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Senet and ADTRAN Partner to Deliver Carrier-Grade LoRaWAN® Connectivity to the Enterprise

Senet and ADTRAN Partner to Deliver Carrier-Grade LoRaWAN® Connectivity to the Enterprise

ADTRAN Selects Senet’s Cloud-Based Network Management Platform to Help Customers Simplify and Streamline the Deployment of IoT Solutions at Scale

PORTSMOUTH, N.H. & HUNTSVILLE, Ala.–(BUSINESS WIRE)–Senet, Inc., a leading provider of cloud-based software and services platforms that enable global connectivity and on-demand network build-outs for the Internet of Things (IoT), and ADTRAN®, Inc. (NASDAQ:ADTN), a leading provider of innovative business and residential connectivity solutions, today announced a partnership to deliver carrier-grade LoRaWAN® network services for IoT applications across enterprise and campus environments.

Through this collaboration, the ADTRAN 7310-08 IoT Gateway is now certified to operate with Senet’s cloud-based network management platform, providing businesses, VARs and system integrators a clear path to deploying and managing cost effective and secure LoRaWAN connectivity in and around commercial buildings at scale. Key benefits include:

  • Rapid deployment and easy configuration on the Senet network with ADTRAN’s IoT App and the micro-sized 7310-08, 8-channel LoRaWAN IoT gateway.
  • Integration with Senet’s cloud-based network operating system, including OSS/BSS features engineered to easily coordinate and scale the delivery of network services beyond the capabilities of a standalone LoRaWAN Network Server (LNS).
  • New business and revenue generation opportunities through participation in the Senet Low Power Wide Area Virtual Network (LVN™).

“Businesses are realizing the strain distributed IoT deployments can put on their network and look for solutions to better plan and manage IoT network resources and large scale sensor-based device deployments,” said Keith Atwell, Head of Global Business Development at ADTRAN. “Partnering with Senet to provide out-of-the-box integration between our gateways and their cloud-hosted network services allows our customers to roll out IoT solutions of any size, knowing they are getting the carrier-grade quality the industry has come to expect from ADTRAN and on a network architected to scale with them as they grow.”

With ADTRAN and Senet removing the complexities of network deployment and management, businesses can focus on improving operations and safety through a broad range of wirelessly-connected solutions. ADTRAN’s micro-sized, 8-channel LoRaWAN IoT gateway is ideal for a broad range of Smart Building applications, including asset tracking, equipment monitoring, lighting controls, room occupancies, biometrics, motion sensing and contact tracing.

“It is one thing to select the most appropriate wireless technology to meet the needs of business-critical IoT projects, but quite another to manage it within a distributed organization,” said Bruce Chatterley, CEO of Senet. “However, with the right network infrastructure and management services in place, enterprise organizations can rapidly overcome the more common challenges. Our partnership with ADTRAN gives businesses a clear path to using a diverse range of LoRaWAN-powered sensors to automate processes and gain new and actionable insights into their operations.”

For more information on Senet’s carrier-grade network services for critical infrastructure and essential business applications, download Senet’s new whitepaper: The Value of Carrier-Grade Network Service for the Delivery of LoRaWAN IoT Solutions.

About Senet, Inc.

Senet develops cloud-based software and services used by Network Operators, Application Developers, and System Integrators for the on-demand deployment of Internet of Things (IoT) networks. In addition to industrial and commercial applications, Senet has designed smart meter networks for many municipal water utility districts across the United States, representing millions of households. With a multi-year head start over competing Low Power Wide Area Network technologies, Senet offers technology in over eighty countries and owns and operates the largest publicly available LoRaWAN network in the United States. Our disruptive go-to-market models and critical technical advantages have helped us become a leading connectivity provider with recognized expertise in building and operating global IoT networks. For additional information, visit www.senetco.com.

About ADTRAN

ADTRAN, Inc. is a leading global provider of open, disaggregated networking and communications solutions that enable voice, data, video and internet communications across any network infrastructure. From the cloud edge to the subscriber edge, ADTRAN empowers communications service providers around the world to manage and scale services that connect people, places and things. ADTRAN solutions are currently in use by service providers, private enterprises, government organizations and millions of individual users worldwide. Find more at www.adtran.com, Linkedin and Twitter.

Senet:

James Gerber

Crackle Communications

508-233-3391

[email protected]

ADTRAN:

Ashley Schulte

919-435-9112

[email protected]

KEYWORDS: New Hampshire Alabama United States North America

INDUSTRY KEYWORDS: Software Utilities Networks Internet Audio/Video Energy Technology VoIP

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Cummins to Acquire 50 Percent of Momentum Fuel Technologies From Rush Enterprises

DALLAS and FORT WORTH, Texas and COLUMBUS, Indiana , June 29, 2021 (GLOBE NEWSWIRE) — Cummins Inc. (NYSE: CMI) and Rush Enterprises, Inc. (NASDAQ: RUSHA & RUSHB) today announced that they have signed a Letter of Intent for Cummins to acquire a 50% equity interest in Momentum Fuel Technologies from Rush Enterprises.

