Archive for November, 2016

$EXPI Fundamental Research Corp. Updates its Coverage

Independent Research Firm Raises Fair Value Estimate and Revenue Forecast

BELLINGHAM, WA–(November 21, 2016) – Fundamental Research Corp., an independent research firm specializing in the small-cap and microcap sectors, has announced that it has updated its analysis of eXp World Holdings, Inc. (OTCQB: EXPI). To view the updated research report in its entirety visit http://www.otcmarkets.com/financialReportViewer?symbol=EXPI&id=163022.

eXp World Holdings, Inc. is the holding company for eXp Realty, the Agent-Owned Cloud Brokerage®. The Company’s real estate brokerage division now has more than 2,200 real estate professionals who span across 41 states, the District of Columbia and parts of Canada. The Company had 864 agents on January 1, 2016.

In the report, Fundamental Research Corp., which initiated coverage of eXp World Holdings, Inc. back in April of this year, cites the Company’s record third quarter revenues, a revision in its long term projections, and a healthy balance sheet among the reasons for its upward revisions.

All research issued by Fundamental Research Corp. is based on public information. Fees were paid by EXPI to FRC. The purpose of the fee is to subsidize the high costs of research and monitoring. FRC takes steps to ensure independence including setting fees in advance and utilizing analysts who must abide by CFA Institute Code of Ethics and Standards of Professional Conduct. Additionally, analysts may not trade in any security under coverage. Our full editorial control of all research, timing of release of the reports, and release of liability for negative reports are protected contractually. To further ensure independence, EXPI has agreed to a minimum coverage term including four reports.

About eXp World Holdings, Inc.

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

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

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

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

Contact:
Sid Rajeev, CFA
www.researchfrc.com
Direct: 604-682-7065

Monday, November 21st, 2016 Uncategorized Comments Off on $EXPI Fundamental Research Corp. Updates its Coverage

$IMMU Comments on Receipt of Director Nominations

MORRIS PLAINS, N.J., Nov. 18, 2016  — Immunomedics, Inc. (Nasdaq:IMMU) (“Immunomedics” or “the Company”) today confirmed that venBio Select Advisor LLC (“venBio”) has submitted a notice of nomination of four director candidates to stand for election to the Immunomedics Board of Directors at the Company’s 2016 Annual Meeting of Stockholders to be held on December 14, 2016. The Company issued the following statement:

The Immunomedics Board of Directors and management team are committed to acting in the best interests of the Company and all stockholders and regularly seeks qualified candidates for the Board. To that end, while venBio did not engage in discussions with the Company prior to nominating a majority slate for election to the Board just four weeks prior to the upcoming 2016 Annual Meeting, Immunomedics’ Governance and Nominating Committee will consider venBio’s director candidates and respond in due course.

Immunomedics has achieved a number of important milestones in 2016, including delivering positive Phase 2 clinical trial results of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC), which have been submitted for publication; achieving our timetable for the manufacturing of clinical materials for the Phase 3 confirmatory trial in TNBC; and nearing completion of enrolling 100 patients into our ongoing open-label Phase 2 trial by year-end 2016. The Company has also retained Greenhill & Co. to pursue licensing and other strategic activities with regard to preclinical and clinical pipeline products as well as platform technologies.

The Company is at a pivotal point in its growth trajectory as it prepares to submit an accelerated approval application to the FDA for IMMU-132 in mid-2017 and believes disruption in its strategy at this time could destroy value and potentially disrupt the Company’s clinical trial activities for late-stage cancer patients. Additionally, as previously announced, at the annual meeting of the American Society of Hematology in December 2016, the Company will premiere a new antibody-drug conjugate known as IMMU-140 and the Company anticipates delivering interim results for IMMU-132 at a symposium on genitourinary cancers to be held in early 2017.

Immunomedics is well-positioned to execute on the Company’s strategy, drive innovation in the targeted treatment of cancer, autoimmune disorders and other serious diseases and enhance stockholder value, and perhaps most importantly help patients suffering from cancer.

The Company presented the Board’s recommendation regarding director nominees in its definitive proxy statement and other materials filed with the SEC on November 2, 2016, and mailed to stockholders.

DLA Piper is serving as legal advisor and Greenhill & Co. is serving as financial advisor to Immunomedics.

About Immunomedics
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of eight clinical-stage product candidates. Immunomedics’ portfolio of investigational products includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. IMMU-132 has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease. Immunomedics has a research collaboration with Bayer to study epratuzumab as a thorium-227-labeled antibody. Immunomedics has other ongoing collaborations in oncology with independent cancer study groups. The IntreALL Inter-European study group is conducting a large, randomized Phase 3 trial combining epratuzumab with chemotherapy in children with relapsed acute lymphoblastic leukemia at clinical sites in Australia, Europe, and Israel. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and preclinical development. These include combination therapies involving its antibody-drug conjugates, bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 299 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its website does not, however, form a part of this press release.

Important Additional Information
Immunomedics, Inc. (the “Company”), its directors and certain of its executive officers may be deemed to be participants in the solicitation of proxies from Company stockholders in connection with the matters to be considered at the Company’s 2016 Annual Meeting. The Company has filed a definitive proxy statement and form of WHITE proxy card with the U.S. Securities and Exchange Commission (the “SEC”) in connection with any such solicitation of proxies from Company stockholders. COMPANY STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS), THE ACCOMPANYING WHITE PROXY CARD AND ANY OTHER RELEVANT DOCUMENTS THAT THE COMPANY FILES WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, is set forth in the proxy statement and other materials filed by the Company with the SEC.  Stockholders will be able to obtain the proxy statement, any amendments or supplements to the proxy statement and other documents filed by the Company with the SEC for no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Company’s website at www.immunomedics.com, by writing to Immunomedics, Inc. at 300 The American Road, Morris Plains, New Jersey 07950, or by calling the Company’s proxy solicitor, or by calling Dr. Chau Cheng, Senior Director, Investor Relations & Corporate Secretary, (973) 605-8200, extension 123.

Forward-Looking Statements
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123
ccheng@immunomedics.com

Media
Dan Katcher / Ed Trissel / Nick Lamplough
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449

Investors
Dan Burch/Bob Marese
MacKenzie Partners, Inc.
(212) 929-5500
Friday, November 18th, 2016 Uncategorized Comments Off on $IMMU Comments on Receipt of Director Nominations

$NVCR Long-Term Analysis of All 695 #Glioblastoma Patients

Patients treated with Optune® together with temozolomide demonstrated a significant increase in progression free and overall survival compared to patients treated with temozolomide alone

EF-14 patients treated with Optune together with temozolomide experienced a 70 percent improvement in survival rate at four years compared to patients treated with temozolomide alone

Novocure (NASDAQ:NVCR) announced today that a long-term analysis of the full trial cohort from its phase 3 pivotal EF-14 trial of Optune® in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) confirmed the superior survival results seen at interim analysis. The long-term analysis demonstrated superior two-, three- and four-year survival of patients treated with Optune together with temozolomide compared to temozolomide alone. The interim analysis results – published in the Journal of the American Medical Association (JAMA) 1 in December 2015 – showed significant extension of both progression free and overall survival in newly diagnosed GBM patients receiving Optune with temozolomide compared to temozolomide alone.

EF-14 Principal Investigator Roger Stupp, M.D., Professor at the University of Zurich and Director of Department of Oncology at the Zurich University Hospital, Zurich, Switzerland, will present these late breaking results at the 21st Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) on Nov. 18, in Scottsdale, Arizona.

“The analysis of the full dataset confirms the improvement in both progression free and overall survival we saw in the trial’s interim analysis, and demonstrates superior long-term survival,” Dr. Stupp said. “These mature results further validate Optune as a standard of care treatment option for glioblastoma, providing patients with a therapy that can extend their survival while maintaining their quality of life.”

“We are excited that Novocure’s long-term analysis of the EF-14 trial confirms the interim analysis results of superior overall and progression free survival, while providing new data on potential long-term survival benefits for newly diagnosed GBM patients,” said Elizabeth M. Wilson, President and CEO of the American Brain Tumor Association. “GBM patients need better treatment options, and it is a great day when new evidence shows that we are making progress in treating this disease.”

The long-term analysis of all patients (n=695) shows that:

  • Patients treated with Optune together with temozolomide demonstrated a significant increase in median progression free survival (PFS) compared to temozolomide alone (median PFS of 6.7 months versus 4.0 months, respectively, hazard ratio=0.63, p=0.00005).
  • Patients treated with Optune together with temozolomide demonstrated a significant increase in median overall survival (OS) compared to temozolomide alone (median OS from randomization of 20.8 months versus 16.0 months, respectively, hazard ratio=0.65, p=0.0006)
  • The percentage of patients alive at two years in the Optune together with temozolomide arm was 43 percent compared to 30 percent in the temozolomide alone arm, a 43% increase in the chance of living two years.
  • The percentage of patients alive at four years in the Optune together with temozolomide arm was 17 percent compared to 10 percent in the temozolomide alone arm, a 70% increase in the chance of living four years.
  • Consistent with the interim analysis, the OS and PFS benefit of Optune together with temozolomide compared to temozolomide alone was seen across all patient subgroups tracked in the EF-14 trial, including patient age, performance status and tumor genetics.
  • The safety profile in the long-term analysis was consistent with the interim analysis of the EF-14 trial.

“The long-term analysis further supports our data showing that Optune together with temozolomide is a better treatment option for newly diagnosed GBM patients compared to temozolomide alone,” said Asaf Danziger, Novocure’s CEO. “We believe these results will give health care providers further confidence in our therapy and transform the standard of care in newly diagnosed GBM. Our priority is to improve the lives of GBM patients, and we believe these results will help us to accomplish our mission.”

About Novocure

Novocure is a commercial-stage oncology company developing a novel, proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed phase 2 pilot trials investigating TTFields in non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.

Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

Approved Indications

In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Important Safety Information

Contraindications

Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Do not use Optune if you are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by Novocure (the device manufacturer).

Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations.

The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression.

The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache.

The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer.

All servicing procedures must be performed by qualified and trained personnel.

Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor.

Do not wet the device or transducer arrays.

If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment.

Please see http://www.optune.com/safety to see the Optune Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on March 1, 2016, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

1 Stupp R, Taillibert S, Kanner AA, et al. Maintenance therapy with tumor-treating fields plus temozolomide vs temozolomide alone for glioblastoma: a randomized clinical trial. JAMA. 2015;314(23):2535-2543.

 

Media and Investor
Novocure
Ashley Cordova, 212-767-7558
acordova@novocure.com

Friday, November 18th, 2016 Uncategorized Comments Off on $NVCR Long-Term Analysis of All 695 #Glioblastoma Patients

$PMBC Increases Financing for #MarqueMedical to $3.9 Million

COSTA MESA, Calif., Nov. 18, 2016  — Pacific Mercantile Bank (“the Bank”), the wholly owned subsidiary of Pacific Mercantile Bancorp (NASDAQ:PMBC), today announced that it has increased the financing for Marque Medical to $3.9 million.  The financing will be used by Marque Medical to open new urgent care clinic locations in Orange County.  In addition to the financing, Marque Medical utilizes a full suite of Pacific Mercantile Bank’s cash management services.

Marque Medical operates Marque Urgent Care, a patient-centered network of walk-in clinics.  Through its six locations in Orange County and San Diego County, Marque Urgent Care treats a range of non-life-threatening injuries and illnesses for adults and children in addition to providing general wellness services.  With each location fully staffed with experienced, multi-specialty physicians, Marque Urgent Care has elevated the standards of walk-in care by combining the best-in-class physicians, upscale and modern facilities, and a first-class approach to serving patients.

“Pacific Mercantile Bank has been highly supportive of our growth plans and provided the short-term and long-term credit facilities we needed to open our newest locations in Mission Viejo and Buena Park,” said Pierre Bergougnan, CEO of Marque Medical.  “We appreciate the time that the team from Pacific Mercantile Bank took to understand our expansion plans and customize a credit facility that accommodates the timing of the opening of our new clinics and supports our increasing working capital needs as our business grows.”

“Marque Medical has proven its business model and filled a critical gap between crowded primary care offices and costly emergency rooms,” said Tom Vertin, President and Chief Executive Officer of Pacific Mercantile Bank.  “We are very pleased to help Marque Medical open new urgent care clinics and better serve the medical needs of residents throughout Orange County.”

About Pacific Mercantile Bank

Pacific Mercantile Bank opened for business March 1, 1999. The Bank, which is FDIC insured and a member of the Federal Reserve System, provides a wide range of commercial banking services to businesses, business owners and business professionals through its combination of traditional banking offices and comprehensive, sophisticated electronic banking services.

The Bank, headquartered in Orange County, operates a total of nine offices in Southern California, located in Orange, Los Angeles, San Diego, and San Bernardino counties. In addition, the Bank offers comprehensive online banking services accessible at www.pmbank.com.  Pacific Mercantile Bancorp (NASDAQ:PMBC) is the parent holding company of Pacific Mercantile Bank.

Forward-Looking Information

This news release contains statements regarding our expectations, beliefs and views about our plans to continue to build our loan portfolio and supporting systems and processes.  These statements, which constitute “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, can be identified by the fact that they do not relate strictly to historical or current facts. Often, they include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “project,” or words of similar meaning, or future or conditional verbs such as “will,” “would,” “should,” “could,” or “may.” These forward-looking statements are subject to numerous risks and uncertainties. Actual results may differ materially from the results discussed in these forward-looking statements because such statements are inherently subject to significant assumptions, risks and uncertainties, many of which are difficult to predict and are generally beyond our control. These risks and uncertainties include, but are not limited to, the following: the impact of interest rates and other external economic factors and competition among financial services providers. We undertake no obligation (and expressly disclaim any such obligation) to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. For additional information concerning factors that could cause actual conditions, events or results to materially differ from those described in the forward-looking statements, please refer to the factors set forth under the headings “Risk Factors” in our most recent Form 10-K and 10-Q reports and to our most recent Form 8-K reports, which are available online at www.sec.gov. No assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on our results of operations or financial condition.

 

Pacific Mercantile Bank Contact:
Kittridge Chamberlain
EVP & Chief Banking Officer
714-438-2500
Friday, November 18th, 2016 Uncategorized Comments Off on $PMBC Increases Financing for #MarqueMedical to $3.9 Million

$TENX Completion of Enrollment for Phase 3 #LEVOCTS Trial in #CardiacSurgery

– 880 total patients enrolled; top-line data readout currently expected in January 2017 –

Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it has completed patient enrollment for its Phase 3 LEVO-CTS trial in cardiac surgery.

The Company will lock its database after 30-day follow-up from the final patient, and currently expects to report top-line results in January 2017 in conjunction with the study’s lead investigators at Duke Clinical Research Institute (DCRI).

“We are very pleased to reach this milestone after more than two years of hard work, and would like to thank all of the patients and investigators who have taken part in the trial,” said John Kelley, CEO of Tenax Therapeutics. “Consistent clinical execution and increased trial visibility has significantly accelerated the enrollment rate during these past 12 months, and we believe the expanded number of patients ensures that we have the best possible chance for success. We now look forward to sharing top-line results with you during the next few months, and we are prepared for a near-term NDA submission and commercial effort if the data reads out positively. We continue to believe that levosimendan has the potential to fill an important void in the current treatment paradigm for cardiac surgery.”

The trial has enrolled a total of 880 patients. This was larger than the original target enrollment number of 760 patients in order to ensure sufficient powering – which was necessary due to a small number of patients who were randomized but did not receive study drug, a small number of patients missing one or more component measurements of the primary endpoint, and a slightly lower primary endpoint event rate than originally projected.

The LEVO-CTS trial is a double-blind, randomized, placebo-controlled study that is evaluating the use of levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome (LCOS) and associated morbidity and mortality. The trial is also measuring secondary endpoints around potential pharmacoeconomic benefits and the incidence rate of LCOS. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan in this indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA).

The full LEVO-CTS trial design was recently published by the study’s investigators in the American Heart Journal in an article titled, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery on Cardiopulmonary Bypass: Rationale and Study Design of the LEVO-CTS Trial.”

About Levosimendan

Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 50 countries for this indication and not available in the United States. Tenax Therapeutics acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma.

About Tenax Therapeutics

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market. The Company owns the North American rights to develop and commercialize levosimendan, and the United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). The Company is currently in a Phase 3 trial with levosimendan for that indication. For more information, visit www.tenaxthera.com.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the company’s control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its transition report on Form 10-KT filed on March 14, 2016, its quarterly report on Form 10-Q filed on November 9, 2016 as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

 

Investor Contact:
Stern Investor Relations, Inc.
Will O‘Connor, 212-362-1200
will@sternir.com

Friday, November 18th, 2016 Uncategorized Comments Off on $TENX Completion of Enrollment for Phase 3 #LEVOCTS Trial in #CardiacSurgery

$MARPS Announces Fourth Quarter Cash Distribution

DALLAS, Nov. 18, 2016  — Marine Petroleum Trust (NASDAQ: MARPS) (“Marine”) today declared a quarterly cash distribution to the holders of its units of beneficial interest of $0.091087 per unit, payable on December 28, 2016, to unitholders of record on November 30, 2016. Marine’s cash distribution history, current and prior year financial reports, a link to filings made with the Securities and Exchange Commission and more can be found on its website at http://www.marps-marine.com/.

This distribution of $0.091087 per unit is higher than the $0.043507 per unit distributed last quarter. As compared to the previous quarter, the prices for both oil and natural gas and the volume of oil produced and included in the current distribution increased, while the volume of natural gas produced and included in the current distribution decreased. This distribution is higher than the $0.066479 per unit distributed in the comparable quarter in 2015.  As compared to the comparable quarter in 2015, the prices realized for both oil and natural gas and the volume of natural gas produced and included in the current distribution decreased, while the volume of oil produced and included in the current distribution increased.

Marine’s distributions to unitholders are determined by royalties received up to the date the distribution amount is declared. In general, Marine receives royalties two months after oil production and three months after natural gas production.

A copy of Marine’s 2016 tax information is expected to be posted on Marine’s website by March 1, 2017.

Contact: Ron E. Hooper
SVP, Royalty Trust Services
Southwest Bank, Trustee
Toll Free – 1.855.588-7839
Friday, November 18th, 2016 Uncategorized Comments Off on $MARPS Announces Fourth Quarter Cash Distribution

$MTBC Declares Monthly #Dividends

SOMERSET, NJ–(Nov 18, 2016) – MTBC (NASDAQ: MTBC) (NASDAQ: MTBCP), a leading provider of proprietary web-based electronic health records, practice management and mHealth solutions, announced today that its Board of Directors has declared monthly cash dividends for its 11% Series A Cumulative Redeemable Perpetual Preferred Stock (“Series A Preferred Stock”) for December 2016, January 2017 and February 2017.

Holders of shares of the Series A Preferred Stock are entitled to receive cumulative cash dividends at the rate of 11% of the $25.00 per share liquidation preference per annum (equivalent to $2.75 per annum per share). Dividends on the Series A Preferred Stock are payable monthly on the 15th day of each month; provided that if any dividend payment date is not a business day, then the dividend may be paid on the next succeeding business day. Dividends are payable to holders of record on the applicable record date, which shall be the last day of the calendar month, whether or not a business day.

