Zscaler Extends the Power of the Zero Trust Exchange™ Platform with Breakthrough Cybersecurity Innovations to Identify, Mitigate, and Manage Large-Scale Attacks

These New Services Transform Secure Branch Connectivity, Provide Continuous Monitoring and Threat Detection for Identity-Based Attacks, Quantify Holistic Risk, and Deliver a Seamless IT Experience

  • Zscaler Risk360™– Powerful risk quantification and visualization framework for remediating cybersecurity risk.
  • Zero Trust Branch Connectivity – Eliminates lateral threat movement by providing AI/ML-powered Zero Trust connectivity from branch sites to data centers and multicloud environments.
  • Zscaler Identity Threat Detection and Response (ITDR)™
    solution – Mitigates the risk of identity attacks with continuous visibility, risk monitoring, and threat detection.
  • ZSLogin™ feature – Streamlines administrative experience with hardened security, unified identity, and easier permissions management.

SAN JOSE, Calif. and LAS VEGAS, June 14, 2023 (GLOBE NEWSWIRE) — Zenith Live–Zscaler, Inc. (NASDAQ: ZS), the leader in cloud security, today debuted four new cybersecurity services and capabilities which further extend the power of its Zscaler Zero Trust Exchange™ cloud security platform. The innovations not only enhance the monitoring and remediation of sophisticated attacks but also deliver a fundamentally new approach to securely connecting branch offices – all while simplifying and streamlining the management process at scale for IT professionals.

Large-scale cybersecurity attacks have become increasingly sophisticated and widespread. These attacks can have a devastating impact on an organization’s reputation, financial stability, and day-to-day operations. To combat these threats, it’s essential for businesses to have a comprehensive cloud security platform that can provide real-time threat detection, automated response, and proactive risk mitigation. Processing over 300 billion transactions per day, the Zscaler platform is a fully integrated, extensible cloud security platform that provides customers with always-on intelligence that allows organizations to take a proactive approach to security, respond to threats efficiently, and optimize their security posture.

At Zenith Live Las Vegas, Zscaler unveiled the following security services and capabilities:

Zscaler Risk360 – A powerful risk quantification and visualization framework

Zscaler Risk360 helps CIOs and CISOs make informed and expedited business decisions that help reduce cyber risk. By leveraging a rich set of signals from internal and external sources within the Zscaler platform, IT and security leaders gain unparalleled visibility and actionable intelligence from more than 100 data-driven factors to enable the following:

  • Powerful Risk Quantification – Delivers real-time risk scores for all stages of cyber breaches, as well as risk visualized across four entities, including workforce, third parties, applications, and assets.
  • Intuitive Visualization and Reporting – Filters top drivers for cyber risk and anticipates financial exposure estimates, including financial remediation recommendations, with the ability to create concise board-level presentation materials.
  • Actionable Remediation – Prioritizes actionable recommendations with guided workflows to investigate and remediate the most critical issues to keep an organization secure and operations running non-stop.

Zero Trust Branch Connectivity – Redefining branch connectivity for superior security and simplified management

Zero Trust Branch Connectivity delivers simplicity, scale, and superior security, dramatically reducing recurring overhead costs associated with MPLS connections for branch locations. This fundamentally new approach to securely connecting branch offices helps eliminate risky site-to-site VPNs over SD-WANs resulting in improved user, application, and data security, lowered costs, and reduced operational complexity, all while being able to significantly accelerate M&A.

A new plug-and-play appliance features zero touch provisioning, making installs effortless. Zero Trust Branch Connectivity enables enterprises to:

  • Replace Site-to-Site VPNs and Costly MPLS Connections with Zero Trust – Securely connecting users, services, and IoT/OT devices between branches and their application stack.
  • Simplify Branch IT Operations – Providing direct-to-internet connectivity to reach cloud-based applications eliminates the need to maintain complex legacy routing and reduces infrastructure.
  • Significantly accelerate M&A and B2B – Reducing time to productivity for organizations that are bringing people and business applications together.

“Enterprises relying on site-to-site VPNs for their branch locations are experiencing increased volumes of security threats,” said Naresh Kumar, VP, Product Management, Zscaler. “Site-to-site VPNs create an entry point for lateral threat movement and lack the security benefits of a zero trust architecture. Zscaler has reimagined branch connectivity by eliminating VPNs and providing secure access via the Zscaler Zero Trust Exchange for users, servers, and devices at branch sites – all you need is a broadband connection.”

Zscaler ITDR
Solution
Mitigating identity attacks with continuous visibility, risk monitoring, and threat detection

Cybercriminals are increasingly targeting users for their identities and credentials. The Zscaler ThreatLabz annual Phishing Report found that most modern phishing attacks rely on stolen credentials. Zscaler ITDR strengthens the business’s security posture with continuous visibility into identity misconfigurations and risky permissions. With Zscaler ITDR, CISOs can:

  • Quantify Identity Risk – Track the posture of the identity attack surface with quantified risks.
  • Find Misconfigurations – Discover risky configurations like GPP password exposure, unconstrained delegation, and stale passwords that open up new attack paths.
  • Real-Time Monitoring – Get alerted to new risks and issues when configurations change.
  • Stop Privilege Escalation – Detect and stop attacks like DCSync, DCShadow, kerberoasting, and more in the event of a compromise.
  • Remediate Issues – Understand the issue, impact, and user affected. Leverage step-by-step remediation guidance along with video tutorials, scripts, and commands.

ZSLogin Feature
– Centralized login dashboard with streamlined authentication for IT processes

Zscaler makes IT Administrators’ lives easier while elevating their effectiveness by providing the following:

  • Centralized Entitlement Management – Simple way to review all entitlements across the platform and ensure administrators receive the appropriate permissions.
  • Passwordless Multi-Factor Authentication – Support for passwordless, multi-factor authentication, increasing the strength of admin authentication that is easier to use and phishing resistant.
  • Automated Administrator Identity Management – Administrator identities can be managed using SCIM to automate the creation, entitlement assignment, and revocation of privileges based on the identity data from customer identity providers.

For additional information, please visit the following pages:
Zscaler Risk360™
Zero Trust Branch Connectivity
Zscaler ITDR™

The new capabilities will be demonstrated at the 2023 Zenith Live conference. To view these innovations live on stage and replay select breakout sessions, please register for Zenith Live virtually here.

About Zscaler

Zscaler (NASDAQ: ZS) accelerates digital transformation so customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange™ platform protects thousands of customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Distributed across more than 150 data centers globally, the SSE-based Zero Trust Exchange™ platform is the world’s largest in-line cloud security platform.

Zscaler™ and the other trademarks listed at


https://www.zscaler.com/legal/trademarks


are either (i) registered trademarks or service marks or (ii) trademarks or service marks of Zscaler, Inc. in the United States and/or other countries. Any other trademarks are the properties of their respective owners.

Media Contact:

Nick Gonzalez
[email protected]

Investor Relations Contact:

Bill Choi, CFA
[email protected]

 



Zscaler Unveils Suite of Cyber Solutions Designed to Harness the Full Potential of Generative AI

Industry’s Largest Cloud Security Data Lake Enables New AI-Powered Security Controls to Detect Millions of New Attacks While Safeguarding Sensitive Data

SAN JOSE, Calif. and LAS VEGAS, June 14, 2023 (GLOBE NEWSWIRE) — Zenith Live — Zscaler, Inc. (NASDAQ: ZS), the leader in cloud security, today announced a set of advanced security solutions designed for IT and security teams to leverage the full potential of generative AI while preserving the safety of enterprises’ intellectual property and their customers’ data. By employing its vast data pool, Zscaler utilizes AI/ML or generative AI to not only predict breaches, but also recommend policies to deliver superior threat detection, prevention and response.

