant for Access Management, Worldwide 2017.* The report evaluated CA’s broad identity and access management portfolio and the company’s ability to execute and completeness of vision.

“Access managers have evolved from early ‘web access managers.’ Target applications may have traditional web application architectures using web browsers and web application servers, and these applications may run on customers’ premises or in the cloud. Capabilities have expanded to support native mobile or hybrid mobile applications. In addition, these applications may run on internet-connected things with or without human operators. Protected target resources may include on-premises or SaaS applications and web services APIs across business-to-employee (B2E), B2B and B2C use cases,” Gartner analysts Gregg Kreizman and Anmol Singh wrote.

CA’s access management technology supports hybrid IT environments with on-premises and cloud solutions such as CA Single Sign-On and CA Identity Service respectively. In addition, CA Advanced Authentication provides contextual, adaptive access; CA API Management enables the right users, partners and apps to access data; and CA Identity Suite and CA Privileged Access Manager round out the companies access management solutions and capabilities managing access of employees and third parties to even a company’s most sensitive systems and data.

According to feedback about CA’s access management technology from a customer via IT Central Station, “It’s flexible, powerful, and super-performing. We can secure many access points, whether they are local apps, on-premises, or in the cloud with third parties, with partners, or with customers.”

“Our customers’ success depends on their ability to adapt to a changing market that includes maintaining and supporting mission critical on-premises applications while adopting modern cloud based applications and infrastructure,” said Mordecai Rosen, general manager, CA Security business. “CA offers the flexibility and assurance in managing access in that hybrid IT environment with a proven security portfolio.”

To receive a complimentary copy of the report, visit “Gartner Magic Quadrant for Access Management, Worldwide.” To learn more about CA Technologies Identity and Access Management solutions, visit www.ca.com/IAM.

* Gartner Magic Quadrant for Access Management, Worldwide, by Gregg Kreizman and Anmol Singh June 7, 2017.

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

About CA Technologies

CA Technologies (NASDAQ:CA) creates software that fuels transformation for companies and enables them to seize the opportunities of the application economy. Software is at the heart of every business in every industry. From planning, to development, to management and security, CA is working with companies worldwide to change the way we live, transact, and communicate – across mobile, private and public cloud, distributed and mainframe environments. Learn more at www.ca.com.

Follow CA Technologies

Legal Notices

Copyright © 2017 CA, Inc. All Rights Reserved. All trademarks, trade names, service marks, and logos referenced herein belong to their respective companies.

 

CA Technologies
Leanne Agurkis
Mobile: (407) 620-2136
leanne.agurkis@ca.com

Tuesday, June 20th, 2017 Uncategorized Comments Off on $CA Positioned as a Leader in Gartner Magic Quadrant

$PBYA Reports Fourth Consecutive Quarter of Revenue Growth

HOUSTON, TX–(Jun 20, 2017) – ProBility Media Corp. (OTCQB: PBYA), an education technology (EdTech) company building the first full-service training, compliance and career advancement brand for the skilled trades, announces it has filed Form 10-Q for its 2017 fiscal second quarter ended April 30, 2017.

ProBility Media also gives insight into how programs coming out of the White House encourage the type of training and education offered by the Company.

Revenues for the second quarter of 2017 totaled $1,840,647, an increase of 253% compared to revenues of $727,286 in the second quarter of 2016. The year-over-year growth represents the fourth straight quarter of increasing revenues. Gross margins increased from 24.6% in the second quarter of 2016 to 37.5% in the second quarter of 2017.

Fiscal 2017 Second-Quarter Highlights:

  • Joined forces with GlobalSim to introduce virtual reality training to the crane industry;
  • Reported third quarter of consecutive quarter-over-quarter growth;
  • Appointed Billy Smith, crane industry veteran, to the newly created vocational advisory board;
  • Received FINRA approval to change the corporate name to ProBility Media Corp.; and
  • Initiated a philanthropic endeavor with Jewish Family Services (JFS) of Houston, Texas.

Fiscal 2017 First-Quarter Subsequent Event Highlights:

  • Expanded distribution with new 2017 electrician exam preparation series; and
  • Signed a binding letter of intent to acquire W Marketing.

“We are extremely proud of our incredibly talented team that continues to deliver sequential revenue growth and record sales,” commented Evan Levine, Noah Davis and Steven Plumb, executive management team members of ProBility Media. “Recent sales are reflective of an increase in volume of our online courses which has resulted in an increase in gross margins and we expect this trend to continue. With the macro business environment now focusing on apprenticeships for the skilled trades, ProBility is well positioned as a formidable competitor delivering high quality education and training.”