MTBC’s Series A Preferred Stock trades on the NASDAQ Capital Market under the ticker symbol “MTBCP.”

The following table shows the monthly dividends and associated record and payment dates:

Dec. 2016 Jan. 2017 Feb. 2017
Dividend per share $0.22917 $0.22917 $0.22917
Ex-dividend date Dec. 28, 2016 Jan. 27, 2017 Feb. 24, 2017
Record date Dec. 31, 2016 Jan. 31, 2017 Feb. 28, 2017
Payment date Jan. 17, 2017 Feb. 15, 2017 Mar. 15, 2017

About MTBC

Medical Transcription Billing, Corp. is a healthcare information technology company that provides a fully integrated suite of proprietary web-based solutions, together with related business services, to healthcare providers throughout the United States. Our integrated Software-as-a-Service (or SaaS) platform helps our customers increase revenues, streamline workflows and make better business and clinical decisions, while reducing administrative burdens and operating costs. MTBC’s common stock trades on the NASDAQ Capital Market under the ticker symbol “MTBC,” and its Series A Preferred Stock trades on the NASDAQ Capital Market under the ticker symbol “MTBCP.”

For additional information, please visit our website at www.MTBC.com.

Follow MTBC on TWITTER, LINKEDIN and FACEBOOK.

SOURCE MTBC

Disclaimer

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

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$AST #RyanChavez Appointed #CFO

FREMONT, Calif., Nov. 17, 2016  — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced the appointment of Ryan Chavez to the position of Chief Financial Officer. In his expanded role, Mr. Chavez, who will also retain the title of General Counsel, will oversee all financial aspects of the company. Mr. Chavez will continue to report to Asterias’ President and Chief Executive Officer Steve Cartt. Mr. Chavez joined Asterias in July 2016 as its Executive Vice President of Finance and General Counsel.

“Since Ryan joined Asterias earlier this year, he has provided strong financial and legal leadership for Asterias,” said Mr. Cartt. “Ryan’s financial and legal background and prior experience within the healthcare industry will continue to be instrumental as we further execute on our strategy to advance the clinical progress of our therapeutic candidates. He has quickly become a key member of our leadership team, and we look forward to Ryan’s many contributions in the years ahead.”

Prior to joining Asterias, Mr. Chavez was Vice President and General Counsel of Mallinckrodt’s Autoimmune and Rare Disease Division. Before joining Mallinckrodt in August 2014, he served as Associate General Counsel at Questcor. Prior to joining Questcor in October 2012, he worked at the law firms of Stradling, Yocca, Carlson & Rauth and Rutan & Tucker. Previously, Mr. Chavez served in various financial roles at General Electric Co. He earned his J.D., magna cum laude, from Chapman University School of Law and his B.A. with honors and distinction from Stanford University.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its immunotherapy and pluripotent stem cell platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury.

AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias after demonstrating promise in a Phase 2 study in Acute Myeloid Leukemia (AML) and completing a successful end-of-Phase 2 meeting with the FDA. The company is currently focused on streamlining and modernizing the manufacturing process for AST-VAC1 in advance of a planned initiation of a confirmatory phase 2b study. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in the first half of 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

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$MBRX Announces Positive #FDA Guidance Regarding #Annamycin #IND

Company Signals Earlier Start to Next Clinical Trial & Expects to File IND Submission before Year-End

HOUSTON, TX–(November 17, 2016) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has received verbal positive guidance from the FDA regarding its planned IND submission indicating that the Company may incorporate by reference the IND established by a prior developer.

Moleculin’s Chairman and CEO, Walter Klemp, commented, “This new positive guidance removes a major question mark and allows us to create a tighter timeline for the estimated beginning of our next clinical trial. To be clear, we still can’t rule out the possibility of a delay in the timeline, but with the knowledge that the FDA is encouraging us to simply incorporate by reference the prior developer’s IND, we believe we can accelerate our IND submission process. On our current path, we expect to be able to file our IND submission before year end. Barring a negative surprise from the FDA’s review of our submission, that should allow us to begin treating patients in our next clinical trial several months sooner than expected.”

The Company has indicated in previous disclosures that it expected to begin its next clinical trial by the first half of 2017, however this development may reduce that time frame by several months. The Company has submitted a pre-IND briefing document to the FDA along with key questions regarding its clinical development plan and a request for a meeting, if the FDA deems it necessary. The FDA recently indicated in writing that it intends to provide written responses to the Company by December 6, 2016 and that it does not believe a live meeting is necessary. Once those written responses are received, the Company will adjust its final IND submission document accordingly and submit for final FDA review. IND submissions are normally reviewed within 30 days of filing.

The beginning of the Company’s next clinical trial for Annamycin will depend on many things, including but not limited to the absence of any objections by the FDA to the Company’s IND submission, review and approval by an appropriate Institutional Review Board (IRB) representing the proposed clinical site or sites, and the ultimate recruitment of patients by qualified clinical testing sites.

Dr. Don Picker, Moleculin’s COO added, “Based on this positive guidance, we have already begun discussions with suitable testing sites so that we can begin recruiting as soon as we have IRB approval. We intend to hit the ground running as soon as the IND is active.”

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a preclinical and clinical-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, a Phase II clinical stage anthracycline for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML. We also have two pre-clinical 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 Moleculin, 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 results of the FDA’s review of our IND submission, the timing of the FDA’s review of our IND submission and our ability to commence our clinical trial several months earlier than expected, and the approval by an appropriate IRB representing the proposed clinical site or sites and the ultimate recruitment of patients by qualified clinical testing sites. 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 the heading “Risk Factors” in our Registration Statement on Form S-1 originally filed with the Securities and Exchange Commission on February 1, 2016, as amended (Registration No. 333-209323). 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.

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

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$FHCO Positive #PREBOOST Study Data

Company Plans to Launch Product in US Before Year End

MIAMI, Nov. 17, 2016  — The Female Health Company / Veru Healthcare (NASDAQ:FHCO) today announced top line interim analysis of an independent, double-blind, randomized, controlled clinical study of the company’s novel PREBOOST® product (topical 4% benzocaine wipes) for the management of premature ejaculation (PE).  The scientific abstract that describes the full interim analysis results has been submitted to a major urological medical conference.  The company plans to launch PREBOOST® in the US before year-end.

The independent clinical study was conducted by Jed Kaminetsky, M.D., Medical Director at Manhattan Medical Research, Clinical Assistant Professor of Urology at New York University Medical Center, and practicing urologist with University Urology Associates; Michael Yang, Clinical Research Coordinator at Manhattan Medical Research and University Urology Associates; Michael Perelman. M.D., Clinical Professor Emeritus of Psychology in Psychiatry at Weill Cornell Medical College; and, Ridwan Shabsigh, M.D., Professor of Urology at Weill Cornell Medical College, and  President of the International Society of Men’s Health.  The clinical study was supported by Veru Healthcare.

The top line results of the interim analysis from 21 men show:

  • After two months, men treated with PREBOOST® had statistically significant improvement in their ability to control ejaculation, with a mean increase in duration of almost four minutes, which was significantly greater than men on placebo.  After treatment with PREBOOST, 80% of men were no longer considered to have PE;
  • Men treated with PREBOOST® reported a statistically significant better sense of ejaculation control, confidence, satisfaction, sexual pleasure, length of intercourse and reduced frustration;
  • PREBOOST® was well tolerated and no transference was reported;
  • The interim clinical study met the primary endpoint of change in average intravaginal ejaculatory latency time (IELT) at two months and secondary outcomes of change in questionnaire assessments, such as global rating of distress, medication assessment, and Index of Premature Ejaculation (IPE).

PREBOOST® is a new, proprietary over-the-counter (OTC) male genital desensitizer used for the treatment of PE.  Unlike currently available OTC anesthetic sprays using lidocaine or gels using benzocaine, PREBOOST® is an individually packaged wipe containing 4% benzocaine, which allows for direct and precise application of the same dosage each time.

“Our interim results in men with PE show that PREBOOST® appears to prolong time to ejaculation, supporting the clinical validity of PREBOOST® for the management of PE,” said Mitchell Steiner, M.D. President and Chief Executive Officer of The Female Health Company / Veru Healthcare.  “These interim analysis results show that PREBOOST® improved both objective and subjective symptoms of PE compared to placebo.  We believe PREBOOST® has significant advantages over currently available therapies, especially with regard to ease of use, delivery system and convenience.”

“Our plan is to launch PREBOOST® in the US later this quarter through digital and social media marketing,” said Shiao Zhu, Vice President of Marketing of Veru Healthcare.  “We look forward to being able to provide a tested medical therapy to men and couples who suffer from PE.”

For more information about PREBOOST®, please visit www.preboost.com.

About Premature Ejaculation (PE):
PE is defined by the International Society for Sexual Medicine as, persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it.  PE is the most common sexual dysfunction, even more common than erectile dysfunction, according to numerous epidemiological studies.  It is a problem for couples and the most commonly observed sexual disorder in men below 40 years of age.  PE is a self-reported diagnosis with a prevalence rate of 20-30 percent.  The estimated prevalence of PE is 50 million men in the US and 60 million men in Europe.  Total worldwide market for premature ejaculation drugs and consumer health care products is estimated to be greater than $500 million annually.

About PREBOOST®:
PREBOOST® is a new, proprietary OTC male genital desensitizer used for the treatment of PE.  There are no prescription products for PE approved by the United States FDA.  Off label use of antidepressants and PDE-5 inhibitors have been used with limited success because of inconsistent efficacy and unacceptable side effects.  Psychological counseling and behavioral therapy are also used with mixed results.  Of the consumer health products, the topical anesthetics are administered as sprays and gels.  The drawbacks of these approaches include inconsistent dosing leading to too much anesthetic and transference of the anesthetics to the partner.  PREBOOST® is compliant with the FDA monograph and is approved in the United States.  PREBOOST® is the only individually packaged medicated wipe that contains a desensitizing agent (benzocaine 4.0%).  The advantages are: 1) Convenient individually wrapped wipes so it is easier to carry and to be discreet, 2) The correct dose is delivered each time 3) The medicine is applied topically and dries quickly which prevents the potential for transference to partner, and 4) Benzocaine at 4.0% temporarily desensitizes, but does not numb the penis.

The Company plans to implement a sampling program targeting urologists, co-promoting with a marketing partner, introducing the product through Walmart, CVS, Walgreens and other OTC distribution outlets, optimizing its internet ecommerce capabilities and digital marketing via www.preboost.com, as well as through out-licensing opportunities for markets outside the U.S.

About The Female Health Company
The Female Health Company is a specialty pharmaceutical and medical device company, with a focus on pharmaceutical products that qualify for the 505(b)(2) FDA regulatory pathway that can result in more rapid approval than a full new drug application.  The company is organized as follows: Veru Healthcare manages the Pharmaceuticals and Medical Devices division, which develops and commercializes pharmaceutical and medical device products for men’s and women’s health and oncology, as well as the Consumer Health division, which is focused on commercializing sexual health products, including FC2 Female Condom® (FC2) and PREBOOST®, for the consumer market.  The Female Health Company through its Global Public Health Division manages the global public health sector FC2 business.  This division markets FC2 to entities, including ministries of health, government health agencies, non-profit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world.

More information about the Female Health Company and its products can be found at www.femalehealth.com, www.veruhealthcare.com and www.femalecondom.org.  For corporate and investor-related information about the company, please visit www.FHCinvestor.com.

“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:
The statements in this release which are not historical fact are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995.  These statements are based upon the Company’s current plans and strategies, and reflect the Company’s current assessment of the risks and uncertainties related to its business, and are made as of the date of this release.  The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events, developments or circumstances.  Such forward-looking statements are inherently subject to known and unknown risks and uncertainties.  The Company’s actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements.  Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following:  product demand and market acceptance; competition in the Company’s markets and the risk of new competitors and new competitive product introductions; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; risks related to the development of the Company’s product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; many of the Company’s products are at an early stage of development and the Company may fail to successfully commercialize such products; the length, cost and uncertain results of the Company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the Company’s product candidates; risks related to intellectual property, including licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay or restructuring; a governmental tender award indicates acceptance of the bidder’s price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other global public health sector customers may order and purchase fewer units than the full maximum tender amount; the Company’s reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public health sector; the economic and business environment and the impact of government pressures; the Company’s reliance on its major customers and risks related to delays in payment of accounts receivable by major customers; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company’s production capacity, efficiency and supply constraints; risks related to the costs and other effects of litigation; the Company’s ability to identify and successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the year ended September 30, 2015 and the Company’s proxy statement filed on August 8, 2016.  These documents are available on the “SEC Filings” section of our website at www.femalehealth.com/investors

Contact:
Kevin Gilbert 312-366-2633
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$SYUT Enters into Definitive #Merger Agreement for #GoingPrivate Transaction

QINGDAO, China and ROCKVILLE, Md., Nov. 17, 2016  — Synutra International, Inc. (Nasdaq: SYUT), (“Synutra” or the “Company”), which owns subsidiaries in China that produce, distribute and sell nutritional products for infants, children and adults, today announced it has entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Beams Power Investment Limited, a company with limited liability incorporated under the laws of the British Virgin Islands (“Parent”), and Beams Power Merger Sub Limited, a Delaware corporation and a wholly-owned subsidiary of Parent (“Merger Sub”), pursuant to which Merger Sub will merge with and into the Company, with the Company continuing as the surviving corporation and a wholly-owned subsidiary of Parent (the “Merger”). Parent currently beneficially owns approximately 63.5% of the Company’s outstanding shares of common stock, $0.0001 par value per share (the “Company Common Stock”). Ms. Xiuqing Meng, spouse of Mr. Liang Zhang, is the sole shareholder of Parent. Mr. Liang Zhang is the chairman and chief executive officer of the Company.

Pursuant to the terms of the Merger Agreement, at the effective time of the Merger, each share of Company Common Stock issued and outstanding immediately prior to such effective time (other than (i) the shares held by (a) Parent, Merger Sub and any other direct or indirect subsidiary of Parent and (b) the Company and (ii) the shares in respect of which appraisal rights have been properly and validly exercised under Delaware law) will be automatically canceled and converted into the right to receive $6.05 in cash (the “Merger Consideration”), without interest. The Merger Consideration represents a 58% premium over the closing price of the Company Common Stock as quoted by NASDAQ Global Select Market (the “NASDAQ”) on January 14, 2016, and a premium of 31% and 20%, respectively, over the Company’s 30- and 60-trading day volume-weighted average price as quoted by the NASDAQ prior to January 14, 2016, the last trading day prior to the Company’s announcement on January 15, 2016 that it had received a non-binding “going private” proposal.

Parent has secured a committed loan facility from Shanghai Pudong Development Bank Co., Ltd. to finance the transactions contemplated by the Merger Agreement, including the Merger.

The Company’s board of directors, acting upon the unanimous recommendation of the special committee formed by the board of directors (the “Special Committee”), unanimously approved the Merger Agreement and the transactions contemplated by the Merger Agreement, including the Merger, and resolved to recommend that the Company’s stockholders adopt the Merger Agreement and the transactions contemplated by the Merger Agreement, including the Merger. The Special Committee, which is composed solely of independent directors of the Company who are unaffiliated with Parent, Merger Sub or management of the Company, exclusively negotiated the terms of the Merger Agreement with the buyer group consisting of Mr. Liang Zhang, Ms. Xiuqing Meng, Parent and Merger Sub, with the assistance of its independent financial and legal advisors.

The Merger is subject to stockholder approval as well as certain other customary closing conditions. Pursuant to the Merger Agreement, adoption of the Merger Agreement by the Company’s stockholders requires the affirmative vote of (i) the holders of at least a majority of the Company Common Stock and (ii) the holders of at least a majority of the Company Common Stock other than the shares of Company Common Stock held by (a) Parent, Merger Sub and any other direct or indirect subsidiary of Parent and (b) the Company. The Company will call a meeting of stockholders for the purpose of voting on the adoption of the Merger Agreement as soon as practicable. If completed, the Merger will, under laws of the State of Delaware, result in the Company becoming a privately-held company and the Company Common Stock would no longer be listed on the NASDAQ.

Houlihan Lokey Capital, Inc. is serving as the financial advisor to the Special Committee, Cleary Gottlieb Steen & Hamilton LLP is serving as U.S. legal counsel to the Special Committee, and Potter Anderson & Corroon LLP is serving as Delaware legal counsel to the Special Committee. Wilson Sonsini Goodrich & Rosati is serving as U.S. and Delaware legal counsel to the Company.

Davis Polk & Wardwell LLP is serving as U.S. legal counsel to the buyer group.

Additional Information about the Transactions

The Company will file with the Securities and Exchange Commission (the “SEC”) a report on Form 8-K regarding the proposed transactions described in this announcement, which will include as an exhibit thereto the Merger Agreement. All parties desiring details regarding the transactions contemplated by the Merger Agreement, including the Merger, are urged to review these documents, which will be available at the SEC’s website (http://www.sec.gov).

In connection with the special meeting of the stockholders of the Company to be held to approve the Merger, the Company will prepare and mail a proxy statement to its stockholders. In addition, certain participants in the Merger will prepare and mail to the Company’s stockholders a Schedule 13E-3 transaction statement. These documents will be filed with or furnished to the SEC. INVESTORS AND STOCKHOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THESE MATERIALS AND OTHER MATERIALS FILED WITH OR FURNISHED TO THE SEC WHEN THEY BECOME AVAILABLE, AS THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE TRANSACTIONS CONTEMPLATED BY THE MERGER AGREEMENT AND RELATED MATTERS. In addition to receiving the proxy statement and Schedule 13E-3 transaction statement by mail, stockholders also will be able to obtain these documents, as well as other filings containing information about the Company, the Merger and related matters, without charge, from the SEC’s website (http://www.sec.gov) or at the SEC’s public reference room at 100 F Street, NE, Room 1580, Washington, D.C. 20549.

The Company and certain of its directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be “participants” in the solicitation of proxies from the Company’s stockholders with respect to the Merger. Information regarding the persons who may be considered “participants” in the solicitation of proxies will be set forth in the proxy statement and Schedule 13E-3 transaction statement relating to the Merger when it is filed with the SEC. Information regarding certain of these persons and their beneficial ownership of the Company Common Stock as of June 13, 2016 is also set forth in the Company’s Form 10-K, which was filed with the SEC on June 13, 2016. Additional information regarding the interests of such potential participants will be included in the proxy statement and Schedule 13E-3 transaction statement and the other relevant documents filed with the SEC when they become available.

This announcement is neither a solicitation of proxy, an offer to purchase nor a solicitation of an offer to sell any securities and it is not a substitute for any proxy statement or other filings that may be made with the SEC should the Merger proceed.

About Synutra International, Inc.