Delivering impactful AI-powered outcomes requires large volumes of diverse, high-quality data and a sophisticated AI engine to precisely train AI models to produce meaningful and accurate results. Zscaler’s AI advantage is the result of 15 years of expertise and leadership in developing and operating the world’s largest cloud security platform, which processes more than 300 billion daily transactions from users, IoT/OT devices, workloads and business-to-business communications. The platform’s proxy-based architecture and cloud security data lake combined with Zscaler’s large language models (LLM) for secure connectivity provide one of the most comprehensive views of an organization’s security posture while also delivering large volumes of valuable anonymized training data to continuously improve the AI models and intelligently predict breaches with precision at an unprecedented pace.

“Generative AI presents a game-changing inflection point in technology, and the organizations that have large volumes of relevant, private enterprise data to seize its potential today will emerge as leaders tomorrow,” said Jay Chaudhry, CEO, Chairman and Founder, Zscaler. “Recognizing the significance of this technology years ago, we’ve implemented AI and ML capabilities to dramatically improve multiple services from data protection to digital experience monitoring. Today, Zscaler is taking a quantum leap forward by introducing a suite of security capabilities that allow our customers to safely harness the power of new generative AI tools to predict and stop breaches.”

Zscaler’s rich suite of AI-powered security innovations helps organizations accelerate their AI transformation journeys while providing the foundation to fully capitalize on generative AI going forward.

Zscaler has delivered innovations that will help customers on their secure AI transformation journeys:

  • Data Protection for AI: Zscaler Data Loss Prevention (DLP) prevents potential data leakage and enables organizations to record and retain content, including prompts to generative AI queries and outputs of publicly available LLMs and AI applications, for security and audit purposes in their own environments.
  • AITotal™: A comprehensive risk scoring system for an exploding number of AI applications, taking into account the applications’ risk profiles and privacy policies.
  • AI Visibility
    and Access Control: A new URL category and cloud application specifically tailored for monitoring AI application usage. This innovative solution offers the versatility to establish a variety of disparate policies for different user sets and groups, granting organizations precise control over access to AI applications. By implementing cloud-based remote browser isolation, Zscaler provides an additional layer of security while restricting potentially hazardous actions, such as uploads, downloads, and cut-and-paste functions when accessing AI applications.

Zscaler has recently developed the following innovations, currently in preview, that will harness generative AI to deliver precision outcomes:

  • Security Autopilot™ with breach prediction: A proactive approach to securing data by enabling AI engines to continuously learn from changing cloud-based policies and logs. By recommending policies and performing impact analysis, Security Autopilot simplifies security operations while helping improve security posture control and preventing future breaches. This is currently piloted by ThreatLabz, Zscaler’s advanced threat research and incident response team.
  • Zscaler Navigator™: A simplified and unified natural language interface to enable customers to interact with Zscaler products and access relevant documentation details using a seamless, secure and user-friendly approach.
  • Multi-Modal DLP: Traditional DLP solutions are limited to understanding and managing text and image-based data, and the world has transitioned to a broader set of visual and audio multimedia formats. Zscaler will revolutionize the way DLP will operate by integrating generative AI and multi-modal capabilities into its DLP offerings to protect customers’ data from leakage across various media formats beyond text and images, such as video and audio formats.

To watch these innovations being announced live on stage and replay select breakout sessions, please register for Zenith Live ’23 virtually here.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact, including statements regarding our planned products and upgrades, business strategy, and plans and objectives of management for future operations of Zscaler are forward-looking statements. These statements involve known and a significant number of unknown risks, uncertainties, assumptions and other factors that could cause results to differ materially from statements made in this message, including any performance or achievements expressed or implied by the forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results or outcomes to differ materially from those contained in any forward-looking statements we may make. Additional risks and uncertainties that could affect our financial and operating results are included in our most recent filings with the Securities and Exchange Commission. You can locate these reports though our website at http://ir.zscaler.com or on the SEC website at www.sec.gov.

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “continues,” “contemplate,” “could,” “estimate,” “expect,” “explore” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these terms or other similar words. Zscaler based these forward-looking statements largely on its current expectations and projections about future events that it believes may affect its business. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements. All forward-looking statements in this message are based on information available to us as of the date hereof, and we do not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made.

About Zscaler

Zscaler (NASDAQ: ZS) accelerates digital transformation so customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange protects thousands of customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Distributed across more than 150 data centers globally, the SSE-based Zero Trust Exchange is the world’s largest in-line cloud security platform.

Zscaler™ and the other trademarks listed at


https://www.zscaler.com/legal/trademarks


are either (i) registered trademarks or service marks or (ii) trademarks or service marks of Zscaler, Inc. in the United States and/or other countries. Any other trademarks are the properties of their respective owners.

Media Contact:

Pavel Radda
[email protected] 

Investor Relations Contact:

Bill Choi, CFA
[email protected] 



Coursera Global Skills Report 2023: U.S. Learners Prioritize STEM Education and Human Skills Amid Changing Job Expectations

Coursera Global Skills Report 2023: U.S. Learners Prioritize STEM Education and Human Skills Amid Changing Job Expectations

Midwestern States Emerge as Business and Technology Talent Hub

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–
The rapid pace of globalization, digital transformation, and AI advancements have created a renewed demand for digital and human skills among U.S. learners, according to Coursera’s latest annual Global Skills Report. The fifth edition of the report also highlights the increasing demand for STEM education and industry micro-credentials.

“The rise of digital jobs and remote work is creating unprecedented opportunities for local talent to participate in the global workforce if they have the right skills and credentials,” said Jeff Maggioncalda, Coursera CEO. “This report provides actionable insights on the changing skills landscape and the rapidly increasing availability of skilled talent around the world to help institutions inform their human capital and workforce strategies.”

Key U.S. findings include:

  • The 22 million U.S. registered learners on Coursera represent 8.4% of the country’s working-age population. In the U.S., the average learner age is 35, with 41% using mobile learning and women representing over half (51%) of learners. The US has the highest demand for industry micro-credentials of any country globally, with learners amassing 1.3 million enrollments in entry-level Professional Certificates, in the last year (a 22% increase). The growing demand underscores the trend that individuals are increasingly turning to online micro-credentials to secure new jobs and advance their careers.
  • STEM training demand rises alongside U.S. job growth. The CHIPS & Science Act calls for pathways for more Americans to enter STEM fields as the demand for talent outpaces supply. The U.S. Bureau of Labor Statistics projects that the U.S. will need over 1 million more STEM professionals than it is currently on track to produce over the next decade. STEM course enrollments from U.S learners grew to 4.6 million as of March 31, 2023, a 22% increase from the previous year, with 41% of enrollments from women. Enrollments in entry-level STEM Professional Certificates grew 47% to 740,000 enrollments in the same timeframe.
  • U.S. learners are prioritizing critical human skills like leadership, collaboration, change management, and conflict resolution more than learners in other countries. Cumulatively these topics have had 1.9 million enrollments. The demand for human skills underscores a growing recognition from individuals and organizations that workforce agility is critical to succeeding in a world characterized by relentless change.
  • The Midwest emerges as a top business talent hub, with Illinois rankings outpacing coastal states. The Midwest represents four out of five leading states for business skill proficiency, including Illinois (1), Wisconsin (2), Indiana (3), Michigan (4), and Maine (5). Illinois ranks first for skill proficiency in business and data science, outranking major coastal hot spots, including New York and California. Florida is rising as a tech talent hub, tied with California as the top-ranking state across technology skill scores.

Overall, U.S. learners perform best in business skills, earning the highest proficiency rankings for accounting (90%), sales (70%), and marketing (74%). However, foundational data science skills present the greatest opportunity for investment, with mathematics, probability, and statistics among the lowest ranking proficiency scores.