The Trump Administration is initiating new programs that acknowledge and support the growth in the very industries that ProBility offers its fully developed learning, training, and compliance products. In a recent quote, President Donald Trump stated, “We’re empowering these companies, these unions… to go out and create new apprenticeships for millions of our citizens… [to] place students into great jobs without crippling debt… instead apprentices earn while they learn.”

About ProBility Media Corp.

ProBility Media Corp. is an EdTEch company building the first full service training, compliance and career advancement brand for the skilled trades. Through its divisions Brown Technical Media Corp., Brown Technical Publications Inc., Brown Book Shop, Inc., National Electrical Wholesale Providers, One Exam Prep, LLC, and its partnership with Globalsim Inc., ProBility is executing a disruptive strategy of defragmenting the skilled trades training market place by offering high quality training courses and materials and preparing the workforce for excellence. ProBility services customers from the tradesman to the small business to the enterprise level corporation.

For more information, visit http://www.ProBilityMedia.com

Forward-Looking Statements

This Press Release may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements reflect the Company’s current beliefs and are based upon information currently available to it. Accordingly, such forward-looking statements involve known and unknown risks, uncertainties and other factors which could cause the Company’s actual results, performance or achievements to differ materially from those expressed in or implied by such statements. The Company undertakes no obligation to update or advise in the event of any change, addition or alteration to the information included in this Press Release including such forward-looking statements.

Company Contact:
Evan Levine
Chairman and Chief Executive Officer
713.652.3937

Tuesday, June 20th, 2017 Uncategorized Comments Off on $PBYA Reports Fourth Consecutive Quarter of Revenue Growth

$ZN Reaches First Casing Point at a Depth of ~1,950 feet

Update of ongoing drilling operations with Zion’s Megiddo-Jezreel #1 well

DALLAS and CAESAREA, Israel, June 19, 2017 — Zion Oil & Gas, Inc. (NASDAQ: ZN) continues active drilling operations at a depth of 2,000 feet, as it continues to drill to a proposed total depth of approximately 15,000 ft.

Zion’s President and COO, Dustin Guinn, stated, “We are pleased to announce that we have reached an early milestone in the drilling of the MJ#1 well.   We are encouraged with the operational results to date and continue to be satisfied with the performance of the Zion staff and service providers with respect to their adherence to our strict safety expectations.”

Zion continues to allow interested investors to participate in its $250 Unit program through July 12, 2017. To learn more about this program, visit Zion’s information on the Direct Stock Purchase Plan (DSPP) – www.zionoil.com/dspp

Zion Oil & Gas explores for oil and gas onshore in Israel and its operations are focused on the Megiddo-Jezreel License (approximately 99,000 acres) south and west of the Sea of Galilee.

For more information on Zion Oil & Gas, go to www.zionoil.com/

Contact Info:
Zion Oil & Gas, Inc. (NASDAQ: ZN)
12655 North Central Expressway, Suite 1000
Dallas, TX 75243
Andrew Summey
Telephone: 888-891-9466
Email: andrew.summey@zionoil.com
www.zionoil.com

Monday, June 19th, 2017 Uncategorized Comments Off on $ZN Reaches First Casing Point at a Depth of ~1,950 feet

$LPCN to Host Conference Call and Webcast on Top-Line Results

Conference Call and Webcast Scheduled for 5:00 p.m. Eastern Time

SALT LAKE CITY, June 19, 2017  — Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the Company will host a conference call and webcast today, June 19, 2017 at 5:00 p.m. Eastern time to discuss top-line results from its Dosing Validation and Dosing Flexibility studies.  The Company plans to issue a press release detailing top-line results prior to the conference call.

Conference call details:
Date:  June 19, 2017
Time:  5:00 p.m. US Eastern time
Dial-in number:  1 (877) 524-8416 / 1 (412) 902-1028

Replay details:
Dates:  June 19, 2017 until July 17, 2017
Dial-in number:  1 (877) 660-6853 / 1 (201) 612-7415
Conference ID: 13664881

Webcast details (live broadcast and replay):
URL: http://public.viavid.com/index.php?id=125030

A replay of the webcast will be available at the Company’s web site, www.lipocine.com, in the “Investor Relations” section.