The proposed transaction is expected to close later this year, subject to completion of customary pre-closing activities and entering into mutually agreeable transaction documentation. The joint venture between Rush Enterprises and Cummins will produce Cummins-branded natural gas fuel delivery systems for the commercial vehicle market in North America, combining the strengths of Momentum Fuel Technologies’ compressed natural gas (CNG) fuel delivery systems, Cummins’ powertrain expertise, and the engineering and support infrastructure of both companies.

“This collaboration shows Cummins’ continued commitment to natural gas powertrains,” said Srikanth Padmanabhan, President of the Engine Business at Cummins. “This partnership will improve customers service for both CNG and RNG through an improved support network. We are thrilled to expand our network of clean and reliable power solutions.”

“The immediate environmental benefits of CNG and RNG, combined with upcoming regulatory requirements, will drive growth in natural gas vehicles for the foreseeable future,” said W.M. “Rusty” Rush, Chairman, Chief Executive Officer and President, Rush Enterprises, Inc. “This partnership will enable Rush Enterprises to continue to provide unparalleled support to our customers through our mutual, wide-ranging portfolio of Cummins’ and RushCare aftermarket solutions and keep trucks up and running across the country.”

The joint venture will offer aftermarket support through Rush Truck Centers dealerships and Cummins distributors which will be able to service both the engine and the fuel delivery system. The partnership between Cummins and Rush Enterprises will benefit customers by providing them with access to an extensive CNG vehicle parts and service network; both Cummins’ and Rush Enterprises’ respective networks, which together represent over 250 locations in the US and Canada, will be equipped with certified technicians and access to a comprehensive CNG vehicle parts inventory.

About Rush Enterprises, Inc.

Rush Enterprises, Inc. is the premier solutions provider to the commercial vehicle industry. The Company owns and operates Rush Truck Centers, the largest network of commercial vehicle dealerships in the United States, with more than 100 dealership locations in 22 states. These vehicle centers, strategically located in high traffic areas on or near major highways throughout the United States, represent truck and bus manufacturers, including Peterbilt, International, Hino, Isuzu, Ford, FUSO, IC Bus and Blue Bird. They offer an integrated approach to meeting customer needs — from sales of new and used vehicles to aftermarket parts, service and body shop operations plus financing, insurance, leasing and rental. Rush Enterprises’ operations also provide CNG fuel systems, telematics products and other vehicle technologies, as well as vehicle up-fitting, chrome accessories and tires. For more information, please visit us at www.rushtruckcenters.com, www.rushenterprises.com and www.rushtruckcentersracing.com, on Twitter @rushtruckcenter and Facebook.com/rushtruckcenters.

About Momentum Fuel Technologies.

Momentum Fuel Technologies, headquartered in the Dallas-Fort Worth Metroplex, is the industry’s first complete compressed natural gas (CNG) fuel system solution for Class 6-8 vehicles.  A division of Rush Enterprises, the company officially launched in 2015 and is a vertically integrated provider of fuel system solutions, featuring state-of-the-art engineering, design and manufacturing processes, complete system installation capabilities and the industry’s most comprehensive sales, service and support network. For more information, please visit www.momentumfueltech.com.

About Cummins Inc.
Cummins Inc., a global power leader, is a corporation of complementary business segments that design, manufacture, distribute and service a broad portfolio of power solutions. The company’s products range from diesel, natural gas, electric and hybrid powertrains and powertrain-related components including filtration, aftertreatment, turbochargers, fuel systems, controls systems, air handling systems, automated transmissions, electric power generation systems, batteries, electrified power systems, hydrogen generation and fuel cell products. Headquartered in Columbus, Indiana (U.S.), since its founding in 1919, Cummins employs approximately 57,800 people committed to powering a more prosperous world through three global corporate responsibility priorities critical to healthy communities: education, environment and equality of opportunity. Cummins serves its customers online, through a network of company-owned and independent distributor locations, and through thousands of dealer locations worldwide and earned about $1.8 billion on sales of $19.8 billion in 2020. Learn more at cummins.com.

