US News – DirectorsTalk Interviews https://www.directorstalkinterviews.com LSE London Stock Exchange PLC Company Interviews Fri, 23 Aug 2019 06:13:49 +0000 en-GB hourly 1 https://wordpress.org/?v=5.2.3 GSK announces positive headline results from the pivotal DREAMM-2 study https://www.directorstalkinterviews.com/gsk-announces-positive-headline-results-from-the-pivotal-dreamm-2-study/412791116 Fri, 23 Aug 2019 06:13:48 +0000 https://www.directorstalkinterviews.com/?p=791116 GlaxoSmithKline plc (LON/NYSE: GSK) today announced positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916). The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The two-arm study met its primary ...

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GlaxoSmithKline plc (LON/NYSE: GSK) today announced positive headline results from the pivotal DREAMM-2 open-label, randomised study of two doses of belantamab mafodotin (GSK2857916).

The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The two-arm study met its primary objective and demonstrated a clinically meaningful overall response rate with belantamab mafodotin in the patient population. The safety and tolerability profile was consistent with that observed in DREAMM-1, the first time in human study of belantamab mafodotin.

Dr Hal Barron, Chief Scientific Officer and President R&D, GlaxoSmithKline said:

“I am pleased with the results of the DREAMM-2 study and excited about what these data could mean for patients with multiple myeloma who have exhausted other lines of treatment. We are on track to file belantamab mafodotin later this year and continue to investigate how it could help even more patients with this disease.”

Data from the DREAMM-2 study will be the basis for regulatory filings starting later this year.

Multiple myeloma is the second most common blood cancer and is generally considered treatable, but not curable[i]. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.

Safety and efficacy results from the DREAMM-2 study will be submitted for presentation at an upcoming scientific meeting. Additional ongoing studies are testing the effect of belantamab mafodotin as third-line monotherapy in relapsed/refractory multiple myeloma and as a combination treatment in the first and second line setting as part of the broader DREAMM clinical development programme.

About B-cell maturation antigen (BCMA)

The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines[ii].

About the DREAMM clinical trial programme for belantamab mafodotin (GSK2857916)

Belantamab mafodotin is an immuno-conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using technology licensed from BioWa.

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CRH returns a further €350 million of cash to shareholders https://www.directorstalkinterviews.com/crh-returns-a-further-e350-million-of-cash-to-shareholders/412789857 Fri, 09 Aug 2019 06:12:42 +0000 https://www.directorstalkinterviews.com/?p=789857 CRH plc (LON: CRH), the global building materials group, has today announced that it has completed the latest phase of its share buyback programme, returning a further €350 million of cash to shareholders. Between 29 April and 7 August 2019, 12.2 million ordinary shares were repurchased on the London Stock Exchange and Euronext Dublin at ...

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CRH plc (LON: CRH), the global building materials group, has today announced that it has completed the latest phase of its share buyback programme, returning a further €350 million of cash to shareholders.

Between 29 April and 7 August 2019, 12.2 million ordinary shares were repurchased on the London Stock Exchange and Euronext Dublin at an average discount of 0.75% to the volume weighted average price over the period.

This brings total cash returned to shareholders under our ongoing share buyback programme to €1.35 billion since its commencement in May 2018. Further share buybacks are under active consideration and details will be announced as part of our Interim Results announcement on 22 August 2019.

CRH (LON: CRH, ISE: CRG, NYSE: CRH) is the leading building materials business in the world, employing c.90,000 people at c.3,700 operating locations in 32 countries. It is the largest building materials business in North America, the largest heavyside materials business in Europe and has a number of strategic positions in the emerging economic regions of Asia and South America. CRH manufactures and supplies a range of integrated building materials, products and innovative solutions which can be found throughout the built environment, from major public infrastructure projects to commercial buildings and residential structures. A Fortune 500 company, CRH is a constituent member of the FTSE 100 index, the EURO STOXX 50 index, the ISEQ 20 and the Dow Jones Sustainability Index (DJSI) Europe. CRH’s American Depositary Shares are listed on the NYSE.

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New York power cut, 70,000 homes and businesses lose power for 5 hours https://www.directorstalkinterviews.com/new-york-power-cut-70000-homes-and-businesses-lose-power-for-5-hours/412787903 Tue, 16 Jul 2019 06:47:02 +0000 https://www.directorstalkinterviews.com/?p=787903 Manhatten Saturday evening saw a power failure that lasted up to 5 hours in the densely populated area which halted trains, traffic lights and stopped lifts (trapping people). Power was restored just before midnight Sunday. While it is unclear of the cause, an investigation is underway at a nearby substation. The moment power was restored ...

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Manhatten Saturday evening saw a power failure that lasted up to 5 hours in the densely populated area which halted trains, traffic lights and stopped lifts (trapping people). Power was restored just before midnight Sunday. While it is unclear of the cause, an investigation is underway at a nearby substation.

While not good for some, Northbridge Industrial Services (LON: NBI) CEO said,

“Good news for Northbridge, this will lead to further testing for back up supplies.”

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GlaxoSmithKline PLC positive headline results in Phase 3 PRIMA study https://www.directorstalkinterviews.com/glaxosmithkline-plc-positive-headline-results-in-phase-3-prima-study/412787741 Mon, 15 Jul 2019 06:30:18 +0000 https://www.directorstalkinterviews.com/?p=787741 GlaxoSmithKline plc (LON/NYSE: GSK) has today announced positive results from PRIMA (ENGOT-OV26/GOG-3012), the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in patients with first-line ovarian cancer following platinum-based chemotherapy. The study met its primary endpoint of a statistically significant improvement in progression free survival for women regardless of their ...

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GlaxoSmithKline plc (LON/NYSE: GSK) has today announced positive results from PRIMA (ENGOT-OV26/GOG-3012), the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in patients with first-line ovarian cancer following platinum-based chemotherapy. The study met its primary endpoint of a statistically significant improvement in progression free survival for women regardless of their biomarker status.

The safety and tolerability profile of niraparib was consistent with previous clinical trials.

Dr Hal Barron, Chief Scientific Officer and President, R&D, GlaxoSmithKline PLC, said:

“Almost 300,000 women around the world are diagnosed with ovarian cancer every year, yet only about 15% of patients are currently eligible to receive PARP inhibitors as their initial therapy. These exciting data demonstrate that ZEJULA has the potential to significantly benefit even more women with this devastating cancer.”

The full results from PRIMA will be presented at an upcoming scientific meeting.

Niraparib is marketed in the United States and Europe under the trade name ZEJULA®.

About PRIMA

PRIMA is a double-blind, randomized Phase 3 study designed to evaluate niraparib versus placebo in first-line Stage III or IV ovarian cancer patients. The study assesses the efficacy of niraparib as maintenance treatment, as measured by progression free survival. Platinum responsive patients were randomized 2:1 to niraparib or placebo. The trial incorporated an individualized niraparib starting dose of 200 mg once-daily in patients with baseline weight <77kg or platelet count <150K/μL and 300 mg in all other patients.

About Ovarian Cancer

Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years.

About niraparib

Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in three pivotal trials. The ongoing development program for niraparib includes the Phase 3 PRIMA trial, a Phase 3 trial for the treatment of patients with germline BRCA-mutated, metastatic breast cancer (the BRAVO trial), and a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab in metastatic, triple-negative breast cancer and advanced, platinum-resistant ovarian cancer (the TOPACIO trial) and niraparib plus bevacizumab in recurrent, platinum-sensitive ovarian cancer (the ENGOT-OV24/AVANOVA trial). Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

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GlaxoSmithKline PLC ViiV switch study shows 2DR as effective as 3DR https://www.directorstalkinterviews.com/glaxosmithkline-plc-viiv-switch-study-shows-2dr-as-effective-as-3dr/412787439 Wed, 10 Jul 2019 06:25:09 +0000 https://www.directorstalkinterviews.com/?p=787439 ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (LON: GSK), with Pfizer Inc. (NYSE: PFE) and Shionogi Limited as shareholders, today announced positive Week 48 results from its phase III TANGO study. The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least ...

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ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (LON: GSK), with Pfizer Inc. (NYSE: PFE) and Shionogi Limited as shareholders, today announced positive Week 48 results from its phase III TANGO study. The TANGO study was conducted to assess whether adults living with HIV-1 who had maintained viral suppression for at least six months on a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs, were able to maintain similar rates of viral suppression after switching to the 2-drug regimen (2DR) of dolutegravir plus lamivudine in a fixed dose combination, compared to continuing the TAF-containing regimen.

The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study. The safety results for the 2DR of dolutegravir plus lamivudine were consistent with the product labelling for the medicines.[1]

Full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019), to be held from 21-24 July in Mexico City.

Kimberly Smith, M.D., Head of Global Research & Medical Strategy at ViiV Healthcare, said:

“When we developed the TANGO study, we asked if virally suppressed people living with HIV could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression. These Week 48 data clearly indicate that they can – individuals who are already on treatment can maintain viral suppression if they switch from a 3-drug, TAF-containing regimen to a 2-drug regimen of dolutegravir plus lamivudine.”

The single-pill, 2DR of dolutegravir plus lamivudine, was authorised in the United States earlier this year for the treatment of HIV-1 infection in adults with no antiretroviral treatment (ARV) history and with no known resistance to either dolutegravir or lamivudine.[2] It was also authorised in Europe in July 2019 for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor (INI) class, or lamivudine.[3]

About TANGO

TANGO is a phase III, randomised, open-label, active-controlled, multicentre study to assess the antiviral efficacy and safety of switching to a 2DR consisting of dolutegravir plus lamivudine in HIV-infected adults who are virally suppressed and stable on a TAF-containing regimen. [4]

Study participants were HIV-1 infected adults on a TAF-containing regimen with HIV-1 RNA<50c/mL for at least six months, without prior virologic failure, no historical nucleoside reverse transcriptase inhibitors (NRTI) or INI major resistance mutation, and no evidence of hepatitis B infection. Participants were randomised to switch to dolutegravir plus lamivudine or continue on the TAF-containing regimen through Week 148. The primary endpoint was the proportion of participants with a viral load of >50 c/mL at Week 48 (FDA Snapshot algorithm) for the Intention To Treat-Exposed (ITT-E) population.4

About dolutegravir and lamivudine

Dolutegravir is an INI for use in combination with other antiretroviral agents for the treatment of HIV.[5] INIs block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Dolutegravir is authorised in over 100 countries across North America, Europe, Asia, Australia, Africa and Latin America.

Lamivudine, commonly known as 3TC, is a nucleoside analogue used in combination with other antiretroviral agents for the treatment of HIV infection. Lamivudine is available in branded (Epivir®) and generic forms.[6]

Dolutegravir plus lamivudine is a once-daily, single-pill, 2-drug regimen that combines the INI dolutegravir (Tivicay, 50 mg) with the NRTI lamivudine (Epivir, 300 mg).2 The fixed dose combination of dolutegravir plus lamivudine is authorised in the EU for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the INI class, or lamivudine,3 and in the US for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either dolutegravir or lamivudine.2

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Important Safety Information for 50mg dolutegravir/300mg lamivudine tablets in the EU

The following Important Safety Information is based on the Summary of Product Characteristics for dolutegravir plus lamivudine. Please consult the full Summary of Product Characteristics for all the safety information.

Dolutegravir plus lamivudine (50mg dolutegravir/300mg lamivudine)

Dolutegravir plus lamivudine is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

The recommended dose of dolutegravir plus lamivudine in adults and adolescents is one 50 mg/300 mg tablet once daily.

Method of administration

Oral use. Dolutegravir plus lamivudine can be taken with or without food.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Dose adjustments

A separate preparation of dolutegravir is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir. In these cases the physician should refer to the individual product information for dolutegravir.

Missed doses

If the patient misses a dose of dolutegravir plus lamivudine, the patient should take dolutegravir plus lamivudine as soon as possible, providing the next dose is not due within 4 hours. If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

Special warnings and precautions for use

Transmission of HIV

While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.

Hypersensitivity reactions

Hypersensitivity reactions have been reported with dolutegravir, and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions. Dolutegravir plus lamivudine and other suspect medicinal products should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, eosinophilia, angioedema). Clinical status including liver aminotransferases and bilirubin should be monitored. Delay in stopping treatment with dolutegravir plus lamivudine or other suspect active substances after the onset of hypersensitivity may result in a life-threatening allergic reaction.

