Nabriva Publishes Clinical Data Analysis Highlighting Benefits of Outpatient Management of Community Acquired Bacterial Pneumonia (CABP) with Oral XENLETA® (lefamulin)

-Post Hoc analysis published in The Journal of Emergency Medicine demonstrates patients with moderate to severe CABP can be managed effectively as outpatients with a 5-day, monotherapy regimen of oral XENLETA

DUBLIN, Ireland, March 16, 2021 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that The Journal of Emergency Medicine has published results from a post-hoc analysis of clinical data from the pivotal Lefamulin Evaluation Against Pneumonia (LEAP) 2 Phase 3 clinical trial. Avoiding hospitalization, with an outpatient 5-day regimen of oral XENLETA, as an alternative to the fluoroquinolone, moxifloxacin, was demonstrated in patients with moderate to severe community-acquired bacterial pneumonia (CABP), including those aged 65 years or older with comorbidities. The U.S. Food and Drug Administration (FDA) approved XENLETA for the treatment of adults with CABP in August 2019. XENLETA is the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades.

“In the treatment of CABP, initiating appropriate empiric oral antimicrobial therapy in the outpatient setting can result in significant economic benefits and successful infection control,” said Dr. Frank LoVecchio, DO, MPH, FACEP, Professor, University of Arizona and Creighton College of Medicine, Phoenix, AZ and lead author of the study. “This analysis suggests that patients who might be considered for hospital admission, either due to advanced age, comorbidities or difficult-to-treat pathogens, can be managed effectively as outpatients using a 5-day monotherapy course of oral XENLETA, as an alternative to fluoroquinolones.”

The LEAP 2 trial compared efficacy and safety of oral lefamulin 600 mg every 12 hours (5 days) versus oral moxifloxacin 400 mg every 24 hours (7 days) in adults (inpatients and outpatients) with Pneumonia Outcomes Research Team (PORT) risk classes II‒IV utilizing two outcome assessments of Early Clinical Response (ECR), an on-therapy endpoint, and Test of Cure (TOC), a post-therapy endpoint. In the post-hoc analysis, investigators examined data of 310 patients who started treatment as outpatients; 151 patients were treated with lefamulin and 159 were treated with moxifloxacin. Demographics and baseline clinical characteristics were generally similar between treatment groups and were broadly reflective of the patient population with CABP. In this cohort, 30% of outpatients were aged 65 years and older, and approximately 15% were aged 75 years and older. Among outpatients, the majority (lefamulin, 77%; moxifloxacin, 76%) entered the study with at least one comorbid condition or risk factor, such as age (65 or older), smoking history, history of hypertension, baseline liver enzyme elevation, moderate to severe renal impairment, history of asthma/COPD, diabetes mellitus, or history of arrhythmia), and 25% of patients in the lefamulin group and 29% in the moxifloxacin group had at least three comorbid conditions or risk factors.

Study findings showed that success rates at ECR/TOC for outpatients treated with oral lefamulin were high and similar to outpatients treated with moxifloxacin (lefamulin, 91% vs. moxifloxacin, 89%/90%), including those with PORT risk class III/IV (lefamulin, 89%/91% vs. moxifloxacin, 88%/91%) and CURB-65 scores of 2‒3 (lefamulin, 87%/90% vs. moxifloxacin, 82%/88%). In addition, the TOC success rate was maintained through late follow-up (Day 30±3 days) in both the lefamulin (91%) and moxifloxacin (90%) groups in outpatients.

Full results of the post-hoc analysis of LEAP 2 data is included in the paper titled: Oral 5-Day Lefamulin for Outpatient Management of Community-Acquired Bacterial Pneumonia: Post Hoc Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 Trial, published in The Journal of Emergency Medicine, March 14th, 2021.