About LPCN 1021

LPCN 1021 is an oral testosterone replacement therapy product candidate containing Testosterone Undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. Lipocine expects LPCN 1021 will help fulfill an unmet need in the treatment of hypogonadism. The current testosterone market primarily uses short-acting injectable products as well as topical products that carry an FDA “black box” warning related to inadvertent transfer of testosterone to others. Per the IMS Health database, an average of 540,000 prescriptions a month have been dispensed from January 2016 through December 2016 for testosterone products.

About Lipocine

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107.  LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1021 was well tolerated and met the primary efficacy end-point in Phase 3 testing, which utilized 24-hour pharmacokinetic data for dose adjustments, and is currently being studied in two additional Phase 3 clinical trials.  LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.  LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed. For more information, please visit www.lipocine.com.

Forward-Looking Statements

This release contains “forward-looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine’s FDA review process relating to LPCN 1021, the DV and DF studies, the possible outcome and timing of the DV and DF studies, the path to approvability by the FDA of LPCN 1021 and other development programs for LPCN 1111 and LPCN 1107. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve LPCN 1021 or any of our other products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans, regulatory developments and requirements, risks related to the FDA approval process, the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

CONTACT: 
Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383 
mb@lipocine.com

Investors:
Hans Vitzhum 
Phone: (646) 597-6979
hans@lifesciadviors.com
Monday, June 19th, 2017 Uncategorized Comments Off on $LPCN to Host Conference Call and Webcast on Top-Line Results

$RWLK Unveils Soft Suit Exoskeleton for Stroke Patients

“Restore” NextGen Exoskeleton System Developed in Collaboration with Harvard’s Wyss Institute

MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, June 19, 2017 — ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk”), leading manufacturer of exoskeleton systems, premiered the prototype for a soft suit exoskeleton intended to assist stroke survivors on Yahoo Finance.

ReWalk CEO Larry Jasinski was joined by collaborators from Harvard University’s Wyss Institute for Biologically Inspired Engineering to showcase the prototype, called Restore, and demonstrate how the system works. ReWalk announced a focus on the development of the soft suit as a core company goal for FY2017.

“We are thrilled with the progress of the Restore system, which will provide life changing technology to a whole new class of patients facing mobility issues,” said Jasinski. “With the prototype finished, we are eager to begin clinical studies and pursue regulatory approvals so that these systems can be provided to millions of patients who can benefit from access to the device.”

ReWalk is working with the Wyss Institute on the development of lightweight designs to complete clinical studies, pursue regulatory approvals and commercialize the systems on a global scale. The first commercial application will be for stroke survivors, followed by Multiple Sclerosis patients and then additional applications. There are an estimated 3 million stroke survivors with lower limb disability in the U.S.

How It Works: the Restore transmits power to key joints of the legs with cable technologies, powered with software and mechanics that are similar to the technologies used in the ReWalk exoskeleton system for individuals with spinal cord injury. The cables are connected to fabric-based designs that attach to the legs and foot, thus lending the name “soft suit.”

Anticipated delivery of a commercial Restore soft suit is slated for 2018.

Watch the Yahoo Finance segment here.

About ReWalk Robotics Ltd.
ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with spinal cord injury. Our mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. Founded in 2001, ReWalk has headquarters in the U.S., Israel and Germany. For more information on the ReWalk systems, please visit www.rewalk.com.

ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.

Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward-looking statements may include projections regarding ReWalk’s future performance and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “should,” “would,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk’s control. Important factors that could cause ReWalk’s actual results to differ materially from those indicated in the forward-looking statements include, among others: ReWalk’s expectations regarding future growth, including its ability to increase sales in its existing geographic markets and to expand to new markets; the conclusion of ReWalk’s management, and the opinion of ReWalk’s auditors in their report on the Company’s consolidated financial statements for the fiscal year ended December 31, 2016, that there are substantial doubts as to ReWalk’s ability to continue as a going concern; ReWalk’s ability to maintain and grow its reputation and to achieve and maintain market acceptance of its products; ReWalk’s ability to achieve reimbursement from third-party payors for its products; ReWalk’s ability to repay its secured indebtedness; ReWalk’s expectations as to its clinical research program and clinical results; ReWalk’s expectations as to the results of, and the Food and Drug Administration’s potential regulatory actions with respect to, ReWalk’s mandatory post-market 522 surveillance study; the outcome of ongoing shareholder class action litigation relating to ReWalk’s initial public offering; ReWalk’s ability to improve its products and develop new products; ReWalk’s ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; ReWalk’s ability to gain and maintain regulatory approvals; ReWalk’s ability to use effectively the proceeds of its 2016 follow-on offering; ReWalk’s ability to secure capital from its at-the-market equity distribution program based on the price range of its ordinary shares and conditions in the financial markets; ReWalk’s ability to maintain relationships with existing customers and develop relationships with new customers; ReWalk’s ability to regain compliance with NASDAQ continued listing requirements; and other factors discussed under the heading “Risk Factors” in ReWalk’s Annual Report on Form 10-K for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission and other documents subsequently filed with or furnished to the U.S. Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause ReWalk’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them. Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Monday, June 19th, 2017 Uncategorized Comments Off on $RWLK Unveils Soft Suit Exoskeleton for Stroke Patients