Synutra International, Inc. (Nasdaq: SYUT) is a leading infant formula company in China. It principally produces, markets and sells its products through its operating subsidiaries under the “Shengyuan” or “Synutra” name, together with other complementary brands. It focuses on selling premium infant formula products, which are supplemented by more affordable infant formulas targeting the mass market as well as other nutritional products and ingredients. It sells its products through an extensive nationwide sales and distribution network covering all provinces and provincial-level municipalities in mainland China. As of September 30, 2016, this network comprised over 960 independent distributors and over 280 independent sub-distributors who sell Synutra products in approximately 26,900 retail outlets.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on our current expectations, assumptions, estimates and projections about Synutra. All statements other than statements of historical fact in this release are forward-looking statements. In some cases, these forward-looking statements can be identified by words or phrases such as “anticipate,” “believe,” “continue,” “estimate,” “expect,” “intend,” “is/are likely to,” “may,” “plan,” “should,” “will,” “aim,” “potential,” “continue,” or other similar expressions. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. Potential risks and uncertainties include, without limitation, uncertainties as to the expected benefits and costs of the proposed Merger, the expected timing of the completion of the Merger, the parties’ ability to complete the Merger considering the various closing conditions, the possibility that various closing conditions to the Merger may not be satisfied or waived, how Synutra’s stockholders will vote at the meeting of stockholders, the possibility that competing offers will be made and other risks and uncertainties discussed in Synutra’s filings with the SEC, as well as the Schedule 13E-3 transaction statement and the proxy statement to be filed by Synutra in connection with the Merger. The forward-looking statements are made as of the date of this press release. Synutra undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date on which the statements are made or to reflect the occurrence of unanticipated events.

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$ONCS Announces Key Corporate Initiatives

– OncoSec is Executing on a Melanoma Registration-Directed Clinical Program with Immunopulse® IL-12 and Anti-PD-1 Therapy – OncoSec Plans to Utilize its DNA Platform Technology to Target Multiple Immune Candidates Within One Therapy – OncoSec Introduces Next-Generation Electroporation Technology to Revolutionize the Electroporation Field – OncoSec Launches Technology Access Program to Facilitate Wider Collaborations

SAN DIEGO, Nov. 17, 2016  — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will provide updates today on multiple key corporate initiatives at the Company’s inaugural Investor and Analyst Day in San Diego, CA, including plans for a melanoma combination directed-registration study of OncoSec’s lead product candidate, ImmunoPulse® IL-12, in combination with  anti-PD-1 therapy.  In addition, the Company will provide details on its preclinical multi-gene plasmid constructs, Tissue-based Real-time Adaptive Controlled Electroporation (TRACE™), and its Technology Access Program (TAP). OncoSec will also highlight the new Phase II melanoma data that was recently presented at the Society for Immunotherapy of Cancer Annual Meeting (“SITC 2016”).

“By focusing our clinical programs on patients who do not respond to anti-PD-1 therapy, we are committed to developing therapies for those in critical need of alternative treatments,” said Punit Dhillon, President and CEO of OncoSec. “The favorable anti-tumor activity and safety data garnered from the Investigator Sponsored Trial (IST) Phase II clinical trial combining ImmunoPulse® IL-12 and KEYTRUDA® (pembrolizumab) provides us with additional confidence to move forward with key regulatory, clinical and commercial efforts aimed at achieving marketing approval for ImmunoPulse® IL-12 in anti-PD-1 non responder advanced melanoma.  We are pleased to be focused on a registration-directed clinical program with a regulatory path that we hope will lead to a potential FDA approval for our first commercial product in 2019.”

“We are changing the way clinicians and scientists think about the use of technology to manipulate cellular activity with the power of DNA construct delivery and activation through our innovative, easy to use, next-generation gene electro-transfer devices,” continued Mr. Dhillon.  “We believe our development strategy for ImmunoPulse® IL-12 will lead to a large market opportunity, and can generate significant value for shareholders and provide a strong foundation for advancing OncoSec’s next clinical candidate in first-in-human studies in 2018.”

A replay of the event webcast will be available shortly after the meeting and can be accessed for up to 12 months through the Events and Presentations section under the Investors tab of OncoSec’s website at www.oncosec.com.

About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer.  ImmunoPulse® is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulse®IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various solid tumors as well as the potential to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse®IL-12, is currently in clinical development for several indications, including metastatic melanoma, head and neck cancer, and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in patients with melanoma who are refractory or non-responsive to anti-PD-1/PD-L1 therapies. In addition to ImmunoPulse® IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse® platform. For more information, please visit www.oncosec.com.

OncoSec Medical Incorporated, Forward Looking Statements
To the extent statements contained in this press release are not descriptions of historical facts regarding OncoSec Medical Incorporated, they may be considered forward looking statements, as described in the Private Securities Litigation Reform Act of 1995, reflecting management’s current beliefs and expectations. Forward looking statements speak only as of the date they are made, and they are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by such statements. You can identify forward-looking statements by words such as “aimed at,” “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “focus,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward looking statements contained in this press release include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop and commercialize our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) our and our partners’ ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process; (v) the size and growth potential of the markets for our product candidates, and our ability to serve those markets; (vi) the rate and degree of acceptance of our product candidates; (vii) our ability to attract and retain key scientific or management personnel; (viii) the anticipated timing of clinical data availability; (ix) the anticipated timing of commercial launch of ImmunoPulse® IL-12; (x) our ability to meet our milestones; (xi) our expectations regarding our ability to obtain and maintain intellectual property protection; (xii) the level of our corporate expenditures; (xiii) the assessment of our technology by potential corporate partners; and, (xiv) the impact of capital market conditions on our Company. Undue reliance should not be placed on forward looking statements. Such statements are subject to factors, risks and uncertainties, such as those described in our periodic filings with the Securities and Exchange Commission, including without limitation our Quarterly Reports on Form 10-Q, our annual reports on Form 10-K and other filings. Various factors may cause actual results to differ materially from those expressed or implied by such forward looking statements. We undertake no obligation to publicly update any forward-looking statements. OncoSec’s investigational drug and device products have not been approved or cleared by the FDA.

CONTACT:
Sophia Ononye, PhD MPH MBA
Associate Director, Investor Relations and Corporate Communications
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com

Thursday, November 17th, 2016 Uncategorized Comments Off on $ONCS Announces Key Corporate Initiatives

$ZDGE Releases New #Ringtone #App for #iOS on #iTunes

“Zedge Ringtones” enables more people to join the 220 million Zedgers who enjoy high quality content to personalize their phones

Zedge, Inc. (NYSE MKT: ZDGE), the global leader in smartphone personalization, today announced the release of its new, free Zedge™ Ringtone App available in the iTunes Store. The new app — Zedge’s second in the iTunes Store — brings the company’s extensive catalogue of popular ringtones to iPhone users interested in personalized sounds that express their emotions and tastes in a fun and entertaining way.

“Zedge has become synonymous with smartphone personalization, and we’re thrilled to deliver Zedgers, everywhere, a unique catalog of fresh, high-quality ringtones, notification sounds and alarms,” said Tom Arnoy, co-founder and CEO of Zedge. “This launch is an important milestone in our commitment to working with Apple and to meeting iPhone users’ demand for personalization content. It also marks a fresh approach for Zedge in designing and delivering great mobile device experiences specifically for the Apple ecosystem.”

The new Zedge Ringtone app is the culmination of Zedge’s goal to re-introduce its popular ringtone offering to iPhone users after Apple pulled the popular Zedge Wallpaper & Ringtones app earlier this year. The new Zedge Ringtone app complements the existing Zedge Wallpaper app on iOS, which has averaged in the top 10 free entertainment apps in iTunes U.S.A. since its launch in March 2016.

“The rollout of Zedge Ringtones on iOS is accompanied by significant investment in developing new and exciting audio content, as well as Zedge’s commitment to ongoing and frequent product enhancements and updates and a focus on capitalizing on new opportunities that are availed via Apple’s iOS platform,” said Arnoy.

The new Zedge Ringtones app is currently available in the U.S. and Canada, and will be available worldwide by December 1, 2016. Overall, Zedge enjoys more than 220 million downloads worldwide across Android and iOS platforms. For more information, please visit www.zedge.net.

About Zedge

Zedge is a global leader in smartphone personalization, with more than 220 million app installs and 32 million monthly active users. People use Zedge to make their smartphones more personal and to express their emotions, tastes and interests using wallpapers, icons, widgets, ringtones and more. The Zedge platform enables brands, artists and creators to share their smartphone personalization content with their fans in order to extend their reach, reinforce their message and gain valuable insight into how customers interact with their content. Follow us on social via @Zedge on Twitter and Facebook at https://www.facebook.com/officialzedge/.

 

mPR, Inc. for Zedge
Jean Lombard, 415-308-5326
jean@mpublicrelations.com
or
Maggie Habib, 310-916-6934
maggie@mpublicrelations.com

Wednesday, November 16th, 2016 Uncategorized Comments Off on $ZDGE Releases New #Ringtone #App for #iOS on #iTunes

$MTLS & #PTC Partner to Offer #Cloud Based, #3DPrinting Solution

Materialise NV (NASDAQ:MTLS), is proud to announce an alliance with PTC, which sees PTC tapping into Materialise’s backbone of 3D printing software and solutions to enable users of PTC’s highly-anticipated Creo® 4.0 software to 3D print designs directly through the cloud-based i.materialise platform. Powered by the Materialise Magics 3D Print Suite and connected to one of the world’s largest and most complete factories for 3D printing, the i.materialise platform offers high-quality 3D prints in 19 different materials and 100+ possible color and finish combinations.

“When we launched the i.materialise platform in 2009, we did so with the aim of giving more consumers, home professionals, and small businesses access to the best that professional-quality 3D printing had to offer, giving physical form to creative ideas in a variety of materials and finishes to match our customers’ functional, aesthetic, and budgetary needs,” stated Materialise CTO, Bart Van der Schueren. “Today, we are excited to be partnering with PTC to expand the reach of these benefits to an even greater audience through a planned integration with Creo 4.0, and we look forward to working together with their team to even further improve the experience of their users.”

Paul Sagar, Vice President of Product Management at PTC, stated, “For more than 20 years, people have been using 3D printing to manufacture rapid prototypes. However, in recent years, the technology has proven increasingly useful for final production parts, in part because 3D printing makes it possible to manufacture ultra-light components by enabling lattice structures that provide all of the strength, with a fraction of the material. Therefore, in Creo 4.0, we’re adding capabilities to design, analyze and optimize these highly complex lattice structures directly inside the model. In addition, the planned integration with i.materialise will allow Creo 4.0 users to directly order professional-grade 3D prints in the material and finishing required.”

As a partner of PTC, Materialise looks forward to giving Creo 4.0 users direct access to a comprehensive range of 3D printing technologies and finishes, and to working further with the PTC team to help their customers successfully design and manufacture end-use parts.

About Materialise
Materialise incorporates more than 25 years of 3D printing experience into a range of software solutions and 3D printing services, which together form the backbone of 3D printing technologies. Materialise’s open and flexible solutions enable players in a wide variety of industries, including healthcare, automotive, aerospace, art and design, and consumer goods, to build innovative 3D printing applications that aim to make the world a better and healthier place. Headquartered in Belgium, with branches worldwide, Materialise combines the largest group of software developers in the industry with one of the largest 3D printing facilities in the world. For additional information, please visit: www.materialise.com.

About i.materialise
i.materialise offers anyone with an eye for design and a head full of ideas the chance to turn dreams into affordable high-quality 3D reality. Be it directly via i.materialise’s on-line printing platform, or indirectly as 3Dprint fulfillment partner for a range of applications, their platform offers a clear and user-friendly interface, in addition to advanced tools for print optimization. Through extensive material research the service caters to creative minds and entrepreneurs worldwide with the largest combination of materials and finishes in the market (including metals and ceramics). For additional information, please visit: i.materialise.com.

Cautionary Statement on Forward-Looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements relating to, among other things, our planned commercialization efforts and regulatory approvals of our technologies as well as the success thereof and our research and development projects. These forward-looking statements are based upon the expectations of management under current assumptions at the time of this press release. We caution you that forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control that may cause our actual results to differ materially from our expectations. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise, unless we have obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.

PTC, Creo, and the PTC logo are trademarks or registered trademarks of PTC Inc. or its subsidiaries in the United States and other countries.

 

Materialise
Press contacts:
Vanessa Palsenbarg, Phone: +32 16 39 66 37
Fax: +32 16 39 66 00
Corporate Communications Manager, Materialise
Email: press@materialise.com
Twitter: @MaterialiseNV
Visit: www.materialise.com

Wednesday, November 16th, 2016 Uncategorized Comments Off on $MTLS & #PTC Partner to Offer #Cloud Based, #3DPrinting Solution

$CLRB #SeeThruEquity Issues Update

NEW YORK, NY / November 16, 2016 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced it issued an update on Cellectar Biosciences, Inc. (NASDAQ: CLRB).

The full report can be downloaded from SeeThruEquity’s website.

Highlights from the update are as follows:

On November 10, 2016, Cellectar provided an upbeat corporate update with the following highlights:

  • Encouraging clinical update from Cohort 2 of its Phase 1 Study of its lead product candidate, CLR 131 for multiple myeloma. CLR 131 showed a positive adverse event profile with improving efficacy data at the single dosage of 18.75mCi/m2

 

  • Significant non-dilutive funding awards including a $2mn NCI grant to fund a Phase 2 study of CLR 131 in multiple myeloma and other selected orphan-designated hematologic malignancies

CLRB announces promising Phase 1 results for CLR 131

On November 10, 2016, Cellectar management provided an upbeat clinical update in which the company reported on Cohort 2 of its Phase 1 study for the potential treatment of relapse / refractory multiple myeloma. The study showed encouraging results with the dose increase in Cohort 2 to 18.75mCi/m2 from 12.5mCi/m2 in Cohort 1, with progression free survival (PFS) increasing by 30% to 120 days and continuing for two of four patients as of October 7, 2016. While the population size of the study was small, it is worth noting that the PFS data compares favorably with pivotal study results for approved multiple myeloma drugs Pomalyst and Daratumumab.

Cohort 3 ongoing, now expecting Phase 2 trial in 1Q17

Management indicated that it has already initiated Cohort 3, and which will consist of a dose of 25mCi/m2, an increase of 33% from 18.75mCi/m2. We are looking forward to data from this Cohort 3 the future. Importantly, Cellectar stated that it was ahead of schedule for the initiation of its Phase 2 Study for CLR 131, which will examine CLR 131 in relapse / refractory multiple myeloma and other hematologic cancers. The company now expects to initiate this study in 1Q17, and should also benefit from access to a $2mn award from the National Cancer Institute (NCI) Fast Track Small Business Innovation Research (“SBIR”), which will be applied to fund a portion of the study. Cellectar stated that the Phase 2 study of CLR 131 will have 60 – 80 patients, and will be designed with the intention to set the stage for a pivotal clinical trial for multiple myeloma. Additionally, the trial should provide meaningful data as to other potential indications for CLR 131.

Maintain price target of $7.44 for Cellectar

We continue to see Cellectar as a high risk / high potential reward company in the biotechnology sector, with the potential to develop and commercialize an impactful new delivery technology in oncology therapeutics.

Please review important disclosures at www.seethruequity.com.

About Cellectar Biosciences, Inc.

Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase 1 study in patients with relapsed or refractory multiple myeloma. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For additional information please visit www.cellectarbiosciences.com.

About SeeThruEquity

Since its founding in 2011, SeeThruEquity has been committed to its core mission: providing impactful, high quality research on underfollowed smallcap and microcap equities. SeeThruEquity has pioneered an innovative business model for equity research that is not paid for and is unbiased. SeeThruEquity is the host of acclaimed investor conferences that are the ultimate event for publicly traded companies with market capitalizations less than $1 billion.

SeeThruEquity is approved to contribute its research reports and estimates to Thomson One Analytics (First Call), the leading estimates platform on Wall Street, as well as Capital IQ and FactSet. SeeThruEquity maintains one of the industry’s most extensive databases of opt-in institutional and high net worth investors. The firm is headquartered in Midtown Manhattan in New York City.

For more information, visit www.seethruequity.com.

Contact:

Ajay Tandon
SeeThruEquity
info@seethruequity.com

Wednesday, November 16th, 2016 Uncategorized Comments Off on $CLRB #SeeThruEquity Issues Update

$MTBC Named in #Deloitte’s 2016 #TechnologyFast500

SOMERSET, NJ–(Nov 16, 2016) – MTBC (NASDAQ: MTBC) (NASDAQ: MTBCP), one of the fastest growing technology companies in the U.S., today announced that it has been named in Deloitte’s Technology Fast 500™ ranking based on its 130% revenue growth from 2012 to 2015.

“As we celebrate our fifteenth year of business, we thank our customers and employees for enabling us to continue growing at a rate that even outpaces most early stage private and public companies,” said Stephen Snyder, President of MTBC. He continued, “Of the 500 companies ranked on Deloitte’s prestigious list in 2016, MTBC was among a smaller subset of the named companies that is publicly traded on NASDAQ and we are honored to be included among this group of market leaders.”

MTBC credits the combination of the company’s leading technology platform and its high quality, cost-efficient operations team across five countries — including approximately 250 IT and R&D professionals — for driving the company’s 130% revenue growth. MTBC’s technology and business model allows it to deliver a superior Software-as-a-Service (“SaaS”) offering to healthcare providers at a lower price point than its competition. MTBC’s proprietary, cloud-based technology platform is leveraged by healthcare providers across the U.S. to streamline business workflows, improve clinical decision-making and increase profitability.

About Deloitte’s 2016 Technology Fast 500™

Deloitte’s Technology Fast 500 provides a ranking of the fastest growing technology, media, telecommunications, life sciences and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2012 to 2015.

In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least $50,000, and current-year operating revenues of at least $5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.

As used in this document, “Deloitte” means Deloitte LLP and its subsidiaries. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.

About MTBC

MTBC is a healthcare information technology company that provides a fully integrated suite of proprietary web-based and mobile health solutions, together with related business services, to healthcare providers throughout the United States. Its integrated SaaS platform helps its customers increase revenues, streamline workflows and make better business and clinical decisions, while reducing administrative burdens and operating costs. MTBC’s common stock trades on the NASDAQ Capital Market under the ticker symbol “MTBC,” and its Series A Preferred Stock trades on the NASDAQ Capital Market under the ticker symbol “MTBCP.”

For more information on MTBC, please visit www.mtbc.com.

Follow MTBC on TWITTER, LINKEDIN and FACEBOOK.

SOURCE MTBC

MTBC Investor and Media Contact:
Christine J. Petraglia
Managing Director
PCG Advisory Group
christine@pcgadvisory.com
(646) 731-9817

Company Contact:
Bill Korn
Chief Financial Officer
Medical Transcription Billing, Corp.
bkorn@mtbc.com
(732) 873-5133

Wednesday, November 16th, 2016 Uncategorized Comments Off on $MTBC Named in #Deloitte’s 2016 #TechnologyFast500

$CLRB Announces #INCResearch as the #CRO for the Phase II Trial of #CLR131

MADISON, Wis., Nov. 15, 2016  — Cellectar Biosciences, Inc. (Nasdaq:CLRB) (the “company”), an oncology-focused, clinical stage biotechnology company, today announced it has selected INC Research (Nasdaq:INCR), a leading global Phase I to IV contract research organization, to oversee its NCI-supported Phase II clinical trial of CLR 131 in patients with multiple myeloma and select hematologic malignancies.  The company anticipates that its $2M NCI grant will cover approximately 50 percent of the study’s cost, and the terms of the grant allow Cellectar to pursue an additional $3M for a pivotal Phase III trial of the company’s lead radiotherapeutic compound.