Media Contacts

Rush Enterprises

Karen S. Konecny
(830) 302-5210
[email protected]

Allison Teska
(830) 302-5243
[email protected]



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Esports Technologies Joins Russell 3000 and Russell Microcap Indexes

PR Newswire

LAS VEGAS, June 29, 2021 /PRNewswire/ — Esports Technologies, Inc. (NASDAQ: EBET), a leading global provider of advanced esports wagering products and technology, has been added to the broad-market Russell 3000 Index and the Russell Microcap Index, effective June 28, 2021.

The 33rd Annual Russell Reconstitution captures the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. FTSE Russell determines membership for its Russell US Indexes primarily by objective, market-capitalization rankings, and style attributes.

Aaron Speach, CEO of Esports Technologies, said, “We have been very pleased with the interest Esports Technologies has received from the investor community since our listing on the Nasdaq in April. Being included in the Russell U.S. indexes is yet another validation of our efforts to build shareholder value as we forge ahead changing the face of esports wagering through innovation and world-class analytics powered by our proprietary technology.”

Russell Indexes are part of FTSE Russell, a leading global index provider. They are widely used by investment managers and institutional investors as the basis for index funds and as benchmarks for active investment strategies. According to FTSE Russell, approximately $10.6 trillion in assets are benchmarked to, or invested in, products based on the Russell U.S. Indexes.

More information on the Russell indexes and their annual reconstitution is available on the FTSE Russell website.

About Esports Technologies
Esports Technologies is developing groundbreaking and engaging wagering products for esports fans and bettors around the world. Esports Technologies is one of the leading global providers of esports product, platform and marketing solutions. The company operates a licensed online gambling platform, gogawi.com, that offers real money betting on esports events and professional sports from around the world in a secure environment. The company is developing esports predictive gaming technologies that allow distribution to both customers and business partners.

CAUTIONARY STATEMENT CONCERNING FORWARD LOOKING STATEMENTS:  This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which statements involve risks and uncertainties. These statements relate to future events, future expectations, plans and prospects. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results or outcomes may prove to be materially different from the expectations expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed in the Company’s filings with the Securities and Exchange Commission, including as set forth in the “Risk Factors” section of the Company’s final prospectus, which was filed with the Securities and Exchange Commission on April 16, 2021, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. The Company does not undertake any obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/esports-technologies-joins-russell-3000-and-russell-microcap-indexes-301321585.html

SOURCE Esports Technologies, Inc.

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(PTON) Long-Term Investor Alert: Did You Acquire Peloton Before September 11, 2020? Should Management be Held Accountable for Investors Losses?

SAN DIEGO, June 29, 2021 (GLOBE NEWSWIRE) — Johnson Fistel, LLP is investigating potential claims on behalf of Peloton Interactive, Inc. (“Peloton” or the “Company”) (NASDAQ: PTON) against certain of its current and former officers and directors. 

Recently a class action lawsuit was filed in federal court against the Company on behalf of purchasers of the securities of Peloton from September 11, 2020 and May 5, 2021 (the “Class Period”).

According to the filed complaint, during the class period, Defendants issued materially false and misleading statements and/or failed to disclose that: (1) in addition to the tragic death of a child, Peloton’s Tread+ had caused a serious safety threat to children and pets as there were multiple incidents of injury to both; (2) safety was not a priority to Peloton as defendants were aware of serious injuries and death resulting from the Tread+, yet did not recall or suggest a halt of the use of the Tread+; (3) as a result of the safety concerns, the U.S. Consumer Product Safety Commission (“CPSC”) declared that the Tread+ posed a serious risk to public health and safety and urgently recommended that consumers with small children cease using the Tread+; (4) the CPSC also found a safety threat to Tread+ users if they lost their balance; and (5) as a result of the foregoing, defendants’ statements about Peloton’s business, operations, and prospects, were materially false and misleading and lacked a reasonable basis at all relevant times.


If you are a current, long-term shareholder of Peloton, holding shares before September 11, 2020, you may have standing to hold Peloton harmless from the alleged harm caused by the officers and directors of the Company by making them personally responsible. You may also be able to assist in reforming the Company’s corporate governance to prevent future wrongdoing. 

If you
are interested in learning more about the investigation, please contact lead analyst Jim Baker (


[email protected]


) at 619-814-4471. If emailing, please include a phone number.


Additionally, if you are a current, long-term shareholder of Peloton, holding shares before September 11, 2020
,


you can
 [Click here to join this action]. There is no cost or obligation to you.

About Johnson Fistel, LLP:
Johnson Fistel, LLP is a nationally recognized shareholder rights law firm with offices in California, New York and Georgia. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits. For more information about the firm and its attorneys, please visit http://www.johnsonfistel.com. Attorney advertising. Past results do not guarantee future outcomes.