$CLVS Announces Proposed Offering of Common Stock

Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that it has commenced an underwritten public offering of shares of its common stock to raise aggregate proceeds of approximately $250 million. All shares of the common stock to be sold in the offering will be offered by Clovis Oncology.

Clovis Oncology intends to use the net proceeds of the offering for general corporate purposes, including sales and marketing expenses associated with Rubraca® (rucaparib) in the United States and, if approved by the European Medicines Agency (EMA), in Europe, funding of its development programs, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

J. P. Morgan Securities LLC and BofA Merrill Lynch are acting as joint book-running managers for the offering. Stifel and SunTrust Robinson Humphrey are acting as co-managers for the offering.

In addition, Clovis Oncology intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of shares sold on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

This offering is being made only by means of a prospectus supplement and related prospectus. Copies of the prospectus supplement and related prospectus relating to this offering may be obtained from J. P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by calling toll-free (866) 803-9204, or from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email to dg.prospectus_requests@baml.com.

The shares are being offered pursuant to an effective shelf registration statement. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado and has additional offices in San Francisco, California and Cambridge, United Kingdom.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and size of the offering, the conditions affecting the capital markets, general economic, industry, or political conditions, and the satisfaction of customary closing conditions related to the proposed public offering. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the prospectus supplement and related prospectus for this offering as well as Clovis Oncology’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission.

 

Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com

Monday, June 19th, 2017 Uncategorized Comments Off on $CLVS Announces Proposed Offering of Common Stock

$NVDQ Enters Into Agreement to be Acquired by Stryker Corporation

TORONTO, June 19, 2017 — NOVADAQ Technologies Inc. (NASDAQ:NVDQ) (TSX:NDQ) (“NOVADAQ” or the “Corporation”), the leading provider of proven comprehensive fluorescence imaging solutions that improve clinical outcomes and reduce healthcare costs in minimally invasive and open surgeries, today announced that it has entered into a definitive arrangement (the “Arrangement Agreement”) with Stryker Corporation (“Stryker”) pursuant to which Stryker has agreed to acquire all of the issued and outstanding shares of NOVADAQ (the “NOVADAQ  Shares”) for US$11.75 per share in cash, implying a total equity value of approximately US$701 million. The transaction price represents a premium of approximately 95.8% over the closing price of the NOVADAQ Shares on the NASDAQ on June 16, 2017, the last trading day before the announcement of the transaction.

“This transformative transaction recognizes the exceptional value we have built at NOVADAQ. Moreover, we believe it creates a strong opportunity for NOVADAQ, its customers, partners, shareholders and employees,” said Rick Mangat, President and Chief Executive Officer of NOVADAQ. “I am proud of the impact our SPY and PINPOINT technology has made throughout the world in breast reconstruction and colorectal surgery, as well as other minimally invasive applications, and look forward to the additional progress we can make as part of Stryker’s organization.”

“This acquisition aligns with our focus on enabling our customers to see and do more by enhancing cross-specialty surgical visualization,” stated Timothy J. Scannell, Stryker’s Group President, MedSurg and NeuroTechnology. “NOVADAQ’s unique, innovative technology complements our advanced imaging portfolio and expands our product offerings into open and plastic reconstructive surgery. Their innovative technology can reduce post-procedure complication rates and the cost of care for a broad variety of surgical treatments.”

Summary of the Transaction
The transaction will be carried out by way of a court approved plan of arrangement under the Canada Business Corporations Act (the “Arrangement”) and will require the approval of, among others, the holders of at least 66⅔% of the NOVADAQ Shares present in person or represented by proxy at a special meeting of NOVADAQ shareholders (the “Special Meeting”) to be called to consider the Arrangement.  The Special Meeting is expected to be held on or about August 4, 2017.