LEAP 2 Study

The Phase 3, double-blind, double-dummy, parallel-group, noninferiority randomized trial was conducted in 99 sites in 19 countries. The clinical trial randomized 738 patients 18 years of age or older who had had PORT risk class II, III, or IV, radiographically documented pneumonia, acute illness, greater than three CABP symptoms, and greater than two vital sign abnormalities. Randomization was stratified by PORT risk class (II vs III/IV), geographic region (US vs ex-US), and prior receipt of a single dose of short-acting antibiotic therapy for CABP (yes vs no). Per protocol, ≤25 percent of the study population could have received a single dose of a short-acting antibiotic, and ≥50 percent were to have PORT risk class of III or IV. The first patient visit was on August 30, 2016, and patients were followed for 30 days, with the final date of follow-up on January 2, 2018.1

About CABP

Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. There are approximately five million cases of pneumonia in the U.S. each year, and pneumonia is the fifth leading cause of hospitalization and one of the leading causes of infection-related death. Streptococcus pneumoniae is the most common cause of bacterial pneumonia in the U.S. According to data from the SENTRY Antimicrobial Surveillance Program, in the U.S., approximately 30 to 60 percent of S. pneumoniae, depending on region, are macrolide-resistant. In a recent publication, these findings were corroborated; macrolide-resistant S. pneumonia had been shown to be significantly more common in outpatients vs. inpatients, with rates as high as 45.3 percent vs. 37.8 percent, respectively, in isolates from 329 US hospitals from 2018-2019.2 In addition to macrolides, fluoroquinolones are another common treatment option for CABP. This broad-spectrum class is an effective option; however, fluoroquinolones carry boxed warnings for several significant safety concerns.

About XENLETA

XENLETA® (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA include diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.xenleta.com.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin), the first pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories. For more information, please visit https://www.nabriva.com.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.

XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.

WARNINGS AND PRECAUTIONS

XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

Clostridium-difficile associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

ADVERSE REACTIONS

The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.

USE IN SPECIFIC POPULATIONS

In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.

Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.

Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.

Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.

XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.

To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for XENLETA.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans for making lefamulin available in China, plans to pursue research and development of other product candidates, expectations regarding the ability of customers to satisfy demand for XENLETA with their existing inventory, the sufficiency of Nabriva Therapeutics’ existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force for XENLETA, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

CONTACTS:

For Investors

Kim Anderson

Nabriva Therapeutics plc

[email protected]

For Media

Mike Beyer

Sam Brown Inc.

[email protected]

312-961-2502


1 Alexander E, Goldberg L, Das A. et al. Oral lefamulin vs moxifloxacin for early clinical response among adults with community-acquired bacterial pneumonia: the LEAP 2 randomized clinical trial. JAMA. 322(17):1661-1671.

2 Gupta, V., Yu, K. C., Schranz, J., Jokinen-Gordon, H., & Gelone, S. P. (2021). A multicenter evaluation of the US prevalence and regional variation in macrolide-resistant S. pneumoniae in ambulatory and hospitalized adult patients in the US [published online February 4, 2021]. Open Forum Infectious Diseases, 8, ofab063. doi:https://doi.org/10.1093/ofid/ofab063



NeuBase Therapeutics to Present at the 2021 Muscular Dystrophy Association Virtual Clinical & Scientific Conference

PITTSBURGH, March 16, 2021 (GLOBE NEWSWIRE) — NeuBase Therapeutics, Inc. (NASDAQ: NBSE) (“NeuBase” or the “Company”), a biotechnology company accelerating the genetic revolution using a new class of synthetic medicines, announced today an oral presentation at the 2021 Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference being held from March 15-18, 2021. The presentation, entitled Resolution of Causality in Myotonic Dystrophy, Type 1 (DM1) via a PATrOL™-Enabled Therapy, will provide an overview of NeuBase’s positive in vitro and in vivo preclinical data for its PATrOL™-enabled therapy for the treatment of myotonic dystrophy type 1 (DM1).

Presentation Details

Title: Resolution of Causality in Myotonic Dystrophy, Type 1 (DM1) via a PATrOL™-Enabled Therapy
Presenter: Dietrich A. Stephan, Ph.D., Chief Executive Officer of NeuBase
Date: March 18, 2021
Time: 9:30 a.m.-9:45 a.m. EDT

For more information and to register for the conference, visit: https://mdaconference.org/.

About NeuBase Therapeutics, Inc.

NeuBase is accelerating the genetic revolution using a new class of synthetic medicines which have been shown to be able to increase, decrease and change gene function, as appropriate, to resolve causal genetic defects in living systems. NeuBase’s designer PATrOL™ therapies are centered around its proprietary drug scaffold to address genetic diseases at the source by combining the highly targeted approach of traditional genetic therapies with the broad organ distribution capabilities of small molecules. With an initial focus on silencing disease-causing mutations in debilitating neurological, neuromuscular and oncologic disorders, NeuBase is committed to redefining medicine for the millions of patients with both common and rare conditions. To learn more, visit www.neubasetherapeutics.com.