With over 120 million learners, 7,000 institutions, and 5,400 courses from 300 of the world’s top universities and industry partners, Coursera has one of the largest data sets for identifying and measuring skill trends. In the Global Skills Report, 100 countries are ranked against one another, with percentile rankings attributed to each skill proficiency. A country that shows 100% skills proficiency ranks at the top of the 100+ countries, and a country with 0% is at the bottom.

To download the full report, visit coursera.org/skills-reports/global.

About Coursera

Coursera was launched in 2012 by two Stanford Computer Science professors, Andrew Ng and Daphne Koller, with a mission to provide universal access to world-class learning. It is now one of the largest online learning platforms in the world, with 124 million registered learners as of March 31, 2023. Coursera partners with over 300 leading university and industry partners to offer a broad catalog of content and credentials, including courses, Specializations, Professional Certificates, Guided Projects, and bachelor’s and master’s degrees. Institutions around the world use Coursera to upskill and reskill their employees, citizens, and students in fields such as data science, technology, and business. Coursera became a Delaware public benefit corporation and a B Corp in February 2021.

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Technology Mobile/Wireless Business Human Resources Training Professional Services Continuing Artificial Intelligence University Software Education Data Analytics Internet Hardware

MEDIA:

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Gilead to Present Latest Liver Disease Research at the European Association for the Study of the Liver (EASL) Congress 2023

Gilead to Present Latest Liver Disease Research at the European Association for the Study of the Liver (EASL) Congress 2023

6 Oral Presentations and 28 Posters Across HDV, HCV, HBV, NASH and PSC Highlight Progress and Gilead’s Leadership in Addressing Unmet Needs for People Affected by Liver Disease

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Gilead Sciences, Inc. (Nasdaq:GILD) today announced new data to be presented at the European Association for the Study of the Liver (EASL) Congress 2023, June 21-24, 2023. Key findings from more than 70 presentations will include Week 96 data from the pivotal Phase 3 study of Hepcludex® (bulevirtide) evaluating the efficacy and safety for the treatment of hepatitis delta virus (HDV) and late-breaking data on the impact of continued treatment with bulevirtide. Gilead will also present real-world data on efforts that support the World Health Organization’s (WHO) goal of eliminating viral hepatitis as a public health threat by 2030 and long-term results from ongoing studies of Vemlidy® (tenofovir alafenamide) in chronic hepatitis B (HBV). Results from ongoing research in liver fibrosis from across nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) will also be presented.

“We are pleased to share our latest viral hepatitis and liver fibrosis data at EASL 2023 as we strive to support the needs of patients and help achieve the WHO goal of viral hepatitis elimination by 2030,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “Despite the significant progress that has been made, considerable challenges still remain for those living with liver disease. We are proud to be able to share our ongoing research and efforts to help address these needs.”

Advancing Treatments in HDV and HBV

As a leader in hepatitis delta research, Gilead will present 15 abstracts in HDV, including the latest Week 96 data from the pivotal Phase 3 MYR301 study of bulevirtide in chronic HDV patients (OS-068). Data on the improved virologic and biochemical response with continued treatment with bulevirtide for 96 weeks in non- and partial-responders (LBP-20) will also be presented. These data reinforce the efficacy and safety of bulevirtide and demonstrate the benefits of continued treatment for people living with HDV, the most severe form of viral hepatitis.

Real-world data from a retrospective observational cohort study will be presented, highlighting a higher prevalence of comorbidities at baseline and an increased risk of liver-related outcomes for people with HDV/HBV co-infection compared to individuals with HBV mono-infection (WED-116). Data will also be presented on the impact of HDV on fatigue and health-related quality of life among untreated individuals living with HDV (FRI-124) highlighting the significant disease burden and high associated healthcare-related costs.

In HBV, final 8-year safety (SAT-153) and efficacy (OS-067) data will be presented from the two global Phase 3 studies (Study 108 and Study 110) evaluating long-term outcomes in chronic HBV patients treated with tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) who subsequently switched to TAF.

Helping to Achieve the WHO Goal of Hepatitis Elimination

Gilead will present nine hepatitis C (HCV) related abstracts that reinforce the need for tailored approaches for screening, linkage to care and management of HCV, and highlight the real-world impact of potential drug-drug interactions (DDIs) to optimize treatment decisions and decrease healthcare resource utilization (HCRU) and costs.

Data include results on optimizing screening and linkage to care which is critical on the path to hepatitis elimination. Results from an initiative using machine learning to improve HCV screening and linkage to care will be presented and have been selected as part of the ‘Scientific Highlights’ (OS-091). Findings from a UK pilot project (FRI-182) conducted in partnership with Practice Plus Group will be presented, with the aim to improve screening and linkage to care for blood borne viruses in Immigration Removal Centers.

Real-world data from the U.S. will be presented (THU-218) evaluating DDI comedication use in people initiating treatment with pangenotypic direct-acting antivirals (DAAs). Among patients with baseline DDI-related comedication use, those initiating treatment with Epclusa® (sofosbuvir/velpatasvir) were less likely to discontinue their DDI-related comedication prior to DAA initiation than patients initiating treatment with glecaprevir/pibrentasvir. Additional research is needed to assess real-world consequences of potential DDIs.

Ongoing Research in Liver Fibrosis

Gilead will present data on the effects of antidiabetic and lipid-lowering therapies on liver fibrosis biomarkers (OS-085) building further insights on the impact of these drugs in people with different genetic predisposition to NASH. Additionally, data will be presented on the association between non-invasive SomaSignal™ NASH scores and histologic assessments obtained from liver biopsy (SAT-438), advancing the potential to assess treatment responses in future NASH trials.

In PSC, Gilead will present data from the Phase 3 PRIMIS study (GS-US-428-4194) of investigational cilofexor (LBO-03). Additional presentations focus on the substantial impact on healthcare resource utilization of PSC (SAT-115) and the contribution of the NOTCH signaling pathway to the progression of fibrosis in liver tissue from PSC patients (FRI-360).

Key Abstracts at EASL 2023:

Abstract

Abstract Title

HDV

OS-068

Efficacy and safety at 96 weeks of bulevirtide 2 mg or 10 mg monotherapy for chronic hepatitis D: results from an interim analysis of a Phase 3 randomized study

LBP-20

Continued treatment of early nonresponder or partial virologic responders with monotherapy in patients with chronic hepatitis D through week 96 leads to improvement in virologic & biochemical responses

WED-116

A retrospective observational cohort study of liver-related events among individuals with hepatitis B virus infection with and without hepatitis delta virus infection

FRI-124

The impact of hepatitis D virus infection on health-related quality of life and fatigue in patients untreated for HDV: descriptive results from a cross-sectional study across Italy, Germany, Spain and the US

HCV

OS-091

Finding undiagnosed hepatitis C cases: using machine learning to identify clinical attributes and social determinants of health to improve the screening-to-diagnosis ratio and improve efficiency and linkage to care

THU-218

Evaluating utilization and management of comedications with potential for drug-drug interactions among patients with chronic hepatitis C initiating treatment with sofosbuvir/velpatasvir or glecaprevir/pibrentasvir

FRI-182

Improving blood borne virus screening in immigration removal centres in the UK

HBV

OS-067

Long-term efficacy of tenofovir alafenamide in HBeAg-positive and -negative chronic hepatitis B patients treated for up to 8 years in 2 Phase 3 studies

SAT-153

Long term safety profile of tenofovir alafenamide in chronic hepatitis B patients; final 8-year results of 2 Phase 3 studies

Liver Fibrosis

OS-085

Use of antidiabetic and lipid-lowering medications associated with lower scores of liver fibrosis biomarkers in Nonalcoholic Steatohepatitis (NASH) patients

SAT-438

Utility of SomaSignal™ panels for drug response and monitoring disease progression in patients with advanced fibrosis due to non-alcoholic steatohepatitis

SAT-115

Healthcare resource use and costs among patients with primary sclerosing cholangitis in Sweden – a retrospective population-based cohort study

FRI-360

Elevated JAG1-NOTCH signaling is associated with fibrosis stages in patients with PSC

LBO-03

A Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of cilofexor in patients with non-cirrhotic primary sclerosing cholangitis (PRIMIS)

For more information, including a complete list of abstract titles being presented at the meeting, please visit https://www.easlcongress.eu/wp-content/uploads/2023/04/Accepted-abstracts_EASL-Congress-2023.pdf.