Contact:
Johnson Fistel, LLP
Jim Baker, 619-814-4471
[email protected]

[Click here to join this action]



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Walmart Revolutionizes Insulin Access & Affordability for Patients With Diabetes With the Launch of the First and Only Private Brand Analog Insulin

Walmart Revolutionizes Insulin Access & Affordability for Patients With Diabetes With the Launch of the First and Only Private Brand Analog Insulin

Walmart’s exclusive ReliOn™ NovoLog® vials and FlexPens® will save customers 58% to 75% off the cash price of branded insulin products.

BENTONVILLE, Ark.–(BUSINESS WIRE)–
Walmart announced the launch of the first-ever private brand analog insulin, which will revolutionize the access and affordability to diabetes care by offering customers a significant price savings without compromising quality. Available exclusively through Walmart’s private ReliOn brand, the new offering includes analog insulin vials ($72.88) and FlexPen® ($85.88). These products will save customers1 between 58% to 75% off the cash price of branded analog insulin products, which translates to a savings of up to $101 per branded vial or $251 per package of branded FlexPens®.

The new private label ReliOn™ NovoLog® Insulin (insulin aspart) injection, manufactured by Novo Nordisk, is available in Walmart pharmacies this week, and Sam’s Club pharmacies in mid-July across the United States. ReliOn™ NovoLog® is a rapid-acting insulin analog used to control high blood sugar in adults and children with diabetes. Customers will need a prescription in order to purchase the products and should always consult with their doctor regarding their diabetes management.

“We know many people with diabetes struggle to manage the financial burden of this condition, and we are focused on helping by providing affordable solutions. We also know this is a condition that disproportionately impacts underserved populations. With ReliOn NovoLog® insulin, we’re adding a high-quality medication for diabetes to the already affordable ReliOn line of products and continuing our commitment to improve access and lowering cost of care,” said Dr. Cheryl Pegus, executive vice president, Walmart Health & Wellness.

Walmart is a destination for affordable diabetes resources, including blood glucose monitors, lancets and other diabetes management essentials in the ReliOn portfolio. Notably, the retailer’s suite of affordable diabetes products offers customers choices when it comes to their diabetes management; however, every patient is unique and may respond differently to treatment, so the ultimate treatment decision should be based on their health care provider’s recommendation.

“Diabetes often comes with high medical costs, estimated around $9,601 per person per year. We welcome all affordable solutions that make diabetes management more accessible to millions of Americans living with diabetes. We encourage everyone to ask their health care provider questions to better understand what the right and affordable treatment is for their unique medical needs,” said Tracey D. Brown, chief executive officer of the American Diabetes Association.

The ReliOn NovoLog® analog insulin offering adds to Walmart’s history of introducing innovative solutions that increase access to quality, affordable health care resources, including the industry-leading $4 generic prescription program launched more than a decade ago. For additional information about Walmart’s affordable diabetes resources, visit Walmart.com/diabetes.

1 The out-of-pocket costs patient pay for insulin depends on a variety of factors. These savings have been calculated based on patients purchasing these insulins without prescription drug insurance.

About Walmart

Walmart Inc. (NYSE: WMT) helps people around the world save money and live better – anytime and anywhere – in retail stores, online, and through their mobile devices. Each week, approximately 220 million customers and members visit approximately 10,500 stores and clubs under 48 banners in 24 countries and eCommerce websites. With fiscal year 2021 revenue of $559 billion, Walmart employs over 2.3 million associates worldwide. Walmart continues to be a leader in sustainability, corporate philanthropy and employment opportunity. Additional information about Walmart can be found by visiting corporate.walmart.com, on Facebook at facebook.com/walmart and on Twitter at twitter.com/walmart.

Indications and Usage

What is NovoLog® (insulin aspart) injection?

  • NovoLog® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information

Do not share your NovoLog® FlexPen®, NovoLog® FlexTouch®, PenFill® cartridge or PenFill® cartridge compatible insulin delivery device with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Who should not take NovoLog®?

Do not take NovoLog® if:

  • your blood sugar is too low (hypoglycemia) or you are allergic to NovoLog® or any of its ingredients.

Before taking NovoLog®, tell your health care provider about all your medical conditions including, if you are:

  • pregnant, plan to become pregnant, or are breastfeeding.
  • taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about how to manage low blood sugar.

How should I take NovoLog®?

  • Read the Instructions for Use and take exactly as directed.
  • NovoLog® starts acting fast. Eat a meal within 5 to 10 minutes after taking it.
  • Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
  • Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
  • Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
  • Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
    • Do not use the exact same spot for each injection.
    • Do not inject where the skin has pits, is thickened, or has lumps.
    • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What should I avoid while taking NovoLog®?

  • Do not drive or operate heavy machinery, until you know how NovoLog® affects you.
  • Do not drink alcohol or use medicines that contain alcohol.