Weight and metabolic parameters

An increase in weight and in levels of blood lipids and glucose may occur during antiretroviral therapy. Such changes may in part be linked to disease control and life style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment. For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines. Lipid disorders should be managed as clinically appropriate.

Liver disease

Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.

Dolutegravir plus lamivudine includes lamivudine, which is active against hepatitis B. Dolutegravir lacks such activity. Lamivudine monotherapy is generally not considered an adequate treatment for hepatitis B, since the risk for hepatitis B resistance development is high. If dolutegravir plus lamivudine is used in patients co-infected with hepatitis B an additional antiviral is therefore generally needed. Reference should be made to treatment guidelines.

If dolutegravir plus lamivudine is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.

Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.

Immune Reactivation Syndrome

In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are Cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP). Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy. Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.

Osteonecrosis

Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART. Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

Opportunistic infections

Patients should be advised that dolutegravir, lamivudine or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection. Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.

Undesirable effects

The most frequently reported adverse reactions are headache (3%), diarrhoea (2%), nausea (2%) and insomnia (2%).

The most severe adverse reaction reported with dolutegravir was a hypersensitivity reaction that included rash and severe liver effects.

Tabulated list of adverse reactions is available in the full information leaflet.

Changes in laboratory biochemistries

Dolutegravir has been associated with an increase in serum creatinine occuring in the first week of treatment when administered with other antiretroviral medicinal products. Increases in serum creatinine occurred within the first four weeks of treatment with dolutegravir plus lamivudine and remained stable through 48 weeks. These changes are linked to the inhibiting effect of dolutegravir on renal tubular transporters of creatinine. The changes are not considered to be clinically relevant and do not reflect a change in glomerular filtration rate.

Co-infection with Hepatitis B or C

In the Phase III studies for the dolutegravir single agent, patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN). Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups. Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some subjects with hepatitis B and/or C co-infection at the start of dolutegravir therapy, particularly in those whose anti-hepatitis B therapy was withdrawn.

Drug interactions

No drug interaction studies have been conducted using dolutegravir plus lamivudine. Dolutegravir plus lamivudine contains dolutegravir and lamivudine, therefore any interactions identified for these individually are relevant to dolutegravir plus lamivudine. No clinically significant drug interactions are expected between dolutegravir and lamivudine.

The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir.

dolutegravir plus lamivudine should not be co-administered with polyvalent cation-containing antacids. Polyvalent cation-containing antacids are recommended to be taken 2 hours after or 6 hours before dolutegravir plus lamivudine.

When taken with food, dolutegravir plus lamivudine and supplements or multivitamins containing calcium, iron or magnesium can be taken at the same time. If dolutegravir plus lamivudine is administered under fasting conditions, supplements or multivitamins containing calcium, iron or magnesium are recommended to be taken 2 hours after or 6 hours before dolutegravir plus lamivudine.

Dolutegravir increased metformin concentrations. A dose adjustment of metformin should be considered when starting and stopping coadministration of dolutegravir plus lamivudine with metformin, to maintain glycaemic control. Metformin is eliminated renally and, therefore, it is of importance to monitor renal function when co-treated with dolutegravir plus lamivudine. This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance 45- 59 mL/min) and a cautious approach is recommended. Reduction of the metformin dose should be highly considered.

The combination of dolutegravir plus lamivudine with cladribine is not recommended.

Dolutegravir plus lamivudine should not be taken with any other medicinal product containing dolutegravir or lamivudine, except where a dose adjustment of dolutegravir is indicated due to drug-drug interactions.

Other established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the full information leaflet.

Fertility, pregnancy and lactation

Women of childbearing potential

Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir plus lamivudine. WOCBP who are taking dolutegravir plus lamivudine should use effective contraception throughout treatment.

Pregnancy

The safety and efficacy of a dual regimen has not been studied in pregnancy. Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir (a component of dolutegravir plus lamivudine) at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).

The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births (0.05-0.1%). As neural tube defects occur within the first 4 weeks of foetal development (at which time the neural tubes are sealed) this potential risk would concern women exposed to dolutegravir at the time of conception and in early pregnancy. Due to the potential risk of neural tube defects with dolutegravir, dolutegravir plus lamivudine should not be used during the first trimester unless there is no alternative.

More than 1000 outcomes from second and third trimester exposure to dolutegravir in pregnant women indicate no evidence of increased risk of malformities and foeto/neonatal negative effects. However, as the mechanism by which dolutegravir may interfere in human pregnancy is unknown, the safety in use during the second and third trimester cannot be confirmed. Dolutegravir plus lamivudine should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.

In animal reproductive toxicology studies with dolutegravir, no adverse development outcomes, including neural tube defects, were identified. Dolutegravir was shown to cross the placenta in animals.

A large amount of data on the use of lamivudine in pregnant women (more than 3000 outcomes from first trimester) indicates no malformative toxicity.

Animal studies showed lamivudine may inhibit cellular DNA replication (see section 5.3). The clinical relevance of these findings is unknown.

Mitochondrial dysfunction

Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly concerned treatment with regimens containing zidovudine. The main adverse reactions reported are haematological disorders (anaemia, neutropenia), and metabolic disorders (hyperlactatemia, hyperlipasemia). These reactions have often been transitory. These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.

Breast-feeding

It is unknown whether dolutegravir is excreted in human milk. Available toxicological data in animals has shown excretion of dolutegravir in milk. In lactating rats that received a single oral dose of 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.

Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age. There are no data available on the safety of lamivudine when administered to babies less than three months old.

It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

Fertility

There are no data on the effects of dolutegravir or lamivudine on human male or female fertility. Animal studies indicate no effects of dolutegravir or lamivudine on male or female fertility.

Effects on ability to drive and use machines

Dolutegravir plus lamivudine has no or negligible influence on the ability to drive and use machines. Patients should be informed that dizziness and somnolence has been reported during treatment with dolutegravir. The clinical status of the patient and the adverse reaction profile of Dolutegravir plus lamivudine should be borne in mind when considering the patient’s ability to drive or operate machinery.

Please refer to the full European Summary of Product Characteristics for Dolutegravir/lamivudine

for full prescribing information, including contraindications, special warnings and precautions for use. For the US, please refer to the US Prescribing Information.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LON: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aims to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

References

[1] ViiV Healthcare: TANGO headline results. Data on file.

[2] Dolutegravir plus lamivudine Prescribing Information. U.S. Approval 8 April 2019. Available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Dovato/pdf/DOVATO-PI-PIL.PDF Accessed July 2019

[3] Dovato EU Summary of Product Characteristics. July 2019. Available at: https://www.medicines.org.uk/emc/product/10446/smpc Accessed July 2019.

[4] Clinical trials.gov. Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO). Available at: https://clinicaltrials.gov/ct2/show/NCT03446573?term=TANGO+dolutegravir&rank=1. Accessed July 2019

[5] Tivicay (dolutegravir) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tivicay-epar-product-information_en.pdf. Accessed July 2019.

[6] European Medicines Agency. Epivir (lamivudine) European Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/epivir-epar-product-information_en.pdf Accessed June 2019.

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Amazon Inc Offer Echo Dot for just 99p https://www.directorstalkinterviews.com/amazon-inc-offer-echo-dot-for-just-99p/412784614 Tue, 11 Jun 2019 09:24:34 +0000 https://www.directorstalkinterviews.com/?p=784614 Amazon.com, Inc. (NASDAQ: AMZN) are now giving away an Echo Dot for just £0.99 when you subscribe to the Amazon music streaming service family plan. Not bad when you consider these sell for £39.99. The Echo Dot offers all the skills the full sized Echo does just in a smaller size, handy for sitting on ...

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Amazon.com, Inc. (NASDAQ: AMZN) are now giving away an Echo Dot for just £0.99 when you subscribe to the Amazon music streaming service family plan. Not bad when you consider these sell for £39.99.

The Echo Dot offers all the skills the full sized Echo does just in a smaller size, handy for sitting on that coffee table or bookshelf. You can make calls, check the weather, control your smart devices and if you take up this offer access the millions of songs available through Amazons Music Unlimited service. Simply ask your dot to play you favorite song.

To get you hands on an echo dot for this ridiculous price sign up to a family plan using this link and after a week of using the service you are sent instructions on how to claim this incredible deal. If after that you are unhappy with the service you can cancel at any time. What do you have to lose?

Amazon.com, Inc. engages in the provision of online retail shopping services. It operates through the following business segments: North America, International, and Amazon Web Services (AWS). The North America segment includes retail sales of consumer products and subscriptions through North America-focused websites such as www.amazon.com and www.amazon.ca. The International segment offers retail sales of consumer products and subscriptions through internationally-focused websites. The Amazon Web Services segment involves in the global sales of compute, storage, database, and AWS service offerings for start-ups, enterprises, government agencies, and academic institutions. The company was founded by Jeffrey P. Bezos in July 1994 and is headquartered in Seattle, WA.

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Verizon is building the future for our customers in Washington, investing more than $878 million since 2015 https://www.directorstalkinterviews.com/verizon-is-building-the-future-for-our-customers-in-washington-investing-more-than-878-million-since-2015-2/412758159 Sat, 08 Sep 2018 17:17:39 +0000 https://www.directorstalkinterviews.com/verizon-is-building-the-future-for-our-customers-in-washington-investing-more-than-878-million-since-2015-2/412758159 Ongoing investment in its industry-leading networks for an unmatched customer experience SEATTLE, Sept. 07, 2018 — We know our customers across the country rely on us to keep them connected—when and where they need it most. To ensure our customers have the network experience they deserve, Verizon invests billions of dollars each year in our ...

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Ongoing investment in its industry-leading networks for an unmatched customer experience

SEATTLE, Sept. 07, 2018 — We know our customers across the country rely on us to keep them connected—when and where they need it most. To ensure our customers have the network experience they deserve, Verizon invests billions of dollars each year in our networks. Since 2015, in Washington alone, Verizon has invested more than $ 878 million to meet and exceed our customers’ growing needs and also build for the future.

Always Innovating

Your life moves fast and so do we. To ensure we continue delivering the value and performance you deserve, we’re investing heavily in our networks and deploying the most innovative technology available in the industry today. These innovations include: 

  • Carrier aggregation which combines multiple bands of spectrum, maximizing speed and efficiencies.
  • 4×4 MIMO antenna technology which allows your device to use multiple antennae to boost data speeds.
  • Enhanced software like 256 QAM, which allows your phone to exchange larger amounts of information for significantly faster data speeds.
  • The combination of these three powerful technologies—4×4 MIMO, 256 QAM and carrier aggregation drive our LTE Advanced network, significantly impacting available capacity and data speeds for our customers in 1,100 U.S. cities today.
  • AWS-3 as well as other spectrum, made available through the decommissioning of CDMA technology, to add 4G LTE capacity for our customers.
  • Added significant capacity at CenturyLink Field and SafeCo Field supporting our customers and fans of the Seattle Seahawks, Mariners and Sounders.
  • Installed new cell sites in Auburn, Renton, Seattle and Tacoma, dramatically improving speed and performance
  • Deployed 28 4G LTE small cells in the City of Seattle.
  • Upgraded antenna and radio technology on more than 350 cell sites in Washington, improving speeds and reliability for our customers.

What does this mean for you?

“Consumers, businesses, first responders and local governments all want an ever-improving network experience—and we can deliver,” said Jonathan LeCompte, Pacific Market President for Verizon. “Our consistent investment in the latest tech, year-round planning and industry-leading team of dedicated and passionate engineers ensure the best reliability, 4G LTE coverage, speed and streaming experience. And, it’s why we continue to have an overwhelming lead over the competition across the vast majority of third party tests.”

No matter how you test it, Verizon’s wireless network is the industry leader

In Washington and nationwide, we are consistently recognized for providing a superior network experience by a wide range of independent third parties. According to RootMetrics by IHS Markit’s new National RootScore® Report* released in late July, Verizon’s wireless network was ranked #1 nationally and in Washington for the tenth consecutive time. And, that’s not all. Other third parties have shared their results in recent months. These include:

  • Verizon ranked highest wireless network quality performance in all six regions and, for the 21st time in a row, received more awards than any other wireless provider according to the latest J.D. Power Wireless Network Quality Performance Study**
  • Best in video streaming, based on analysis of data collected nationally by Nielsen***
  • Verizon customers are much more likely to have a better LTE experience than customers of any other network, according to the P3 US State Connectivity Report****
  • Verizon’s network download speeds were 40% faster in Washington than the other three national providers’ according to Tutela‘s real-world download speed tests taken in July 2018*****

Building the future

2018 is an exciting year for network innovations by Verizon including our launch of the first 5G wireless residential broadband internet service in four cities, Sacramento, LA, Houston and Indianapolis. By continuing to invest in our networks and delivering several technology firsts, Verizon is leading the way in transforming how we live, learn, work and play right here in Washington and across the country. To learn more about some of those improvements and about the work our engineers are doing, check out these videos on why we’re Best For a Good Reason.