The board of directors of NOVADAQ, after consultation with its financial and legal advisors, and on the unanimous recommendation of a Special Committee of NOVADAQ’s board of directors (the “Special Committee”), unanimously determined that the Arrangement is in the best interests of the Corporation and recommends that NOVADAQ shareholders vote in favor of the Arrangement. NOVADAQ’s board of directors and the Special Committee have also received a fairness opinion from each of Piper Jaffray & Co. and Perella Weinberg Partners LP in connection with the Arrangement to the effect that, as of the date of such opinions, and subject to the assumptions, limitations and qualifications set forth therein, the consideration to be received by NOVADAQ’s shareholders pursuant to the Arrangement is fair from a financial point of view.

In addition to shareholder and court approvals, the Arrangement is subject to applicable regulatory approvals, including Canadian Competition Act and U.S. Hart-Scott-Rodino approvals, and the satisfaction of certain other closing conditions customary in transactions of this nature.  The transaction is not subject to a financing condition.

The Arrangement Agreement includes a non-solicitation covenant on the part of NOVADAQ, subject to a right to match provision and customary fiduciary out provisions, and provides for the payment of a termination fee of US$21.0 million by NOVADAQ to Stryker in certain circumstances.

All transaction consideration will be payable in U.S. dollars.  However, NOVADAQ securityholders will be permitted to make an election prior to the effective time of the Arrangement to receive their consideration in Canadian dollars by having the depositary arrange for such exchange on their behalf at the prevailing exchange rate.

Complete details regarding the terms of the transaction are set out in an Arrangement Agreement which will be publicly filed by NOVADAQ under its profile at www.sedar.com.  Further details will also be set out in the management information circular of NOVADAQ that will be mailed to shareholders of NOVADAQ in due course in connection with the Special Meeting and also publicly filed by NOVADAQ under its profile at www.sedar.com.

Piper Jaffray & Co. is serving as lead financial advisor to NOVADAQ and delivered a fairness opinion to NOVADAQ’s board of directors. Perella Weinberg Partners LP is serving as a financial advisor to NOVADAQ and delivered a fairness opinion to NOVADAQ’s board of directors. Stikeman Elliott LLP and Dechert LLP are serving as legal advisors to NOVADAQ. Covington & Burling LLP and Osler, Hoskin & Harcourt LLP are serving as legal advisors to Stryker.

About NOVADAQ Technologies Inc.
NOVADAQ’s global mission is to enable physicians with point-of-care imaging solutions that provide real-time clinically significant and actionable information to improve care quality and lower healthcare costs. Using NOVADAQ’s SPY fluorescence imaging technology, physicians can personalize therapy and achieve optimal results through the precise visualization of blood flow in vessels, micro-vessels, tissue perfusion and critical anatomical structures during the course of treatment. SPY technology enables the delivery of personalized therapies and the achievement of the optimal results for each individual patient. More than 250 peer-reviewed publications demonstrate that the use of SPY technology will reduce post-procedure complication rates and the cost of care for a broad variety of surgical treatments for cancer, cardiovascular diseases and other conditions, helping to ensure that patients benefit from the very best possible treatment and outcome.

SPY Imaging Systems are U.S. Food and Drug Administration 510(k) cleared, Health Canada licensed, CE Marked and registered worldwide for use in multiple surgical specialties and medical applications. The endoscopic version of SPY technology, known as PINPOINT, combines the fluorescence imaging capabilities of SPY with the high definition visible light visualization to establish a new standard in the quality and performance of minimally invasive surgery. The SPY PHI open surgery portable, handheld imager is FDA (510)k cleared and CE Marked and is indicated for the visualization of blood flow and tissue perfusion in plastic, reconstructive, micro and gastrointestinal surgeries. NOVADAQ’s LUNA System is used to visualize blood flow and tissue perfusion while treating patients with atherosclerotic cardiovascular disease that impairs blood flow to the extremities and increases the risk for the development of complications such as acute and chronic non-healing wounds and limb loss. NOVADAQ is the exclusive worldwide distributor of LifeNet Health’s DermACELL acellular tissue products for wound and breast reconstruction surgery

NOVADAQ, SPY, PINPOINT, LUNA and the illumination square design are registered trademarks of NOVADAQ Technologies, Inc. SPY PHI is a trademark of NOVADAQ Technologies, Inc. DermACELL is a registered trademark of LifeNet Health, Inc.