What are the possible side effects of NovoLog®?

Serious side effects can lead to death, including:

Low blood sugar. Some signs and symptoms include:

  • anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache.

Your insulin dose may need to change because of:

  • weight gain or loss, increased stress, illness, or change in diet or level of physical activity.

Other common side effects may include:

  • low potassium in your blood, injection site reactions, itching, rash, serious whole body allergic reactions, skin thickening or pits at the injection site, weight gain, and swelling of your hands and feet.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please see Prescribing Information for NovoLog at https://www.novo-pi.com/novolog.pdf

ReliOn NovoLog® is a registered trademark of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2021 Novo Nordisk All rights reserved. June 2021

Marilee McInnis 800-331-0085

KEYWORDS: Arkansas United States North America

INDUSTRY KEYWORDS: Retail Health Diabetes Other Retail Discount/Variety Department Stores Pharmaceutical

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MetaBank’s Christopher Soupal Named Division President, Head of Commercial Finance

SIOUX FALLS, S.D., June 29, 2021 (GLOBE NEWSWIRE) — MetaBank®, N.A., an industry leading financial enablement company, announced the promotion of Christopher Soupal to Commercial Finance Division President. He will report to Brett Pharr, co-president and Chief Operating Officer of MetaBank.

Soupal brings more than 20 years of finance and capital management experience to the new role. He will lead all aspects of Commercial Finance, including the Crestmark and AFS/IBEX divisions as well as commercial operations.

“Chris has shown a proven ability to expand our commercial finance business into niche sectors with innovative applications of our lending products,” said Pharr. “He is a true asset to our business, our clients, and is well-deserving of this new role.”

Soupal joined Crestmark in 2014 as national sales director of the newly formed government guaranteed lending group which he grew into an industry-leading platform providing SBA and USDA loans to niche industries. Soupal was promoted to president of the Government Guaranteed Lending business unit in 2019; and in 2020, he was named head of the Equipment Finance, Vendor Finance, and Joint Ventures business units, as well as Renewable Energy lending and Product Development. In his new role, Soupal will oversee all product lines of the Commercial Finance division, including asset-based lending and accounts receivable financing through the Business Credit and Commercial Capital business units.

“In tough economic times, and in periods of prosperity, companies need partners that can provide flexible and innovative financing,” said Soupal. “I look forward to working with everyone on the team as we continue to support our clients with financial enablement services that support the growth of their businesses.”

Prior to Crestmark, Soupal was managing director for a special opportunity fund which provided creative capital solutions, in the form of debt or equity, to platforms in niche industries.

Soupal holds a bachelor’s degree in accounting from Ferris State University and has received the Executive Certificate in Leadership and Management from the University of Notre Dame’s Mendoza School of Business.

About MetaBank

®

, N.A.
MetaBank®, N.A., a national bank, is a subsidiary of Meta Financial Group, Inc.® (Nasdaq: CASH), a South Dakota-based financial holding company. MetaBank, is a financial enablement company that works to increase financial availability, choice, and opportunity for all. MetaBank strives to remove barriers that traditional institutions put in the way of financial access, and promote economic mobility by providing responsible, secure, high quality financial products that contribute to individuals and communities at the core of the real economy. Additional information can be found by visiting www.metabank.com.

Media Relations Contact
[email protected]
 
Investor Relations Contact
Brittany Kelley Elsasser
605-362-2423
[email protected]



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Moog Announces Sale of Ground Based Navigation Aids Business

Moog Announces Sale of Ground Based Navigation Aids Business

EAST AURORA, N.Y.–(BUSINESS WIRE)–
Moog Inc. (NYSE: MOG.A and MOG.B) announced today that the company has entered into a definitive agreement to sell the assets of its Navigation Aids (Navaids) business to Thales. The Navaids business represents less than 1% of Moog Inc.’s annual sales and the company does not anticipate any material charges as a result of the sale.

Navaids is engaged in the business of designing, developing, manufacturing and marketing ground and ship-based radio frequency navigation beacons and related antennas for military and civilian applications. The business is based in Salt Lake City, Utah.

The transaction is subject to regulatory review and customary closing conditions. Additional financial terms were not disclosed.

Moog Inc. is a worldwide designer, manufacturer, and integrator of precision control components and systems. Moog’s high-performance systems control military and commercial aircraft, satellites and space vehicles, launch vehicles, missiles, automated industrial machinery, marine, and medical equipment. Additional information about the Moog can be found at www.moog.com.

Additional information about Thales can be found at www.thalesgroup.com.