Verizon Communications Inc. (NYSE, Nasdaq: VZ), headquartered in New York City, generated $ 126 billion in 2017 revenues. The company operates America’s most reliable wireless network and the nation’s premier all-fiber network, and delivers integrated solutions to businesses worldwide. Its Oath subsidiary reaches people around the world with a dynamic house of media and technology brands.

VERIZON’S ONLINE MEDIA CENTER: News releases, stories, media contacts and other resources are available at www.verizon.com/about/news/. News releases are also available through an RSS feed. To subscribe, visit www.verizon.com/about/rss-feeds/.

*Rankings based on the RootMetrics by IHS Markit US National and, State 1H 2018. Tested with best commercially available smartphones on 4 national mobile networks across all available network types. Your experiences may vary. The RootMetrics award is not an endorsement of Verizon. Visit www.rootmetrics.com for more details.

**Verizon Wireless received the highest numerical score among wireless service providers in the J.D. Power 2017 (V1 & V2) & 2018 (V1 & V2) U.S. Wireless Network Quality Performance Studies rating it Highest Wireless Network Quality Performance across the Nation. 2018 V2 study is based on 36,320 total responses, measuring the network quality experienced by customers with wireless phones, surveyed January – June 2018. Your experiences may vary. Visit jdpower.com.

*** Based on Nielsen Video Network Scores using data collected nationally between 1.1.18 and 6.30.18.

**** The data used by P3 was collected during the period of three months, from April to June 2018 and comprises of 39,359,819,776 samples from 2,313,376 users.

***** Verizon customers received the best overall download speeds across the U.S., according to the study of United States’ mobile performance in July 2018 by Tutela, a widely installed network testing software that collects more than 2 billion network quality measurements every day in the USA.

Media contact:
Heidi Flato

925.324.8692
Heidi.Flato@verizon.com

This article has been provided by Nasdaq Globe Newswire.

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US Signals Liberalization of Fundraising Rules https://www.directorstalkinterviews.com/us-signals-liberalization-of-fundraising-rules-2/412758156 Sat, 08 Sep 2018 16:18:23 +0000 https://www.directorstalkinterviews.com/us-signals-liberalization-of-fundraising-rules-2/412758156 In the news, The United States Securities and Exchange Commission (SEC) has signaled it wants to enable ordinary investors to invest in non-stock exchange listed companies. This and other news from South Korea & India as well. Georgetown, Cayman Islands, Sept. 08, 2018 — The United States Securities and Exchange Commission (SEC) has signaled it ...

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In the news, The United States Securities and Exchange Commission (SEC) has signaled it wants to enable ordinary investors to invest in non-stock exchange listed companies. This and other news from South Korea & India as well.

Georgetown, Cayman Islands, Sept. 08, 2018 — The United States Securities and Exchange Commission (SEC) has signaled it wants to enable ordinary investors to invest in non-stock exchange listed companies. SEC Chair Jay Clayton told the Wall Street Journal that the Commission is considering liberalizing rules for non-accredited investors, who are defined as individuals with a net-worth of less than $ 1 million or who have an annual income of less than $ 200,000.

Clayton’s comments reflect the falling number of publicly traded companies and the fact that many of the most exciting tech companies remain privately funded for many years before any possible Initial Public Offering (IPO). The Chair commented that it’s important to ask “who is participating” in funding the highest growth companies. In many cases, critics allege, it is a small circle of Wall Street institutions and Silicon Valley funds who get their pick of the most exciting startups. A survey by McKinsey said that 91% of investors believe private markets generate better returns than public assets.

Meanwhile, Initial Coin Offerings (ICOs) collected over $ 11bn in the first half of 2018, with US citizens and residents largely excluded from supporting such projects due to the SEC rules.

Dima Zaitsev, ICOBox PR Director: The SEC’s comments are welcome as investing in the hottest startups shouldn’t be reserved for just a “chosen few.” The SEC has an important role to play in preventing fraud and market manipulation but shouldn’t bar people from making their own investment decisions just because they, for example, “only” make $ 199,000 per year. Cryptocurrencies and decentralized networks are democratizing finance and technology but the US has until now seemed content to lag behind the rest of the world.

South Korea to Pave the Way for Wider Public Blockchain Implementation

The Korea Internet & Security Agency (KISA) has just announced its plans to double the number of blockchain trials in the public sector in 2019, bringing them up to 12. The agency also signaled its intent to support privately-built blockchain projects in the country. The 2019 blockchain pilot budget will be increased to more than 10 billion Korean won, or $ 9 million, which will be allocated in addition to the $ 9 million earmarked for both 2018 and 2019.

The South Korean government has also announced its plans to train several dozen highly skilled blockchain professionals who will act as a support resource for startups aiming to enter the blockchain market.

Daria Generalova, ICOBox co-founder: Naturally, this is fantastic news! It confirms the Korean government’s continued commitment to developing the already burgeoning national blockchain economy. And they are certainly putting their money where their mouths are: over the course of the next year alone, the government’s investment in blockchain and related innovative technologies is expected to surpass $ 4.4 billion. Things are really moving there, I can’t wait to see what kind of amazing creativity will come out of it. Step aside, world: South Korea is on a roll!

High Fives for India’s Official Cryptocurrency Study Tours

While some countries have decided to stick their heads in the sand over cryptocurrency and blockchain technology in recent weeks, India certainly cannot be diagnosed with ostrich syndrome any time soon. The country has progressively started to move more and more toward embracing cryptocurrencies, ICOs, and blockchain. According to their 2017-18 Annual Report, the Securities and Exchange Board of India (SEBI) organized tours to the US, Japan, and Switzerland last year specifically so officials could study cryptocurrencies and initial coin offerings (ICOs) and how those countries are dealing with them.

There’s still some trepidation around the technology in general in India—the RBI recently got its knuckles rapped by their Supreme Court for ending dealings with crypto businesses—but overall there’s been really positive movement in the sector. No matter how the situation surrounding cryptocurrency market regulation in India turns out, no one will be able to accuse the county’s officials of not at least giving it all they’ve got.

Daria Generalova, ICOBox co-founder : There are two ways you can react to the introduction of technologies that are new, perhaps seemingly opaque, and not yet fully understood in the mainstream. The first and easiest is to gainsay them and retreat into your shell and make a hundred arguments about why your conventional, old-fashioned system is best. The second is to greet innovative ideas with an open mind and really check them out, try them on for size, take them out for a serious test drive. I wholeheartedly applaud SEBI’s choice to send its officials to learn about cryptocurrencies and ICOs from their colleagues in other countries with an eye to adopting the technology. India’s move here is setting a world class example for everyone else.

About ICOBox

ICOBox is the first and biggest new generation blockchain growth promoter and business facilitator for companies seeking to sell their products and services via ICO crowdsales.

CONTACT: Clayton Wood ICOBox 415-481-8528 clayton.wood@icobox.io 

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Apple Rush Company, Inc. Announces Proofing of 8oz Can Run https://www.directorstalkinterviews.com/apple-rush-company-inc-announces-proofing-of-8oz-can-run-2/412758153 Sat, 08 Sep 2018 15:17:41 +0000 https://www.directorstalkinterviews.com/apple-rush-company-inc-announces-proofing-of-8oz-can-run-2/412758153 Product Line Extension Increases Hospitality Market Reach TITUSVILLE, Fla., Sept. 07, 2018 — Apple Rush Company, Inc. (APRU) is pleased to announce Tony Torgerud, CEO of Apple Rush Company Inc. attended and approved the proofing run of its new 8oz can product line. The can line is being produced for lower calorie consumers. The can ...

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Product Line Extension Increases Hospitality Market Reach

TITUSVILLE, Fla., Sept. 07, 2018 — Apple Rush Company, Inc. (APRU) is pleased to announce Tony Torgerud, CEO of Apple Rush Company Inc. attended and approved the proofing run of its new 8oz can product line. The can line is being produced for lower calorie consumers. The can packaging will extend Apple Rush’s reach into, hotels, resorts and restaurants and especially schools and school sporting events where glass may be prohibited.

Tony Torgerud, remarks, “Our primary customer research has been that we need a lower total calorie option as most consumers only drink 8 ounces of juice because of its naturally high sugar content.  Bars and event locations wanted an option as a mixer that they didn’t have to waste 4 ounces when making each drink, and resorts requested them for the beach and pool areas.  Production of the cans is scheduled prior to the winter holiday season.  This proofing run is to verify color and layout on the 8 ounce slim can and set production dates for the manufacturing of the cans.”  He continues, “Several Anheuser Busch distributors have also requested the cans as some customers are resistant to glass bottles.”  Also attending the proofing was Tom Jahnke of Advertising Art Studios, Inc. the design company that produced the Apple Rush logo in 2007.  He produces all the design work for Pabst and does packaging for Miller, Steas, Celsius, and many craft brewers.  Tom comments, “This all natural sparking juice product fits nicely in the lifestyles of consumers seeking higher quality natural products without refined sugars.”

Please see link:  Apple Rush 8oz can Family

About the Apple Rush Co., Inc. 
The Apple Rush Company, Inc. through its subsidiary APRU, LLC is a distributor of Consumer Packaged Goods (CPG) products under the trademarked Apple Rush and other labels. The Apple Rush brand has over 40 years of existence in the natural beverage industry. For more information please see www.applerush.com.

About APRU, LLC: APRU, LLC focuses on the development and sale of all-natural Apple Rush sparkling juices. The Company also as well as research and development of premium hemp extracts that contain a broad range of cannabinoids and natural hemp derivatives and other active ingredients such as our exclusive agathos active, kratom, kava, blue lotus, and ginseng. For more information, please go to http://www.aprullc.com.

Safe Harbor Act: Forward-Looking Statements are included within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, including words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and similar expressions are forward-looking statements and involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. We are under no obligation to (and expressly disclaim any such obligation to) update or alter forward-looking statements, whether as a result of new information, future events or otherwise.

Investor relations Contact:
Tony Torgerud
888-741-3777 ext 2

This article has been provided by Nasdaq Globe Newswire.

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Larson Electronics LLC Releases New ATEX/IECEx Rated Explosion Proof LED Fixture https://www.directorstalkinterviews.com/larson-electronics-llc-releases-new-atex-iecex-rated-explosion-proof-led-fixture/412758151 Sat, 08 Sep 2018 14:17:38 +0000 https://www.directorstalkinterviews.com/larson-electronics-llc-releases-new-atex-iecex-rated-explosion-proof-led-fixture/412758151 KEMP, Texas, Sept. 08, 2018 — Larson Electronics LLC, a leader in explosion proof lighting and accessories, has added an explosion proof mini momentary push button test switch replacement for explosion proof units. This replacement switch is 125/250 volt rated and constructed of stainless steel, and is suitable for Class I, Divisions 1 and 2, ...

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KEMP, Texas, Sept. 08, 2018 — Larson Electronics LLC, a leader in explosion proof lighting and accessories, has added an explosion proof mini momentary push button test switch replacement for explosion proof units. This replacement switch is 125/250 volt rated and constructed of stainless steel, and is suitable for Class I, Divisions 1 and 2, Class II, Division 1 and 2 rated environments.

The EXP-MPB-SPST-MO is an explosion proof mini momentary push button with an SPDT contact configuration and 125/250 voltage rating. This black stainless-steel test switch replacement offers 5 amps at 125 volts and 3 amps at 250 volts and features a 1000 megaohm insulation resistance. The button has a 3/8”-16 thread size and is NEMA 4, 7 and 9 rated for industrial locations. This push button is simple to replace on existing units.