Forward-Looking Statements
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on NOVADAQ’s current beliefs as well as assumptions made by and information currently available to NOVADAQ and relate to, among other things, the Corporation’s strategy, strategic goals, research and development activities, research and clinical testing outcomes, taxes, capital expenditures, future operations, future financial position, future revenues/results, projected costs, prospects and plans, objectives of management and the obtaining of NOVADAQ shareholder approval, court, regulatory and other required approvals in connection with the Arrangement.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by NOVADAQ in its public securities filings available at www.sec.gov and www.sedar.com, actual events may differ materially from current expectations. NOVADAQ disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

NOVADAQ, SPY, PINPOINT, LUNA and the illumination square design are registered trademarks of NOVADAQ Technologies, Inc. SPY PHI is a trademark of NOVADAQ Technologies, Inc. DermACELL is a registered trademark of LifeNet Health, Inc.

For more information, please contact:
Lynn Pieper Lewis or Leigh Salvo
(415) 937-5404
investors@novadaq.com
Monday, June 19th, 2017 Uncategorized Comments Off on $NVDQ Enters Into Agreement to be Acquired by Stryker Corporation

$TNXP to Present at the 2017 BIO International Convention

NEW YORK, June 16, 2017  — Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, announced today that it will present at the 2017 BIO International Convention being held June 19-22, 2017 in San Diego, CA.

Seth Lederman, M.D., president and chief executive officer of Tonix, will provide an overview of Tonix’s pipeline candidates, including its lead development program, TNX-102 SL*, a Breakthrough Therapy designated by the U.S. Food and Drug Administration (FDA) for the treatment of posttraumatic stress disorder (PTSD).  A Phase 3 HONOR study of TNX-102 SL in military-related PTSD is currently ongoing.

Information on the presentation is as follows:

Event: 2017 BIO International Convention
Date: Wednesday, June 21, 2017
Time: 4:45 p.m. PDT
Location: Theater 3, San Diego Convention Center

The presentation will be webcast live and remain available for 90 days. To access the webcast, please visit the Events tab of the Investor Relations section in Tonix’s website at www.tonixpharma.com.

*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

About TNX-102 SL and the Phase 3 HONOR Study

TNX-102 SL is a patented sublingual transmucosal formulation of cyclobenzaprine that is in Phase 3 development. PTSD is a serious condition characterized by chronic disability, inadequate treatment options especially for military-related PTSD, and an overall high utilization of healthcare services that contributes to significant economic burdens. In a Phase 2 study, TNX-102 SL 5.6 mg was found to be effective in treating military-related PTSD, which formed the basis of the Breakthrough Therapy designation granted by the FDA. Tonix is currently conducting a Phase 3 trial of TNX-102 SL in military-related PTSD in the United States, the HONOR study, which is a 12-week randomized, double-blind, placebo-controlled trial evaluating the efficacy of TNX-102 SL 5.6 mg in participants with military-related PTSD. This two-arm, adaptive-design trial is targeting enrollment of up to approximately 550 participants across approximately 35 clinical sites. An unblinded interim analysis will be conducted once the study has accumulated efficacy results from approximately 275 randomized participants. In a recent cross-disciplinary Breakthrough meeting, the FDA confirmed that a single-study new drug application (NDA) approval could be possible if the topline data from the HONOR study are statistically very persuasive. Additional details of the HONOR study are available at www.thehonorstudy.com or https://clinicaltrials.gov/ct2/show/NCT03062540. The U.S. Patent and Trademark Office has issued a patent (U.S. Patent No. 9,636,408) protecting the composition and manufacture of the unique TNX-102 SL formulation. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. This patent is expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034.

About Tonix Pharmaceuticals Holding Corp.

Tonix is developing innovative pharmaceutical products to address major public health challenges. In addition to TNX-102 SL for PTSD, Tonix is developing TNX-601 (tianeptine oxalate), a clinical candidate at pre-IND (Investigational New Drug) application stage, designed as a daytime treatment for PTSD and TNX-801, a live synthetic version of horsepox virus, at the pre-IND application stage, to be developed as a potential smallpox-preventing vaccine.

About the 2017 BIO International Convention

The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.  The BIO International Convention is the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

This press release and further information about Tonix can be found at www.tonixpharma.com.

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,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’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 need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development 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 pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission (the “SEC”) on April 13, 2017, and future periodic reports filed with the SEC on or after the date hereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof. 