In April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting full Marketing Authorization (MA) for bulevirtide for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted conditional MA in July 2020 to provide people living with HDV urgent access to treatment. In the U.S. and outside of the European Economic Area, bulevirtide is an investigational agent. In these regions, health authorities have not established the safety and efficacy of bulevirtide.

Cilofexor and selgantolimod are investigational compounds and are not approved by the FDA or any other regulatory authority; their safety and efficacy have not been established.

Please see below for the U.S. Indications and Important Safety Information, including BOXED WARNINGS, for Epclusa and Vemlidy.

U.S. Important Safety Information And Indication for Epclusa

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

Contraindications

  • If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions

  • Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.
  • Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers and/or Moderate to Strong Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John’s wort and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

Adverse Reactions

  • The most common adverse reactions (≥10%, all grades) with EPCLUSA in adults and pediatric patients 6 years of age and older were headache and fatigue; and when used with RBV in adults with decompensated cirrhosis were fatigue, anemia, nausea, headache, insomnia and diarrhea. The most common adverse reactions (≥10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting up the drug.

Drug Interactions

  • Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan.

  • Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.

Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments.

Indication

EPCLUSA is indicated for the treatment of adult and pediatric patients 3 years of age and older with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis.

U.S. Important Safety Information and Indication for Vemlidy

BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Warnings and Precautions

  • Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.
  • New Onset or Worsening Renal Impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with TAF-containing products. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration.
  • Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse Reactions

Most common adverse reactions (incidence ≥5%; all grades) in all clinical studies through week 144 were headache, upper respiratory tract infection, abdominal pain, cough, back pain, arthralgia, fatigue, nausea, diarrhea, dyspepsia, and pyrexia.

Drug Interactions

  • Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.

  • Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.

Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

  • Testing Prior to Initiation: HIV infection.
  • Prior to or When Initiating, and During Treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
  • Dosage: 1 tablet taken once daily with food.
  • Renal Impairment: Not recommended in patients with end stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment. No data are available to make dose recommendations in pediatric patients with renal impairment.
  • Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

Indication

VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 12 years of age and older with compensated liver disease.

About HDV

Chronic hepatitis delta virus (HDV) is the most severe form of viral hepatitis and can have mortality rates as high as 50% within five years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have hepatitis B virus (HBV). It is estimated that at least 12 million people worldwide are likely currently co-infected with HDV and HBV. HDV co-infection is associated with a faster progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death. In the U.S. and Europe, there are approximately more than 230,000 people living with HDV; however, it remains underdiagnosed globally.

About Gilead Sciences in Liver Disease

For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease. The company has transformed the trajectory of many liver diseases through a relentless pursuit of innovation and pioneering access programs to bring meaningful therapies to people around the world. More work is required, and Gilead is committed to advancing innovative therapeutics to address the most pressing unmet needs in liver disease and overcoming barriers to better care.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Epclusa, Vemlidy, Hepcludex (bulevirtide), cilofexor and selgantolimod; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the European Commission may not grant full Marketing Authorization of Hepcludex, and the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV, and the risk that any such approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Hepcludex, Epclusa, Vemlidy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Jacquie Ross, Investors

[email protected]

Meaghan Smith, Media

[email protected]

KEYWORDS: Europe United States North America California

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical General Health Health Hospitals Clinical Trials

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Kymera Therapeutics’ STAT3 Degrader KT-333 and IRAKIMiD Degrader KT-413 Demonstrate Desired Target Knockdown and Safety with Continued Dose Escalation in Ongoing Phase I Clinical Trials

Data shared today on PK/PD and safety from additional KT-333 and KT-413 patient dose escalation cohorts show target knockdown at or near levels associated with clinical efficacy in preclinical tumor models

N
o dose limiting toxicities observed in either program        

KT-333 data will be presented in a poster session at the
International Conference on Malignant Lymphoma (ICML)
on June 16

WATERTOWN, Mass., June 14, 2023 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today shared new data demonstrating that its oncology programs KT-333 and KT-413 continue to demonstrate robust dose-dependent target knockdown in ongoing Phase 1a dose escalation clinical trials, with no dose limiting toxicities (DLTs) observed. The KT-333 clinical data will be presented in a poster at the International Conference on Malignant Lymphoma (ICML) on June 16, 2023, in Lugano, Switzerland.

“Our focus this year for our ongoing KT-333 and KT-413 clinical trials will be to analyze the degradation profiles and safety of these first-in-class mechanisms and evaluate their biological and clinical impact in the appropriate patient populations. We continue to see encouraging data from the trials’ dose escalation phases as they show fidelity of PK/PD translation from preclinical models to patients, demonstrating target degradation without any dose limiting toxicities observed, and approaching levels we believe are needed to achieve antitumor activity,” said Nello Mainolfi, Founder, President and CEO, Kymera Therapeutics. “We are proud and excited to be the first company to have shown clinical translation of our degraders’ profiles across three programs and across multiple diseases and indications. We look forward to sharing additional data evaluating antitumor activity in the target patient populations for these programs later this year.”

KT-333 STAT3 Program

KT-333 is designed as a potent degrader of STAT3, a transcriptional regulator that has been linked to numerous cancers as well as to inflammatory and autoimmune diseases. KT-333 is being developed for the treatment of STAT3-dependent hematological malignancies and solid tumors. The Phase 1 clinical trial of KT-333 is designed to evaluate the safety, tolerability, PK/PD and clinical activity of KT-333 dosed weekly on 28-day cycles in adult patients with relapsed and/or refractory lymphomas, leukemias and solid tumors. 

As of the data cut-off of May 1, 2023, thirteen patients received a mean of five doses across the first four dose levels (DL1-4) of the trial, including patients with solid tumors as well as peripheral and cutaneous T-cell lymphoma. This includes 2 patients enrolled in DL4, which remains open to accrual. As of the cut-off date, there were no AEs reported in DL4. Data reported from the 3 completed dose levels (DL1-3) found:

  • Plasma exposure increased with dose, reaching levels close to those predicted to be efficacious.
  • KT-333 demonstrated dose-dependent STAT3 degradation with up to 88% mean maximum reduction in peripheral blood mononuclear cells (PBMCs), with evidence of STAT3 pathway inhibition and downregulation of inflammatory biomarkers in peripheral blood. Degradation profiles at DL-3 were near levels of knockdown that led to profound antitumor activity in preclinical models.
  • No DLTs were observed in the study.

KT-333 Poster Presentation at ICML

Title: Phase 1 Trial of KT-333, a STAT3 Degrader, in Patients with Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia and Solid Tumors
Presentation ID: 424
Session Time: 12:30 p.m. – 1:00 p.m. CEST, June 16, 2023
Location: Marquee Parco Ciani
Presenter: Dr. Adam Olszewski, Lifespan Cancer Institute, Rhode Island Hospital

KT-413 IRAKIMiD Program

KT-413 is a novel heterobifunctional degrader targeting both IRAK4 and the IMiD substrates Ikaros and Aiolos. Designed to address both the IL-1R/TLR and Type 1 IFN pathways synergistically with a single molecule, KT-413 is in development for the treatment of MYD88-mutant B-cell malignancies. The Phase 1 clinical trial of KT-413 is designed to evaluate the safety, tolerability, PK/PD and clinical activity of KT-413 administered as an IV infusion once every 3 weeks to adult patients with relapsed and/or refractory B-cell non-Hodgkin’s lymphomas.