About Larson Electronics LLC: Larson Electronics LLC is a manufacturer of industrial lighting equipment and accessories. The company offers an extensive catalog of industry-grade lighting and power distribution products for the following sectors: manufacturing, construction, food processing, oil and gas, military, marine and automobile. Customers can benefit from the company’s hands-on, customized approach to lighting solutions. Larson Electronics provides expedited service for quotes, customer support and shipments.

For further information, please contact:
Rob Bresnahan, President and CEO
Toll-free: 1-800-369-6671
Phone: 214-616-6180
Fax: 903-498-3364
E-mail: sales@larsonelectronics.com

This article has been provided by Nasdaq Globe Newswire.

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TrackStreet Completes SOC 2 Type 1 Certification https://www.directorstalkinterviews.com/trackstreet-completes-soc-2-type-1-certification/412758150 Sat, 08 Sep 2018 13:18:00 +0000 https://www.directorstalkinterviews.com/trackstreet-completes-soc-2-type-1-certification/412758150 Rigorous security protocols ensure TrackStreet maintains status as a trusted vendor in highly regulated industries Las Vegas, Nevada, Sept. 07, 2018 — TrackStreet, the leading SaaS platform to protect + grow the world’s best brands, has completed a SOC 2 Type 1 Certification, with SOC 2 Type 2 certification scheduled for Q4. As part of ...

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Rigorous security protocols ensure TrackStreet maintains status as a trusted vendor in highly regulated industries

Las Vegas, Nevada, Sept. 07, 2018 — TrackStreet, the leading SaaS platform to protect + grow the world’s best brands, has completed a SOC 2 Type 1 Certification, with SOC 2 Type 2 certification scheduled for Q4. As part of its audit, A-Lign affirms that TrackStreet’s information security procedures and operations meet the SOC 2 Type 1 standards for security, availability and confidentiality.

“The SOC 2 Type 1 certification is a key milestone for TrackStreet as a leading SaaS technology company,” said Andrew Schydlowsky, TrackStreet’s Founder and CEO. “The hidden market data we uncover and act on for our clients, truly gives them an advantage over their competitors and control over their market. Our SOC 2 compliance is a reflection of the care and safeguards we put in place to protect our customers. Our customers can remain confident that TrackStreet has the internal controls and processes in place to provide mission-critical Sales Intelligence and Brand Protection services in a continuous fashion.”

As companies increasingly rely on outside vendors to perform activities that are core to their business, like enforcing Resale Pricing or MAP policies, there is a need for trust and transparency into the SaaS provider’s operations, processes and controls. TrackStreet’s SOC 2 report verifies the existence of internal controls, which have been designed and implemented to meet the security principles set forth in the Trust Services Principles and Criteria for Security.  This certification and the underlying independent validation of security controls can be crucial for customers in a range of highly regulated industries.

CONTACT: Scott Barnett TrackStreet 8777816102 x 702 scott@trackstreet.com 

This article has been provided by Nasdaq Globe Newswire.

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Professional Diversity Network, Inc. Announces Cooperation with Dragon Gate Investment Partners https://www.directorstalkinterviews.com/professional-diversity-network-inc-announces-cooperation-with-dragon-gate-investment-partners/412758149 Sat, 08 Sep 2018 12:22:38 +0000 https://www.directorstalkinterviews.com/professional-diversity-network-inc-announces-cooperation-with-dragon-gate-investment-partners/412758149 CHICAGO, Sept. 07, 2018 — Professional Diversity Network, Inc. (NASDAQ: IPDN), (“IPDN” or the “Company”), a global developer and operator of online and in-person networks that provide access to networking, training, educational and employment opportunities for diverse individuals, today announced that it has engaged Dragon Gate Investment Partners (DGIP) to lead an investor relations program. ...

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CHICAGO, Sept. 07, 2018 — Professional Diversity Network, Inc. (NASDAQ: IPDN), (“IPDN” or the “Company”), a global developer and operator of online and in-person networks that provide access to networking, training, educational and employment opportunities for diverse individuals, today announced that it has engaged Dragon Gate Investment Partners (DGIP) to lead an investor relations program.

“We are delighted to cooperate with Dragon Gate Investment Partners,” said Michael Wang, CEO of Professional Diversity Network. “DGIP’s expertise in investor relations will help us enhance US operation to better address investors’ concerns and build a transparent and trustful communication channel with our investors.”

Lijie Zhu, Managing Director of Dragon Gate Investment Partners, said, “We are honored to become a partner of IPDN, a company with multiple well-established brands and continuous effort on social responsibility. By enhancing the communication, we will help IPDN to better serve the interests of its shareholders and fulfill its commitment to investors.”

About Professional Diversity Network
Professional Diversity Network, Inc. (NASDAQ: IPDN) is a global developer and operator of online and in-person networks that provides access to networking, training, educational and employment opportunities for diverse professionals. We operate subsidiaries in the United States and China including National Association of Professional Women (NAPW), which is one of the largest, most recognized networking organizations of professional women in the country, spanning more than 200 industries and professions. Through an online platform and our relationship recruitment affinity groups, we provide our employer clients a means to identify and acquire diverse talent and assist them with their efforts to comply with the Equal Employment Opportunity Office of Federal Contract Compliance Program. Our mission is to utilize the collective strength of our affiliate companies, members, partners and unique proprietary platform to be the standard in business diversity recruiting, networking and professional development for women, minorities, veterans, LGBT and disabled persons globally.

About Dragon Gate Investment Partners
Headquartered in New York City’s midtown Manhattan, Dragon Gate Investment Partners is a unique investment firm with a special focus on globalizing and localizing sustainable and promising companies in the U.S. and China. The team has well-earned reputation of excellence in providing sensible and cost-effective cross-border business solutions for a wide breadth of clientele, including public companies, financial institutions, and high-net-worth individuals.

Contact:
Dragon Gate Investment Partners LLC

Tel: +1(646)-801-2803
Email: ipdn@dgipl.com

This article has been provided by Nasdaq Globe Newswire.

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OHA Investment Corporation Announces Amendment and Extension of its Credit Facility https://www.directorstalkinterviews.com/oha-investment-corporation-announces-amendment-and-extension-of-its-credit-facility/412758148 Sat, 08 Sep 2018 11:17:11 +0000 https://www.directorstalkinterviews.com/oha-investment-corporation-announces-amendment-and-extension-of-its-credit-facility/412758148 NEW YORK, Sept. 07, 2018 —  OHA Investment Corporation (NASDAQ: OHAI) (the “Company”) today announced that it has amended its credit facility with MidCap Financial Trust (“Credit Facility”) to extend the maturity date to September 9, 2019, which can be extended for an additional six-month period at the Company’s option. In connection with the extension, ...

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NEW YORK, Sept. 07, 2018 —  OHA Investment Corporation (NASDAQ: OHAI) (the “Company”) today announced that it has amended its credit facility with MidCap Financial Trust (“Credit Facility”) to extend the maturity date to September 9, 2019, which can be extended for an additional six-month period at the Company’s option. In connection with the extension, the Company made a repayment of principal of  $ 7.0 million of its Credit Facility, reducing the principal amount outstanding to $ 29.0 million.  The $ 7.0 million principal repayment is available to the Company to be re-borrowed as a delayed draw term loan, which is committed until September 9, 2019.

In addition, the interest rate for the borrowings under the Credit Facility was reduced to LIBOR plus 4.95% for Eurodollar Loans and prime plus 3.95% for Base Rate Loans. Certain financial covenants were also amended.

About OHA Investment Corporation
OHA Investment Corporation (NASDAQ: OHAI) is a specialty finance company designed to provide its investors with current income and capital appreciation. OHAI focuses primarily on providing creative direct lending solutions to middle market private companies across industry sectors. OHAI is externally managed by Oak Hill Advisors, L.P., a leading independent investment firm (www.oakhilladvisors.com). Oak Hill Advisors has deep experience in direct lending, having invested approximately $ 5 billion in over 140 direct lending investments over the past 15 years.

Forward-Looking Statements
This press release may contain forward-looking statements.  We may use words such as “anticipates,” “believes,” “intends,” “plans,” “expects,” “projects,” “estimates,” “will,” “should,” “may” and similar expressions to identify forward-looking statements.  These forward-looking statements are subject to various risks and uncertainties.  Certain factors could cause actual results and conditions to differ materially from those projected, including the uncertainties associated with the timing or likelihood of transaction closings, changes in interest rates, availability of transactions, the future operating results of our portfolio companies, regulatory factors, changes in regional, national, or international  economic conditions and their  impact on the industries in which we invest, other changes in the conditions of the industries in which we invest and other factors enumerated in our filings with the Securities and Exchange Commission (the “SEC”).  You should not place undue reliance on such forward-looking statements, which speak only as of the date they are made.  We undertake no obligation to update our forward-looking statements made herein, unless required by law.

Persons considering an investment in OHA Investment Corporation should consider the investment objectives, risks, and charges and expenses of the Company carefully before investing.  Such information and other information about us is available in our annual report on Form 10-K, in our quarterly reports on Form 10-Q, in our current reports on Form 8-K, and in prospectuses we issue from time to time in connection with our offering of securities.  Such materials are filed with the SEC and copies are available on the SEC’s website, www.sec.gov, and in the Investor Relations section of our website at www.ohainvestmentcorporation.com. Prospective investors should read such materials carefully before investing.

CONTACTS:
Steven T. Wayne – President and Chief Executive Officer
Cory E. Gilbert – Chief Financial Officer
Lisa R. Price – Chief Compliance Officer
OHAICInvestorRelations@oakhilladvisors.com 

For media inquiries, contact Kekst and Company, (212) 521-4800
Jeremy Fielding – Jeremy-Fielding@kekst.com 
Aduke Thelwell – Aduke.Thelwell@kekst.com 

This article has been provided by Nasdaq Globe Newswire.

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Pzena Investment Management, Inc. Announces August 31, 2018 Assets Under Management https://www.directorstalkinterviews.com/pzena-investment-management-inc-announces-august-31-2018-assets-under-management/412758147 Sat, 08 Sep 2018 10:17:08 +0000 https://www.directorstalkinterviews.com/pzena-investment-management-inc-announces-august-31-2018-assets-under-management/412758147 NEW YORK, Sept. 07, 2018 — Pzena Investment Management, Inc. (NYSE: PZN) today reported its preliminary assets under management as of August 31, 2018. AUM for month-end August 2018, month-end July 2018, and month-end August 2017 are listed below:   Pzena Investment Management, Inc. Assets Under Management1 ($ billions)       As of   ...

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NEW YORK, Sept. 07, 2018 — Pzena Investment Management, Inc. (NYSE: PZN) today reported its preliminary assets under management as of August 31, 2018.

AUM for month-end August 2018, month-end July 2018, and month-end August 2017 are listed below:

 
Pzena Investment Management, Inc.
Assets Under Management1
($ billions)
 
    As of   As of   As of
    August 31, 2018     July 31, 2018    August 31, 2017
Account Type2                  
Separately Managed Accounts   $ 14.6   $ 14.2   $ 13.9
Sub-Advised Accounts     22.2     22.3     18.8
Pzena Funds     2.1     2.1     1.4
Total   $ 38.9   $ 38.6   $ 34.1
Investment Strategy                  
U.S. Value Strategies                  
Large Cap Value   $ 10.8   $ 10.9   $ 10.1
Mid Cap Value     2.9     2.9     2.5
Value     2.2     2.3     2.0
Small Cap Value     1.7     1.7     1.4
Other U.S. Strategies     0.2     0.2     0.1
Total U.S. Value Strategies     17.8     18.0     16.1
Global & Non-U.S. Value Strategies                  
Global Value     6.6     6.7     5.4
International Value     6.6     6.6     5.7
Emerging Markets Value     4.1     4.1     3.9
European Value     3.5     2.9     2.9
Other Global & Non-U.S. Value Strategies     0.3     0.3     0.1
Total Global & Non-U.S. Value Strategies     21.1     20.6     18.0
Total   $ 38.9   $ 38.6   $ 34.1
Account Domicile                  
U.S.   $ 26.7   $ 26.2   $ 23.0
Non-U.S.     12.2     12.4     11.1
Total   $ 38.9   $ 38.6   $ 34.1
 
1 Numbers may be subject to rounding.
2 Beginning January 2018, the Company changed the classification of assets under management (“AUM”) to better reflect the composition of its client base. The Company now groups its assets into three new categories: Separately Managed Accounts, Sub-Advised Accounts, and Pzena Funds, which better illustrate the characteristics inherent in its client relationships. Historical data has been reclassified for all periods presented and did not impact reported totals of AUM.
 