 

Contacts

Jessica Smiley
Investor Relations
investor.relations@tonixpharma.com
(212) 980-9155 x18

Russo Partners (media)
Rich Allan
rich.allan@russopartnersllc.com
(646) 942-5588
Friday, June 16th, 2017 Uncategorized Comments Off on $TNXP to Present at the 2017 BIO International Convention

$ADXS to Present at 2017 BIO International Convention

Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company developing cancer immunotherapies, today announced that Ranya Dajani, Vice President, Business Development, will present a company overview at the 2017 Biotechnology Innovation Organization’s (BIO) International Convention in San Diego, CA.

Event: 2017 BIO International Convention
Presentation Date: June 20, 2017
Presentation Time: 4 p.m. PT
Location: San Diego Convention Center, Theater 2

The BIO International Convention is the world’s largest gathering among the biotechnology industry attended by more than 16,000 biotechnology professionals from more than 3,100 companies. The convention will highlight innovation in biotech with keynote speakers, fireside chats, partnering meetings, company presentations and exhibitors from all fields.

About Advaxis, Inc.

Located in Princeton, N.J., Advaxis, Inc. is a late-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology. 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™ immunotherapies axalimogene filolisbac and ADXS-DUAL target HPV-associated cancers and are in clinical trials for invasive and metastatic cervical cancer, head and neck cancer and anal cancer. The FDA has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings, as well as Fast Track designation for adjuvant therapy for HRLACC patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac has also been classified as an advanced therapy medicinal product for the treatment of cervical cancer by the EMA’s CAT. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development. In addition, Advaxis and Amgen are developing ADXS-NEO, an investigational cancer immunotherapy treatment designed to activate a patient’s immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient’s tumor, with plans to enter the clinic in 2017.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, and YouTube.

Advaxis Forward-Looking Statement

This press release 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, axalimogene filolisbac and ADXS-DUAL. 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, 2016, which is available at http://www.sec.gov.

Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof other than as required by law.

You are cautioned not to place undue reliance on any forward-looking statements.

 

Company:
Advaxis, Inc.
Noelle Heber, 609-250-7575
Sr. Director Corporate Communications and Government Affairs
heber@advaxis.com
or
Media Contact:
JPA Health Communications
David Connolly, 617-657-1301
dconnolly@jpa.com

Friday, June 16th, 2017 Uncategorized Comments Off on $ADXS to Present at 2017 BIO International Convention

$MYO to Rings NYSE MKT Closing Bell

CEO Paul R. Gudonis and MyoPro Orthosis Users to Participate, in Commemoration of Myomo’s IPO

Myomo, Inc. (NYSE MKT: MYO) (“Myomo” or the “Company”), a commercial stage medical robotics company, today announced that its Chairman and CEO, Paul R. Gudonis, will ring today’s closing bell at the New York Stock Exchange (NYSE) MKT in New York City in commemoration of its initial public offering (IPO) closing on June 9, 2017. Gudonis will be joined by Arthur Jerome “Jay Jay” Johnson, a U.S. veteran from Cleveland, and Jessica Peters, a stroke survivor from Salem, Mass., users of Myomo’s MyoPro myoelectric arm orthosis. The MyoPro is the only lightweight wearable device that helps restore function in the paralyzed or weakened arms and hands of individuals who have suffered a stroke, spinal cord or nerve injury, or other neuromuscular disability.

“We are very pleased to complete our IPO as the first Regulation A+ issuer to trade on the NYSE MKT, providing us with the resources to accomplish our mission of addressing upper limb paralysis with our proprietary life-changing technology,” said Gudonis. “In commemorating our IPO, we acknowledge our broad stakeholder community, including ‘Jay Jay,’ who has successfully regained mobility, and Jessica, who has returned to the workforce and serves as a peer mentor to other young victims of stroke. We also acknowledge the NYSE, in conjunction with the Jumpstart Our Business Startups (JOBS) Act, for paving the way for small growth companies such as ours to raise capital. We look forward to continuing to execute our growth agenda and returning value to our shareholders.”

Gudonis, Johnson and Peters will ring the closing bell at 4:00 PM EDT today, concluding Myomo’s first week of trading on the NYSE MKT. A live stream of the closing bell ceremony can be found at https://livestream.com/nyse.