Cellectar plans to leverage the results of its 80-patient, Phase II study to optimally design its pivotal trial of CLR 131 in multiple myeloma and other hematologic malignancies. The multi-armed study will include relapse/refractory patients with multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL), who have been treated with standard therapy for their underlying malignancies.  The company recently accelerated its guidance and announced plans to initiate the trial during the first quarter of 2017.

“INC Research has outstanding experience in cancer clinical research and a strong reputation within the hematology community. With strong investigator relationships, proven operational expertise and a commitment to high-quality data, they are the ideal partner for this important trial,” said Jim Caruso, president and CEO of Cellectar.  “Given the accelerated initiation of our Phase II study to the first quarter of 2017 and that we will utilize as many as 15 participating sites, we can confidently plan on providing initial efficacy data in the second half of 2017.”

About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies.  It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma.  The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017.  Based upon preclinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life.  CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells.  The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs).  The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications.  The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells.  Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in over 70 different xenograft models of cancer.

About Relapsed or Refractory Multiple Myeloma
Multiple myeloma is the second most common blood or hematologic cancer with approximately 30,000 new cases in the United States every year.  It affects a specific type of blood cells known as plasma cells.  Plasma cells are white blood cells that produce antibodies to help fight infections.  While treatable for a time, multiple myeloma is incurable and almost all patients will relapse or the cancer will become resistant/refractory to current therapies.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells.  Cellectar’s PDC platform is based on the company’s proprietary phospholipid ether analogs.  These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers.  Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging.  The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload.  CLR 131 is currently being evaluated under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma.  In addition, the company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017.   The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1602-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts.  For more information please visit www.cellectar.com.

About INC Research
INC Research (Nasdaq:INCR) is a leading global contract research organization (“CRO”) providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industries. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. The Company was named “Best Contract Research Organization” in December 2015 by an independent panel for Scrip Intelligence, and ranked “Top CRO to Work With” among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey.  INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 110 countries. For more information, please visit www.incresearch.com and connect with us on LinkedIn and Twitter @inc_research.

This news release contains forward-looking statements.  You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates.  These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made.  These statements are based on our current beliefs and expectations as to such future outcomes.  Drug discovery and development involve a high degree of risk.  Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.  A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2015.  These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

CONTACT:

Jules Abraham
JQA Partners
917-885-7378
jabraham@jqapartners.com

INVESTOR CONTACT:
Stephanie Prince
Managing Director
PCG Advisory Group
646-762-4518
sprince@pcgadvisory.com
Tuesday, November 15th, 2016 Uncategorized Comments Off on $CLRB Announces #INCResearch as the #CRO for the Phase II Trial of #CLR131

$EXPI Reports #Record #Revenue and #Growth for #Q3 2016

eXp Realty Drives Revenue Increase of 112%

BELLINGHAM, WA–(November 15, 2016) – eXp World Holdings, Inc. (OTCQB: EXPI), today released its third quarter financial results.

Financial Highlights

  • Revenues were $15.7 million, up 112% from $7.4 million for the 3 months ended September 30, 2016 vs 2015, respectively;
  • Cash and cash equivalents at September 30, 2016 was $944 thousand up 110 % vs September 30, 2015;
  • Net loss attributable to common shareholders of $14.6 million for the 3 months ended September 30, 2016, which was primarily attributable to a $14.1 million non-cash stock option compensation expense;
  • Adjusted net loss attributable to common shareholders was reported at $559 thousand for the 3 months ended September 30, 2016;
  • Total Stockholder’s Equity is up 141% to $2.0 million as of September 30, 2016 vs 2015, respectively

The increase in revenue in the third quarter of 2016 is a direct result of the increased sales agent base and higher sales volume realized by the Company’s real estate brokerage division, eXp Realty, The Agent-Owned Cloud Brokerage®.

Today, eXp Realty has more than 2,130 real estate professionals across 41 states, The District of Columbia, and Alberta, Canada. As previously reported, agent count for the quarter was up 151% vs the end of Q3 2015.

Glenn Sanford, the Company’s Chairman and Chief Executive Officer, commented on the Company’s performance, “I am immensely proud of our entire team, from our agents, to our managing brokers, to our leadership and our staff. It continues to be gratifying to know that creating a cloud-based brokerage focused on the agent resonates so clearly that it is reflected in the continued high rate of growth in agent count and revenues. With this level of growth also comes the responsibility to manage that growth so it is sustainable over the long haul. Continually evaluating and investing in the infrastructure and tools necessary to support our growth and ensure scalability of eXp’s Realty’s business model is a top priority and is a commitment shared at all levels of the organization, from the board, senior leadership and other stakeholders.”

Non-GAAP Financial Measurement

Adjusted net loss attributable to common shareholders

The Company has started reporting adjusted net income (loss) attributable to common shareholders. We believe the omission of non-cash income or expense based on fluctuations in the Company’s stock price, significantly outside of its control, is more reflective of the key factors that affect our operating performance. Since the equity-linked instruments were issued early in our existence, and there being no further performance requirements associated with earning the awards, we believe that omitting these fluctuations provide a useful supplemental measure in evaluating the performance of our operations and provides better transparency into our results of operations. Our management does not evaluate the Company’s performance, either financial or operational, inclusive of fluctuations in the intrinsic value of the awards issued prior becoming a public company.

The following is a reconciliation of adjusted net income (loss) attributable to common shareholders to net income (loss) attributable to common shareholders in accordance with GAAP:

Three Months Ended September 30, Three Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30,
2016 2015 2016 2015
Adjusted net income (loss) attributable to common shareholders $ (558,757 ) $ (10,226 ) $ (816,794 ) $ (1,018,921 )
Increase (decrease) in intrinsic value 14,088,341 (1,527,334 ) 20,456,078 2,478,942
Net income (loss) attributable to common shareholders $ (14,647,098 ) $ 1,517,108 $ (21,272,872 ) $ (3,497,863 )

About eXp World Holdings, Inc.

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

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

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

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

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

Trade and Media Contact Information:
Russ Cofano
President
eXp World Holdings, Inc.
russ.cofano@exprealty.com

Tuesday, November 15th, 2016 Uncategorized Comments Off on $EXPI Reports #Record #Revenue and #Growth for #Q3 2016

$NWMH Engages #NetworkNewsWire for #CorporateCommunications Solutions

NEW YORK, NY / November 15, 2016 / National Waste Management Holdings, Inc. (the “Company”) (OTC: NWMH), a growing and emerging vertically integrated solid waste management company, announces that it has engaged the expertise of NetworkNewsWire (“NNW”), a multifaceted financial news and publishing company that delivers a new generation of social communication solutions, news aggregation and syndication, and enhanced news release services. NNW’s strategies help public and private organizations find their voice and build market visibility via social media and a rapidly expanding distribution network of well over 5,000 key syndication outlets.

“Simply put, National Waste is on the move. Since 2015 we have completed four strategic acquisitions, demonstrating our commitment to build shareholder and corporate value as well as our ability to penetrate chosen markets with tactical execution of our acquisition strategy. As we continue to advance our operations and offerings, we believe clear communication with shareholders will further propel the success of our corporate initiatives,” says Louis Paveglio, CEO of National Waste. “By partnering with NNW, we are able to focus on our acquisition-based growth strategy while strengthening our corporate message.”

As part of the Client-Partner relationship with National Waste, NNW will leverage its investor-based Brand Network of partners, various newsletters, social media channels, blogs, and other outreach tools to generate greater brand awareness for the Company.

“National Waste is rightfully enthused about its growing position in the waste management industry. The Company has reported three straight quarters of revenue growth, powered by the performance of its Florida landfill and supplemented by an aggressive acquisition strategy,” states Sherri Franklin, Director of Content Marketing for NNW. “We look forward to working alongside National Waste’s management team to elevate the company’s corporate communications with existing shareholders and the broader investment community.”

About National Waste Management Holdings Inc.

National Waste Management Holdings Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services.

For more information, visit www.NationalWasteMgmt.com

About NetworkNewsWire

NetworkNewsWire (NNW) provides news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of journalists and writers, NNW is uniquely positioned to best serve private and public companies who need to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

For more information, visit https://www.NetworkNewsWire.com

Please see full disclaimers on the NetworkNewsWire website: http://nnw.fm/Disclaimer

Contact:

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.net

Tuesday, November 15th, 2016 Uncategorized Comments Off on $NWMH Engages #NetworkNewsWire for #CorporateCommunications Solutions

$RPRX Reports #Topline #Positive #Clinical Data #Proellex in #UterineFibroids

  • Primary endpoint of induction of amenorrhea met for both pooled oral and vaginal delivery compared to placebo, p<0.0001 and p=0.0071, respectively
  • Statistically significant reduction in fibroid size from baseline achieved by the combined active arms for the pooled oral dosage form compared to placebo, p=0.0004
  • Statistically significant improvement in Uterine Fibroid Symptom Severity Score (UFSQOL) achieved for the pooled oral dosage form compared to placebo, p=0.0211
  • On the basis of a comparison of oral and vaginal delivery systems, the Company will  propose the oral route of administration for Phase 3 development
  • The Company plans to submit a request to the FDA before the end of 2016 to discuss the Phase 3 program

THE WOODLANDS, Texas, Nov. 14, 2016  — Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported the topline results for both its pooled oral and vaginal delivery Phase 2 studies in the treatment of uterine fibroids. Both studies enrolled women with confirmed fibroids by MRI at baseline and who were experiencing more than 80 mL of blood loss during menses as confirmed by alkaline hematin assessment. Proellex® at doses of both 6 and 12 mg, delivered by either route, substantially and significantly reduced excessive menstrual bleeding, the key symptom of uterine fibroids and the primary endpoint of the studies. The study of vaginal delivery enrolled 42 subjects and the oral delivery study’s intent-to-treat population included 41 subjects.

Amenorrhea, cessation of menses, is known to occur when a sufficiently high plasma concentration of Proellex® is achieved.  Subjects received 18 weeks of blinded treatment and were then withdrawn from the study medication to allow for menses.  After menses occurred, a second 18 week course of treatment ensued.  The study treatment assignments remained blinded to the subjects, physicians and those managing the study and data.

The incidence of amenorrhea in active treatment groups consistently showed a statistically significantly difference from the rate in placebo-treated subjects with both routes of administration. At the end of the second course of treatment (36 weeks total active treatment, or Last Observation Carried Forward, LOCF), 92.9% of oral Proellex®-treated subjects achieved amenorrhea, while only 50% of vaginally treated subjects stopped menses. The oral dosage form provided for consistent suppression of menses with evidence of a dose response. Furthermore, among those women who completed the second 18 week course of oral drug administration, 100% of the women at the 12 mg dose exhibited amenorrhea, whereas 88.9% of women on the 6 mg dose achieved amenorrhea.

Along with changes in menstrual patterns, fibroid size, measured by MRI, was reduced in volume. Fibroid volume decreased in the oral Proellex®-treated arms by a median of 42.0% (LOCF) and was statistically different from the change from baseline volume in the placebo subjects (0%, p = 0.0004).   For women who completed the two 18 week courses of treatment, fibroid size reduction for the 12 mg oral and 6 mg oral doses was 58.2% and 32.9%, respectively, providing some evidence of a dose response effect.

The Uterine Fibroid Symptom Quality of Life Survey (UFSQOL) was utilized in this study.  The UFSQOL assesses distress from both bleeding and the bulk symptoms of uterine fibroids.  Bulk symptoms include distress associated with pelvic pressure, frequent urination and fatigue. Proellex®-treated subjects experienced a LOCF median 70.9% improvement while placebo-treated subjects reported a 37.5% improvement (p = 0.0211).

The drug was generally well tolerated.

Joseph Podolski, President and CEO of Repros, commented, “We believe the benefit:risk profile of Proellex® could afford a significant advantage over GnRH agonists and antagonists in the treatment of uterine fibroids. The longer treatment period and apparent improvement in efficacy based on the incidence of amenorrhea compared to other selective progesterone antagonists is also encouraging.”

The Company plans to request, before the end of this year, a meeting with the FDA to discuss Phase 3 development of the oral dosage form.

About Repros Therapeutics Inc.®

Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

Forward-Looking Statements

Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to ongoing and future clinical studies and the timing and results thereof, the Company’s plans to communicate with the FDA, possible submission of one or more NDAs and the commercial potential of Proellex®, risks relating to the Company’s ability to protect its intellectual property rights and such other risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information, please visit the Company’s website at http://www.reprosrx.com.

CONTACT: Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com
Monday, November 14th, 2016 Uncategorized Comments Off on $RPRX Reports #Topline #Positive #Clinical Data #Proellex in #UterineFibroids

$CRBP Reports #Positive #Topline #Results #Resunab in #Sclerosis

Difference in CRISS scores over trial period between JBT-101 and placebo groups was significant (p = 0.044); Median CRISS score at week 16 reached 33% in JBT-101 group versus 0% in placebo group; Management to host conference call and webcast today at 8:30 a.m. EST

NORWOOD, MA–(November 14, 2016) – Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, today announced positive topline results from its Phase 2 study evaluating Resunab (“JBT-101”) for the treatment of diffuse cutaneous systemic sclerosis (“systemic sclerosis”). JBT-101 out-performed placebo in the American College of Rheumatology (ACR) Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS) score, reaching 33% at week 16, versus 0% for placebo. The higher the CRISS score the greater the improvement; a CRISS score ≥ 20% (CRISS20) can be considered a medically meaningful improvement. The difference in CRISS scores between JBT-101 and placebo groups over the trial period was significant (p = 0.044). Differences in categorical levels of CRISS responses and changes from baseline in the five individual domains of the CRISS score also supported clinical benefit of JBT-101.

“This is the first double-blind, randomized, placebo controlled trial in diffuse cutaneous systemic sclerosis to demonstrate a clinical benefit using the CRISS as an endpoint, with a drug that was safe and well tolerated in the trial. These results bring hope to patients and their physicians that JBT-101 may be an effective drug for systemic sclerosis where currently there are no proven treatments,” said Principal Investigator Robert Spiera, M.D., Director of the Vasculitis and Scleroderma Program at the Hospital for Special Surgery, Weill Cornell Medical College in New York City.

Corbus management will host a conference call and live webcast, with accompanying presentation slides, for investors, analysts and other interested parties today at 8:30 a.m. ET (details below).

“The positive results of this study exceed our expectations and validate the unique mechanism of action of JBT-101. Our drug previously demonstrated clear and consistent evidence of activity in cellular and animal models as well as in healthy volunteers, repeatedly showing that its engagement with the CB2 receptor and its activation of inflammatory resolution translates into a potent effect on inflammation and fibrosis. With the data from this Phase 2 study, we now show that this mechanism of action provided clinical benefit in patients with systemic sclerosis in this trial,” stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company. “We look forward to the next stages in the clinical development of this drug. We are sincerely grateful to the patients, their physicians and the clinical staff who participated in this trial.”

The multi-center, double-blind, randomized, placebo-controlled Phase 2 study evaluated JBT-101’s clinical benefit and safety in 27 subjects who received JBT-101 and 15 who received placebo. Subjects had disease duration up to 6 years and were allowed to receive stable doses of immunosuppressive drugs during this study. Subjects were randomized (2 to 1 overall JBT-101 to placebo ratio) to receive JBT-101 for the first four weeks at 5 mg once a day (n = 9), 20 mg once a day (n = 9), or 20 mg twice a day (n = 9) or placebo for the first four weeks, then all JBT-101 subjects received 20 mg twice a day for the next 8 weeks. All subjects were followed off study drug from weeks 13 through 16.

The primary efficacy objective was to evaluate clinical benefit in all subjects who received JBT-101 versus subjects who received placebo using the ACR CRISS score, a measure of improvement in systemic sclerosis. The CRISS is an exponentially weighted algorithm of change from baseline that includes the modified Rodnan skin score (mRSS), a measure of skin thickening, physician global assessment (MDGA), patient global assessment (PtGA), and Health Assessment Questionnaire – Disability Index (HAQ-DI), and forced vital capacity (FVC).

Results:
The median (25th percentile, 75th percentile) CRISS scores for the combined JBT-101 group and the placebo group at Weeks 4, 8, 12, and 16 are provided in the table below. The difference in CRISS scores between JBT-101 and placebo groups over the trial period was significant (p = 0.044), 1-sided mixed model repeated measures using rank transformed data.

Group Median CRISS Score1, % (25th percentile, 75th percentile)
Week 4 Week 8 Week 12 Week 16
JBT-101 3% 19% 27.5% 33%
n = 26 (0.6%, 11.4%) (0.3%, 69.2%) (1.9%, 67.8%) (0.8%, 82.1%)
Placebo 1% 1% 1% 0%
n = 15 (0.3%, 8.8%) (0.1%, 15.2%) (0.1%, 60.1%) (0.1%, 16%)
1) Modified intent to treat population, last observation carried forward

Results of secondary efficacy outcome measures supported the finding of clinical benefit of JBT-101, including numerical superiority of JBT-101 in each of the five domains of the CRISS score, with divergence starting early at Week 4 or Week 8.

There were no serious, severe, or unexpected adverse events related to JBT-101. One of 27 subjects (3.7% of subjects) who received JBT-101 withdrew from the study for an adverse event which was moderate dizziness.

“We are excited about these positive clinical outcomes in the JBT-101 group in this study, especially given its short duration and relatively small number of diverse systemic sclerosis subjects,” stated Barbara White, M.D., Chief Medical Officer of the Company. “With these clinical data and findings of acceptable safety and tolerability, we plan to reach out to regulatory authorities to confirm the next steps forward.”

The primary treatment period has been completed and subjects are now enrolled in a one- year open label extension to obtain data on long-term safety and durability of response. Corbus received approval for an open-label extension to its Phase 2 clinical study of JBT-101 for systemic sclerosis from the U.S. Food and Drug Administration (“FDA”) in April of 2016. The open-label extension enables all the participants in the study to receive JBT-101 for an additional 12 months.

JBT-101 was granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis by the FDA in 2015.

For more information on the Phase 2 study with JBT-101 for the treatment of systemic sclerosis, please visit ClinicalTrials.gov and reference Identifier NCT02465437.

Conference Call and Webcast Information
Corbus management will host a conference call for investors, analysts and other interested parties today, November 14, 2016 at 8:30 am ET to discuss the topline data from the Phase 2 Study evaluating JBT-101 for the treatment of systemic sclerosis.

The conference call and live webcast will be accompanied by presentation slides. To participate in the call, please dial (877) 407-3978 (domestic) or (412) 902-0039 (international). The live webcast and accompanying slides will be accessible on the Events page of the Investors section of Corbus website, www.corbuspharma.com, and will be archived for 60 days.