About Pzena
Pzena Investment Management, LLC, the firm’s operating company, is a value-oriented investment management firm. Founded in 1995, Pzena Investment Management has built a diverse, global client base. More firm and stock information is posted at www.pzena.com.

Forward-Looking Statements
This press release may contain, in addition to historical information, 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. Forward-looking statements provide the Company’s current views, expectations, or forecasts of future events and performance, and include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking.

Among the factors that could cause actual results to differ from those expressed or implied by a forward-looking statement are those described in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K, as filed with the SEC on March 9, 2018 and in the Company’s Quarterly Reports on Form 10-Q as filed with the SEC. In light of these risks, uncertainties, assumptions, and factors, actual results could differ materially from those expressed or implied in the forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date stated, or if no date is stated, as of the date of this release.

The Company is not under any obligation and does not intend to make publicly available any update or other revisions to any forward-looking statements to reflect circumstances existing after the date of this release or to reflect the occurrence of future events even if experience or future events make it clear that any expected results expressed or implied by those forward-looking statements will not be realized.

Contact: Gary Bachman, 212-355-1600 or bachman@pzena.com.

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Impac Mortgage Holdings, Inc. Announces Cancellation of Special Meeting of Series B Preferred Stockholders https://www.directorstalkinterviews.com/impac-mortgage-holdings-inc-announces-cancellation-of-special-meeting-of-series-b-preferred-stockholders/412758146 Sat, 08 Sep 2018 09:17:08 +0000 https://www.directorstalkinterviews.com/impac-mortgage-holdings-inc-announces-cancellation-of-special-meeting-of-series-b-preferred-stockholders/412758146 IRVINE, Calif., Sept. 07, 2018 — Impac Mortgage Holdings, Inc. (the “Company”) today announced that the Special Meeting of the Company’s 9.375% Series B Cumulative Redeemable Preferred Shares (“Series B Preferred Shares”), which was scheduled to be held on September 13, 2018, has been cancelled.  On September 5, 2018,  the Circuit Court for Baltimore City ...

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IRVINE, Calif., Sept. 07, 2018 — Impac Mortgage Holdings, Inc. (the “Company”) today announced that the Special Meeting of the Company’s 9.375% Series B Cumulative Redeemable Preferred Shares (“Series B Preferred Shares”), which was scheduled to be held on September 13, 2018, has been cancelled.  On September 5, 2018,  the Circuit Court for Baltimore City granted a stay pending conclusion of the appeal of its July 16, 2018 Judgement Order (the “Judgement Order”) requiring the Company to hold a special meeting of the Series B Preferred Shares to elect directors.  The Company had filed a notice of an appeal of the Judgement Order.

For additional information, questions or comments, please contact Alliance Advisors, LLC at 844-670-2148.

About the Company

Impac Mortgage Holdings, Inc. (IMH or Impac) provides innovative mortgage lending and warehouse lending solutions, as well as real estate solutions that address the challenges of today’s economic environment.  Impac’s operations include mortgage and warehouse lending, servicing, portfolio loss mitigation and real estate services as well as the management of the securitized long-term mortgage portfolio, which includes the residual interests in securitizations.

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Royal Financial, Inc.  Announces Audited Fiscal Year 2018 Earnings Results https://www.directorstalkinterviews.com/royal-financial-inc-announces-audited-fiscal-year-2018-earnings-results/412758145 Sat, 08 Sep 2018 08:17:09 +0000 https://www.directorstalkinterviews.com/royal-financial-inc-announces-audited-fiscal-year-2018-earnings-results/412758145 CHICAGO, Sept. 07, 2018 — Royal Financial, Inc. (the “Company”) (OTCQX: RYFL), incorporated under the laws of Delaware on December 15, 2004, for the purpose of serving as the holding company of Royal Savings Bank (the “Bank”), announces the audited earnings results and statement of condition for the fiscal year ended 2018. Net income for ...

This article Royal Financial, Inc.  Announces Audited Fiscal Year 2018 Earnings Results was written by DirectorsTalk Interviews.


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CHICAGO, Sept. 07, 2018 — Royal Financial, Inc. (the “Company”) (OTCQX: RYFL), incorporated under the laws of Delaware on December 15, 2004, for the purpose of serving as the holding company of Royal Savings Bank (the “Bank”), announces the audited earnings results and statement of condition for the fiscal year ended 2018.

Net income for the fourth quarter of fiscal 2018 was $ 1.2 million, or $ 0.50 per share, compared to $ 747,000, or $ 0.30 per share, for the same period in 2017.  Net income for the year ended June 30, 2018, was $ 1.7 million, or $ 0.69 per share, compared to $ 2.0 million, or $ 0.81 per share in 2017.

The Company also reported total assets of $ 413.2 million and stockholders’ equity of $ 34.5 million as of June 30, 2018.  As of the same date, the Company’s book value per share was $ 13.77 and tangible book value per share was $ 12.69.

Comparison of Results of Operations for the Quarters Ended June 30, 2018 and June 30, 2017

Net income for the quarter ended June 30, 2018 was $ 1.2 million or $ 0.50 per share and increase in net income of $ 497,000 (66%) from June 30, 2017.  Net interest income increased by $ 777,000 (27%) from the quarter ended June 30, 2017.  The increase in net interest income resulted mainly from an increase in loan income by $ 1.1 million (40%) to $ 4.0 million, offset by an increase in deposit and borrowings cost of funds of $ 384,000 (107%) to $ 744,000. The increase in loan income was a result of a full year of the Company’s participation in $ 30.6 million of owner-occupied, one to four-family residential loans from June 2017 as well as organic loan growth in commercial loans of $ 32.0 million from the prior year.  

Total non-interest income for the quarter ended June 30, 2018 increased $ 324,000 (324%) to $ 224,000, from the same period last year.  During the quarter ended June 30, 2017, the Company incurred a loss of $ 257,000 for the sale of securities as the Company liquidated securities to fund loan growth, which the Company did not incur during the quarter ended June 30, 2018.  The Company recognized an increase in deposit fee income of $ 31,000 (24%), secondary mortgage income of $ 3,000 (14%), and rental income of $ 33,000 from the quarter ended June 30, 2017.

Total non-interest expense increased $ 72,000 (3%) compared to the same period last year. The increase in non-interest expense was driven by an increase in occupancy and equipment costs of $ 128,000 (34%), data processing expense of $ 22,000 (13%), and FDIC insurance expense of $ 23,000 (91%). These increases were due to the acquisition of Washington Federal Bank for Savings (“WaFed”) in December 2017. These increases were offset by decreases in professional services of $ 51,000 (33%), insurance premiums of $ 10,000 (29%), and a recovery in acquisition expenses of $ 33,000.

During the quarter ended June 30, 2018, the Company recognized $ 100,000 of income tax benefit as a result of reversing a portion of the State of Illinois valuation allowance on deferred tax assets. A valuation allowance of $ 200,000 remains.      

Comparison of Results of Operations for the Fiscal Years Ended June 30, 2018 and 2017

Net income for the fiscal year ended June 30, 2018 was $ 1.7 million, a decrease in net income of $ 304,000 (15%) from June 30, 2017. The decrease in net income for the year ended June 30, 2018 was due to the $ 2.1 million tax expense due to the passing of the Tax and Jobs Act in December 2017. Net interest income for the year ended 2018 increased $ 2.0 million (19%), to $ 13.1 million.  The primary driver for the increase in net interest income was a $ 3.2 million (29%) increase in loan interest income and fees.  The increases in interest-bearing assets were partially offset by a $ 962,000 (101%) increase in interest expense on deposits and a $ 354,000 (163%) increase in interest expense on borrowings.      

The provision for loan losses in 2018 increased $ 485,000 (206%) over prior year.  The increase in the allowance for loan losses was to provide for the increased growth in the loan portfolio.

Non-interest income for the year ended 2018 was $ 873,000, a increase of $ 410,000 (89%) from the previous year. The increase in non-interest income was primarily a result of the increase in service charges of $ 63,000 (12%), secondary mortgage market income of 86,000 (233%), and rental income of $ 123,000 (851%).  The increase in service charges was a result of a change in fees made by the Company and the addition of WaFed. Secondary mortgage market income increased due to the hiring of additional business bankers to grow the portfolio. Rental income increased as the Company rented out unused space in the Bank’s branches. Non-interest income for the year ended 2018 also included $ 36,000 of net losses on the sale of securities available for sale.  The Company sold $ 39.8 million of securities during the year to provide funding for loan growth and deposit run-off.      

Non-interest expense increased $ 821,000 (9%) for fiscal year 2018.  The increase in non-interest expense is primarily due to an increase of $ 526,000 in acquisition expenses and an increase of $ 212,000 in occupancy and equipment costs. The Company acquired the insured deposits of WaFed in December 2017 and converted all accounts over to the Company’s data processor as of April 2018. Occupancy and equipment expense increased due to the additional maintenance cost from the acquisition of the two WaFed branches. Salaries and employee benefits increased $ 189,000 (4%) from the prior year. This increase is a result of new hires from the acquisition and additions to loan personnel due to the increase in loan growth. The increases in non-interest expense were offset by a decrease in data processing and professional services, which decreased $ 61,000 each during the year ended 2018.

For the fiscal year ended 2018, the provision for income taxes was $ 1.9 million compared to $ 439,000 for the same period in 2017.  The Company had a one-time downward adjustment of the DTA of $ 2.0 million due to the new federal income tax rate change enacted in December 2017. 

Comparison of Financial Condition at June 30, 2018 and June 30, 2017

The Company’s total assets increased $ 96.1 million (30%), to $ 413.2 million at June 30, 2018, from $ 317.1 million at June 30, 2017.

Securities available for sale increased $ 16.8 million (65%), to $ 42.9 million at June 30, 2018 from $ 26.0 million at June 30, 2017.  The increase in securities available for sale resulted from the purchase of $ 90.0 million in taxable Government Sponsored Entity (“GSE”) securities to use the excess liquidity acquired from WaFed, offset by the sale of $ 39.8 million of securities to fund loan growth.

Loans, net of allowance for loan losses, increased $ 77.2 million (31%), to $ 322.8 million at June 30, 2018, from $ 245.7 million at June 30, 2017.  The Company participated in $ 43.3 million of 100% adjustable-rate mortgages in February 2018.  Additional organic loan growth came from $ 32.0 million of commercial loans throughout the year.

The allowance for loan losses was $ 2.4 million, or 0.73% of total loans, at June 30, 2018, as compared to $ 1.7 million, or 0.67% of total loans, at June 30, 2017.  In addition to the allowance for loan losses, net purchase discount on acquired loans was $ 1.0 million at June 30, 2018 compared to $ 1.4 million at June 30, 2017.  Individual loan discounts are being accreted into interest income over the life of the loans, however, they can offset loan losses upon loan default. Nonperforming loans totaled $ 899,000, or 0.28% of outstanding loans, at June 30, 2018 compared to $ 327,000, or 0.13%, at June 30, 2017.  

Premises and equipment increased $ 1.9 million (15%) to $ 14.8 million at June 30, 2018. The increase is primarily the result of the acquisition of the two branches from the Federal Deposit Insurance Corporation as receiver for WaFed. 

Other real estate owned (OREO) decreased $ 146,000 to $ 305,000 at June 30, 2018, from $ 452,000 at June 30, 2017.  The decrease is the result of the sale of three one-to-four family residential properties. The remaining OREO is a medical office condominium resulting from business deterioration caused by timeliness of government insurance reimbursements.  The property is recorded at fair value, less estimated costs to sell. 

The DTA decreased by $ 1.6 million (13%) from $ 12.0 million on June 30, 2017, to $ 10.4 million on June 30, 2018.  In December 2017, the Company reduced the DTA by $ 2.0 million to record the change in estimated value resulting from federal income tax rate changes enacted into law.  The Company reversed $ 300,000 of the valuation allowance for the State of Illinois DTA during the quarter ended March 31, 2018. The Company reversed an additional $ 100,000 of the valuation allowance for State of Illinois DTA during the quarter ended June 30, 2018 based on new earnings results. The remaining valuation allowance as of June 30, 2018 is $ 200,000.

The Core Deposit Intangibles (“CDI”) held by the Company increased $ 225,000 (24%) as of June 30, 2018. The increase in the CDI was due to acquisition of WaFed deposits.