As of the data cut-off of June 1, 2023, DL1-3 have been completed and DL4 remains open to accrual. Five patients were treated across DL1-4 and received a mean of 2.2 doses. These included patients with transformed activated B-cell-like (ABC)-diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, marginal zone lymphoma, and plasmablastic lymphoma, all of whom were MYD88 wild-type except for one who had a MYD88 gain-of-function mutation. Data reported across the 4 DLs through the cut-off date show:

  • Plasma exposure increased with dose, reaching levels close to those predicted to be efficacious.
  • KT-413 achieved dose-dependent degradation of up to 70% IRAK4 and 96-100% Ikaros and Aiolos in PBMC after a single dose. Degradation profiles at DL3-4 were consistent with knockdown levels associated with profound antitumor activity in preclinical models of MYD88 mutant lymphomas.
  • No DLTs or drug-related neutropenia were observed in the study.

Updated data with more details for both programs can be found in the Kymera corporate presentation on the Company’s website, as well as the KT-333 ICML poster presentation.

About Kymera Therapeutics

Kymera is a biopharmaceutical company pioneering the field of targeted protein degradation, a transformative approach to address disease targets and pathways inaccessible with conventional therapeutics. Kymera’s Pegasus platform is a powerful drug discovery engine, advancing novel small molecule programs designed to harness the body’s innate protein recycling machinery to degrade dysregulated, disease-causing proteins. With a focus on undrugged nodes in validated pathways, Kymera is advancing a pipeline of novel therapeutic candidates designed to address the most promising targets and provide patients with more effective treatments. Kymera’s initial programs target IRAK4, IRAKIMiD, and STAT3 within the IL-1R/TLR or JAK/STAT pathways, and the MDM2 oncoprotein, providing the opportunity to treat patients with a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors.

Founded in 2016, Kymera is headquartered in Watertown, Mass. Kymera has been named a “Fierce 15” company by Fierce Biotech and has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston’s top workplaces. For more information about our people, science, and pipeline, please visit www.kymeratx.com or follow us on Twitter or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements by Kymera Therapeutics regarding its: strategy, business plans and objectives for the IRAKIMiD and STAT3 degrader programs; plans and timelines for the preclinical and clinical development of its product candidates, including the therapeutic potential, clinical benefits and safety thereof; expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our current and future preclinical studies and clinical trials, supply chain, strategy and future operations; the delay of any current and future preclinical studies or clinical trials or the development of Kymera Therapeutics’ drug candidates; the risk that the results of current preclinical studies and clinical trials may not be predictive of future results in connection with current or future preclinical and clinical trials, including those for KT-474, KT-333, KT-413 and KT-253; Kymera Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Kymera Therapeutics’ planned interactions with regulatory authorities; obtaining, maintaining and protecting its intellectual property; and Kymera Therapeutics’ relationships with its existing and future collaboration partners. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 filed on May 4, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Kymera Therapeutics’ subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Kymera Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Kymera Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Contact: 

Bruce Jacobs 
Chief Financial Officer 
[email protected] 
857-285-5300 

 

Chris Brinzey 
Managing Director, Westwicke 
[email protected] 
339-970-2843 

Media Contact: 

Todd Cooper 
Senior Vice President, Corporate Affairs 
[email protected] 
857-285-5300 

 



NextDecade Announces Framework Agreements with Global Infrastructure Partners and TotalEnergies to Support the Development of the Rio Grande LNG Project

NextDecade Announces Framework Agreements with Global Infrastructure Partners and TotalEnergies to Support the Development of the Rio Grande LNG Project

 

HOUSTON–(BUSINESS WIRE)–
NextDecade Corporation (NextDecade) (NASDAQ: NEXT) today announced that it has entered into framework agreements with Global Infrastructure Partners (GIP) and TotalEnergies (NYSE: TTE) to enable the final investment decision (FID) for the Rio Grande LNG project (RGLNG) Trains 1, 2 and 3 (Phase 1) and to provide momentum for the further development of RGLNG Train 4 and Train 5.

NextDecade, GIP and TotalEnergies have entered into framework agreements whereby GIP would become a majority investor in Phase 1, and TotalEnergies would become a 16.67% investor, both subject to execution of definitive documentation and FID. The agreements are expected to further provide GIP and TotalEnergies options to invest in RGLNG Train 4 and Train 5 and options to invest in the planned carbon capture and sequestration (CCS) project at RGLNG.

In addition, TotalEnergies has agreed to purchase 5.4 million tonnes per annum (MTPA) of LNG from Phase 1 for 20 years on a free on board (FOB) basis indexed to Henry Hub and has options to purchase LNG from Train 4 and Train 5. TotalEnergies has also agreed to acquire in three tranches a 17.5% common stock position in NextDecade for an aggregate purchase price of $219.4 million.

The first tranche of $40 million of NextDecade common stock was issued and sold today at $4.9837 per share. The second tranche of $110 million will be issued and sold at the same price after FID on Phase 1. The third tranche will be issued and sold in an amount such that the combined stock purchases equal 17.5% of the outstanding common stock of NextDecade after the closing of the third tranche. The issuance and sale of the common stock in the third tranche will be conditioned on the approval of NextDecade shareholders. Based on current estimates, NextDecade expects to sell approximately 45.1 million shares of common stock in the aggregate to TotalEnergies at an average price per share of approximately $4.86.

“This announcement marks a momentous milestone for NextDecade,” said Matt Schatzman, NextDecade Chairman and Chief Executive Officer. “We are excited to work with GIP and TotalEnergies on RGLNG and our proposed CCS project at RGLNG. We are also eager to grow our partnership with GIP and TotalEnergies focusing on our shared vision to reduce carbon emissions in the energy sector.”

“With the world increasingly moving toward sustainable solutions, this partnership among GIP, TotalEnergies and NextDecade reinforces our shared commitment to helping lead the transition and shaping of the future of energy,” said Bayo Ogunlesi, Chairman and Chief Executive Officer of Global Infrastructure Partners. “This venture marks a critical step in displacing coal usage and upholds GIP’s commitment to promoting decarbonization, energy security and energy affordability. Our shared vision with TotalEnergies and NextDecade, combined with our capabilities, will undoubtedly help catalyze the development of cleaner energy.”

“We are delighted to join forces with NextDecade and GIP on the development of this new US LNG project, for which TotalEnergies shall leverage its extensive experience in LNG and technical expertise in major industrial project development,” said Patrick Pouyanné, Chairman and CEO of TotalEnergies. “Our involvement in this project will enhance our LNG capacity by 5.4 MTPA strengthening our ability to ensure Europe’s gas supply security and to provide Asian customers with an alternative fuel that emits half as much as coal.”

NextDecade continues to target FID on Phase 1 by the end of the second quarter with FIDs of its remaining trains to follow thereafter.

About NextDecade Corporation

NextDecade Corporation is an energy company accelerating the path to a net-zero future. Leading innovation in more sustainable LNG and carbon capture solutions, NextDecade is committed to providing the world access to cleaner energy. Through our wholly owned subsidiaries Rio Grande LNG and NEXT Carbon Solutions, we are developing a 27 MTPA LNG export facility in South Texas along with one of the largest carbon capture and storage (CCS) projects in North America. We are also working with third-party customers around the world to deploy our proprietary processes to lower the cost of carbon capture and storage and reduce CO2 emissions at their industrial-scale facilities. NextDecade’s common stock is listed on the Nasdaq Stock Market under the symbol “NEXT.” NextDecade is headquartered in Houston, Texas. For more information, please visit www.next-decade.com.

About Global Infrastructure Partners (GIP)

GIP is a leading independent infrastructure fund manager that makes equity and debt investments in infrastructure assets and businesses. GIP targets investments in the energy, transport, digital infrastructure, and water/waste sectors in both OECD and select emerging market countries. Headquartered in New York, GIP operates out of 10 offices: New York, London, Stamford, Sydney, Melbourne, Brisbane, Delhi, Singapore and Hong Kong. GIP manages c. US $100 billion for its investors. GIP’s portfolio companies have combined annual revenues of c. US $80 billion and employ over 100,000 people. For more information, visit www.global-infra.com.