About Systemic Sclerosis
Systemic sclerosis is a chronic, systemic autoimmune rheumatic disease with an unclear etiology. Systemic sclerosis affects approximately 90,000 people in the United States and Europe, with disease onset typically in mid-life. About 80 percent of systemic sclerosis patients are women. The disease process in systemic sclerosis includes activation of the immune system, with damage to small blood vessels and fibrosis of the skin on internal organs, including lungs, heart, kidneys, gastrointestinal tract and musculoskeletal system. Chronic disease burden, morbidity and mortality are significant. Cardiopulmonary disease is the major cause of death in systemic sclerosis. Immunosuppressive medications such as oral corticosteroids, methotrexate, cyclophosphamide, and mycophenolate mofetil are used to treat patients with more severe signs and symptoms of disease. Currently, there are no FDA-approved treatments specifically indicated for the treatment of systemic sclerosis, other than pulmonary artery hypertension secondary to connective tissue diseases such as systemic sclerosis.

About Resunab (“JBT-101”)
JBT-101 is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Preclinical and Phase 1 studies have shown JBT-101 to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in preclinical models of inflammation and fibrosis. JBT-101 is designed to trigger the production of “Specialized Pro-resolving Lipid Mediators” that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of multiple inflammatory mediators. JBT-101 has direct effects on fibroblasts to halt tissue scarring. In effect, JBT-101 triggers endogenous pathways to turn “off” chronic inflammation and fibrotic processes, without causing immunosuppression.

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. Our lead product candidate, JBT-101, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation, and fibrotic processes. JBT-101 is currently in Phase 2 clinical studies for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis and skin-predominant dermatomyositis, with a fourth Phase 2 trial in systemic lupus erythematosus planned to commence during the first half of 2017.

For more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, Google+ and Facebook.

Forward-Looking Statements
This press release contains certain 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 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email: jenene@jenenethomascommunications.com

Media Contact
David Schull
Russo Partners, LLC
Phone: +1 (858) 717-2310
Email: david.schull@russopartnersllc.com

Monday, November 14th, 2016 Uncategorized Comments Off on $CRBP Reports #Positive #Topline #Results #Resunab in #Sclerosis

$EGLE Announces #Acquisition of #SDARI64 #Ultramax Newbuilding Vessel

STAMFORD, Conn., Nov. 14, 2016  — Eagle Bulk Shipping Inc. (Nasdaq: EGLE) (the “Company” or “Eagle Bulk”) today announced that it has acquired a resale 2017-built 64,000 deadweight SDARI-64 Ultramax dry bulk vessel constructed at Chengxi Shipyard Co., Ltd.  The vessel is scheduled to be delivered to the Company in January 2017, and will be named the M/V Singapore Eagle.

Including the acquisition of the M/V Stamford Eagle, which was announced last week, the Eagle Bulk fleet will consist of 42 owned vessels.

About Eagle Bulk Shipping

Eagle Bulk Shipping Inc. is a Marshall Islands corporation headquartered in Stamford, Connecticut. Eagle owns one of the largest fleets of Supramax dry bulk vessels in the world. Supramax vessels, which are constructed with on-board cranes, range in size from approximately 50,000 to 65,000 dwt. The Company transports a broad range of major and minor bulk cargoes, including but not limited to coal, grain, ore, pet coke, cement and fertilizer, along worldwide shipping routes.

Forward-Looking Statements

Matters discussed in this release may constitute forward-looking statements. Forward-looking statements reflect management’s current expectations and observations with respect to future events and financial performance. Where the Company expresses an expectation or belief as to future events or results, such expectation or belief is expressed in good faith and believed to have a reasonable basis. However, the Company’s forward-looking statements are subject to risks, uncertainties, and other factors, which could cause actual results to differ materially from future results expressed, projected, or implied by those forward-looking statements.  The Company’s actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including changes in the Company’s financial resources and operational capabilities and as a result of certain other factors listed from time to time in the Company’s filings with the U.S. Securities and Exchange Commission.  The Company disclaims any intent or obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Monday, November 14th, 2016 Uncategorized Comments Off on $EGLE Announces #Acquisition of #SDARI64 #Ultramax Newbuilding Vessel

$NWMH Reports 269% Increase in #Q3 #Revenue

Third consecutive quarter of triple-digit revenue growth

HERNANDO, FL–(Nov 14, 2016) – National Waste Management Holdings, Inc. (OTCQB: NWMH) (“National Waste”) today announces financial results for the three and nine months ended September 30, 2016, as well as provided a general business update.

Third Quarter 2016 Highlights:

  • Revenue for the three months ended September 30, 2016, increased 269% to $1.7 million;
  • Revenue for the nine months ended September 30, 2016, increased 262% to $4.8 million;
  • Cash flows from operating activities for the nine months ended September 30, 2016, increased 76% to $860,665;
  • Appointed corporate finance veteran Dali Kranzthor as National Waste CFO
  • Continued to see positive results from aggressive acquisition strategy

Louis Paveglio, CEO of National Waste Management Holdings Inc., stated, “We are pleased to report our third-quarter 2016 results, marking three consecutive quarters of triple-digit quarterly revenue growth. Our third-quarter performance largely reflects the effectiveness of our acquisition strategy and, in correlation, our growing customer base. Moving forward, we expect to see continued improvements in profitability as a result of our acquisitions of WRE and Gateway in 2015, supported by our acquisition of Sivart Services earlier this year and our rapidly expanding presence in the northeast. We are excited about the momentum of our initiatives, and look forward to expanding our solid waste solutions to meet growing demand.”

Revenue for the three months ended September 30, 2016, increased 269% to $1.7 million, as compared to revenue of $479,698 reported for the comparable quarter of 2015. This increase is due to the WRE and Gateway acquisitions during the fourth quarter of 2015 as well as increases in the overall customer base and expanding sales to current customers.

Net loss for the three months ended September 30, 2016, was $(210,649) versus net income of $81,754 for the comparable quarter of 2015. The $292,403 decrease is primarily attributable to the increased charges to depreciation and amortization expense after the acquisitions of WRE and Gateway.

“During the third quarter of 2016 we continued to execute on our business model and build our team and footprint through effective management and acquisitions,” says National Waste CFO Dali Kranzthor. “When I joined National Waste in the fall of this year, I walked into a flurry of progression and look forward to providing my expertise for continued growth for the remainder of 2016 and beyond.”

About National Waste Management Holdings Inc.
National Waste Management Holdings Inc. is a growing and emerging vertically integrated solid waste management company with a concentration on C&D collection, hauling and recycling. National Waste services Florida’s west coast and upstate New York and is a distinguished leader in solid waste services. More information may be found at the Company’s website: http://www.nationalwastemgmt.com.

This release contains certain statements that are, or may be deemed to be, 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, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as “expect,” “believe,” and “should.” Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company’s Form SEC filings.

Communications Contact:
NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Email Contact

Monday, November 14th, 2016 Uncategorized Comments Off on $NWMH Reports 269% Increase in #Q3 #Revenue

$NETE Reports #Q3 and Nine Months #FinancialResults

Quarterly revenues continue to increase year over year, net loss attributable to shareholders narrows by 23% ($1.04 million) over same period in 2015

MIAMI, FL–(Nov 14, 2016) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a provider of global mobile payment technology solutions and value-added transactional services, today reported financial results for the third quarter and nine months ended September 30, 2016 and provided an update on recent strategic and operational initiatives.

For third quarter ended September 30, 2016, net revenues increased 11% to $14,009,652 as compared to $12,675,123 in the prior year. The $1,334,529 increase in net revenues is primarily due to organic growth in North America Transaction Solutions:

  • North America Transaction Solution segment: Continued organic growth of SMB merchants in this segment with emphasis on value-added offerings. Revenues for this segment for the third quarter 2016 were $3.4 million, a 43% increase over the prior year.
  • Mobile Solutions segment: Net revenues dropped by 36% over the prior year to $1.2 million and gross margin increased by 389% over the prior year due to shift into branded content business.
  • Online Solutions: Net revenues for this segment for the third quarter 2016 were $1.6 million, a 22% drop over the prior year. Drop in net revenue is a result of discontinuance of payment processing for foreign currency dealers.

For nine months ended September 30, 2016, net revenues increased 55% to $38,963,559 as compared to $25,122,250 in the prior year. The $13,841,309 increase in net revenues is primarily due to organic growth in the Company’s three segments:

  • North America Transaction Solution segment: Continued organic growth of SMB merchants in this segment with emphasis on value-added offerings. Revenues for this segment for nine months ended September 30, 2016 were $29.4 million, a 53% increase over the prior year.
  • Mobile Solutions segment: Net revenues increased by 43% over the prior year to $5.0 million over the prior year due to shift into branded content business.
  • Online Solutions: Processed volume for nine months ended September 30, 2016 for this segment was $336 million, a 30% increase over the prior year, while net revenues for this segment for nine months ended September 30, 2016 were $4.5 million, a 92% increase over the prior year.

Recent Highlights

  • Entered into settlement agreement with sellers over PayOnline acquisition
  • Entered into $10 million stock purchase agreement with ESOUSA Holdings, LLC
  • Dunkin’ Donuts became a client of Net Element’s PayOnline in Russia. PayOnline enables online ordering and payments for one of the world’s largest coffee and baked goods chain
  • Named one of the fastest-growing technology companies in South Florida Business Journal’s 2016 Technology Awards
  • PayOnline payments module became available for most popular e-commerce and CMS platforms. Fully-integrated payment acceptance is now available on 19 most popular e-commerce and CMS platforms
  • PayOnline continued expansion into Central Asia. Dynamic organic growth during the last twelve months lead to office opening in Kazakhstan
  • PayOnline partnered with Round Bank. Integrated first 70 online merchants to its platform under new collaboration agreement with Round Bank

“We are pleased with our continued improvement as we narrow our losses for the quarter. Our results are a reflection of our ability to implement our business objectives in a dynamic environment,” commented Oleg Firer, CEO of Net Element. “We continue to be excited about our strategic initiatives for the remainder of the year.”

Conference Call:
The Company will host a conference call to discuss Third Quarter 2016 financial results and business highlights on November 15, 2016 at 8:30 AM ET. The conference call can be accessed live over the phone by dialing +1 (877) 303-9858, or for international callers +1 (408) 337-0139, and referencing password 18929736. It is recommended that participants dial in approximately 10 minutes prior to the start of the 8:30 am Eastern call.

The call will also be webcast live from http://edge.media-server.com/m/p/y4vbhvpa. Following completion of the call, a recorded replay of the webcast will be available on the www.netelement.com/en/ir website.

Results of Operations for the Three Months Ended September 30, 2016 Compared to the Three Months Ended September 30, 2015

We reported an adjusted, non-GAAP, net loss attributable to Net Element, Inc. stockholders of $2,736,839, or $0.20 per share, for the three months ended September 30, 2016 as compared to an adjusted, non-GAAP, net loss attributable to Net Element, Inc. stockholders of $2,908,127, or $0.42 per share, for the three months ended September 30, 2015. The decrease in net loss of $171,288 was primarily due to a higher gross margin and lower interest expense offset by increased other expenses for stock value guarantee payment accrual.

Net revenues consist primarily of payment processing fees. Net revenues were $14,009,652 for the three months ended September 30, 2016 as compared to $12,675,123 for the three months ended September 30, 2015. The increase in net revenue is primarily a result of an increase in revenue from our North America Transaction Solutions segment, amounting to $3,359,320, offset by decreases in revenue from our Mobile Solutions and Online Solutions segments of $1,569,243 and $455,548, respectively. Increases in our North America Transaction Solutions segment revenue were primarily due to a net increase in merchants processing with us. The following table sets forth our sources of revenues, cost of revenues and gross margins for the three months ended September 30, 2016 and 2015.

Gross Margin Analysis

Source of Revenues Three Months
Ended
September 30, 2016
Mix Three Months
Ended
September 30, 2015
Mix Increase /
(Decrease)
North America Transaction Solutions $ 11,186,287 80 % $ 7,826,967 62 % $ 3,359,320
Mobile Solutions 1,226,241 9 % 2,795,484 22 % (1,569,243 )
Online Solutions 1,597,124 11 % 2,052,672 16 % (455,548 )
Total $ 14,009,652 100 % $ 12,675,123 100 % $ 1,334,529
Cost of
Revenues
Three Months
Ended
September 30, 2016
%
of revenues
Three Months
Ended
September 30, 2015
%
of revenues
Increase /
(Decrease)
North America Transaction Solutions $ 9,585,952 86 % $ 6,489,695 83 % $ 3,096,257
Mobile Solutions 1,045,836 85 % 2,785,590 99 % (1,712,754 )
Online Solutions 1,063,380 67 % 1,457,042 71 % (393,662 )
Total $ 11,695,168 83 % $ 10,705,327 84 % $ 989,841
Gross Margin Three Months
Ended
September 30, 2016
%
of revenues
Three Months
Ended
September 30, 2015
%
of revenues
Increase /
(Decrease)
North America Transaction Solutions $ 1,600,335 14 % $ 1,337,272 17 % $ 263,063
Mobile Solutions 180,405 15 % 36,894 1 % 143,511
Online Solutions 533,744 33 % 595,630 29 % (61,886 )
Total $ 2,314,484 17 % $ 1,969,796 16 % $ 344,688

Cost of revenues represents direct costs of generating revenues, including commissions, mobile operator fees, content provider fees, purchases of short numbers, interchange expense and processing fees. Cost of revenues for the three months ended September 30, 2016 were $11,695,168 as compared to $10,705,327 for the three months ended September 30, 2015.

The $989,841 increase in cost of revenue was primarily a result of an increase in U.S. transaction volume. The decreases in cost of revenue in each of our Mobile Solutions and Online Solutions segments coincided with the decreases in sales for the period in such segments.

Gross Margin for the three months ended September 30, 2016 was $2,314,484, or 17% of net revenue, as compared to $1,969,796, or 16% of net revenue, for the three months ended September 30, 2015.

Total operating expenses, excluding share based compensation, were $3,350,792 for the three months ended September 30, 2016, as compared to total operating expenses, excluding share based compensation of $3,295,190 for the three months ended September 30, 2015. Total operating expenses for the three months ended September 30, 2016 consisted of general and administrative expenses of $2,284,737, provision for bad debts of $301,170 and depreciation and amortization of $764,886. For the three months ended September 30, 2015, total operating expenses, excluding share based compensation, consisted of general and administrative expenses of $2,159,170, provision for bad debts of $284,384 and depreciation and amortization of $851,636. The components of our general and administrative expenses are discussed below.

General and administrative expenses were $2,284,737 for the three months ended September 30, 2016 as compared to $2,159,170 for the three months ended September 30, 2015. General and administrative expenses for the three months ended September 30, 2016 and 2015 consisted of operating expenses not otherwise delineated in our unaudited condensed consolidated statements of operations and comprehensive loss as follows:

Three months ended September 30, 2016
Category North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
Salaries, benefits, taxes and contractor payments $ 327,785 $ 107,310 $ 167,802 $ 442,497 $ 1,045,394
Professional fees 89,985 36,874 161,394 384,227 672,480
Rent 942 35,682 116,703 153,327
Business development 10,827 4,869 27,752 43,448
Travel expense 61,700 2,563 5,978 50,466 120,707
Filing fees 17,789 17,789
Transaction (gains) losses (11,068 ) (655 ) (141,639 ) (153,362 )
Other expenses 143,621 9,394 49,949 181,990 384,954
Total $ 633,918 $ 150,884 $ 447,902 $ 1,052,033 $ 2,284,737
Three months ended September 30, 2015
Category North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
Salaries, benefits, taxes and contractor payments $ 207,229 $ 84,527 $ 120,763 $ 596,922 $ 1,009,441
Professional fees 77,174 67,127 281,445 250,785 676,531
Rent 12,455 37,169 47,542 97,166
Business development 2,893 375 10,876 14,144
Travel expense 14,425 8,525 8,762 25,962 57,674
Filing fees 1,258 1,258
Transaction (gains) losses 39 158 2,490 2,687
Other expenses 122,689 (26,676 ) 98,921 105,335 300,269
Total $ 424,410 $ 146,372 $ 558,094 $ 1,030,294 $ 2,159,170

Salaries, benefits, taxes and contractor payments were $1,045,394 for the three months ended September 30, 2016 as compared to $1,009,441 for the three months ended September 30, 2015, representing an increase of $35,953 as follows:

Segment Salaries and benefits for the three months ended September 30, 2016 Salaries and benefits for the three months ended September 30, 2015 Increase /
(Decrease)
North America Transaction Solutions $ 327,785 $ 207,229 $ 120,556
Mobile Solutions 107,310 84,527 22,783
Online Solutions 167,802 120,763 47,039
Corporate Expenses & Eliminations 442,497 569,922 (154,425 )
Total $ 1,045,394 $ 1,009,441 $ 35,953

The primary reason for the increase was a $120,556 increase in salaries from North America Transaction Solutions due to higher headcount and additional sales incentives for retention and portfolio performance. Additionally, we had an increase of $47,039 from the acquisition of PayOnline (acquired May 20, 2015) and a $22,783 increase to Mobile Solutions from changes in personnel and compensation that was offset by a $154,425 decrease to corporate salaries from reduced headcount.

Professional fees were $672,480 for the three months ended September 30, 2016 as compared to $676,531 for the three months ended September 30, 2015, representing a decrease of $4,051 as follows:

Three months ended September 30, 2016
Professional Fees North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
General Legal $ 5,818 $ 56 $ 847 $ 99,179 $ 105,900
SEC Compliance Legal Fees 43,750 43,750
Accounting and Auditing 101,732 101,732
Tax Compliance and Planning 33,200 33,200
Consulting 84,167 36,818 160,547 106,366 387,898
Total $ 89,985 $ 36,874 $ 161,394 $ 384,272 $ 672,480
Three months ended September 30, 2015
Professional Fees North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
General Legal $ 4,698 $ 414 $ 90,338 $ 205,846 $ 301,296
SEC Compliance Legal Fees 43,749 43,749
Accounting and Auditing 850 1,995 14,798 138,453 156,096
Tax Compliance and Planning 18,450 18,450
Consulting 71,626 64,718 176,309 (155,713 ) 156,940
Total $ 77,174 $ 67,127 $ 281,445 $ 250,785 $ 676,531
Variance
Professional Fees North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
General Legal $ 1,120 $ (358 ) $ (89,419 ) $ (106,667 ) $ (195,396 )
SEC Compliance Legal Fees 1 1
Accounting and Auditing (850 ) (1,995 ) (14,798 ) (36,721 ) (54,364 )
Tax Compliance and Planning 14,750 14,750
Consulting 12,541 (27,900 ) (15,762 ) 262,079 230,958
Total $ 12,811 $ (30,253 ) $ (120,051 ) $ 133,442 $ (4,051 )

General legal expenses decreased $195,396 for the three months ended September 30, 2016 compared to the three months ended September 30, 2015 primarily due to decreased litigation activity due to the settlement of certain litigation matters. Offsetting the decrease was an increase in consulting fees of $230,958 primarily due to a non-cash, one-time accounting adjustment. This was offset by a decrease in consulting fees for outside sales support and outsourced operations for our Mobile Solutions and Online Solutions segments.