Total deposits increased $ 74.8 million (28%), to $ 341.2 million at June 30, 2018 from $ 266.4 million at June 30, 2017. Total deposit growth was the result of the acquisition of insured deposits from WaFed. 

Federal Home Loan Bank advances increased $ 11.0 million (138%) to supplement funding for loan growth. Notes payable increased by $ 8.6 million (177%), resulting from a favorable response by the lender to the Company’s request to increase and restructure its loan to provide funds to support a capital injection to capitalize the Bank properly in support of the WaFed acquisition.  The loan is structured to amortize in full over eight years with quarterly payments of $ 450,000 in principal reduction and interest at the rate of 0.15% below the Wall Street Journal Prime Rate.

Total stockholders’ equity increased $ 815,000 (2%), to $ 34.5 million at June 30, 2018 from $ 33.7 million at June 30, 2017. The increase is primarily a result of net income of $ 1.7 million (16%) offset by a decrease in accumulated other comprehensive income of $ 982,000 (799%).

For the fiscal year ended June 30, 2018, the Bank paid cash dividends of $ 1.6 million to the Company. The upstream of funds enabled the Company to make debt and interest payments on its notes payable, as well as pay general business expenses for fiscal 2018.

To meet the minimum requirement to be well capitalized under prompt corrective action regulations, the Bank is required to maintain regulatory capital sufficient to meet Tier 1 capital leverage ratio, and risk-based ratios for Common Equity Tier 1 capital, Tier 1 capital and Total capital of at least 5.0%, 6.5%, 8.0% and 10.0%, respectively.  At June 30, 2018, the Bank exceeded each of its capital requirements with ratios of 9.11%, 14.45%, 14.45% and 15.37%, respectively.

At June 30, 2018, the book value per common share, shares outstanding of 2,507,112, was $ 13.77 compared to the book value per common share, shares outstanding of 2,507,112, of $ 13.45 at June 30, 2017. The tangible book value per share was $ 12.69 at June 30, 2018 compared to tangible book value per share of $ 13.08 at June 30, 2017.  

The audited consolidated financial statements for 2018 and 2017 are available at www.royal-bank.us.

About Royal Financial, Inc.

Royal Savings Bank offers a range of checking and savings products and a full line of home and commercial lending solutions.  Royal Savings Bank has been operating continuously in the south and southeast communities of Chicago since 1887, and currently has nine branches in Chicagoland and lending centers in Homewood and St. Charles, Illinois. Visit Royal Financial, Inc. and Royal Savings Bank at www.royalbankweb.com.

Safe–Harbor

Forward Looking Statements: This press release may include forward-looking statements.  These forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by use of the words “believe,” “expect,” “intend,” “anticipate,” “estimate,” “project,” or similar expressions.  Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain and actual results may differ materially from those predicted in such forward-looking statements.  Factors that could have a material adverse effect on the operations and future prospects of the Company and the Bank include, but are not limited to, changes in interest rates; the economic health of the local real estate market; general economic conditions; continued credit deterioration in our loan portfolio that would cause us to further increase our allowance for loan losses; legislative/regulatory changes; monetary and fiscal policies of the U.S. government, including policies of the U.S. Treasury and the Federal Reserve Board; the quality or composition of the loan and securities portfolios; demand for loan products in our market areas; deposit flows; competition; demand for financial services in our market areas; and changes in accounting principles, policies, and guidelines.  These risks and uncertainties should be considered in evaluating forward-looking statements, and undue reliance should not be placed on such statements
.

Contact:  Mr. Leonard Szwajkowski
President and CEO
Telephone:  (773) 382-2111
E-mail:  lszwajkowski@royal-bank.us

Royal Financial, Inc. and Subsidiary    
Consolidated Statements of Financial Condition    
June 30, 2018 and June 30, 2017    
     
  June 30, 2018 June 30, 2017    
Assets        
         
Cash and non-interest bearing balances in financial institutions $ 2,825,543   $ 2,803,915      
Interest Bearing Financial Institutions   11,357,538     11,867,746      
Federal Funds Sold   45,159     83,078      
Total Cash and Cash Equivalents $ 14,228,240   $ 14,754,739      
         
Investment Certificates of Deposit $ 1,844,000   $ 2,342,000      
Securities available for sale   42,863,407     26,044,643      
Loans Receivable, net of Allowance for loan losses   322,859,548     245,651,278      
of $ 2,388,428 at June 30, 2018, $ 1,673,924 at June 30, 2017        
Federal Home Loan Bank Stock   724,100     544,700      
Premises & Equipment, net   14,810,797     12,911,712      
Accrued Interest Receivable   1,354,267     1,095,586      
Other Real Estate Owned   305,311     451,655      
Deferred Tax Asset   10,406,528     12,013,833      
Core Deposit Intangible   1,143,504     918,615      
Goodwill   1,572,344          
Other Assets   1,116,626     391,171      
Total Assets $   413,228,672   $   317,119,932      
         
         
Liabilities & Stockholders Equity        
Total Deposits $ 341,228,412   $ 266,465,215      
Advances from Borrowers for Taxes and Insurance   3,691,202     3,333,119      
FHLB Advances   19,000,000     8,000,000      
Notes Payable   13,500,000     4,879,286      
Accrued Interest Payable and Other Liabilities   1,277,951     725,727      
Total Liabilities $ 378,697,565   $ 283,403,347      
         
Stockholder’s Equity        
Common Stock $ 26,450   $ 26,450      
Additional Paid-In Capital   24,012,821     23,954,746      
Retained Earnings   12,609,097     10,871,097      
Treasury Stock   (1,012,924 )   (1,012,925 )    
Unrealized G/L in Equity   (1,104,337 )   (122,783 )    
Total Capital $ 34,531,107   $ 33,716,585      
         
Total Liabilities and Stockholder’s Equity $   413,228,672   $   317,119,932      
         
         
This report has not been prepared in accordance with Securities and Exchange Commission (“SEC”) rules applicable
to SEC registrant companies and is not intended to comply with such rules.      
         

Royal Financial, Inc. and Subsidiary
Consolidated Statements of Operations
Quarters and Year Ended June 30, 2018 and 2017
 
                               
  Quarters Ended
June 30,

  Years Ended
June 30,

    2018       2017       2018       2017  
               
Interest income              
Loans, including fees $ 3,990,242     $ 2,856,511     $ 14,250,158     $ 11,009,500  
Securities   353,806       316,881       1,197,494       1,221,007  
Federal funds sold and other   17,523       26,729       220,046       59,565  
Total interest income   4,361,571       3,200,121       15,667,698       12,290,072  
               
Interest expense              
Deposits   507,908       306,319       1,911,337       949,539  
Borrowings   235,879       53,070       570,116       216,528  
Total interest expense   743,787       359,389       2,481,453       1,166,067  
               
Net interest income   3,617,784       2,840,732       13,186,245       11,124,005  
               
Provision/(Credit) for loan losses   75,000       160,000       720,000       235,000  
               
Net interest income after provision/ (credit) for loan losses   3,542,784       2,680,732       12,466,245       10,889,005  
               
Non-interest income              
Service charges on deposit accounts   162,311       131,081       592,389       529,531  
Secondary mortgage market fees   26,402       23,221       123,466       37,024  
Income (loss) on other real estate owned, net   34,987       1,809       137,443       14,459  
Gain on sale of other real estate owned               5,442        
Gain (loss) on sale of investment securities         (257,217 )     (36,067 )     (145,352 )
Gain on acquisitions         987             26,269  
Other   257       210       55,934       1,239  
Total non-interest income   223,957       (99,909 )     878,607       463,170  
               
Non-interest expense              
Salaries and employee benefits   1,070,409       1,073,258       4,427,479       4,238,717  
Occupancy and equipment   505,747       377,770       1,846,528       1,649,692  
Data processing   190,349       167,947       752,162       813,566  
Professional services   106,507       157,824       433,016       494,275  
Director fees   45,000       39,000       172,000       156,000  
Marketing   11,623       12,800       49,824       67,058  
FDIC insurance expense   47,794       24,998       155,595       89,984  
Insurance premiums   23,994       33,964       101,098       134,803  
Foreclosed Asset expense   4,882       6,970       71,697       64,763  
Acquisition Expense   (33,132 )     2,915       673,968       147,860  
Core Deposit Intangibles Amortization   35,207       27,672       123,412       105,997  
Other   223,148       236,488       890,877       922,972  
Total non-interest expense   2,231,528       2,161,605       9,697,656       8,885,687  
               
Income before income taxes   1,535,213       419,218       3,647,196       2,466,488  
               
Provision (Benefit) for income taxes   289,831       (327,500 )     1,909,195       439,000  
Net Income (Loss) $ 1,245,382     $ 746,718     $ 1,738,001     $ 2,027,488  
               
Basic earnings per share $ 0.50     $ 0.30     $ 0.69     $ 0.81  
Diluted earnings per share $ 0.49     $ 0.30     $ 0.68     $ 0.80  
               
               
This report has not been prepared in accordance with Securities and Exchange Commission (“SEC”)      
rules applicable to SEC registrant companies and is not intended to comply with such rules.        
               

 

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Flexion Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) https://www.directorstalkinterviews.com/flexion-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-2/412758144 Sat, 08 Sep 2018 07:17:07 +0000 https://www.directorstalkinterviews.com/flexion-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-2/412758144 BURLINGTON, Mass., Sept. 07, 2018 — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced a grant of inducement stock options to four new employees for an aggregate of 10,500 shares of common stock. The Compensation Committee of the Board of Directors approved the grants with an effective date of September 4, 2018. The stock options have an ...

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BURLINGTON, Mass., Sept. 07, 2018 — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced a grant of inducement stock options to four new employees for an aggregate of 10,500 shares of common stock. The Compensation Committee of the Board of Directors approved the grants with an effective date of September 4, 2018. The stock options have an exercise price of $ 22.67 per share and were granted as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). 

The stock options vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and 1/48 of the shares vesting monthly thereafter, subject to the new employee’s continued service relationship with the Company. The stock options are subject to the terms and conditions of the Company’s 2013 Equity Incentive Plan and a stock option agreement pursuant to which the stock option was granted.

About Flexion Therapeutics
Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis. The company’s core values are focus, ingenuity, tenacity, transparency and fun. For the past two years, Flexion has been named one of the Best Places to Work by the Boston Business Journal, and Flexion was also recognized as a Top Place to Work in Massachusetts by The Boston Globe in 2017.

Contact:
Scott Young
Vice President, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com

This article has been provided by Nasdaq Globe Newswire.

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Pomerantz Law Firm Announces the Filing of a Class Action against Fanhua, Inc. and Certain Officers – FANH https://www.directorstalkinterviews.com/pomerantz-law-firm-announces-the-filing-of-a-class-action-against-fanhua-inc-and-certain-officers-fanh/412758143 Sat, 08 Sep 2018 06:17:07 +0000 https://www.directorstalkinterviews.com/pomerantz-law-firm-announces-the-filing-of-a-class-action-against-fanhua-inc-and-certain-officers-fanh/412758143 NEW YORK, Sept. 07, 2018 — Pomerantz LLP announces that a class action lawsuit has been filed against Fanhua, Inc. (“Fanhua” or the “Company”) (NASDAQ: FANH) and certain of its officers.   The class action, filed in United States District Court, Southern District of New York, and index under 18-cv-08183, is on behalf of a class ...

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NEW YORK, Sept. 07, 2018 — Pomerantz LLP announces that a class action lawsuit has been filed against Fanhua, Inc. (“Fanhua” or the “Company”) (NASDAQ: FANH) and certain of its officers.   The class action, filed in United States District Court, Southern District of New York, and index under 18-cv-08183, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise acquired Fanhua securities between April 20, 2018 through August 27, 2018, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Fanhua securities between April 20, 2018 and August 27, 2018, both dates inclusive, you have until November 6, 2018, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here to join this class action]

Founded in 1998, Fanhua (formerly known as “CNinsure Inc.”) is a leading independent online-to-offline financial services provider. Through its online platforms and offline sales and service network, Fanhua offers a wide variety of life and property and casualty insurance products, and provides insurance claims adjusting services.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Fanhua engaged in improper business practices, including irregular accounting; (ii) the foregoing practices were intended to benefit Company insiders and overstated Fanhua’s financial assets and performance metrics; and (iii) as a result, Fanhua’s public statements were materially false and misleading at all relevant times.