Cautionary Statement

Information included or incorporated by reference in this report that does not consist of historical facts, including statements accompanied by or containing words such as “may,” “will,” “should,” “believes,” “expects,” “expected,” “intends,” “plans,” “projects,” “approximate,” “estimates,” “predicts,” “potential,” “outlook,” “forecast,” “anticipates,” “presume” and “assume,” are forward-looking statements. Such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Company’s current views with respect to certain current and future events and financial performance and are not guarantees of future performance. This includes but is not limited to, the Company’s expectation and ability to pay a quarterly cash dividend on its common stock in the future, subject to the determination by the board of directors, and based on an evaluation of company earnings, financial condition and requirements, business conditions, capital allocation determinations and other factors, risks and uncertainties. The impact or occurrence of these could cause actual results to differ materially from the expected results described in the forward-looking statements. These important factors, risks and uncertainties include:

COVID-19 Pandemic Risks

  • We face various risks related to health pandemics such as the global COVID-19 pandemic, which may have material adverse consequences on our operations, financial position, cash flows, and those of our customers and suppliers.

Strategic Risks

  • We operate in highly competitive markets with competitors who may have greater resources than we possess;
  • Our new products and technology research and development efforts are substantial and may not be successful which could reduce our sales and earnings;
  • Our inability to adequately enforce and protect our intellectual property or defend against assertions of infringement could prevent or restrict our ability to compete; and
  • Our sales and earnings may be affected if we cannot identify, acquire or integrate strategic acquisitions, or as we conduct divestitures.

Market Condition Risks

  • The markets we serve are cyclical and sensitive to domestic and foreign economic conditions and events, which may cause our operating results to fluctuate;
  • We depend heavily on government contracts that may not be fully funded or may be terminated, and the failure to receive funding or the termination of one or more of these contracts could reduce our sales and increase our costs;
  • The loss of The Boeing Company as a customer or a significant reduction in sales to The Boeing Company could adversely impact our operating results; and
  • We may not realize the full amounts reflected in our backlog as revenue, which could adversely affect our future revenue and growth prospects.

Operational Risks

  • Our business operations may be adversely affected by information systems interruptions, intrusions or new software implementations;
  • We may not be able to prevent, or timely detect, issues with our products and our manufacturing processes which may adversely affect our operations and our earnings;
  • If our subcontractors or suppliers fail to perform their contractual obligations, our prime contract performance and our ability to obtain future business could be materially and adversely impacted; and
  • The failure or misuse of our products may damage our reputation, necessitate a product recall or result in claims against us that exceed our insurance coverage, thereby requiring us to pay significant damages.

Financial Risks

  • We make estimates in accounting for over-time contracts, and changes in these estimates may have significant impacts on our earnings;
  • We enter into fixed-price contracts, which could subject us to losses if we have cost overruns;
  • Our indebtedness and restrictive covenants under our credit facilities could limit our operational and financial flexibility;
  • The phase out of LIBOR may negatively impact our debt agreements and financial position, results of operations and liquidity;
  • Significant changes in discount rates, rates of return on pension assets, mortality tables and other factors could adversely affect our earnings and equity and increase our pension funding requirements;
  • A write-off of all or part of our goodwill or other intangible assets could adversely affect our operating results and net worth; and
  • Unforeseen exposure to additional income tax liabilities may affect our operating results.

Legal and Compliance Risks

  • Contracting on government programs is subject to significant regulation, including rules related to bidding, billing and accounting standards, and any false claims or non-compliance could subject us to fines, penalties or possible debarment;
  • Our operations in foreign countries expose us to political and currency risks and adverse changes in local legal and regulatory environments;
  • Government regulations could limit our ability to sell our products outside the United States and otherwise adversely affect our business;
  • We are involved in various legal proceedings, the outcome of which may be unfavorable to us; and
  • Our operations are subject to environmental laws, and complying with those laws may cause us to incur significant costs.

General Risks

  • The United Kingdom’s decision to exit the European Union may result in short-term and long-term adverse impacts on our results of operations;
  • Escalating tariffs, restrictions on imports or other trade barriers between the United States and various countries may impact our results of operations;
  • Future terror attacks, war, natural disasters or other catastrophic events beyond our control could negatively impact our business; and
  • Our performance could suffer if we cannot maintain our culture as well as attract, retain and engage our employees.

These factors are not exhaustive. New factors, risks and uncertainties may emerge from time to time that may affect the forward-looking statements made herein. Given these factors, risks and uncertainties, investors should not place undue reliance on forward-looking statements as predictive of future results. We disclaim any obligation to update the forward-looking statements made in this report.