Other general and administrative expenses were $384,954 for the three months ended September 30, 2016 as compared to $300,269 for the three months ended September 30, 2015, representing an increase of $84,685. This increase is primarily caused by an increase in insurance expense of $121,232 and office expenses of $34,990, which were partially offset by decreases in utilities of $40,243 and taxes of $41,017.

We recorded bad debt expense of $301,170 for the three months ended September 30, 2016 as compared to $284,384 for the three months ended September 30, 2015. For the three months ended September 30, 2016, we recorded a loss provision which was primarily comprised of $301,132 in ACH rejects. For the three months ended September 30, 2015, we recorded a $284,384 loss provision which was comprised of $307,154 in ACH rejects partially offset by a $22,811 recovery from our Russian operations.

Depreciation and amortization expense consists primarily of the amortization of merchant portfolios plus depreciation expense on fixed assets, client acquisition costs, capitalized software expenses, trademarks, domain names and employee non-compete agreements. Depreciation and amortization expense was $764,886 for the three months ended September 30, 2016 as compared to $851,636 for the three months ended September 30, 2015. The $86,751 decrease in depreciation and amortization expense was primarily due to a reduction in portfolio amortization.

Interest expense was $608,716 for the three months ended September 30, 2016 as compared to $1,605,034 for three months ended September 30, 2015, representing a decrease of $996,318. The decrease in interest expense was due to conversion of convertible notes payable during 2015 resulting in lower interest costs as remaining note balances have lower interest carrying costs.

The net loss attributable to non-controlling interests amounted to $33,683 for three months ended September 30, 2016 as compared to $23,577 for the three months ended September 30, 2015.

During the three months ended September 30, 2016, we recognized a charge of $1,433,475 relating to an amendment to the PayOnline acquisition agreement, which we entered into on October 25, 2016. Such amendment calls for our assumption of certain merchant reserve liabilities equal to the charge taken.

Results of Operations for the Nine Months Ended September 30, 2016 Compared to the Nine Months Ended September 30, 2015

We reported an adjusted, non-GAAP, net loss attributable to Net Element, Inc. stockholders of $7,555,434, or $0.61 per share, for the nine months ended September 30, 2016 as compared to an adjusted, non-GAAP, net loss attributable to common stock of $7,730,915, or $1.43 per share, for the nine months ended September 30, 2015. This resulted in an decrease in adjusted, non-GAAP, net loss attributable to Net Element, Inc. stockholders of $175,481, which was primarily due to a $3,722,142 loss from the stock price guarantee in connection with the PayOnline acquisition and an increase in depreciation and amortization of $580,637 offset by an $1,821,009 decrease in interest expense, $2,063,323 increase in gross margin, and a $441,749 increase in other income. These items are discussed further below.

Net revenues consist primarily of payment processing fees. Net revenues were $38,963,559 for the nine months ended September 30, 2016 as compared to $25,122,250 for the nine months ended September 30, 2015.

The increase in net revenue is primarily a result of an increase in revenue from our North American Transaction Solutions segment, amounting to $10,166,983, and increases in revenue from our Mobile Solutions and Online Solutions segments of $1,509,902 and $2,164,424, respectively. Increases in our North American Transaction Solutions revenue were primarily due to organic net increases in merchants.

The following table sets forth our sources of revenues, cost of revenues and gross margins for the nine months ended September 30, 2016 and 2015.

Gross Margin Analysis
Source of Revenues Nine Months
Ended
September 30, 2016
Mix Nine Months
Ended
September 30, 2015
Mix Increase /
(Decrease)
North America Transaction Solutions $ 29,442,868 76 % $ 19,275,885 77 % $ 10,166,983
Mobile Solutions 4,999,452 13 % 3,489,550 14 % 1,509,902
Online Solutions 4,521,239 12 % 2,356,815 9 % 2,164,424
Total $ 38,963,559 100 % $ 25,122,250 100 % $ 13,841,309
Cost of
Revenues
Nine Months
Ended
September 30, 2016
%
of revenues
Nine Months
Ended
September 30, 2015
%
of revenues
Increase /
(Decrease)
North America Transaction Solutions $ 25,206,769 86 % $ 16,543,190 86 % $ 8,663,579
Mobile Solutions 4,427,043 89 % 2,786,984 80 % 1,640,059
Online Solutions 2,931,390 65 % 1,457,042 62 % 1,474,348
Total $ 32,565,202 84 % $ 20,787,216 83 % $ 11,777,986
Gross Margin Nine Months
Ended
September 30, 2016
%
of revenues
Nine Months
Ended
September 30, 2015
%
of revenues
Increase /
(Decrease)
North America Transaction Solutions $ 4,236,099 14 % $ 2,732,695 14 % $ 1,503,404
Mobile Solutions 572,409 11 % 702,566 20 % (130,157 )
Online Solutions 1,589,849 35 % 899,773 38 % 690,076
Total $ 6,398,357 16 % $ 4,335,034 17 % $ 2,063,323

Cost of revenues represents direct costs of generating revenues, including commissions, mobile operator fees, content provider fees, purchases of short numbers, interchange expense and processing fees. Cost of revenues for the nine months ended September 30, 2016 were $32,565,202 as compared to $20,787,216 for the nine months ended September 30, 2015.

The year over year increase in cost of revenue of $11,777,986 was primarily a result of an increase in U.S. transaction volume, which resulted in an $8,663,579 increase in cost of revenue in our North American Transaction Solutions segment. Additionally, there was a $1,640,059 increase in cost of revenue in our Mobile Solutions segment, which now includes mobile operator fees and content provider fees when we provide branded content. We also had $1,474,348 in new costs resulting from PayOnline operations (acquired May 20, 2015).

Gross Margin for the nine months ended September 30, 2016 was $6,398,357 or 16% of net revenue, as compared to $4,335,034 or 17% of net revenue, for the nine months ended September 30, 2015. There were increased margins from our Russian online transaction processing offset by lower margins from our branded content provided by Mobile Solutions. Included in the Mobile Solutions gross margin for the nine months ended September 30, 2016 is $328,428 of branded content.

Total operating expenses, excluding non-cash compensation, were $9,548,047 for the nine months ended September 30, 2016, as compared to total operating expenses, excluding non-cash compensation of $9,120,877 for the nine months ended September 30, 2015. Total operating expenses, excluding share based compensation, for the nine months ended September 30, 2016 consisted of general and administrative expenses of $6,372,361, provision for bad debts of $678,150 and depreciation and amortization of $2,497,538. For the nine months ended September 30, 2015, total operating expenses, excluding share based compensation, consisted of general and administrative expenses of $6,778,751, provision of bad debts of $425,225 and depreciation and amortization of $1,916,901. The components of our general and administrative expenses are discussed below.

General and administrative expenses for the nine months ended September 30, 2016 and 2015 consisted of operating expenses not otherwise delineated in our unaudited condensed consolidated statements of operations and comprehensive loss as follows.

Nine months ended September 30, 2016
Category North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
Salaries, benefits, taxes and contractor payments $ 962,618 $ 343,247 $ 423,238 $ 1,498,541 $ 3,227,644
Professional fees 372,492 39,422 462,650 999,627 1,874,191
Rent 3,260 104,056 317,317 424,633
Business development 31,784 4,869 92,544 129,197
Travel expense 152,795 9,657 15,964 88,368 266,784
Filing fees 77,185 77,185
Transaction (gains) losses (394,880 ) 38,449 (115,797 ) (472,228 )
Other expenses 401,607 15,657 91,976 335,715 844,955
Total $ 1,921,296 $ 21,232 $ 1,228,877 $ 3,200,956 $ 6,372,361
Nine months ended September 30, 2015
Category North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
Salaries, benefits, taxes and contractor payments $ 570,054 $ 298,154 $ 180,021 $ 1,679,556 $ 2,727,785
Professional fees 347,628 186,171 404,444 1,681,439 2,619,682
Rent 41,927 39,362 256,963 338,252
Business development 28,879 802 19,347 49,028
Travel expense 91,265 18,039 8,762 72,921 190,987
Filing fees 84,690 84,690
Transaction (gains) losses 1,513 159 (88,018 ) (86,346 )
Other expenses 371,399 83,075 107,539 292,660 854,673
Total $ 1,409,225 $ 629,681 $ 759,634 $ 3,980,211 $ 6,778,751

Salaries, benefits, taxes and contractor payments were $3,227,644 for the nine months ended September 30, 2016 as compared to $2,727,785 for the nine months ended September 30, 2015, representing an increase of $499,859 as follows:

Segment Salaries and benefits for the nine months ended September 30, 2016 Salaries and benefits for the nine months ended September 30, 2015 Increase /
(Decrease)
North America Transaction Solutions $ 962,618 $ 570,054 $ 392,564
Mobile Solutions 343,247 298,154 45,093
Online Solutions 423,238 180,021 243,217
Corporate Expenses & Eliminations 1,498,541 1,679,556 (181,015 )
Total $ 3,227,644 $ 2,727,785 $ 499,859

The primary reason for the increase was a $392,564 in salaries from North America Transaction Solutions and $243,217 from the acquisition of PayOnline (acquired May 20, 2015) offset by an $181,015 decrease to our corporate division salaries and benefits. North America Transaction Solutions increase is due to increased management headcount, increased risk management headcount and additional incentives for portfolio performance.

Professional fees were $1,874,191 for the nine months ended September 30, 2016 as compared to $2,619,682 for the nine months ended September 30, 2015, representing a decrease of $745,491 as follows:

Nine months ended September 30, 2016
Professional Fees North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
General Legal $ 39,215 $ 268 $ 3,867 $ 168,039 $ 211,389
SEC Compliance Legal Fees 60,000 71,250 131,250
Accounting and Auditing 578 326,132 326,710
Tax Compliance and Planning 44,200 44,200
Consulting 273,277 39,154 458,205 390,006 1,160,642
Total $ 372,492 $ 39,422 $ 462,650 $ 999,627 $ 1,874,191
Nine months ended September 30, 2015
Professional Fees North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Total
General Legal $ 57,099 $ 449 $ 94,172 $ 504,192 $ 655,912
SEC Compliance Legal Fees 47,304 65,001 112,305
Accounting and Auditing 850 1,995 14,798 438,202 455,845
Tax Compliance and Planning 34,725 34,725
Consulting 242,375 183,727 295,474 639,319 1,360,895
Total $ 347,628 $ 186,171 $ 404,444 $ 1,681,439 $ 2,619,682
Variance
Professional Fees North America Transaction Solutions Mobile Solutions Online Solutions Corporate Expenses & Eliminations Increase / (Decrease)
General Legal $ (17,884 ) $ (181 ) $ (90,305 ) $ (336,153 ) $ (444,523 )
SEC Compliance Legal Fees 12,696 6,249 18,945
Accounting and Auditing (850 ) (1,995 ) (14,220 ) (112,070 ) (129,135 )
Tax Compliance and Planning 9,475 9,475
Consulting 30,902 (144,573 ) 162,731 (249,313 ) (200,253 )
Total $ 24,864 $ (146,749 ) $ 58,206 $ (681,812 ) $ (745,491 )

Total professional fees decreased $745,491 during for the nine months ended September 30, 2016 compared to the nine months ended September 30, 2015 primarily due to decreased litigation activity at the corporate level and at our Mobile Solutions segment. Consulting fees decreased $200,253 primarily due a transition of consultants into permanent positions in corporate.

We recorded bad debt expense of $678,150 for the nine months ended September 30, 2016 as compared to $425,225 for the nine months ended September 30, 2015. For the nine months ended September 30, 2016, we recorded a loss which was primarily comprised of $710,508 in ACH rejects offset by a $32,358 recovery from our Russian operations. For the nine months ended September 30, 2015, we recorded a loss provision which was primarily comprised of $542,763 in ACH rejects offset by an $117,569 recovery from our mobile payments business.

Depreciation and amortization expense consists primarily of the amortization of merchant portfolios plus depreciation expense on fixed assets, client acquisition costs, capitalized software expenses, trademarks, domain names and employee non-compete agreements. Depreciation and amortization expense was $2,497,538 for the nine months ended September 30, 2016 as compared to $1,916,901 for the nine months ended September 30, 2015. The $580,637 increase in depreciation and amortization expense was primarily related to the PayOnline acquisition ($703,479 for IP Software, $49,998 for domain names, $74,834 for PCI Certification and $186,096 for portfolios and client lists), offset by a $600,068 decrease in portfolio amortization in our North American Transaction Solutions segment as legacy portfolios fully amortized.

Interest expense was $1,605,034 for the nine months ended September 30, 2016 as compared to $3,007,216 for nine months ended September 30, 2015, representing a decrease of $1,402,182. The decrease in interest expense was due to conversion of convertible notes payable during 2015 resulting in lower interest costs as remaining note balances have lower interest carrying costs.

The net loss attributable to non-controlling interests amounted to $110,350 for nine months ended September 30, 2016 as compared to $42,850 for the nine months ended September 30, 2015 due to increased losses at Aptito.

During the nine months ended September 30, 2016, we recognized a charge of $3,722,142 relating to the PayOnline acquisition agreement entered into on May 20, 2015. The PayOnline acquisition agreement calls for a guarantee payment in cash for decreases in the market value of certain restricted common shares issued in accordance with the acquisition agreement at 12 months from the date of the respective issuances. In addition, this includes a charge of $1,433,475 in connection with an amendment to the PayOnline acquisition agreement entered into on October 25, 2016, which calls for our assumption of certain merchant reserve liabilities equal to the charge taken.

Reconciliation of Non-GAAP Financial Measures and Regulation G Disclosure

To supplement its consolidated financial statements presented in accordance with United States generally accepted accounting principles (“GAAP”), the Company provides additional measures of its operating results by disclosing its adjusted net loss. Adjusted net loss is calculated as net loss excluding non-cash share based compensation and other non-cash, non-recurring items not present in this year or last year results. Net Element discloses this amount on an aggregate and per share basis. These measures meet the definition of non-GAAP financial measures. The Company believes that application of these non-GAAP financial measures is appropriate to enhance the understanding of its historical performance through use of a metric that seeks to normalize period-to-period earnings.

This press release contains non-GAAP financial measures within the meaning of Regulation G promulgated by the Securities and Exchange Commission. Pursuant to Regulation G, a reconciliation of these non-GAAP financial measures with the comparable financial measures calculated in accordance with GAAP for the three and nine months ended September 30, 2016 and 2015 is presented in the following Non-GAAP Financial Measures Table.

GAAP Non-Cash
Share-based Compensation
Derivative Activity, Debt Extinguishment and Restructure Adjusted
Non-GAAP
Three Months Ended September 30, 2016
Net (loss) income attributable to Net Element Inc stockholders $ (3,469,540 ) $ 732,701 $ $ (2,736,839 )
Basic and diluted earnings per share $ (0.25 ) $ 0.05 $ $ (0.20 )
Basic and diluted shares used in computing earnings per share 14,030,204 14,030,204
GAAP Share-based Compensation Derivative Activity, Debt Extinguishment and Restructure Adjusted
Non-GAAP
Three Months Ended September 30, 2015
Net (loss) income attributable to Net Element Inc stockholders $ (4,513,201 ) $ 601,371 $ 1,003,703 $ (2,908,127 )
Basic and diluted loss per share $ (0.66 ) $ 0.09 $ 0.15 $ (0.42 )
Basic and diluted shares used in computing loss per share 6,850,442 6,850,442
GAAP Non-Cash
Share-based Compensation
Derivative Activity, Debt Extinguishment and Restructure Adjusted
Non-GAAP
Nine Months Ended September 30, 2016
Net (loss) income attributable to Net Element Inc stockholders $ (10,663,708 ) $ 3,108,274 $ $ (7,555,434 )
Basic and diluted earnings per share $ (0.87 ) $ 0.25 $ $ (0.61 )
Basic and diluted shares used in computing earnings per share 12,325,926 12,325,926
GAAP Share-based Compensation Derivative Activity, Debt Extinguishment and Restructure Adjusted
Non-GAAP
Nine Months Ended September 30, 2015
Net (loss) income attributable to Net Element Inc stockholders $ (8,516,695 ) $ 1,804,113 $ (1,018,333 ) $ (7,730,915 )
Basic and diluted loss per share $ (1.58 ) $ 0.33 $ (0.19 ) $ (1.43 )
Basic and diluted shares used in computing loss per share 5,396,960 5,396,960
NET ELEMENT, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
September 30,
2016
December 31,
2016
ASSETS
Current assets:
Cash $ 1,385,286 $ 1,025,747
Accounts receivable, net 5,866,714 5,198,993
Prepaid expenses and other assets 1,425,685 1,106,016
Total current assets, nets 8,677,685 7,330,756
Fixed assets, net 128,470 162,123
Intangible assets, net 4,153,065 5,423,880
Goodwill 9,643,752 9,643,752
Other long term assets 792,834 353,050
Total assets $ 23,395,806 $ 22,913,561
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable 5,650,932 5,858,837
Accrued expenses 5,654,994 2,975,066
Deferred revenue 878,913 743,910
Notes payable (current portion) 147,577 518,437
Due to related parties 447,660 329,881
Total current liabilities 12,780,076 10,426,131
Notes payable (net of current portion) 4,047,140 3,446,563
Total liabilities 16,827,216 13,872,694
STOCKHOLDERS’ EQUITY
Series A Convertible Preferred stock ($.0001 par value, 1,000,000 shares authorized, no shares issued and outstanding at September 30, 2016 and December 31, 2015)
Common stock ($.0001 par value, 400,000,000 shares authorized and 15,099,845 and 11,261,959 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively) 1,510 1,126
Paid in capital 163,285,658 154,361,694
Accumulated other comprehensive loss (2,188,390 ) (1,565,822 )
Accumulated deficit (154,618,755 ) (143,955,048 )
Non-controlling interest 88,567 198,917
Total stockholders’ equity 6,568,590 9,040,867
Total liabilities and stockholders’ equity 23,395,806 22,913,561
NET ELEMENT, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Three months ended
September 30,
Nine months ended
September 30,
2016 2015 2016 2015
Net Revenues
Service fees $ 12,874,386 $ 12,675,123 $ 34,355,912 $ 25,122,250
Branded content 1,135,266 4,607,647
Total Revenues 14,009,652 12,675,123 38,963,559 25,122,250
Costs and expenses:
Cost of service fees 10,683,897 10,705,327 28,285,984 20,787,216
Cost of branded content 1,011,271 4,279,218
General and administrative 2,284,737 2,159,170 6,372,361 6,778,751
Non-cash compensation 732,701 601,371 3,108,274 1,804,113
Bad debt expense 301,170 284,384 678,150 425,225
Depreciation and amortization 764,886 851,636 2,497,538 1,916,901
Total costs and operating expenses 15,778,662 14,601,888 45,221,525 31,712,206
Loss from operations (1,769,010 ) (1,926,765 ) (6,257,966 ) (6,589,956 )
Interest expense, net (608,716 ) (1,605,034 ) (1,186,207 ) (3,007,216 )
(Loss) gain on change in fair value and settlement of beneficial conversion derivative (1,083,028 ) 939,008
Loss from stock value guarantee (1,559,281 ) (3,722,142 )
Gain on debt extinguishment 79,325 79,325
Gain on asset disposal 44,928 68,786
Other income (expense) 433,784 (46,204 ) 392,257 (49,492 )
Net loss before income taxes (3,503,223 ) (4,536,778 ) (10,774,058 ) (8,559,545 )
Income taxes
Net loss (3,503,223 ) (4,536,778 ) (10,774,058 ) (8,559,545 )
Net loss attributable to the non-controlling interest 33,683 23,577 110,350 42,850
Net loss attributable to Net Element, Inc. stockholders (3,469,540 ) (4,513,201 ) (10,663,708 ) (8,516,695 )
Dividends for the benefit of preferred stockholders (621,273 ) (1,146,470 )
Net loss attributable to common stockholders (3,469,540 ) (5,134,474 ) (10,663,708 ) (9,663,165 )
Foreign currency translation (96,786 ) (189,644 ) (622,568 ) (414,168 )
Comprehensive loss attributable to common stockholders $ (3,566,326 ) $ (5,324,118 ) $ (11,286,276 ) $ (10,077,333 )
Loss per share – basic and diluted $ (0.25 ) $ (0.75 ) $ (0.87 ) $ (1.79 )
Weighted average number of common shares outstanding – basic and diluted 14,030,204 6,850,442 12,325,926 5,396,960
NET ELEMENT, INC.
CONSOLIDATED STATEMENT OF CASH FLOWS
Nine months ended
September 30,
2016 2015
Cash flows from operating activities
Net loss $ (10,663,708 ) $ (8,516,695 )
Adjustments to reconcile net loss to net cash (used in) provided by operating activities
Non controlling interest (110,350 ) (42,850 )
Share based compensation 3,108,274 1,804,113
Deferred revenue 135,003 (36,764 )
Gain on Change in fair value and settlement of beneficial conversion derivative (939,008 )
Depreciation and amortization 2,497,538 1,916,901
Non cash interest 741,857
Amortization of debt discount 2,610,030
Gain on disposal of fixed asset (68,786 )
Gain on debt extinguishment (79,325 )
Changes in assets and liabilities
Accounts receivable (610,384 ) (1,236,319 )
Prepaid expenses and other assets (331,498 ) (89,835 )
Accounts payable and accrued expenses 4,165,778 1,172,979
Net cash (used in) provided by operating activities (1,067,490 ) (3,505,559 )
Cash flows from investing activities
Purchase of portfolio and client acquisition costs (423,250 )
Sale of Portfolio 300,000
Note Receivable (26,795 )
Acquisition of PayOnline assets, net of cash received (3,195,452 )
Purchase of fixed, intangible and other assets (1,346,718 ) (484,137 )
Net cash used in investing activities (1,346,718 ) (3,829,634 )
Cash flows from financing activities
Proceeds from Preferred stock 5,500,000
Proceeds from indebtedness 2,668,500 650,000
Repayment of indebtedness (110,434 )
Related party advances 117,779 650,000
Net cash provided by (used in) financing activities 2,675,845 6,800,000
Effect of exchange rate changes on cash 97,902 347,578
Net (decrease) increase in cash 359,539 (187,615 )
Cash at beginning of period 1,025,747 503,343
Cash at end of period $ 1,385,286 $ 315,728
Supplemental disclosure of cash flow information
Cash paid during the period for:
Interest $ 461,673 $ 397,186
Taxes $ 94,718 $ 74,417
Non Cash activities:
Notes payable (net of discount) $ $ 694,445
Funds in escrow from issuance of notes $ $ 5,000,000
Derivative Liability – warrants $ $ 3,978,495
Preferred dividends paid in common stock $ $ 1,146,470
Share issuance for settlement of unpaid compensation $ 1,042,509 $
Shares issued for redemption of indebtedness $ 2,328,351 $
Shares issued in settlement of advances from board member $ 909,285 $