About TotalEnergies

TotalEnergies is a global multi-energy company that produces and markets energies: oil and biofuels, natural gas and green gases, renewables and electricity. Our more than 100,000 employees are committed to energy that is ever more affordable, cleaner, more reliable and accessible to as many people as possible. Active in nearly 130 countries, TotalEnergies puts sustainable development in all its dimensions at the heart of its projects and operations to contribute to the well-being of people.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of U.S. federal securities laws. The words “anticipate,” “contemplate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “might,” “will,” “would,” “could,” “should,” “can have,” “likely,” “continue,” “design,” “assume,” “budget,” “guidance,” and “forecast” and other words and terms of similar expressions are intended to identify forward-looking statements, and these statements may relate to the business of NextDecade and its subsidiaries. These statements have been based on assumptions and analysis made by NextDecade in light of current expectations, perceptions of historical trends, current conditions and projections about future events and trends and involve a number of known and unknown risks, which may cause actual results to differ materially from expectations expressed or implied in the forward-looking statements. These risks include the execution of definitive documentation in respect of equity investments by GIP and TotalEnergies in Phase 1; NextDecade’s progress in the development of its LNG liquefaction and export projects and CCS projects and the timing of that progress; the timing of achieving a final investment decision on the Rio Grande LNG terminal (the “Terminal”); reliance on third-party contractors to successfully complete the Terminal, the pipeline to supply gas to the Terminal and any CCS projects; ability to develop NCS’ business though implementation of CCS projects; ability to secure additional debt and equity financing in the future to complete the Terminal and CCS projects on commercially acceptable terms; accuracy of estimated costs for the Terminal and CCS projects; ability to achieve operational characteristics of the Terminal and CCS projects, when completed, including liquefaction capacities and amount of CO2 captured and stored, and any differences in such operational characteristics from expectations; development risks, operational hazards and regulatory approvals applicable to NextDecade’s development, construction and operation activities and those of its third-party contractors and counterparties; technological innovation which may lessen NextDecade’s anticipated competitive advantage or demand for its offerings; global demand for and price of LNG; availability of LNG vessels worldwide; changes in legislation and regulations relating to the LNG and CCS industries, including environmental laws and regulations that impose significant compliance costs and liabilities; scope of implementation of carbon pricing regimes aimed at reducing greenhouse gas emissions; global development and maturation of emissions reduction credit markets; adverse changes to existing or proposed carbon tax incentive regimes; global pandemics, including the 2019 novel coronavirus pandemic, the Russia-Ukraine conflict, other sources of volatility in the energy markets and their impact on NextDecade’s business and operating results, including any disruptions in its operations or development of the Terminal and the health and safety of its employees, and on its customers, the global economy and the demand for LNG; risks related to doing business in and having counterparties in foreign countries; NextDecade’s ability to maintain the listing of our securities on the Nasdaq Capital Market or another securities exchange or quotation medium; changes adversely affecting the businesses in which NextDecade is engaged; management of growth; general economic conditions; ability to generate cash; and the result of future financing efforts and applications for customary tax incentives; and other matters discussed in the “Risk Factors” section of NextDecade’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission. Additionally, any development of the Terminal or CCS projects remains contingent upon completing required commercial agreements, securing all financing commitments and potential tax incentives, achieving other customary conditions and making a final investment decision to proceed. The forward-looking statements in this press release speak as of the date of this release. Although NextDecade believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that the expectations will prove to be correct. NextDecade may from time to time voluntarily update its prior forward-looking statements, however, it disclaims any commitment to do so except as required by securities laws.

Global Infrastructure Partners (GIP)

Media: [email protected]

TotalEnergies

Media Relations: +33 (0)1 47 44 46 99 l [email protected] l @TotalEnergiesPR

Investor Relations: +33 (0)1 47 44 46 46 l [email protected]

NextDecade Corporation

INVESTORS

[email protected]

MEDIA

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KEYWORDS: Africa United States North America Asia Pacific Middle East Europe Texas

INDUSTRY KEYWORDS: Environment Oil/Gas Sustainability Alternative Energy Green Technology Energy

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First Solar Announces Limited Production Run of World’s First Bifacial Thin Film Photovoltaic Module

First Solar Announces Limited Production Run of World’s First Bifacial Thin Film Photovoltaic Module

Pre-commercial version of first alternative to bifacial crystalline silicon technology makes Intersolar Europe debut

TEMPE, Ariz.–(BUSINESS WIRE)–First Solar, Inc. (NASDAQ: FSLR) today announced a limited production run of the world’s first bifacial solar panel utilizing an advanced thin film semiconductor. A fully functional pre-commercial Series 6 Plus Bifacial photovoltaic (PV) module will make its industry debut at Intersolar Europe in Munich, Germany and will be on display at First Solar’s booth (#520) in Hall A1 from June 14 to 17, 2023.

The module, which is undergoing field and laboratory testing, builds on the track record of First Solar’s successful Series 6 monofacial module platform. The module features an innovative transparent back contact, pioneered by First Solar’s research and development (R&D) teams, which, in addition to enabling bifacial energy gain, allows infrared wavelengths of light to pass through rather than be absorbed as heat, and is expected to lower the operational temperature of the bifacial module and result in a higher specific energy yield.

“This module combines the quality, sustainability, reliability, and long-term performance of our Series 6 Plus platform with our first increment of bifaciality,” said Pat Buehler, chief product officer, First Solar. “Once commercialized, we expect Series 6 Plus Bifacial to represent the first real alternative to crystalline silicon-based bifacial technology, effectively combining bifaciality with the industry’s best warranted degradation rate, CdTe thin film’s ability to deliver more energy per nameplate watt, best-in-class reliability and durability, and innovative module design.”

Series 6 Plus monofacial module features an industry-best 0.3 percent warranted degradation rate, superior temperature coefficient, spectral response, and shading behavior, and an anti-reflective coating to enhance energy production. Moreover, unlike crystalline silicon (c-Si) panels, First Solar’s Series 6 Plus module does not experience losses from Light Induced Degradation (LID) and Light and elevated Temperature Induced Degradation (LeTID). The module is manufactured under one roof with 100 percent traceable quality assurance, exceeding International Electrotechnical Commission (IEC) standards in high temperature, high humidity, and extreme desert and coastal applications.

In October 2022, First Solar announced that it would construct a new R&D innovation center in Perrysburg, Ohio. The facility, representing an investment of approximately $370 million, is believed to be the first of its scale in the Western Hemisphere and is expected to accelerate the development and production of advanced thin film PV. Scheduled to be completed in 2024, the new R&D center will be located near First Solar’s existing Perrysburg manufacturing facility, covering an area of approximately 1.3 million square feet. It will feature a high-tech pilot manufacturing line allowing for the production of full sized prototypes of thin film and tandem PV modules.

About First Solar, Inc.

First Solar is a leading American solar technology company and global provider of responsibly produced eco-efficient solar modules advancing the fight against climate change. Developed at R&D labs in California and Ohio, the company’s advanced thin film photovoltaic (PV) modules represent the next generation of solar technologies, providing a competitive, high-performance, lower-carbon alternative to conventional crystalline silicon PV panels. From raw material sourcing and manufacturing through end-of-life module recycling, First Solar’s approach to technology embodies sustainability and a responsibility towards people and the planet. For more information, please visit www.firstsolar.com.