Ann Marie Luhr

716-687-4225

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Software Technology Hardware Other Technology

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ChannelAdvisor Adopts Flexible Work Policy, Begins Office Reopening

E-commerce leader reopens two office locations in the U.S. and adopts flexible work policy, enabling employees to choose when and where they want to work

PR Newswire

RESEARCH TRIANGLE PARK, N.C., June 29, 2021 /PRNewswire/ — ChannelAdvisor Corporation (NYSE: ECOM), a leading provider of cloud-based e-commerce solutions that enable brands and retailers to increase global sales, today announced it has reopened two office locations in the U.S. after more than 15 months of operating 100% virtually, and has adopted a flexible work policy giving its employees the freedom to choose to work remotely, in-office, or a mix based on their needs.

“We have always put our employees’ health and safety first, and when we went 100% virtual in March of 2020, none of us expected that to last well over a year,” said David Spitz, ChannelAdvisor CEO. “Our team rose to the challenge, delivering outstanding results and demonstrating that we can operate effectively regardless of where employees do their work.  Many of our employees have told us they’d like to continue working remotely because of the flexibility it offers, while at the same time others look forward to returning to our offices, and so we’ve given them the option to decide what works best for them individually.  This will also give us the opportunity to expand our talent pool globally and optimize our facility costs, so it’s a win-win.”

Headquartered in North Carolina’sResearch Triangle Park, ChannelAdvisor employs approximately 800 people globally, with office locations in Denver, Berlin, Paris, London, Southend On Sea, Limerick, Madrid, and Melbourne. ChannelAdvisor continues to monitor health guidelines for all of its locations and plans to reopen other offices in accordance with local government guidelines as conditions warrant.

To explore career opportunities at ChannelAdvisor, please visit corporate Careers page at https://www.channeladvisor.com/careers/.

For more details about ChannelAdvisor, visit ChannelAdvisor’s blog, follow ChannelAdvisor on Twitter @ChannelAdvisor, like ChannelAdvisor on Facebook and connect with ChannelAdvisor on LinkedIn.

About ChannelAdvisor
ChannelAdvisor (NYSE: ECOM) is a leading multichannel commerce platform whose mission is to connect and optimize the world’s commerce. For over two decades, ChannelAdvisor has helped brands and retailers worldwide improve their online performance by expanding sales channels, connecting with consumers across the entire buying cycle, optimizing their operations for peak performance, and providing actionable analytics to improve competitiveness. Thousands of customers depend on ChannelAdvisor to securely power their e-commerce operations on channels such as Amazon, eBay, Google, Facebook, Walmart, and hundreds more. For more information, visit www.channeladvisor.com.

ChannelAdvisor Media Contact:
Tamara Gibbs
[email protected]
919-249-9798

 

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SOURCE ChannelAdvisor Corporation

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Harmony Biosciences Initiates A Phase 2 Clinical Trial In Myotonic Dystrophy

Trial to evaluate safety and efficacy of pitolisant for excessive daytime sleepiness and other non-muscular symptoms in adult patients with type 1 myotonic dystrophy

PR Newswire

PLYMOUTH MEETING, Pa., June 29, 2021 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced initiation of a Phase 2 clinical trial to evaluate the safety and efficacy of pitolisant for excessive daytime sleepiness (EDS) and other non-muscular symptoms in adult patients with type 1 myotonic dystrophy (DM1).

“In addition to the primary symptoms of myotonia and muscle weakness in patients with type 1 myotonic dystrophy, the non-muscular symptoms of excessive daytime sleepiness, fatigue, and cognitive dysfunction are very common in these patients and have a negative impact on daily functioning as much as, or more so, than the primary muscle symptoms of the disease,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “Pitolisant’s novel mechanism of action increases histamine transmission in the brain which provides the scientific rationale for its potential clinical utility for the common non-muscular symptoms in patients with DM1. We listened to the needs of patients and caregivers in the myotonic dystrophy patient community and are pleased to have initiated this Phase 2 clinical trial to assess the potential clinical benefit of pitolisant in patients with this rare neurological disease, for which there are currently no approved treatment options.”

Myotonic dystrophy is the most common form of adult-onset muscular dystrophy. It is a genetic disorder inherited in an autosomal-dominant pattern. Latest estimates suggest a prevalence of about one per 2,100 people with the genetic defect for DM1, which is the most common form of this disorder. This equates to about 160,000 people in the U.S. with the genetic defect for DM1. Estimates suggest there are 40,000 people currently diagnosed with DM1 in the U.S., with up to 90% of them reporting EDS and fatigue and over 60% of them experiencing cognitive dysfunction.

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of pitolisant in patients with DM1 ages 18 – 65 years. Approximately 135 patients will be randomized at baseline to low-dose pitolisant, high-dose pitolisant, or placebo in a 1:1:1 treatment ratio titrated over three weeks, followed by eight weeks of stable dosing. Patients who complete the randomized, controlled phase of the trial will be eligible to participate in an open-label extension phase to assess the long-term safety and effectiveness of pitolisant in patients with DM1.