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 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. 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. 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, 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

Monday, November 14th, 2016 Uncategorized Comments Off on $NETE Reports #Q3 and Nine Months #FinancialResults

$GNCA Proprietary #ATLAS Tech Maps #PersonalizedVaccine #Cancer Antigens

– ATLAS discovers neoantigens, through functional T cell responses, which were not identified by predictive algorithms –

– Majority of antigens predicted by algorithms not biologically relevant in ATLAS assays –

– Data to be presented at 2016 SITC Annual Meeting –

CAMBRIDGE, Mass., Nov. 11, 2016  — Genocea Biosciences, Inc. (NASDAQ:GNCA), a company developing T cell-directed vaccines and immunotherapies, today presented new findings supporting the potential of ATLASTM, the Company’s proprietary rapid antigen identification screening system, to identify clinically meaningful personalized neoantigens that could guide development of neoantigen vaccines. This study, conducted in collaboration with Memorial Sloan Kettering Cancer Center (MSK), analyzed neoantigens in one non-small cell lung cancer (NSCLC) patient successfully treated with pembrolizumab (KEYTRUDA®) and will be presented at the Society for Immunotherapy of Cancer’s (SITC) 31st Annual Meeting & Associated Programs in National Harbor, Maryland on Saturday, November 12, 2016.

Genocea’s ATLAS technology screened 103 patient-specific tumor mutations with the patient’s own T cells to determine which were true neoantigens and potentially contributing to their anti-tumor immune response. Specifically, ATLAS discovered several neoantigens as biologically relevant T cell targets associated with significant cytotoxic T cell responses. Many of the neoantigens were not identified by commonly used predictive computer algorithms. Furthermore, the majority of neoantigens that were identified by those algorithms were not associated with meaningful T cell responses in ATLAS.  Additionally, multiple neoantigens were identified by ATLAS that were associated with a downregulation of immune response. (Poster #374: Genome-scale neoantigen using ATLASTM prioritizes candidates for immunotherapy in a non-small cell lung cancer patient). As part of this ongoing collaboration, further analysis of multiple additional patient tumor samples will be conducted.

“These data are the first evidence that personalized neoantigens can be comprehensively identified using functional evidence of T cell responses through ATLAS,” said Jessica Baker Flechtner, Ph.D., chief scientific officer at Genocea. “The differences between neoantigens identified by ATLAS and those noted by standard predictive algorithms reinforces the weaknesses of these algorithms and the potential for ATLAS to find better neoantigens. We believe that by improving antigen selection we can develop more effective cancer vaccines.”

Genocea’s proprietary ATLAS technology comprehensively re-creates a patient’s actual T cell immune response to cancer ex vivo. This means ATLAS can potentially identify – not just predict – targets to which patient T cells are responding to kill a tumor. It may also allow ATLAS to distinguish between neoantigen candidates that stimulate productive T cell responses and those that are irrelevant or are associated with inhibitory responses.

“For the immune system’s T cells to effectively activate tumor destruction, they must first recognize antigens that direct them to specific, impactful targets at the site of the tumor. If this system fails, disease can progress,” said Timothy A. Chan, M.D., Ph.D., Vice Chair, Department of Radiation Oncology at MSK. “These findings support the hypothesis that next-generation personalized T cell immunotherapies with biologically evidenced neoantigens may improve outcomes for patients for whom current therapies are ineffective.”

The collaboration between Genocea and Timothy A. Chan, M.D., Ph.D., Vice Chair, Department of Radiation Oncology, and Jedd D. Wolchok, M.D., Ph.D., Chief of Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center, will seek to further validate these findings in ongoing studies and continue to provide a meaningfully different picture of relevant – and potentially inhibitory – antigens than traditional methods currently produce.

About ATLAS
ATLAS is a first of its kind proprietary rapid antigen identification screening system that is designed to find targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or target indication in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.

About Genocea
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immunity. Using ATLASTM, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline includes GEN-003, a novel T cell-enabled immunotherapy for genital herpes in Phase 2 clinical development, and earlier-stage investments in immuno-oncology. For more information, please visit the company’s website at www.genocea.com.

Forward-Looking Statements
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea’s ability to progress any product candidates in preclinical or clinical trials; the ability of ATLAS to identify promising product candidates in oncology; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and efficacious; Genocea’s ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea’s ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under “Risk Factors” in Genocea’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and other filings with the Securities and Exchange Commission (the “SEC”). Further information on the factors and risks that could affect Genocea’s business, financial conditions and results of operations is contained in Genocea’s filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.

For media:
Liz Bryan
Spectrum Science Communications
O: 202-955-6222
lbryan@spectrumscience.com

For investors:
Jonathan Poole
Genocea Biosciences
O: 617-876-8191
jonathan.poole@genocea.com
Friday, November 11th, 2016 Uncategorized Comments Off on $GNCA Proprietary #ATLAS Tech Maps #PersonalizedVaccine #Cancer Antigens

$VUZI Lands Four #CES2017 Innovation Awards for #Blade3000 #SmartSunglasses

ROCHESTER, N.Y., Nov. 11, 2016  — Vuzix® Corporation (NASDAQ: VUZI), (“Vuzix” or the “Company”), a leading supplier of Smart Glasses, Augmented Reality (AR) and Virtual Reality (VR) technologies and products for the consumer and enterprise markets, is pleased to announce that the Company has received four International CES Innovation 2017 awards, for its upcoming Blade 3000 Smart Sunglasses. These award-winning AR Smart Sunglasses will be showcased at the Las Vegas Convention Center, Central Hall #13246, from January 5-8, 2017.

The Blade 3000 Smart Sunglasses provide a wearable smart display with a see-through viewing experience utilizing Vuzix’ proprietary waveguide optics and Cobra II display engine. It’s like having your computer or smartphone screen information with you wherever you go. Blade 3000 Sunglasses with vibrant full color monocular display does it all with style and performance, providing immediate heads up access to information that wearers would normally have to view by looking down at their smartphone or smartwatch.  Never before has a product been designed where you can see overlaid information, indoors or out, such as patient data, GPS mapping directions, restaurant menus, weather information, alerts and more without picking up a second screen.  Truly revolutionary, the Blade 3000 Sunglasses are a perfect companion to a smartphone, allowing users to keep their phone in their pockets for almost everything. Finally fashion meets technology in the wearable display arena.

The Blade 3000 supports Wi-Fi and Bluetooth connectivity for standalone or smartphone connected use; wirelessly displaying virtual information – similar in many ways to a smart watch. You can also view social media messaging, text, maps, notifications, etc., from both Android and iOS smartphones. Designed specifically for the exploding digital information world that wants mobile access – anywhere, anytime and connected to the real world.

Vuzix Blade 3000 Smart Sunglasses include an integrated HD camera, head-motion tracker, touch pad, tactile haptic vibration feedback, built-in noise cancelling mics with speech recognition and of course built-in batteries. The smart sunglasses will run Android on its modern internal processor and is completely wireless.

The Blade 3000 Smart Sunglasses have been honored with four CES Innovation Awards for innovative design and engineering. Blending fashion and technology, Vuzix Blade 3000 will be one of the world’s first smart sunglasses. The Blade 3000 is designed for prosumer and office enterprise applications, with significantly improved display resolution, ergonomics, computing power, and sensor technologies. A video overview and introductory product info on the Blade 3000 is available at Blade 3000 Video .

“Receiving four CES Innovation Awards is an emphatic acknowledgement from industry experts that Vuzix is at the forefront of the wearable display and smart glasses markets,” said Paul Travers, President and Chief Executive Officer of Vuzix.  “AR is the future and we understand the impact these technologies can have on both corporations and consumers.”

The CES Innovation Awards are sponsored by the Consumer Technology Association, the producer of CES 2017, and have been recognizing achievements in product design and engineering since 1976.  Products entered in this program are judged by a preeminent panel of independent industrial designers, independent engineers and members of the trade media to honor outstanding design and engineering in cutting edge consumer electronics products across 27 product categories.

Vuzix’ award winning Blade 3000 and its other existing and new products will be displayed at CES 2017 in the Las Vegas Convention Center, Central Hall Booth # 13246, from January 5-8, 2017. Further information on the product, its pricing, and ultimate availability dates will be unveiled at CES in January 2017.

About Vuzix Corporation

Vuzix is a leading supplier of Smart-Glasses, Augmented Reality (AR) and Virtual Reality (VR) technologies and products for the consumer and enterprise markets. The Company’s products include personal display and wearable computing devices that offer users a portable high quality viewing experience, provide solutions for mobility, wearable displays and virtual and augmented reality. Vuzix holds 49 patents and 40 additional patents pending and numerous IP licenses in the Video Eyewear field. The Company has won Consumer Electronics Show (or CES) awards for innovation for the years 2005 to 2016 and several wireless technology innovation awards among others. Founded in 1997, Vuzix is a public company (NASDAQ: VUZI) with offices in Rochester, NY; Oxford, UK; and Tokyo, Japan.

Forward-Looking Statements Disclaimer

Certain statements contained in this news release are “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. Forward looking statements contained in this release relate to the new Blade 3000 Smart Sunglasses, its technological advancements and proposed features, among other things, and the Company’s leadership in the Video Eyewear, VR and AR display industry. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and MD&A filed with the United States Securities and Exchange Commission and applicable Canadian securities regulators (copies of which may be obtained at www.sedar.com or www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

For further information:

Media and Investor Relations Contact:

Andrew Haag
Managing Partner
IRTH Communications
vuzi@irthcommunications.com
Tel: (866) 976-4784

Vuzix Corporation
25 Hendrix Road, Suite A
West Henrietta, NY 14586 USA
Investor Information – Grant Russell
IR@Vuzix.com
Tel: (585) 359-7562
www.vuzix.com

For further sales, and product information, please visit:

North America:
http://www.vuzix.com/contact/

Europe/UK:
https://www.vuzix.eu/contact/

Asia:
http://www.vuzix.jp/contact.html

Friday, November 11th, 2016 Uncategorized Comments Off on $VUZI Lands Four #CES2017 Innovation Awards for #Blade3000 #SmartSunglasses

$CALA Four Abstracts Incl. #CB1158 Selected for #SITC2016

CB-1158 Pharmacodynamic Effects Observed in Patients

SOUTH SAN FRANCISCO, Calif., Nov. 11, 2016  — Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced that data for its drug candidates CB-839, the company’s novel glutaminase inhibitor, and CB-1158, the company’s novel arginase inhibitor, will be presented at the Society for Immunotherapy of Cancer (SITC) 2016 Annual Meeting, which is being held from November 9-13, 2016 in National Harbor, Maryland.

“Both CB-839 and CB-1158 have the distinction of targeting metabolic and immune checkpoints which we believe, through rational combinations, have the potential to be transformational in the treatment of cancer. CB-839 and CB-1158 are each in clinical trials with cohorts planned in combination with approved immunotherapy agents,” said Susan Molineaux, Ph.D., President and Chief Executive Officer of Calithera.  “We are pleased that CB-1158 shows significant pharmacodynamic effects in patients at the first dose level tested.”

Preclinical CB-839 data will be presented in a poster titled, “Targeting tumor glutamine metabolism with CB-839 enhances the efficacy of immune checkpoint inhibitors,” by Andy MacKinnon, Ph.D., Calithera Biosciences (Poster #230).  Included in the presentation are data that provide further insights into the mechanism by which inhibition of glutaminase by CB-839 enhances T-cell activation and increases the anti-tumor activity of anti-PD-L1 and anti-PD-1 antibodies.  Glutamine deprivation during T-cell activation was shown to block Myc expression and Myc-driven metabolic re-programming, and to promote expression of T-cell suppressive markers such as BTLA, CTLA-4, PD-1, and CD73.  In two syngeneic animal models, CT26 (colon cancer) and B16 (melanoma) the combination of CB-839 and anti-PD-L1 or anti-PD-1 showed significantly enhanced anti-tumor activity over checkpoint inhibition alone resulting in increased tumor regressions in the CT26 model. Depletion of CD8+ T-cells from these tumor-bearing animals reversed the anti-tumor effects of the combination, confirming an immune-mediated mechanism of action.

CB-1158 data will be presented in a poster titled, “Arginase inhibitor CB-1158 alleviates immunosuppression and enhances anti-tumor responses as a single agent and in combination with other immunotherapies,” by Amani Makkouk, Ph.D., Calithera Biosciences (Poster #231).  Arginase is expressed in myeloid derived suppressor cells (MDSCs) and exerts an immunosuppressive effect on T-cells and NK cells by depleting arginine and blocking activation.  Tumor cell infiltrates in patients with solid tumor cancers contain significant numbers of arginase-expressing MDSCs; as a result, these patients have increased levels of plasma arginase and decreased levels of plasma arginine compared to healthy individuals.  CB-1158, a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency, has single agent immune-mediated efficacy in multiple syngeneic animal models. Inhibition of tumor growth was accompanied by an increase in the local concentration of arginine, and the induction of multiple pro-inflammatory changes in the tumor microenvironment.  Treatment with CB-1158 also enhanced the anti-tumor activity of adoptive T-cell therapy, checkpoint blockade and chemotherapy in these animal models.  CB-1158 is currently being tested in a Phase 1 clinical trial in patients with solid tumors.  Three patients in the first cohort were treated with 50 mg of CB-1158 twice daily.  This dose was well-tolerated and was pharmacologically active, resulting in sustained elevation of arginine in the plasma of all three patients.  The trial is continuing to enroll patients to complete the dose escalation phase of the study, to be followed by combination studies with a PD-1 antibody.

In addition, two posters describing trial design will be presented during the “Clinical Trials in Progress” session:

CX-1158-101: A first-in-human phase I study of a small molecule inhibitor of arginase (CB-1158) as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor in patients with solid tumors

Presenter: Siqing Fu, M.D., Ph.D., University of Texas, MD Anderson Cancer Center, Poster #155

CX-839-004: A phase I/II study of the safety, pharmacokinetics, and pharmacodynamics of the glutaminase inhibitor CB-839 combined with nivolumab in patients with renal cell carcinoma, melanoma, and non-small cell lung cancer

Presenter: Elaine Lam, M.D., University of Colorado, Denver, Poster #166

About Calithera Biosciences

Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer.  Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival. It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents.  CB-1158 is a first-in-class immuno-oncology metabolic checkpoint inhibitor targeting arginase, a critical immunosuppressive enzyme responsible for T-cell suppression by myeloid-derived suppressor cells.  Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells.  CB-1158 is currently in a Phase I clinical trial.  Calithera is headquartered in South San Francisco, California.  For more information about Calithera, please visit www.calithera.com.

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. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “poised” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements.  Examples of these statements include the ability for CB-839 and CB-1158 to be transformational in the treatment of cancer, the pharmacodynamics effects of CB-1158, the potential for increases in the number of tumor regressions or inhibition of tumor growth and the efficacy of CB-839 and CB-1158.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.  The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release.  Such product candidates may not be beneficial to patients or successfully commercialized.  The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price.  Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

Jennifer McNealey
ir@Calithera.com
650-870-1071
Friday, November 11th, 2016 Uncategorized Comments Off on $CALA Four Abstracts Incl. #CB1158 Selected for #SITC2016

$VDTH to #Merge With #DishTV

NEW DELHI, November 11, 2016  —

The Board of Directors of Dish TV (NSE: DISHTV) (‘Dish TV’) and Videocon d2h Limited (NASDAQ: VDTH) (‘Vd2h’) today approved a scheme of arrangement for the amalgamation of Vd2h into Dish TV (the ‘Scheme’) and the execution of definitive agreements in relation to such amalgamation (the ‘Proposed Transaction’).