Use of Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements are distinguished by use of words such as “will,” “would,” “anticipate,” “expect,” “believe,” “designed,” “plan,” or “intend,” the negative of these terms, and similar references to future periods. These views involve risks and uncertainties that are difficult to predict and, accordingly, our actual results may differ materially from the results discussed in our forward-looking statements. Our forward-looking statements contained herein speak only as of the date of this press release. Factors or events that we cannot predict, including those risk factors contained in our filings with the U.S. Securities and Exchange Commission, may cause our actual results to differ from those expressed in forward-looking statements. The Company may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of the Company could differ materially from those described in or implied by the statements in this press release, including: the Company’s plans to develop and commercialize its product candidates; the timing of initiation of the Company’s planned clinical trials; the timing of the availability of data from the Company’s clinical trials; the timing of any planned investigational new drug application or new drug application; the Company’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of the Company’s product candidates; the Company’s commercialization, marketing and manufacturing capabilities and strategy; global health conditions, including the impact of COVID-19; the Company’s ability to protect its intellectual property position; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all, as well as those risk factors contained in our filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

NeuBase Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
OP: (617) 535-7746

NeuBase Media Contact:

Cait Williamson, Ph.D.
LifeSci Communications
[email protected]
OP: (646) 751-4366



BXS Unveils Rebranding With Launch of New Website and Platform

NEW YORK, March 16, 2021 (GLOBE NEWSWIRE) — BXS, the industry’s leading compliance reporting and analytics solutions provider, today announced a company rebranding complete with launches of a revamped website and product platform. Both the website and platform feature a sleek, modern design that illustrates the power of the firm’s solutions, providing clients with a more visually appealing and intuitive experience while supporting the robust functionalities they rely on.

BXS (formerly Best Execution Solutions) offers a diverse suite of products that broker-dealers, buy-side firms and market centers leverage to meet a range of compliance obligations and realize an array of business benefits. Products include regulatory reporting modules, detailed execution statistics, peer-to-peer analysis tools, trade surveillance capabilities and more.

In addition to its cutting-edge technology, the firm’s rebranding also reflects its growth since launching in 2015. In that time, BXS has made numerous enhancements to its platform, added staff and gained industry recognition, displaying a knack for innovation that demands a dynamic look.

BXS’ rebranding also reflects the momentous changes that the industry has witnessed in the past year. BXS has continued to innovate throughout the pandemic, launching a next-generation trade surveillance platform, a specialized Canadian best execution module and a Rule 606 Consolidator tool, which enables market centers to analyze how their clients and prospects are routing order flow and how their competitors are interacting with these entities. Through periods of heightened volatility and volumes, as well as general uncertainty, BXS has proven its ability is to remain a stable and reliable force for clients.

This rebranding is just one of many initiatives planned by BXS in the coming months, with additional tool releases, product updates and appearances at industry events slated for the weeks and months ahead.

About BXS

BXS is a trade data analytics firm that builds cutting-edge technology to deliver high-performance compliance solutions and powerful market insights to broker-dealers, buy-side firms and market centers. BXS focuses on providing Best Execution tools, regulatory reporting, trading analytics and surveillance software across a range of asset classes, which enable market participants to meet a variety of reporting obligations while also unlocking competitive advantages. Founded in 2015 by the team that helped shape the modern regulatory reporting landscape and built on a robust modular platform, BXS combines made-to-measure solutions with exceptional client service, enabling a streamlined, highly intuitive process that minimizes cost.



Sam Belden
Forefront Communications for BXS
212-320-8986
[email protected]

F-star Therapeutics to Host Full-Year 2020 Investor Call and Provide Corporate Update on March 29, 2021

CAMBRIDGE, United Kingdom and CAMBRIDGE, Mass., March 16, 2021 (GLOBE NEWSWIRE) — F-star Therapeutics, Inc. (NASDAQ: FSTX), a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, announced today that it will host a full year 2020 investor conference call and webcast on Monday, March 29, 2021 at 9:00 a.m. EDT. The F-star Therapeutics management team, including Eliot Forster, CEO and Darlene Deptula-Hicks, CFO, will discuss 2020 financial results and provide a corporate update.