About Myomo
Myomo, Inc. is a commercial stage medical robotics Company that offers expanded mobility for those suffering from neurological disorders and upper limb paralysis. Based on patented technology developed at MIT and the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces to restore function in the paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord or nerve injury such as brachial plexus injury, or other neuromuscular disability such as amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). It is provided through clinical relationships with VA medical centers, leading rehabilitation hospitals, and Orthotics and Prosthetics (“O&P”) practices. Several hundred have been successfully used by patients. It is the only device that, sensing a patient’s own neurological signals through non-invasive sensors on the arm, can restore their ability to use their arms and hands so that they can return to work, live independently and reduce their cost of care. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals across the U.S. For more information, please visit www.myomo.com.

Forward Looking Statements
This press release contains forward-looking statements regarding the Company’s future business expectations, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors. Other risks and uncertainties include, among others, risks related to new products, services, and technologies, government regulation and taxation, and fraud. More information about factors that potentially could affect Myomo’s financial results is included in Myomo’s filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

 

For Myomo:
ir@myomo.com
or
Investor Relations:
PCG Advisory
Vivian Cervantes, 212-554-5482
vivian@pcgadvisory.com
or
Public Relations:
Greenough
Rachel Robbins, 617-275-6521
rrobbins@greenough.biz

Friday, June 16th, 2017 Uncategorized Comments Off on $MYO to Rings NYSE MKT Closing Bell

$PTOTF Announces Upsize of Previously Announced Special Warrant Financing to $4.0 Million

Canada NewsWire

VANCOUVER, June 16, 2017

/NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES./

VANCOUVER, June 16, 2017 – Patriot One Technologies Inc. (the “Company”) (TSX VENTURE: PAT) (OTCQB: PTOTF) (FRANKFURT: 0PL) announced today that it has entered into an amended and restated engagement letter (the “Amended and Restated Engagement Letter”) with Canaccord Genuity Corp. (the “Agent”) to increase the size of the Company’s previously announced private placement of special warrants of the Company (“Special Warrants”) from up to $3,010,000 to up to $4,025,000 in gross proceeds (the “Offering”).

Under the terms of the Amended and Restated Engagement Letter, the Agent has agreed to offer for sale up to 5,750,000 Special Warrants on a commercially reasonable basis at a price of $0.70 per Special Warrant. The Agent may invite other registered investment dealers to participate as syndicate members in the Offering. The Company has also granted the Agent an option (the “Agent’s Option”) to sell up to an additional 15% of the Special Warrants sold pursuant to the Offering, which Agent’s Option is exercisable by giving notice to the Company not less than 48 hours prior to the closing of the Offering. Closing of the Offering is expected to occur on or about July 5, 2017, subject to receipt of regulatory approvals.

Other than for the increase in the size of the Offering all terms of the Special Warrants and their qualification under a short form prospectus remain the same and as set out in the Company’s news release of June 14, 2017.

The Company intends to use the net proceeds of the Offering (including any proceeds received as a result of the exercise of the Agent’s Option) to fund international expansion, accelerate deployment of its technology and for general corporate purposes.

The Offering is subject to certain conditions including, but not limited to receipt of all necessary approvals, including the approval of the TSX Venture Exchange.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

About Patriot One Technologies, Inc. (TSX VENTURE: PAT) (OTCQB: PTOTF) (FRANKFURT: 0PL):
Patriot One has developed PATSCAN CMR™ the next generation of its award-winning Patriot One Technologies™ NForce CMR1000 software and radar solution. PATSCAN CMR is a first-of-its-kind Cognitive Microwave Radar concealed weapons detection system as an effective tool to combat active shooter threats before they occur. Designed for cost-effective deployment in weapon-restricted buildings and facilities, the Patriot One software solution and related hardware can be installed in hallways and doorways to covertly identify weapons and to alert security of an active threat entering the premises. Owner/operators of private and certain public facilities can now prominently post anti-weapons policies with compliance assured. The Company’s motto Deter, Detect and Defend is based on the belief that widespread use of its technology will act as an effective deterrent, thereby diminishing the epidemic phenomena of active shooters across the globe. For more information, visit: www.patriot1tech.com. Patriot One Technologies are proud winners of the 2017 Anti-Terrorism / Force Protection category of the Security Industry Association’s New Product Showcase at ISC West.

CAUTIONARY DISCLAIMER STATEMENT:
No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to the timing and completion of the Offering, the use of proceeds of the Offering and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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

SOURCE Patriot One Technologies Inc.

Friday, June 16th, 2017 Uncategorized Comments Off on $PTOTF Announces Upsize of Previously Announced Special Warrant Financing to $4.0 Million