On August 27, 2018, stock analyst Seligman Investments published an article that described Fanhua as a “questionable company” and detailed a history of alleged fraud within the Company, including accounting irregularities in the Company’s second quarter 2018 financial results.   The article also described “company insiders” engaging in “self-dealing tactics”, and asserted that Fanhua’s “numerous acquisitions, mostly of other insurance intermediaries . . . are rife with related-party abuses.” 

On this news, Fanhua’s ADS price fell $ 2.75 per share, or 10.52%, to close at $ 23.40 on August 27, 2018.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 9980

This article has been provided by Nasdaq Globe Newswire.

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SaaS Video Creation Market Leader Vyond Appoints Gary Lipkowitz as CEO https://www.directorstalkinterviews.com/saas-video-creation-market-leader-vyond-appoints-gary-lipkowitz-as-ceo-2/412758142 Sat, 08 Sep 2018 05:17:08 +0000 https://www.directorstalkinterviews.com/saas-video-creation-market-leader-vyond-appoints-gary-lipkowitz-as-ceo-2/412758142 Lipkowitz to lead company through next phase of growth as Chief Executive Officer, founder Alvin Hung named Executive Chairman. San Mateo, Calif., Sept. 07, 2018 — Vyond, a SaaS video creation company that allows everyone to create video quickly and easily, today announced its Board of Directors has appointed Gary Lipkowitz as Chief Executive Officer. ...

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Lipkowitz to lead company through next phase of growth as Chief Executive Officer, founder Alvin Hung named Executive Chairman.

San Mateo, Calif., Sept. 07, 2018 — Vyond, a SaaS video creation company that allows everyone to create video quickly and easily, today announced its Board of Directors has appointed Gary Lipkowitz as Chief Executive Officer. Lipkowitz will oversee all of the core functions of the business and will join Vyond’s Board of Directors. Lipkowitz, a media and entertainment expert, has served as Chief Operating Officer of Vyond since 2011. Alvin Hung, Vyond’s founder, has moved on from his post as Chief Executive Officer and has been named Executive Chairman.
       

“Gary and I have worked side by side for over seven years. Along with our dedicated team of employees, we have built a healthy, profitable growth business with great customers, both large and small, from all over the world,” Hung said. “After months of contemplation, we believe that adopting a more traditional management model where the Executive Chairman and CEO positions are held by separate leaders will benefit the creativity, energy, and growth potential of Vyond. We are currently in the midst of our strongest year ever. With Gary at the helm, we will continue on our mission of making video accessible to everyone, everywhere.”

Hung will continue to serve on the Board of Directors as its Executive Chairman. His primary role will be working alongside Lipkowitz and the Board to chart the right course for Vyond’s next phase of growth. Billy Chung has been appointed as General Manager of GoAnimate HK Ltd., and will manage daily administrative, HR, and finance responsibilities.

“I know that I speak for everyone at Vyond in thanking Alvin for his leadership and dedication to building a solid business our employees and customers can be proud of,” Lipkowitz said. “We have a talented team that is passionate about innovating, supporting, and marketing our product in new ways. I am excited about this new role and continuing to work closely with Alvin and the Board to move the business forward.”

Vyond has nearly 100 employees across the globe. The company rebranded from GoAnimate in May 2018 to extend its market leadership position in video creation software. To learn more, visit vyond.com.

About Vyond

At Vyond, our mission is to put the power of video in the hands of everyone. Vyond allows people of all skill levels in all industries and job roles to create dynamic and powerful media. With features that go beyond moving text and images, you can build character-driven stories or compelling data visualizations that engage audiences and deliver results.

Founded as GoAnimate in 2007, Vyond has helped Global 2000 organizations, small businesses, and individuals produce more than 30 million videos.

CONTACT: Stacy Adams Vyond +1 (650) 525-4225 press@vyond.com 

This article has been provided by Nasdaq Globe Newswire.

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ACADIA PHARMACEUTICALS SHAREHOLDER ALERT: CLAIMSFILER REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against ACADIA Pharmaceuticals Inc. – ACAD https://www.directorstalkinterviews.com/acadia-pharmaceuticals-shareholder-alert-claimsfiler-reminds-investors-with-losses-in-excess-of-100000-of-lead-plaintiff-deadline-in-class-action-lawsuit-against-acadia-pharmaceuticals-inc-acad/412758141 Sat, 08 Sep 2018 04:17:30 +0000 https://www.directorstalkinterviews.com/acadia-pharmaceuticals-shareholder-alert-claimsfiler-reminds-investors-with-losses-in-excess-of-100000-of-lead-plaintiff-deadline-in-class-action-lawsuit-against-acadia-pharmaceuticals-inc-acad/412758141 NEW ORLEANS, Sept. 07, 2018 — ClaimsFiler, a FREE shareholder information service, reminds investors that they have until September 17, 2018 to file lead plaintiff applications in a securities class action lawsuit against ACADIA Pharmaceuticals Inc. (NasdaqGS: ACAD), if they purchased the Company’s securities between April 29, 2016 and July 9, 2018, inclusive (the “Class ...

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NEW ORLEANS, Sept. 07, 2018 — ClaimsFiler, a FREE shareholder information service, reminds investors that they have until September 17, 2018 to file lead plaintiff applications in a securities class action lawsuit against ACADIA Pharmaceuticals Inc. (NasdaqGS: ACAD), if they purchased the Company’s securities between April 29, 2016 and July 9, 2018, inclusive (the “Class Period”).  This action is pending in the United States District Court for the Southern District of California.

Get Help

ACADIA investors should visit us at https://www.claimsfiler.com/cases/view-acadia-pharmaceuticals-inc-securities-litigation-1  or call to speak to our claim center toll-free at (844) 367-9658.  

About the Lawsuit

ACADIA and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws. 

On July 9, 2018, a report published by the Southern Investigative Reporting Foundation highlighted problems associated with the Company’s sole drug, Nuplazid, a treatment for Parkinson’s disease, as well as the Company’s growth strategies that “have attracted intense regulatory scrutiny for other drug companies” including “dispensing wads of cash to doctors to incentivize prescription writing and downplaying mounting reports of patient deaths.”

On this news, the price of ACADIA’s shares plummeted $ 1.21/share, or 6.8%, to close at $ 16.63/share on July 9, 2018.

About ClaimsFiler

ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. ClaimsFiler’s team of experts monitor the securities class action landscape and cull information from a variety of sources to ensure comprehensive coverage across a broad range of financial instruments.

To learn more about ClaimsFiler, visit www.claimsfiler.com. 

This article has been provided by Nasdaq Globe Newswire.

This article ACADIA PHARMACEUTICALS SHAREHOLDER ALERT: CLAIMSFILER REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against ACADIA Pharmaceuticals Inc. – ACAD was written by DirectorsTalk Interviews.


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VUZIX SHAREHOLDER ALERT BY FORMER LOUISIANA ATTORNEY GENERAL: KAHN SWICK & FOTI, LLC REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against Vuzix Corporation – VUZI https://www.directorstalkinterviews.com/vuzix-shareholder-alert-by-former-louisiana-attorney-general-kahn-swick-foti-llc-reminds-investors-with-losses-in-excess-of-100000-of-lead-plaintiff-deadline-in-class-action-lawsuit-against/412758140 Sat, 08 Sep 2018 03:17:08 +0000 https://www.directorstalkinterviews.com/vuzix-shareholder-alert-by-former-louisiana-attorney-general-kahn-swick-foti-llc-reminds-investors-with-losses-in-excess-of-100000-of-lead-plaintiff-deadline-in-class-action-lawsuit-against/412758140 NEW ORLEANS, Sept. 07, 2018 — Kahn Swick & Foti, LLC (“KSF”) and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors that they have until September 24, 2018 to file lead plaintiff applications in a securities class action lawsuit against Vuzix Corporation (NasdaqCM: VUZI), if they purchased the Company’s securities: ...

This article VUZIX SHAREHOLDER ALERT BY FORMER LOUISIANA ATTORNEY GENERAL: KAHN SWICK & FOTI, LLC REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against Vuzix Corporation – VUZI was written by DirectorsTalk Interviews.


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NEW ORLEANS, Sept. 07, 2018 — Kahn Swick & Foti, LLC (“KSF”) and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors that they have until September 24, 2018 to file lead plaintiff applications in a securities class action lawsuit against Vuzix Corporation (NasdaqCM: VUZI), if they purchased the Company’s securities: a) issued in connection with the Company’s January 25, 2018 Secondary Public Offering; and/or, b) between November 9, 2017, and March 20, 2018, inclusive (the “Class Period”).  This action is pending in the United States District Court for the Southern District of New York.

What You May Do

If you purchased securities of Vuzix and would like to discuss your legal rights and how this case might affect you and your right to recover for your economic loss, you may, without obligation or cost to you, contact KSF Managing Partner Lewis Kahn toll-free at 1-877-515-1850 or via email (lewis.kahn@ksfcounsel.com), or visit https://www.ksfcounsel.com/cases/nasdaqcm-vuzi/ to learn more. If you wish to serve as a lead plaintiff in this class action, you must petition the Court by September 24, 2018.

About the Lawsuit

Vuzix and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.

On March 16, 2018, Mox Reports published an in-depth report charging the Company with utilizing an illegal and wide-ranging stock promotion scheme to artificially inflate its share price and volume, and then raise $ 30 million.

On this news, the price of Vuzix shares plummeted $ 1.70 per share, or more than 22%, on heavy volume, over the course of three trading sessions, to close on March 21, 2018 at $ 5.95 per share.

About Kahn Swick & Foti, LLC

KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is a law firm focused on securities, antitrust and consumer class actions, along with merger & acquisition and breach of fiduciary litigation against publicly traded companies on behalf of shareholders. The firm has offices in New York, California and Louisiana.

To learn more about KSF, you may visit www.ksfcounsel.com.

Contact:

Kahn Swick & Foti, LLC
Lewis Kahn, Managing Partner
lewis.kahn@ksfcounsel.com
1-877-515-1850
1100 Poydras St., Suite 3200
New Orleans, LA 70163

This article has been provided by Nasdaq Globe Newswire.

This article VUZIX SHAREHOLDER ALERT BY FORMER LOUISIANA ATTORNEY GENERAL: KAHN SWICK & FOTI, LLC REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against Vuzix Corporation – VUZI was written by DirectorsTalk Interviews.


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Kalytera Announces Next Payment of Invoices in Shares under Payments Agreements with Salzman Group https://www.directorstalkinterviews.com/kalytera-announces-next-payment-of-invoices-in-shares-under-payments-agreements-with-salzman-group/412758139 Sat, 08 Sep 2018 02:17:08 +0000 https://www.directorstalkinterviews.com/kalytera-announces-next-payment-of-invoices-in-shares-under-payments-agreements-with-salzman-group/412758139 SAN FRANCISCO and TEL AVIV, Israel, Sept. 07, 2018 — Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera“) today announced that the Company has elected to issue 10,242,697 common shares of the Company (“Common Shares”) to The Salzman Group in payment of invoices issued under the payments agreement with The ...

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SAN FRANCISCO and TEL AVIV, Israel, Sept. 07, 2018 — Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera“) today announced that the Company has elected to issue 10,242,697 common shares of the Company (“Common Shares”) to The Salzman Group in payment of invoices issued under the payments agreement with The Salzman Group previously announced on December 7, 2017 (the “December 2017 Agreement”) and the additional payments agreement announced on June 15, 2018 (the “June 2018 Agreement”). Under the December 2017 Agreement, The Salzman Group provides, among other services, clinical study management services in relation to the Phase 2 study evaluating the use of cannabidiol in the prevention of graft versus host disease. Under the June 2018 Agreement, The Salzman Group and its affiliates provide general and administrative support services, study set-up work for planned studies in connection with use of CBD in treatment of GVHD, and research and development work in connection with Kalytera’s exclusive license of cannabidiol-naproxen conjugates for treatment of pain.

The invoiced amounts to be paid in Common Shares to The Salzman Group total to the amount of US$ 629,101 (or C$ 829,658.40 based on the daily average exchange rate for September 6, 2018 published by the Bank of Canada). The number of Common Shares to be issued is based on a deemed issue price of C$ 0.081 per Common Share, being 90% of the closing price of the Common Shares on the TSXV on September 6, 2018, the trading day prior to the Company’s election to pay the invoiced amounts in Common Shares. The Common Shares are expected to be issued to The Salzman Group on or about September 10, 2018.