To access the call, participants may join via a live webcast on the Investors and News section of the F-star Therapeutics website, under Events and Presentations or participants can dial 1-833-471-0868 in the US/Canada or 1-914-987-7751 for International calls, at least 10 minutes prior to the start of the call.

A replay of the conference call will be available beginning March 30, 2021 and may be accessed in the Investors & News/Events and Presentations section on the F-star Therapeutics website for 90 days.

About F-star Therapeutics, Inc.

F-star is a clinical-stage biopharmaceutical company developing tetravalent bispecific antibodies for a paradigm-shift in cancer therapy. By developing medicines that seek to block tumor immune evasion, the Company’s goal is to offer patients greater and more durable benefits than current immuno-oncology treatments. Through its proprietary tetravalent, bispecific natural antibody (mAb²™) format, F-star’s mission is to generate highly differentiated best-in-class drug candidates with monoclonal antibody-like manufacturability. For more information visit https://www.f-star.com/ and follow us on LinkedIn and Twitter.

For further information, please contact:

For investor inquiries

Lindsey Trickett

VP Investor Relations & Communications
+1 240 543 7970
[email protected] 

For media inquiries

Helen Shik

Shik Communications LLC
617-510-4373
[email protected] 



Satori Announces Data Users Directory for Streamlined Enterprise Data Access Management, GDPR Compliance

TEL AVIV, Israel, March 16, 2021 (GLOBE NEWSWIRE) — Satori, the industry’s leading provider of Data Governance-as-a-Service and data access, today announced the Data Users Directory service, which leverages universal data access groups to provide customers with a more streamlined data entitlement process. In accordance with GDPR requirements that companies implement appropriate technical and organizational measures to protect data, the Data Users Directory service helps companies organize internal data users in a way that matches their data access needs while still safeguarding access to sensitive data.

“Most organizations have a strong foundation of identity management with a single source of truth for identity information,” said Yoav Cohen, CTO and co-founder of Satori. “However, when data engineering and governance teams are faced with the challenge of managing access to data, the traditional role-based access control approach is not flexible enough and requires data teams to ask for changes in how users and groups are modeled from IT, resulting in back-and-forth tickets and discussions. The Satori Directory enables data teams to model the identity space of the organization in the context of access to data independently, while still leveraging existing user and group associations where applicable.”

This service decouples user management from database Role-based access control (RBAC) and permissions implementations. Taking into account database users, their roles and identity providers (IdP), this strategy provides simplified role management for databases and helps define universal data access identities and groups across enterprise data stores. In effect, data engineering teams can reduce time spent on database RBAC implementations and ongoing maintenance.

This capability is available to all Satori customers. Leveraging Satori, customers simply organize existing users and groups in a way that fits data access instead of database administrative tasks or HR organizational structure. Satori groups are built for organizations that do not use an identity provider, in cases where the association of users to groups in the identity provider does not match how their data is actually accessed, and for organizations that have data engineering teams who don’t want to be dependent on external stakeholders such as IT.

“The Satori Directory lets me organize both users and programmatic access to data according to their Okta groups or Snowflake roles, and apply data access policies in a more streamlined way,” said Eyal Fishman, Data Engineer at Via – On-Demand Transit.

For more information on Satori and the Data Users Directory service, visit https://satoricyber.com/product/.

About Satori

Satori is revolutionizing data protection and governance. Satori provides a Universal Data Access Service that allows companies to modernize their data infrastructure and scale data operations. Satori provides a platform for cloud data stores that delivers data governance, compliance, security and privacy as a service, allowing companies to move from existing manual operations to scalable DataOps.

Contact:

Debra Montner
Montner Tech PR
[email protected]

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/178b4748-8799-4942-a7cd-f8f0758ff733

https://www.globenewswire.com/NewsRoom/AttachmentNg/6bc1b648-80b8-4f9e-8798-de153e61c678



Voyager Therapeutics, Inc. Investors: Last Days to Participate Actively in the Class Action Lawsuit; Portnoy Law Firm

Investors with losses are encouraged to contact the firm before March 24, 2021; click


here


to submit trade information

LOS ANGELES, March 16, 2021 (GLOBE NEWSWIRE) — The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of Voyager Therapeutics, Inc. (NASDAQ: VYGR) investors that acquired shares between June 1, 2017 and November 9, 2020. Investors have until March 24, 2021 to seek an active role in this litigation.