The primary objective of the trial is to evaluate the effect of pitolisant compared with placebo on EDS. Secondary objectives include assessments of fatigue, specific measures of cognitive function using validated computer-based assessments, and overall disease burden utilizing a disease-specific, patient-reported outcomes instrument for DM1. Topline results are anticipated from the Phase 2 trial in the second half of 2022.

Pitolisant is marketed as WAKIX® in the U.S. for the treatment of EDS or cataplexy in adult patients with narcolepsy.

About WAKIX® (pitolisant) Tablets
WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. WAKIX has been commercially available in the U.S. since Q4 2019. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H3) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H3 receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States. 


Important Safety Information

WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation and in patients with severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment.

WAKIX prolongs the QT interval. Avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use of WAKIX in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.

The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is not recommended in patients with end-stage renal disease (ESRD).

In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash.

Please see the Full Prescribing Information for WAKIX for more information.

About Harmony Biosciences 
Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The Company was established by Paragon Biosciences, LLC, with a vision to provide novel treatment options for people living with rare neurological disorders who have unmet medical needs. For more information on Harmony, please visit the company’s website: www.harmonybiosciences.com.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our product WAKIX. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of WAKIX, pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreement with Bioprojet; the availability of favorable insurance coverage and reimbursement for WAKIX; the impact of the COVID-19 pandemic; the timing of and our ability to obtain regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; and the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony’s common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 25, 2021, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Harmony Biosciences Media Contact: 

Nancy Leone 
215-891-6046 
[email protected] 

Harmony Biosciences Investor Contact: 

Lisa Caperelli 
484-539-9736 
[email protected] 

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SOURCE Harmony Biosciences

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TRACON Pharmaceuticals Announces Orphan Drug Designation for Envafolimab in Soft Tissue Sarcoma

Application Included Clinical Trial Data from Soft Tissue Sarcoma Patients Treated with Envafolimab in Phase 1 Trials

SAN DIEGO, June 29, 2021 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to envafolimab, a novel, single-domain antibody against PD-L1, for the treatment of patients with soft tissue sarcoma following submission of an amended application that included Phase 1 clinical trial data from sarcoma patients treated with single agent envafolimab. Clinical trial data were submitted in response to an FDA request to provide data using envafolimab to treat patients with soft tissue sarcoma that demonstrated a therapeutic effect.

The Orphan Drug Designation submission for envafolimab in sarcoma included clinical data demonstrating confirmed objective partial responses by RECIST with duration of response in excess of six months, in two of five patients with refractory metastatic alveolar soft part sarcoma (ASPS) who received single agent envafolimab in Phase 1 clinical trials conducted by TRACON’s partners 3D Medicines and Alphamab Oncology. Patients with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) were not treated as part of Phase 1 trials.

“The receipt of Orphan Drug Designation is one of multiple milestones we expect this year for envafolimab, including interim efficacy data from the pivotal ENVASARC trial in the second half of 2021,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “The 40% response rate demonstrated by envafolimab in ASPS patients is similar to the 42% response rate reported by the National Cancer Institute in ASPS patients treated with the PD-L1 antibody Tecentriq, which is consistent with data in MSI-H colorectal cancer, suggesting that subcutaneously administered envafolimab is as active as approved intravenously administered PD-1 antibodies.”

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user fees and eligibility for seven years of marketing exclusivity.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of the KEYNOTE-164 clinical trial.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRACON

TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization.  In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S.  To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com.

About Alphamab Oncology

Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.

Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).

The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of an European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.

About 3D Medicines

3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated next-generation immuno-oncology drugs for cancer patients. The world’s first subcutaneous injection PD-L1 antibody Envafolimab (KN035), is currently under clinical development in the United States, China and Japan. 3D Medicines is building a pipeline targeting major indications through combination strategy, either with in-house assets or in collaboration with partners around the world. With a professional team in the China and US, 3D Medicines is capable of conducting global clinical development and registration.

Forward-Looking Statements

Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding plans to further develop envafolimab, expectations regarding the timing and scope of clinical trials and availability of clinical data, expected development and regulatory milestones and timing thereof, the potential benefits of Orphan Drug Designation, and TRACON’s business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with the COVID-19 pandemic or other pandemics; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials, initiate additional trials or seek regulatory approval of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Company Contact: Investor Contact:
Mark Wiggins Brian Ritchie
Chief Business Officer LifeSci Advisors LLC
(858) 251-3492 (212) 915-2578
[email protected] [email protected]