About Kalytera Therapeutics
Kalytera Therapeutics, Inc. (“Kalytera“) is pioneering the development of a next generation of cannabinoid therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of novel cannabinoid medicines for a range of important unmet medical needs, with an initial focus on graft versus host disease (“GVHD”).

Kalytera also intends to develop a new class of proprietary cannabidiol (“CBD“) therapeutics. CBD is a versatile compound that has shown activity against a number of pharmacological targets. However, there are limitations associated with natural CBD, including its poor oral bioavailability. Kalytera will seek to develop innovative CBD formulations and prodrugs in an effort to overcome these limitations, and to target specific disease sites within the body. Kalytera intends to file composition of matter and method of use patents covering its novel inventions, with the goal of limiting future competition.

  • Website Home: https://kalytera.co/
  • News and Insights: https://kalytera.co/news/
  • Investors: https://kalytera.co/investors/

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

This press release may contain certain forward-looking information and statements (“forward-looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable results. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third-parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera’s control. The forward-looking information contained in this press release are expressly qualified by this cautionary statement and are made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

Contact Information
Robert Farrell
President, CEO
(888) 861-2008
info@kalytera.co

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Brookstone® Signs Letter of Intent with Bluestar Alliance, LLC Reflecting Enhanced Stalking Horse Bid https://www.directorstalkinterviews.com/brookstone-signs-letter-of-intent-with-bluestar-alliance-llc-reflecting-enhanced-stalking-horse-bid/412758138 Sat, 08 Sep 2018 01:17:07 +0000 https://www.directorstalkinterviews.com/brookstone-signs-letter-of-intent-with-bluestar-alliance-llc-reflecting-enhanced-stalking-horse-bid/412758138 MERRIMACK, N.H., Sept. 07, 2018 — Brookstone® Company, Inc. today announced that it has signed a Letter of Intent with Bluestar Alliance, LLC to acquire the brand assets of the company and to serve as a stalking horse bidder in Brookstone’s Chapter 11 restructuring. In addition, yesterday, the Bankruptcy Court for the District of Delaware ...

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MERRIMACK, N.H., Sept. 07, 2018 — Brookstone® Company, Inc. today announced that it has signed a Letter of Intent with Bluestar Alliance, LLC to acquire the brand assets of the company and to serve as a stalking horse bidder in Brookstone’s Chapter 11 restructuring. In addition, yesterday, the Bankruptcy Court for the District of Delaware approved Bluestar as the “Stalking Horse” bidder for the Company’s auction scheduled for the end of the month. Importantly, Bluestar’s improved offer includes an option for Bluestar to select a transaction that would keep up to 50 existing Brookstone stores open, with a penalty of $ 400,000 payable if Bluestar either does not select this option or selects it and fails to keep at least 30 stores open.

“This agreement with Bluestar is an indication of the value of Brookstone’s cherished brand, and we are particularly encouraged by Bluestar’s enthusiasm to seriously consider a bid that includes operating Brookstone retail outlets,” said CEO Piau Phang Foo. “We continue to see interest in our company from multiple potential buyers. During this time, we remain focused on serving our loyal customers, and we are grateful for the support of our dedicated employees.”

The new offer, worth approximately $ 56.35 million comprising $ 50.45 million in cash and at least $ 5.9 million of value in the form of readily salable inventory, substantially improves upon Bluestar’s earlier offer of $ 43 million. The signed Letter of Intent with Bluestar supersedes the previously-announced, $ 35 million proposal made by Authentic Brands Group, and is subject to negotiation of an Asset Purchase Agreement.

Bluestar’s approved stalking horse bid is subject to higher and better offers in the auction to take place on September 26, 2018. The deadline to submit competing bids is September 20, 2018.

About Brookstone

Founded in 1965, Brookstone is a U.S.-based product developer and retailer of wellness, entertainment, and travel products that are fun to discover, smart to use and beautiful in design. Brookstone products are available at its 34 airport retail locations in airports throughout the U.S., online at Brookstone.com and through select premium retailers worldwide.

About Bluestar Alliance, LLC

Founded by Joseph Gabbay and Ralph Gindi in 2006. Bluestar Alliance, LLC owns, manages, and markets a portfolio of consumer brands that span across many tiers of distribution from luxury to mass market with a heavy emphasis on department store retail brands including Tahari, Bebe, Kensie, Catherine Malandrino, Nanette Lepore, Joan Vass, Michael Bastian, English Laundry and Limited Too.

Bluestar Alliance specializes in licensing, branding and marketing consumer brand companies through extensive relationships with leading retailers, brand licensing manufacturers and a network of media and strategic partners.

Bluestar Alliance’s current international and domestic partners offer the opportunity to take a niche brand to a visible worldwide lifestyle brand. Since its inception, the company has acquired select brands with retail sales exceeding $ 2.5 billion. Bluestar Alliance manages a current portfolio of over 250 licensees and a growing branded retail platform of over 100 stores worldwide throughout North America, Europe, Australia, South America, Asia, Middle East and India.

Media Inquiries:

media@Brookstone.com
Abernathy MacGregor
Sydney Isaacs, sri@abmac.com, 713.817.9346
Rivian Bell, rlb@abmac.com, 310.463.9229

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SaaS Video Creation Market Leader Vyond Appoints Gary Lipkowitz as CEO https://www.directorstalkinterviews.com/saas-video-creation-market-leader-vyond-appoints-gary-lipkowitz-as-ceo/412758137 Sat, 08 Sep 2018 00:17:08 +0000 https://www.directorstalkinterviews.com/saas-video-creation-market-leader-vyond-appoints-gary-lipkowitz-as-ceo/412758137 Lipkowitz to lead company through next phase of growth as Chief Executive Officer, founder Alvin Hung named Executive Chairman. Hong Kong, Sept. 07, 2018 — Vyond, a SaaS video creation company that allows everyone to create video quickly and easily, today announced its Board of Directors has appointed Gary Lipkowitz as Chief Executive Officer. Lipkowitz ...

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Lipkowitz to lead company through next phase of growth as Chief Executive Officer, founder Alvin Hung named Executive Chairman.

Hong Kong, Sept. 07, 2018 — Vyond, a SaaS video creation company that allows everyone to create video quickly and easily, today announced its Board of Directors has appointed Gary Lipkowitz as Chief Executive Officer. Lipkowitz will oversee all of the core functions of the business and will join Vyond’s Board of Directors. Lipkowitz, a media and entertainment expert, has served as Chief Operating Officer of Vyond since 2011. Alvin Hung, Vyond’s founder, has moved on from his post as Chief Executive Officer and has been named Executive Chairman.
       

“Gary and I have worked side by side for over seven years. Along with our dedicated team of employees, we have built a healthy, profitable growth business with great customers, both large and small, from all over the world,” Hung said. “After months of contemplation, we believe that adopting a more traditional management model where the Executive Chairman and CEO positions are held by separate leaders will benefit the creativity, energy, and growth potential of Vyond. We are currently in the midst of our strongest year ever. With Gary at the helm, we will continue on our mission of making video accessible to everyone, everywhere.”

Hung will continue to serve on the Board of Directors as its Executive Chairman. His primary role will be working alongside Lipkowitz and the Board to chart the right course for Vyond’s next phase of growth. Billy Chung has been appointed as General Manager of GoAnimate HK Ltd., and will manage daily administrative, HR, and finance responsibilities.

“I know that I speak for everyone at Vyond in thanking Alvin for his leadership and dedication to building a solid business our employees and customers can be proud of,” Lipkowitz said. “We have a talented team that is passionate about innovating, supporting, and marketing our product in new ways. I am excited about this new role and continuing to work closely with Alvin and the Board to move the business forward.”

Vyond has nearly 100 employees across the globe. The company rebranded from GoAnimate in May 2018 to extend its market leadership position in video creation software. To learn more, visit vyond.com.

About Vyond

At Vyond, our mission is to put the power of video in the hands of everyone. Vyond allows people of all skill levels in all industries and job roles to create dynamic and powerful media. With features that go beyond moving text and images, you can build character-driven stories or compelling data visualizations that engage audiences and deliver results.

Founded as GoAnimate in 2007, Vyond has helped Global 2000 organizations, small businesses, and individuals produce more than 30 million videos.

CONTACT: Stacy Adams Vyond +1 (650) 525-4225 press@vyond.com 

This article has been provided by Nasdaq Globe Newswire.

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Golden Leaf Holdings Refiles Amended and Restated MD&A https://www.directorstalkinterviews.com/golden-leaf-holdings-refiles-amended-and-restated-mda/412758136 Fri, 07 Sep 2018 23:17:08 +0000 https://www.directorstalkinterviews.com/golden-leaf-holdings-refiles-amended-and-restated-mda/412758136 TORONTO, Sept. 07, 2018 — Golden Leaf Holdings Ltd. (“GLH” or the “Company”) (CSE:GLH) (OTCQB:GLDFF), a cannabis company with cultivation, production and retail operations built around recognized brands, today announced that it has supplemented the disclosure in its Management Discussion and Analysis for the period ended March 31, 2018 and has filed an amended and ...

This article Golden Leaf Holdings Refiles Amended and Restated MD&A was written by DirectorsTalk Interviews.


©2017 DirectorsTalk Interviews
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TORONTO, Sept. 07, 2018 — Golden Leaf Holdings Ltd. (“GLH” or the “Company”) (CSE:GLH) (OTCQB:GLDFF), a cannabis company with cultivation, production and retail operations built around recognized brands, today announced that it has supplemented the disclosure in its Management Discussion and Analysis for the period ended March 31, 2018 and has filed an amended and restated version of such MD&A (the “Revised MD&A”). The refiling was made in connection with a continuous disclosure review by the Ontario Securities Commission (the “OSC”) to conform to the guidance provided in Staff Notice 51-352 (Revised) Issuers with U.S. Marijuana-Related Activities (the “Staff Notice”) published by the Canadian Securities Administrators on February 8, 2018.

The Revised MD&A enhances disclosure regarding each of the Company’s material assets and investments in the United States, including describing whether each asset or investment constitutes “direct”, “indirect” or “ancillary” involvement in the United States marijuana industry (as such concepts are defined in the Staff Notice). The Revised MD&A also includes disclosures regarding the regulatory framework in each United States jurisdiction in which the Company operates, as well as disclosures regarding its compliance with applicable laws and regulatory requirements in such jurisdictions. The Revised MD&A includes a description of the Company’s systems for monitoring compliance with applicable laws and the regulatory requirements in each applicable United States jurisdiction. The Company, in this disclosure, has expanded the risk factor disclosure relating to the Company’s involvement in the United States cannabis industry.

The Revised MD&A was filed simultaneously with the press release on SEDAR at www.sedar.com on August 20th, 2018. The Revised MD&A replaces and supersedes the previously filed version. The revisions relate only to MD&A disclosures and no changes were made to the Company’s financial statements for the reporting period.

To be added to the distribution list please email GLH@kcsa.com with “GLH” in the subject line. 

About Golden Leaf Holdings

Golden Leaf Holdings Ltd.is a Canadian company operating in multiple jurisdictions, including Canada, Oregon, Nevada, and California, with cultivation, production and retail operations built around recognized brands. Golden Leaf distributes its products through its branded Chalice Farms retail dispensaries, as well as through third party dispensaries. Golden Leaf’s cannabis retail operations and products are designed with the customer in mind, focused on superlative in-store experience and quality products. Visit http://goldenleafholdings.com/ to learn more.

Investor Relations:
Phil Carlson
KCSA Strategic Communications
pcarlson@kcsa.com
212-896-1233 

Media Contacts:
Anne Donohoe / Nick Opich
KCSA Strategic Communications 
adonohoe@kcsa.com/ nopich@kcsa.com
212-896-1265 / 212-896-1206

Company:
William Simpson
Chief Executive Officer
Golden Leaf Holdings Ltd.
503-201-0659
William@chalicefarms.com 

This article has been provided by Nasdaq Globe Newswire.

This article Golden Leaf Holdings Refiles Amended and Restated MD&A was written by DirectorsTalk Interviews.


©2017 DirectorsTalk Interviews
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