Investors are encouraged to contact attorney Lesley F. Portnoy, to determine eligibility to participate in this action, by phone 310-692-8883 or email, or click here to join the case.

It is alleged in the complaint that Voyager made misleading and false statements to the market. Voyager’s IND submission to the FDA for VY-HTT01 failed to include essential information in regard to chemistry, manufacturing and controls matters including product characterization and drug-device compatibility. Based on this failure, Voyager’s IND submission for VY-HTT01 was deficient. Voyager overstated the likelihood of the IND submission achieving FDA approval. Voyager’s public statements were materially misleading and false throughout the class period, based on these facts. Investors suffered damages when the market learned the truth about Voyager.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than March 24, 2021.

Please visit our website to review more information and submit your transaction information.

The Portnoy Law Firm represents investors in pursuing claims arising from corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.

Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
[email protected]
310-692-8883
www.portnoylaw.com

Attorney Advertising

 



Gold Rush Returns to Where it Originally Began; New Mexico grants U.S. Money Transmitter License to Coro Global’s gold payment app

Miami, March 16, 2021 (GLOBE NEWSWIRE) — Coro Global Inc. (OTCQB: CGLO) announced today that its subsidiary Coro Corp., was granted a U.S. Money Transmitter license in the state of New Mexico. The company created CORO, a mobile payment app that allows customers to exchange, send and save gold and dollars easily and securely.

https://youtu.be/xkuCQ6tAv-0

Coro Global is a Florida-based fintech on a mission to support people in understanding the value of using gold as resilient money. Coro democratizes access to gold aiming to lead towards a more sustainable world with better social cooperation. Coro is leveraging deep financial know-how and the new generation of distributed ledger technology (hashgraph) to build the infrastructure and tools for anyone to be able to buy gold in the smallest denominations and use it as easily as traditional currencies in their everyday lives. 

New Mexico is an important landmark for Coro as it has a very strong cultural and historical connection to gold. The first gold rush west of the Mississippi occurred in New Mexico in the 1820s, establishing New Mexico as a “treasure” state. Gold will always hold a special place for people in the area, and Coro is now democratizing access to it.

The new license authorizes Coro to transmit currency, monetary value, or payment instruments within New Mexico, as well as from the state to other jurisdictions. The licensure approval required implementing a rigorous compliance program and developing an advanced AML/KYC onboarding and monitoring system for anti-money laundering compliance, as well as a strict financial audit process.

Coro is now licensed and onboarding residents of 26 U.S. states and the District of Columbia and intends to expand the availability of its gold payment app across the country over the course of 2021. International expansion is also in the works with Mexico and Canada next.
CORO App is currently available in the Apple App and Google Play stores to residents of Alabama, Alaska, Arkansas, Arizona, Delaware, Idaho, Illinois, Iowa, Florida, Georgia, Massachusetts, Minnesota, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Virginia, Washington, Washington D.C., and Wisconsin.

Coro Global CEO, Mr. David Dorr stated: “Coro is excited to announce the granting of yet another money transmitter license, this time in the state of New Mexico. The purchasing power of the U.S. dollar has fallen by 98% since 1913. Part of the problem is that governments can, and do, freely print currencies to stimulate economic activity, which fuels inflation. People are concerned with inflation, the falling value of the dollar, and the Federal Reserve’s ongoing money issuance policy. We believe gold offers stability and a hedge against inflation. People are seeking change, and are gravitating towards an economy where gold is considered money. We are seeing clear signs of this trend as several U.S. states are declaring gold legal tender, moves which are likely to generate further interest in using gold as money which should well position our app to be a part of this powerful trend,” concluded Mr. Dorr.

About Coro Global Inc.

Coro Global Inc. is a Miami, Florida-based fintech company that is creating a new financial payment system where gold can be used as money in everyday transactions as easily as fiat currencies. Coro’s platform is powered by cutting-edge Distributed Ledger Technology, allowing customers to send and receive global payments and exchange currency, including gold, seamlessly and securely.