For First Solar Investors

This release contains forward-looking statements, which are made pursuant to safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to statements concerning First Solar’s expectation that 1) the back contact will lower the operational temperature of the bifacial module versus the monofacial equivalent, and will result in higher specific energy yield; and 2) First Solar’s plan to invest approximately $370 million in a new R&D innovation center in Ohio. These forward-looking statements are often characterized by the use of words such as “estimate,” “expect,” “anticipate,” “project,” “plan,” “intend,” “seek,” “believe,” “forecast,” “foresee,” “likely,” “may,” “should,” “goal,” “target,” “might,” “will,” “could,” “predict,” “continue” and the negative or plural of these words and other comparable terminology. Forward-looking statements are only predictions based on our current expectations and our projections about future events and therefore speak only as of the date of this release. You should not place undue reliance on these forward-looking statements. We undertake no obligation to update any of these forward-looking statements for any reason, whether as a result of new information, future developments or otherwise. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to differ materially from those expressed or implied by these statements. These factors include, but are not limited to, the matters discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our most recent Annual Report on Form 10-K, as supplemented by our other filings with the Securities and Exchange Commission.

Media

Reuven Proença

First Solar Media

[email protected]

Investors

Robyn Remes

First Solar Investor Relations

[email protected]

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Supply & Demand Chain Executive Names Covenant Logistics as a Recipient of the 2023 Top Supply Chain Projects Award

This award profiles innovative case study-type projects designed to automate, optimize, streamline, and improve the supply chain

CHATTANOOGA, Tenn., June 14, 2023 (GLOBE NEWSWIRE) — Supply & Demand Chain Executive, the only publication covering the entire global supply chain, named Covenant Logistics Group, Inc as one of the winners of this year’s Top Supply Chain Projects award, which profiles innovative case study-type projects designed to automate, optimize, streamline and improve the supply chain.

“From demand planning and forecasting to implementing the ultimate in warehouse automation, the past 12 months has seen companies within the supply chain and logistics space upgrade, enhance, adopt and adapt in order to achieve greater efficiency along the chain,” says Marina Mayer, Editor-in-Chief of Supply & Demand Chain Executive and Food Logistics. “That’s why it’s important today’s supply chains run on collaboration.”

“Companies partnered to implement each other’s software and technology and work smarter, together. And it’s these partnerships that have enabled many supply chain organizations to better manage inventory, reduce costs, retain employees, track data and analytics and build resilience for whatever disruptions may lie ahead,” Mayer adds.

“At Covenant, our customer’s success is our success, so we start by aligning our goals with our customers. Customers who partner with Covenant for their distribution projects bring us in as a critical part of their team. Having this level of collaboration and trust allows us to design a solution that can meet not only the current needs of the network but also be attentive to our customers’ five and ten-year strategic plans and how we will contribute to that vision.” Says Jim Massengill, Senior Vice President of Warehouse Operations.

“Our customers come to us to operate complex distribution channels on their behalf, which means building an operation whose people, processes, and systems are ready to tackle not just customer supply and demand chain challenges for the next three years, but for the next 10 or 15 years as well. Once our operations meet the productivity and execution standards that are needed, our focus turns to our engineering and continuous improvement teams to break down and document all the workflows we interact with or execute to see where we can improve efficiency, streamline, or automate.” Massengill continues.

“Our customers tell us that our operations are viewed as conduits for evaluating the rest of their 3PL network and often their internal processes and workflows. We take that responsibility very seriously and are proud of our ability to execute for our customers and be a crucial part of their success.” Says Nathan Cowart, Vice President of Contract Sales.

Go to https://sdce.me/av7r0h to view the full list of Top Supply Chain Projects winners.
Go to www.SDCExec.com/awards to learn more about upcoming Supply & Demand Chain Executive awards.

About Covenant

Covenant Logistics Group, Inc., through its subsidiaries, offers a portfolio of transportation and logistics services to customers throughout the United States. Primary services include asset-based expedited and dedicated truckload capacity, asset-light warehousing, transportation management, and freight brokerage capabilities. In addition, Transport Enterprise Leasing is an affiliated company providing revenue equipment sales and leasing services to the trucking industry. Covenant’s Class A common stock is traded on the NASDAQ Global Select Market under the symbol “CVLG.”

About Supply & Demand Chain Executive

Supply & Demand Chain Executive is the only supply chain publication covering the entire global supply chain, focusing on trucking, warehousing, packaging, procurement, risk management, professional development and more. Supply & Demand Chain Executive and sister publication Food Logistics also operate SCN Summit and Women in Supply Chain Forum. Go to www.SDCExec.com to learn more.

Media Contact:


Angie Harrison
 
+1.423.463.3291

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a0706916-e0a8-4b94-a65d-1e84ca008a11



World’s leading steel company, ArcelorMittal and LanzaTech announce first ethanol samples from commercial flagship carbon capture and utilisation facility in Ghent, Belgium

  • €200 million commercial scale CCU plant first of its kind in the European steel industry
  • Facility employing LanzaTech’s cutting-edge carbon recycling process couples decarbonization technology with chemical production to advance EU’s 2030 Climate Target Plan and a circular economy

CHICAGO, June 14, 2023 (GLOBE NEWSWIRE) — ArcelorMittal and LanzaTech Global Inc. (Nasdaq: LNZA) today announced a next step toward full operation of ArcelorMittal’s commercial flagship carbon capture and utilisation (‘CCU’) facility in Ghent, Belgium. The €200 million ‘Steelanol’ facility is a first of its kind for the European steel industry, deploying technology developed by leading carbon utilization company LanzaTech.

This week saw new progress toward full operation of a commercial scale facility that will capture carbon-rich waste gases from steelmaking and biologically convert them into advanced ethanol through LanzaTech’s bio-based process. Unlike traditional fermentation, the process ferments gases instead of sugars and uses a biocatalyst instead of yeast. The facility was inaugurated in December 2022, with cold commissioning taking place thereafter. The biocatalyst has now been introduced into the facility (a process called inoculation) to begin growth and verify production of new molecules.

In May 2023, the first gases from the steel mill’s blast furnace were safely introduced to LanzaTech’s biocatalyst. After a successful inoculation, initial samples that contained ethanol were produced this week, demonstrating that the carbon in the gases is being converted into new chemical products. Commercial-scale ethanol production from the bioreactors will follow, with expected ramp up of production in the coming months. This advanced ethanol can then be used as a building block to produce a variety of products, including sustainable transport fuels, packaging materials, apparel, and even cosmetic fragrances, hence helping to advance the decarbonization efforts of the global chemical sector. The ethanol will be jointly marketed by ArcelorMittal and LanzaTech under the Carbalyst® brand name.

The Steelanol plant has the annual capacity to produce 80 million litres of advanced ethanol, around half of the total current demand in Belgium. It expects to reduce carbon emissions from the Ghent plant by 125,000 tonnes annually, thereby advancing the EU’s 2030 Climate Target Plan to reduce greenhouse gas emissions by 55% by the end of the decade. Project partners include Primetals Technologies and E4tech with support from CINEA, the European Climate, Infrastructure and Environment Executive Agency.

The product samples from the facility this week mark an important step toward the circular use of carbon and the end of single-use carbon, whereby gases are no longer regarded as waste but as raw materials. In addition, the recycling of carbon means Steelanol’s process of Carbalyst® ethanol production does not compete in any way with food crops, as is the case for traditional methods of ethanol production.

“This is a momentous occasion. ArcelorMittal has long been a leader in decarbonization of the steel industry, and today we are delighted to announce the first product samples from the Steelanol plant,” said Jennifer Holmgren, CEO LanzaTech. “LanzaTech, ArcelorMittal, Primetals and E4Tech have worked together and have been supported by CINEA, to create a vision of a new circular carbon economy in Europe, displacing fossil carbon from the ground. To many people, using CCU to capture emissions to make everyday products seems like science fiction, but we have shown the world what is possible at industrial scale today.”