Following the closing of the Proposed Transaction, the merged entity will be renamed as Dish TV Videocon Limited (‘Dish TV Videocon’). Pursuant to the Scheme, Dish TV Videocon shall issue 857.79[1] million shares as consideration for the Scheme and the Vd2h shareholders shall be allotted 2.02[1] new shares of Dish TV Videocon for every one share held in Vd2h (subject to certain adjustments as set out in the Scheme), which would result in Dish TV shareholders owning 1,066.86[1] million existing shares or 55.4% of Dish TV Videocon, and Vd2h shareholders owning 857.79[1] million new shares or 44.6% of Dish TV Videocon.

Dish TV Videocon will be led by Jawahar Lal Goel as Chairman and Managing Director, combining the strength of senior and operating management teams while offering further career growth opportunities for employees of the two merging companies. The Vd2h principals shall have the right to nominate two directors on the Dish TV Videocon Board, one of whom shall be Vice Chairman and the other, a Deputy Managing Director.

The Proposed Transaction is expected to create a leading cable and satellite distribution platform in India. Dish TV Videocon would serve 27.6 million net subscribers in India, as of September 30, 2016 on a pro forma basis, out of a total of 175 million TV households in India highlighting significant room for growth. The combined entity would have a revenue of Rs. 59,158 mn and EBITDA[2] of Rs. 18,262 mn on a pro forma basis for the fiscal year ended 31 March, 2016 positioning it as a leading media company in India. The Proposed Transaction is expected to provide better synergies and growth opportunities and enable Dish TV Videocon to provide differentiated and superior service to all customers through deeper after-sales, distribution and technology capabilities, and also become a more effective partner for TV content providers in India.

Jawahar Lal Goel, Chairman and Managing Director of Dish TV said, “We are pleased to announce this combination at a time when the cable and satellite industry in India is rapidly progressing on the path to digitization. This transaction, that brings together two powerhouse brands of the cable and satellite industry in India, will provide us with a gateway to harness growth opportunities in an ultra competitive multi player environment. This combine will enhance value for all stakeholders – consumers, government, employees and shareholders. Dish TV has been a pioneering and path-breaking company which has taken the pain and responsibility of establishing many new processes, like the electronic and digital payments system that were the business need of the initial years and went on to become the industry norm of a dynamic and throbbing Industry. Now, we take the next leap in our very exciting and exhilarating journey.”

Saurabh Dhoot, Executive Chairman of Vd2h said, “Since the commercial launch of Vd2h seven years ago, we have created a highly successful and high-growth DTH business with a solid foundation. We went public on the NASDAQ with a vision to take the company to the next level and emerge as a leading, innovative and highly profitable Indian media platform. Today, we are very excited about this strategic combination to create a solid platform with decisive and proven leadership at the front, leading Dish TV Videocon to create value for all stakeholders, our customers, employees, and shareholders.”

At the close of the Proposed Transaction, the current promoters of Dish TV shall continue as promoters of Dish TV Videocon. The Dish TV principals are also in discussion with the Vd2h principals to purchase some of the Vd2h principals’ shares in Dish TV Videocon post the amalgamation, details of which are likely to be finalized soon.

Upon closing of the Proposed Transaction, Dish TV Videocon shall continue to be listed on the National Stock Exchange of India and the BSE Limited in India and on the Luxembourg Stock Exchange in the form of GDRs. In the Scheme, holders of Vd2h ADRs will receive their new shares in the form of GDRs, unless they elect to receive and hold new shares directly.

The Proposed Transaction remains subject to approvals, including from the Securities and Exchange Board of India, the stock exchanges, shareholders and creditors of both companies, the Competition Commission of India, the High Court of Bombay and the Ministry of Information and Broadcasting. The Proposed Transaction is expected to close in the second-half of 2017.

Morgan Stanley is acting as exclusive financial advisor to Dish TV and YES Securities (India) Limited is acting as lead financial advisor to Vd2h. The other advisors involved in the transaction are EY, SR Batliboi & Co. LLP, Luthra & Luthra Law Offices for Dish TV, and KPMG, Shardul Amarchand Mangaldas & Co., and Edelweiss Capital for Vd2h. Shearman & Sterling is acting as international legal advisor to both Dish TV and Vd2h in respect of the, US federal securities law and related aspects of the Proposed Transaction.

 

1. The fully diluted share count of Dish TV at 1,066,863,665 shares, which will lead to 857,785,766 shares of Dish TV Videocon being issued to Vd2h shareholders. Exchange ratio rounded off to two decimal places. One Vd2h ADS represents four equity shares of Vd2h.

2. Dish TV EBITDA are reported EBITDA figures, while Vd2h EBITDA are reported adjusted EBITDA figures; EBITDA is not a standardized term, hence direct comparison between companies using the same term may not be possible. Other companies may calculate EBITDA differently from Dish TV and Vd2h, limiting their usefulness as comparative measures

 

About Dish TV

Dish TV is Asia Pacific’s largest direct-to-home (DTH) company. Dish TV has on its platform more than 582 channels & services including 22 audio channels and over 55 HD channels & services. Dish TV offers a host of active services including Comedy Active, Playin TV Active, Kids Active and Games Active. Other Active services include Anandam Active, Ibadat Active, Music Active and Job Active etc. Dish TV uses the NSS-6 satellite platform along with the Asiasat 5 and SES-8 platforms which makes its total bandwidth capacity equal 828 MHz, amongst the largest held by any DTH player in the country. The Company has a vast distribution network of over 2,268 distributors & over 244,668 dealers that span across 9,322 towns in the country. Dish TV has more than 1,090 service franchisees that strive to achieve a TAT of 4 hours for customer service. Dish TV has thirteen 24* 7 call centres catering to 11 different languages to take care of subscriber requirement at any point in time. For more information on the company, please visit http://www.dishtv.in

About Vd2h

Videocon d2h is India’s fastest growing DTH service provider which offers over 570 channels and services. Vd2h is launching HD Smart Connect Set top Box (Connected Set top box) which converts your existing normal TV into a Smart TV. The Connected set top box allows one to browse content from Facebook, Twitter, Daily Motion, video on demand sites,  news sites, weather sites, etc through applications residing on STB.   Powered by the MPEG-4 and DVB-S2 technology, Vd2h transforms your TV into a hub of entertainment and knowledge. It offers a wide range of active services including Smart English, Smart Games. The other active services include d2h Hollywood HD, d2h music, d2h spice, d2h cinema in both Standard Definition and HD, etc. It launched India’s first 4K Ultra HD DTH channel service.  Vd2h offers India’s first Radio Frequency Remote Control. Vd2h has a pan India sales & distribution channel, strong service orientation and a track record of introducing technologically innovative product and service offerings. Vd2h has over 300 own service centres spread across 7,500 towns in India to attend and resolve the service issues within four to six hours. For more details on the company, please visit http://www.videocond2h.com

Disclaimer

In furnishing this press release, neither Videocon d2h Limited, Dish TV India Limited nor its associates and affiliates, nor any of their respective officers, directors, advisors, undertake any obligation to provide to the recipient (a) access to any additional information or to update this document, or (b) to correct any inaccuracies therein which may or may not become apparent.

The proposed transaction is subject to approval of various regulatory and other authorities, including without limitation, the Competition Commission of India, the Securities and Exchange Board of India, the Ministry of Information and Broadcasting and the  High Court of Bombay.

Forward Looking Statements

This press release may contain forward-looking statements, as defined in the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. We caution you that reliance on any forward-looking statement involves risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. These and other factors are more fully discussed in Vd2h’s annual report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) and available at http://www.sec.gov. All information provided in this press release is as of the date hereof, unless the context otherwise requires. Other than as required by law, Vd2h does not undertake to update any forward-looking statements or other information in this press release.

Further Information

This announcement is not intended to and does not constitute or form part of any offer to sell or subscribe for, or any invitation to purchase or subscribe for, or the solicitation of an offer to purchase or otherwise subscribe for any securities, or the solicitation of any vote or approval in any jurisdiction pursuant to the Proposed Transaction or otherwise nor shall there be any sale, issuance or transfer of securities of Dish TV or Vd2h in any jurisdiction in contravention of applicable laws. The Proposed Transaction will be made solely pursuant to the Scheme which will contain the full terms and conditions of the Scheme, including details of how to vote in respect of the Scheme. Any vote or response in relation to the Scheme should be made solely on the basis of the Scheme Document.

This announcement does not constitute a prospectus or prospectus equivalent document.

Notice to U.S. Investors

The Proposed Transaction relates to the shares of an Indian company and is being made by means of a scheme of arrangement provided for under Sections 391 to 394 of the Companies Act, 1956 and/or applicable Sections of the Companies Act, 2013.  The Proposed Transaction, implemented by way of a scheme of arrangement, is not subject to the U.S. tender offer rules and is not subject to the U.S. proxy solicitation rules under the U.S. Securities Exchange Act of 1934, as amended.  Accordingly, the Proposed Transaction is subject to the disclosure requirements and practices applicable to a scheme of arrangement involving a company in India, which differ from the disclosure requirements of United States tender offer and proxy solicitation rules.

The new shares of Dish TV Videocon to be issued pursuant to the Scheme have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act.  New shares of Dish TV Videocon to be issued pursuant to the Scheme will be issued pursuant to the exemption from registration provided by Section 3(a)(10) under the Securities Act.

Neither the SEC nor any U.S. state securities commission has approved or disapproved of the new shares of Dish TV Videocon to be issued pursuant to the Scheme, or determined if this announcement is accurate or complete.  Any representation to the contrary is a criminal offence in the United States.

Dish TV and Vd2h are incorporated under the laws of India. In addition, most their respective officers and directors reside outside the United States, and some or all of their assets are or may be located in jurisdictions outside the United States.  Therefore, investors may have difficulty effecting service of process within the United States upon those persons or recovering against Dish TV, Vd2h or their respective officers or directors on judgments of United States courts, including judgments based upon the civil liability provisions of the United States federal securities laws.  It may not be possible to sue Dish TV or Vd2h or any of their respective officers or directors in a non-U.S. court for violations of the U.S. securities laws.

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$PTCT #CHMP Recommends Renewal of #Translarna Marketing Authorization for #MD

SOUTH PLAINFIELD, N.J., Nov. 11, 2016  — PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients five years and older. In connection with the renewal, the marketing authorization will include a specific obligation to conduct an additional long-term post-authorization trial.

“We are pleased with this outcome which took into account all available data for Translarna,” said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. “This decision reflects the benefit that Translarna is having for patients suffering from nonsense mutation Duchenne muscular dystrophy.”

The CHMP opinion forms the basis for a European Commission decision on the renewal of the marketing authorization. The European Commission generally delivers its decision within three months.

“Translarna has shown clinically meaningful benefits for patients,” said Eugenio Mercuri, M.D., Professor of Pediatric Neurology at the Catholic University, Rome, Italy. “Duchenne is a devastating disease with a progressive loss of function. Maintaining function is of the utmost importance to patients.”

“The consistency of Translarna’s benefit shown across key endpoints is impressive for a dystrophin replacement therapy,” said Craig McDonald, M.D., Professor of Pediatrics and Chair of the Department of Physical Medicine & Rehabilitation at University of California. “I am encouraged for the DMD community by the CHMP’s recommendation.”

The CHMP has requested that PTC conduct a new 18-month randomized, placebo-controlled study in patients with nonsense mutation Duchenne muscular dystrophy, as a specific post-authorization obligation, with results expected to be available in the first quarter of 2021. This study will be followed by an 18-month open-label extension period where all patients will be switched to Translarna. PTC has proposed a trial similar in size to ACT DMD and details of the protocol are expected to be finalized in future interactions with the EMA. Conditional marketing authorizations are subject to annual reassessment and renewal.

“For boys with Duchenne, every day matters and functional loss cannot be regained. Patients need access to innovative new therapies like Translarna,” stated Filippo Buccella, founder of the Italian Parent Project, a patient advocacy group for Duchenne Muscular Dystrophy.

About Translarna™ (ataluren)
Translarna, discovered and developed by PTC Therapeutics, Inc., is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. A nonsense mutation is an alteration in the genetic code that prematurely halts the synthesis of an essential protein. The resulting disorder is determined by which protein cannot be expressed in its entirety and is no longer functional, such as dystrophin in Duchenne muscular dystrophy. Translarna is licensed in the European Economic Area for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. Translarna is an investigational new drug in the United States. The development of Translarna has been supported by grants from Cystic Fibrosis Foundation Therapeutics Inc. (the nonprofit affiliate of the Cystic Fibrosis Foundation); Muscular Dystrophy Association; FDA’s Office of Orphan Products Development; National Center for Research Resources; National Heart, Lung, and Blood Institute; and Parent Project Muscular Dystrophy.

About Duchenne Muscular Dystrophy
Primarily affecting males, Duchenne muscular dystrophy (DMD) is a progressive muscle disorder caused by the lack of functional dystrophin protein. Dystrophin is critical to the structural stability of skeletal, diaphragm, and heart muscles. Patients with DMD, the more severe form of the disorder, lose the ability to walk as early as age 10 and experience life-threatening lung and heart complications in their late teens and twenties. It is estimated that a nonsense mutation is the cause of DMD in approximately 13 percent of patients.

About PTC Therapeutics
PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of orally administered, proprietary small molecule drugs targeting an area of RNA biology we refer to as post-transcriptional control. Post-transcriptional control processes are the regulatory events that occur in cells during and after a messenger RNA, or mRNA, molecule is copied from DNA through the transcription process. PTC’s internally discovered pipeline addresses multiple therapeutic areas, including rare disorders and oncology. PTC has discovered all of its compounds currently under development using its proprietary technologies. PTC plans to continue to develop these compounds both on its own and through selective collaboration arrangements with leading pharmaceutical and biotechnology companies. For more information on the company, please visit our website www.ptcbio.com.

For More Information:

Investors:
Emily Hill
+ 1 (908) 912-9327
ehill@ptcbio.com

Media:
Jane Baj
+1 (908) 912-9167
jbaj@ptcbio.com

Forward Looking Statements:
All statements, other than those of historical fact, contained in this press release, are forward-looking statements, including statements regarding: the future expectations, plans and prospects for PTC; the timing and outcome of PTC’s regulatory process, including the final determination by the European Commission with respect to renewal of the marketing authorization in the European Economic Area (EEA) for Translarna for the treatment of nmDMD; the final design, enrollment, timing, conduct, cost, evaluation and results of the clinical trial of Translarna for the treatment of nmDMD that PTC will undertake pursuant to the specific obligation associated with the Translarna marketing authorization (if renewal is granted by the European Commission); the clinical utility and potential advantages of Translarna; PTC’s ability to continue to supply Translarna to patients across Europe and in other territories; PTC’s strategy, future operations, future financial position, future revenues or projected costs; and the objectives of management.  Other forward-looking statements may be identified by the words “will,” “plan,” “target,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “potential,” “project,” “possible,” “potential,” “would,” “could,” “should,” “continue,” and similar expressions.

PTC’s actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: PTC’s ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in the EEA, including whether the European Commission determines to approve the renewal of such authorization and whether the EMA determines in future annual renewal cycles that the benefit-risk balance of Translarna authorization supports renewal of such authorization; the final design of the new nmDMD trial that PTC will undertake pursuant to the specific obligation associated with the marketing authorization (following renewal) and PTC’s ability to enroll, fund and conduct such trial; the outcome of future interactions PTC has with the FDA with respect to Translarna for the treatment of nmDMD, including whether PTC is required to perform additional clinical and non-clinical trials at significant cost and whether such trials, if successful, may enable FDA review of a New Drug Application (NDA) submission; the EMA’s determinations with respect to PTC’s variation submission which seeks to add Translarna for the treatment of nonsense mutation cystic fibrosis to PTC’s marketing authorization in the EEA; the scope of regulatory approvals or authorizations for Translarna (if any), including labeling and other matters that could affect the availability or commercial potential of Translarna; the outcome of ongoing or future clinical trials or studies in Translarna, including ACT CF and the Phase 2 study of Translarna for nmDMD in pediatric patients; the eligible patient base and commercial potential of Translarna and PTC’s other product candidates; PTC’s ability to commercialize and commercially manufacture Translarna in general and specifically as a treatment for nmDMD, including its ability to establish and maintain arrangements with manufacturers, suppliers, distributors and production and collaboration partners on favorable terms; the outcome of pricing and reimbursement negotiations in those territories in which PTC is authorized to sell Translarna; whether patients and healthcare professionals may be able to access Translarna through alternative means if pricing and reimbursement negotiations in the applicable territory do not have a positive outcome; expectations for regulatory approvals, including PTC’s ability to make regulatory submissions in a timely manner (or at all), the period during which the outcome of regulatory reviews will become available, adverse decisions by regulatory authorities (or other delay or deceleration of the regulatory process), and PTC’s ability to meet existing or future regulatory standards with respect to Translarna; PTC’s ability to fulfill any additional obligations, including with respect to further trials or studies relating to cost-effectiveness, obtaining licenses or satisfying requirements for labor and business practices, in the territories in which it may obtain regulatory approval, including the United States, EEA and other territories; PTC’s scientific approach and general development progress; the sufficiency of PTC’s cash resources and PTC’s ability to obtain adequate financing in the future for PTC’s foreseeable and unforeseeable operating expenses and capital expenditures; and the factors discussed in the “Risk Factors” section of PTC’s most recent Quarterly Report on Form 10-Q as well as any updates to these risk factors filed from time to time in PTC’s other filings with the SEC. You are urged to carefully consider all such factors.

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that Translarna will receive full regulatory approval in any territory or maintain its current marketing authorization in the EEA, or prove to be commercially successful in general, or specifically with respect to the treatment of nmDMD.

The forward-looking statements contained herein represent PTC’s views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.

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$PCRX to Present at Investor Conferences in November

PARSIPPANY, N.J., Nov. 10, 2016  — Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that senior leadership is scheduled to present an overview of the company at the following investor conferences in November:

  • Jefferies 2016 London Healthcare Conference at 2:00 p.m. GMT (7:00 p.m. ET) in London on Thursday, November 17, 2016.
  • 28th Annual Piper Jaffray Healthcare Conference at 11:00 a.m. ET in New York on Tuesday, November 29, 2016.

Live audio webcasts of the Pacira presentations can be accessed by visiting the “Investors & Media” section of the company’s website at investor.pacira.com. Replays of the webcasts will be archived on the Pacira website for two weeks following the respective presentation dates.

About Pacira

Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

Company Contact:
Pacira Pharmaceuticals, Inc.
Jessica Cho, (973) 254-3574
jessica.cho@pacira.com
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