Cautionary Note Regarding Forward-Looking Statements

Matters discussed in this press release contain forward-looking statements. When used in this press release, the words “anticipate,” “believe,” “estimate,” “may,” “intend,” “expect” and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These include, but are not limited to, risks and uncertainties associated with our history of losses and our need to raise additional financing, the acceptance of our products and technology in the marketplace, our ability to demonstrate the commercial viability of our products and technology and our need to increase the size of our organization. Further information on the Company’s risk factors is contained in the Company’s filings with the Securities and Exchange Commission. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason except as may be required under applicable law.



Anna Milaeva
[email protected] 

Watsco to Acquire Temperature Equipment Corporation, $291 Million Chicago-Based HVAC Distributor

Enables Entrance into New Markets with 32 Locations and 10,000 Contractor-Customers

MIAMI, March 16, 2021 (GLOBE NEWSWIRE) — Watsco, Inc. (NYSE: WSO) and Carrier Global Corp. (NYSE: CARR) announced today that they have signed an agreement to acquire Temperature Equipment Corporation (TEC).

Watsco recently reported record 2020 results with over $5 billion in sales, record profits and record cash flow. TEC marks Watsco’s first entry into the U.S. Midwest.

Founded in Chicago, Illinois in 1935, TEC is one of the largest HVAC distributors in North America with sales of $291 million in 2020. TEC serves approximately 10,000 customers from 32 locations in Illinois, Indiana, Wisconsin, Kansas, Michigan, Minnesota and Missouri. Its product offering includes various brands of residential, light-commercial and applied HVAC equipment made by Carrier as well as complimentary systems, parts, supplies and accessories sourced from approximately 1,200 vendors. More information about TEC can be found at www.tecmungo.com.

TEC will operate as an independent business as an addition to the highly-successful group of joint ventures between Watsco and Carrier, a collaboration that has provided growth and value for both companies over the last several years. Watsco will own 80% of TEC and Carrier 20%. Closing of the transaction is subject to customary conditions and is expected to occur within the next 30 days.

Albert H. Nahmad, Watsco’s Chairman & Chief Executive Officer said: “TEC is one of the most iconic, entrepreneurial, long-standing family businesses in our industry. Skip Mungo and his team have built a great company and they will continue TEC’s focus on growth with their name, identity and unique culture in what will be new markets for our company. We look forward to supporting their growth with capital, ideas, technology and our industry relationships to build on their historical success. We are pleased to become part of the TEC family.”

Skip Mungo, TEC’s President & CEO said: “We are excited to become a member of the Watsco family and provide the catalyst for growth in the Midwest. Partnering with Watsco will enable us to think bigger while retaining our unique culture and approach to the market. We look forward to launching their innovative technology platforms over time to support our customers, complementing the historical capabilities and customer focus that is at the heart of TEC’s culture.”

Watsco’s Buy and Build Growth Strategy

Watsco has acquired 63 businesses since 1989, most of which were successful, multi-generation, family-owned businesses. Watsco’s “buy and build” strategy can be summarized as follows:

  • Identify and partner with great businesses focused on the HVAC/R industry
  • Support their leadership team and honor the culture and legacy they have created
  • Ask for aggressive growth plans and help leadership achieve their ambitions
  • Motivate teams and reaffirm an ownership culture with long-term equity
  • Deploy the industry’s most comprehensive suite of customer-focused technologies
  • Solicit and collaborate on big ideas to foster a spirit of innovation and growth
  • Build a stronger Watsco because of our association with these companies

We are actively seeking additional opportunities to invest and grow through acquisitions given our relative low market share of the estimated $40 billion North American distribution marketplace for HVAC/R products.

About
 
Watsco

Watsco is the largest distribution network for heating, air conditioning and refrigeration (HVAC/R) products. Locations in the United States, Canada, Mexico and Puerto Rico, and on an export basis to Latin America and the Caribbean. Watsco estimates that over 90,000 contractor customers and their estimated 300,000 technicians visit or call one of its 600 locations each year to get information, obtain technical support and buy products. HVAC/R products provide comfort to homes and businesses regardless of the outdoor climate. Older systems often operate below today’s government mandated energy efficiency and environmental standards. Watsco has an opportunity to accelerate the replacement of these systems at a scale greater than its competitors as the movement toward reducing energy consumption and its environmental impact continues. This is especially important since heating and cooling accounts for approximately half of the energy consumed in a typical U.S. home. Additional information about Watsco may be found at http://www.watsco.com.