“ArcelorMittal has a passion for sustainability and circularity and has found the right partner in LanzaTech to realize that today.
The beauty of the Steelanol facility is that we are enabling a new form of industrial symbiosis, connecting industries together by using gases from steel production as a feedstock for other sectors,” reflected Manfred Van Vlierberghe, CEO ArcelorMittal Belgium. “This is part of the Smart Carbon Strategy we are developing. By coming together and sharing these resources between sectors, we are not only furthering our circular, Smart Carbon mission, but also helping to solve climate, CO2 and waste challenges.”

The LanzaTech process implemented at this site is fully flexible: not only can it use industrial gases from today’s steel production methods but also it can adapt as the industry transitions to future steel production technologies with increased green hydrogen input. This versatility enables the carbon recycling application to evolve with available residue, waste streams, and green H2. LanzaTech’s process is already employed by three operational commercial facilities, and LanzaTech anticipates the launch of two additional commercial facilities, in Asia, before the end of the year.

Funding for the commercial Steelanol facility was obtained from various sources, including the Flemish government, the Belgian federal government and the European Union’s Horizon 2020 research and innovation program under grant agreement No 656437. Part of the funding was also secured with a loan from the European Investment Bank.

The Steelanol facility is expected to reach full operational capacity before the end of the year.


About ArcelorMittal

ArcelorMittal is the world’s leading steel and mining company, with a presence in 60 countries and primary steelmaking facilities in 16 countries. In 2022, ArcelorMittal had revenues of $79.8 billion and crude steel production of 59.0 million metric tonnes, while iron ore production reached 45.3 million metric tonnes. Our purpose is to produce ever smarter steels that have a positive benefit for people and planet. Steels made using innovative processes which use less energy, emit significantly less carbon and reduce costs. Steels that are cleaner, stronger and reusable. Steels for electric vehicles and renewable energy infrastructure that will support societies as they transform through this century. With steel at our core, our inventive people and an entrepreneurial culture at heart, we will support the world in making that change. This is what we believe it takes to be the steel company of the future. ArcelorMittal is listed on the stock exchanges of New York (MT), Amsterdam (MT), Paris (MT), Luxembourg (MT) and on the Spanish stock exchanges of Barcelona, Bilbao, Madrid and Valencia (MTS). For more information about ArcelorMittal please visit: 

https://corporate.arcelormittal.com/

   
Contact information ArcelorMittal Investor Relations  
   
General +44 20 7543 1128
Retail +44 20 3214 2893
SRI +44 20 3214 2801
Bonds/Credit
E-mail
+33 171 921 026
[email protected]
   
   
Contact information ArcelorMittal Corporate Communications  
   
Paul Weigh
Tel:
E-mail:
+44 20 3214 2419
[email protected]
   
Contact ArcelorMittal Belgium Communications  
   
Jan Cornelis
Tel:
E-mail:
+32 9 347 31 11 [email protected]



About LanzaTech


Headquartered in Skokie, IL, LanzaTech Global, Inc. (Nasdaq: LNZA) captures waste carbon and transforms it into materials such as sustainable fuels, fabrics, packaging, and other products. Using a variety of waste feedstocks, LanzaTech’s technology platform highlights a future where consumers are not dependent on virgin fossil feedstocks for everything in their daily lives. LanzaTech’s goal is to challenge and change the way the world uses carbon, enabling a new circular carbon economy where carbon is reused rather than wasted, skies and oceans are kept clean, and pollution becomes a thing of the past. For more LanzaTech visit https://lanzatech.com.

Forward-Looking Statements

This press release includes forward-looking statements regarding LanzaTech based on the beliefs and assumptions of its management. Although LanzaTech believes that its plans, intentions, and expectations reflected in or suggested by these forward-looking statements are reasonable, LanzaTech cannot assure you that it will achieve or realize these plans, intentions, or expectations. Forward-looking statements are inherently subject to risks, uncertainties, and assumptions. You should not put undue reliance on these statements, which speak only as of the date hereof. LanzaTech undertakes no obligations to update or revise publicly any forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

Contacts:

Media Contact – LanzaTech

Kit McDonnell, Director of Communications
[email protected]

European Media Contact – LanzaTech

Freya Burton, Chief Sustainability Officer
[email protected]

Investor Relations Contact – LanzaTech

Omar El-Sharkawy
Director, Corporate Development
[email protected]



Outbrain Launches “Onyx” – a New Branding Platform Built to Maximize Attention

Onyx leverages the company’s AI prediction technology across dedicated environments for high-impact display and video advertising

NEW YORK, June 14, 2023 (GLOBE NEWSWIRE) — Outbrain Inc. (NASDAQ: OB) today announced Onyx by Outbrain™, a new branding platform designed to maximize business impact of awareness and consideration campaigns. Onyx runs exclusively within dedicated, in-article environments across Outbrain’s premium publisher partners.

Onyx is designed to meet brand objectives and deliver value beyond traditional ‘ad views’ by leveraging Outbrain’s +15 years of technology built to predict user engagement through AI. Onyx features custom large ad formats designed to drive high attention from contextual Pre-Roll Video and High-Impact Display experiences. Initial launch partners include Ford via Xaxis among other brands across the automotive, tech, retail, health, and CPG categories.

Launched in partnership with Adelaide, a leader in the rapidly growing field of attention-based media quality measurement, Onyx aims to increase campaign effectiveness and ROAS (Return on Ad Spend) for enterprise brands and agencies.

“Onyx is part of our long-term strategy to become a full-funnel marketing partner, significantly growing our business with enterprise brands and agencies,” said David Kostman, Co-CEO, Outbrain. “Onyx delivers a unique opportunity for advertisers to win real attention and drive business impact while benefiting our publisher partners with incremental revenue vital to sustain free and independent journalism.”

According to Adelaide, initial findings showed that Onyx units outperformed their benchmarks for display and rich media formats across all device types by 26%. Onyx units also scored 53% higher than standard mobile banners and exceeded mobile rich media formats by 20.1%. Assessment of Adelaide’s attention metric (AU) at the domain level revealed that top-performing Onyx placements surpassed format averages by more than 15%, highlighting a significant opportunity for AU-based optimization across sites and placements.

“We are pleased to partner with Outbrain and empower marketers to run advertising more effectively by focusing on attention metrics,” said Marc Guldimann, Founder & CEO, Adelaide. “Onyx’s combination of high attention placements and engaging ad formats is a promising recipe for marketers seeking to maximize brand impact of display and video campaigns with AU on premium publishers across the open web.”

Onyx is now available for enterprise brands and agencies in the US, UK, Germany, France, and Italy and will be launched in other markets later this year.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. You can generally identify forward-looking statements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “designed to,” “guidance,” “outlook,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “foresee,” “potential” or “continue” or the negative of these terms or other similar expressions that concern our expectations, strategy, plans or intentions. We have based these forward-looking statements largely on our current expectations and projections regarding future events and trends that we believe may affect our business, financial condition and results of operations. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors, including but not limited to overall advertising demand and traffic generated by our media partners; factors that affect advertising demand and spending, such as the continuation or worsening of unfavorable economic or business conditions or downturns, instability or volatility in financial markets, and other events or factors outside of our control, such as U.S. and global recession concerns, geopolitical concerns, including the ongoing conflict between Russia and Ukraine, supply chain issues, inflationary pressures, labor market volatility, and the pace of recovery or any resurgences of the COVID-19 pandemic and the risks described in the section entitled “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed for the year ended December 31, 2022 and in subsequent reports filed with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those projected in the forward-looking statements. We undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

About Outbrain 
Outbrain (Nasdaq: OB) is a leading technology platform that drives business results by engaging people across the open internet. Outbrain predicts moments of engagement to drive measurable outcomes for advertisers and publishers using AI and machine learning across more than 7,000 online properties globally. Founded in 2006, Outbrain is headquartered in New York with offices in Israel and across the United States, Europe, Asia-Pacific, and South America. To learn more, visit www.outbrain.com

Media Contact 
[email protected]