This document includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may address, among other things, our expected financial and operational results and the related assumptions underlying our expected results. These forward-looking statements are distinguished by use of words such as “will,” “would,” “anticipate,” “expect,” “believe,” “designed,” “plan,” or “intend,” the negative of these terms, and similar references to future periods. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from these expectations due to changes in economic, business, competitive market, new housing starts and completions, capital spending in commercial construction, consumer spending and debt levels, regulatory and other factors, including, without limitation, the effects of supplier concentration, competitive conditions within Watsco’s industry, seasonality of its product sales, the ability of the Company to expand its business, insurance coverage risks and final GAAP adjustments. Detailed information about these factors and additional important factors can be found in the documents that Watsco files with the Securities and Exchange Commission, such as Form 10-K, Form 10-Q and Form 8-K. Forward-looking statements speak only as of the date the statements were made. Watsco assumes no obligation to update forward-looking information to reflect actual results, changes in assumptions or changes in other factors affecting forward-looking information, except as required by applicable law.

Barry S. Logan

Executive Vice President
 

(305) 714-4102

e-mail: [email protected]



CleanSpark, Inc. Investors: Last Days to Participate Actively in the Class Action Lawsuit; Portnoy Law Firm

Investors with losses are encouraged to contact the firm before March 22, 2021; click


here


to submit trade information

LOS ANGELES, March 16, 2021 (GLOBE NEWSWIRE) — The Portnoy Law Firm advises investors that a class action lawsuit has been filed on behalf of CleanSpark, Inc. (NASDAQ: CLSK) investors that acquired shares between December 31, 2020 and January 14, 2021. Investors have until March 22, 2021 to seek an active role in this litigation.

Investors are encouraged to contact attorney Lesley F. Portnoy, to determine eligibility to participate in this action, by phone 310-692-8883 or email, or click here to join the case.

The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors concerning whether the Company fabricated key elements of its business. On January 14, 2021, Culper Research published a report titled “Cleanspark (CLSK): Back to the Trash Can,” alleging, among other things, that CleanSpark has “fabricated key elements of its business, including purported customers and contracts” and is also “rife with undisclosed related party transactions.” On this news, CleanSpark’s shares fell $3.63 per share, or 9.23%, to close at $35.71 per share on January 14, 2021, thereby injuring investors.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than March 22, 2021.

Please visit our website to review more information and submit your transaction information.

The Portnoy Law Firm represents investors in pursuing claims arising from corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.

Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
[email protected]
310-692-8883
www.portnoylaw.com

Attorney Advertising



Victory Square Technologies Completes $6,000,000 Sale Of VPN Platform To Cloud Nine Web3 Technologies

  • Victory Square received 4,411,765 common shares of Cloud Nine Web3 Technologies Inc. (CSE: CNI) at a deemed issue price of $1.36 per common share for a purchase price of $6,000,000
  • The share price of Cloud Nine (CSE: CNI) closed on March 15, 2021 at $1.79 per common share, valuing Victory Square’s 4,411,765 common shares at $7,897,059.35
  • Victory Square will have the right to dividend up to 15% of the total number of the Consideration Shares issuable hereunder to its shareholders
  • Company exercised 350,000 warrants in Argo Blockchain PLC (LON: ARB) for an approximate $1,488,000 gain (as at March 15th, 2021)

VANCOUVER, British Columbia, March 16, 2021 (GLOBE NEWSWIRE) — Victory Square Technologies Inc. (“Victory Square” or the “Company“) (CSE:VST) (OTC:VSQTF) (FWB:6F6) — is pleased to announce that it has signed and closed an asset purchase agreement dated March 15, 2021 to sell certain intellectual property assets related to a development stage VPN platform (the “Acquisition”) to Cloud Nine Web3 Technologies Inc. (“Cloud Nine” )(CSE: CNI).

“We’ve spent the last 6 years connecting with and investing in some of the brightest and disruptive minds in the Technology space; quietly building up a stockpile of applications and IP while waiting for an inflection point to start unleashing these applications to market,” said Victory Square CEO Shafin Diamond Tejani. “This 6 million sale of IP and the $1.5 million gain on Argo points to the extensive depth of the Victory Square portfolio and our ability to monetize and provide value to our shareholders.”

In consideration for the Acquisition, Victory Square received 4,411,765 common shares of Cloud Nine at a deemed issue price of $1.36 per common share for a sale price of $6,000,000. The common shares are subject to a restricted period of four months and one day.

The current share price of Cloud Nine Web3 Technologies Inc. (CSE: CNI) on March 15, 2021 is $1.79 per common share, valuing Victory Square’s 4,411,765 common shares of Cloud Nine at $7,897,059.35.

Terms of the Acquisition

In consideration for the Acquisition, Cloud Nine Web3 Technologies Inc issued 4,411,765 common shares in the capital of the Cloud Nine at a deemed issue price of $1.36 per common share for a purchase price of $6,000,000. The common shares are subject to a restricted period of four months and one day. The Company will have the right to dividend up to 15% of the total number of the Consideration Shares issuable hereunder to the Company’s shareholders on a pro rata basis provided that: (i) the Company provides at least 60 days prior written notice to the Purchaser of the proposed dividend; and (ii) such dividend is undertaken by the Company in compliance with applicable securities laws.

Victory Square exercised 350,000 warrants in Argo Blockchain PLC (LON: ARB) for an approximate $1,488,000 gain (as at March 15th, 2021)

Visit VictorySquare.com and sign up for the official newsletter of Victory Square at www.VictorySquare.com/newsletter.

On behalf of the board,

Shafin Diamond Tejani
Chief Executive Officer

For further information about the Company, please contact:

Investor Relations Contact – Edge Communications Group
Email: [email protected]
Telephone: 604 283-9166

Media Relations Contact – Howard Blank, Director
Email: [email protected]
Telephone: 604-928-6066

ABOUT VICTORY SQUARE TECHNOLOGIES INC.

Victory Square (VST) builds, acquires and invests in promising startups, then provides the senior leadership and resources needed to fast-track growth.
VST’s sweet spot is the cutting-edge tech that’s shaping the 4th Industrial Revolution. Our portfolio consists of 20 global companies using AI, VR/AR and blockchain to disrupt sectors as diverse as fintech, insurance, health and gaming.

What we do differently for startups

VST isn’t just another investor. With real skin in the game, we’re committed to ensuring each company in our portfolio succeeds. Our secret sauce starts with selecting startups that have real solutions, not just ideas. We pair you with senior talent in product, engineering, customer acquisition and more. Then we let you do what you do best — build, innovate and disrupt. In 24-36 months, you’ll scale and be ready to monetize.

What we do differently for investors

VST is a publicly-traded company headquartered in Vancouver, Canada, and listed on the Canadian Securities Exchange (VST), Frankfurt Exchange (6F6) and the OTCQX (VSQTF).

For investors, we offer early-stage access to the next unicorns before they’re unicorns. Our portfolio represents a uniquely liquid and secure way for investors to get access to the latest cutting-edge technologies. Because we focus on market-ready solutions that scale quickly, we’re able to provide strong and stable returns while also tapping into emerging global trends with big upsides. For more information, please visit www.victorysquare.com.

ABOUT THE CANADIAN SECURITIES EXCHANGE (CSE)

The Canadian Securities Exchange, or CSE, is operated by CNSX Markets Inc. Recognized as a stock exchange in 2004, the CSE began operations in 2003 to provide a modern and efficient alternative for companies looking to access the Canadian public capital markets.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof.

FORWARD-LOOKING INFORMATION

This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the outlook of the business of Victory Square, including, without limitation, statements relating to future performance, execution of business strategy, future growth, business prospects and opportunities of Victory Square and its related subsidiaries and other factors beyond our control. Such forward-looking statements may, without limitation, be preceded by, followed by, or include words such as “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans”, “continues”, “project”, “potential”, “possible”, “contemplate”, “seek”, “goal”, or similar expressions, or may employ such future or conditional verbs as “may”, “might”, “will”, “could”, “should” or “would”, or may otherwise be indicated as forward-looking statements by grammatical construction, phrasing or context. All statements other than statements of historical facts contained in this news release are forward-looking statements. Forward-looking information is based on certain key expectations and assumptions made by the management of Victory Square. Although Victory Square believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on them because Victory Square can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. The statements contained in this news release are made as of the date of this news release. Victory Square disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws. The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof.