BioNTech Broadens Management Board by Appointing Jens Holstein as CFO

MAINZ, Germany, May 18, 2021 — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), announced today that the Supervisory Board has appointed Jens Holstein to the Management Board as Chief Financial Officer (CFO). As of July 1, 2021, Jens Holstein will join the Management Board to help strengthen BioNTech on its growth trajectory as a global, fully integrated immunotherapy company with an approved or authorized product. He previously served as CFO for MorphoSys AG and in various CFO and general management roles within the Fresenius SE Group. Jens Holstein takes over the CFO role from Dr. Sierk Poetting who will fully focus on his tasks as Chief Operating Officer (COO) going forward.

Under Sierk Poetting’s leadership, BioNTech grew from approximately 300 employees when he joined the company in 2014, to more than 2,000 employees to date. In his position as CFO, Sierk has played a fundamental role in BioNTech’s successful IPO in October 2019 as the eighth German company to be listed on Nasdaq. Over the past months, Sierk’s and his teams’ efforts have been crucial to the expansion of BioNTech’s manufacturing partner network to meet the global demand of the Company’s COVID-19 vaccine, including the Marburg site, which is one of the largest mRNA manufacturing facilities worldwide. In his role as COO, he will drive the further development and execution of a digital strategy, which is comprised of the automation of R&D and production and the further expansion of BioNTech’s global manufacturing footprint, including the recently announced site in Singapore.

“The success of BioNTech’s COVID-19 vaccine development program ‘Project Lightspeed’ has led to the accelerated transformation to a global immunotherapy company which requires extensive manufacturing capacities to support worldwide supply. The extension of the Management Board allows Sierk to further focus on manufacturing as well as the digital transformation of BioNTech,” said Helmut Jeggle, Chairman of the BioNTech Supervisory Board. “We are looking forward to Jens Holstein joining the Management Board. He has extensive international business and financial leadership experience of more than 25 years in the pharmaceutical industry. Jens is an excellent addition to drive BioNTech’s next phase of growth and jointly foster the foundation for long-term, global success.”

“Through the development of a well-tolerated and effective COVID-19 vaccine, BioNTech has achieved a historic breakthrough for science. This first product authorized for use marked a crucial milestone in the Company’s growth path. I am thrilled to join the Management Board at this exciting time in the Company’s development,” said Jens Holstein. “With the proceeds from the COVID-19 vaccine, BioNTech will be in a position to accelerate its research pipeline in cancer therapies, infectious diseases, regenerative therapies, inflammatory reactions, as well as autoimmune diseases. I’m looking forward to supporting this outstanding team in fulfilling its mission of improving the health of people worldwide.”

As CFO, Jens will work closely with the other Management Board members to drive BioNTech’s financial performance. He will be responsible for Finance, Tax, Treasury, Human Resources and Purchasing. In addition, Jens will play a leadership role in the development and execution of the Company’s regional expansion plans.

Prior to joining BioNTech, Jens was CFO of dual-listed MorphoSys AG where he was instrumental in building a fully integrated biopharmaceutical company. Before joining MorphoSys in 2011, Jens served in multiple CFO positions as well as general management roles within the Fresenius SE Group. He served as Regional CFO for the region EME (Europe/Middle East) and as Managing Director of Fresenius Kabi Deutschland GmbH. From 2006 to 2010, he was Regional Chief Financial Officer of Fresenius Kabi Asia Pacific Ltd., based in Hong Kong. Prior to this appointment, Jens Holstein was Managing Director of Fresenius ProServe GmbH, and CFO and Labor Director of the company’s subsidiary Wittgensteiner Kliniken AG. Earlier positions within Fresenius included General Manager of hospitalia care GmbH, Commercial Manager of the Projects & Service business unit of Fresenius AG and Commercial Manager of hospitalia international GmbH. Jens Holstein also spent several years in the consulting industry, including in M&A with positions in Frankfurt and London. Jens Holstein holds a Diploma in Business Administration from the University of Münster, Germany. He is also a Non-Executive Member of the Board of Directors at global genomic diagnostics company Veracyte Inc.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

For more information, please visit www.BioNTech.de 

Forward-Looking Statements

This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; and the potential benefits of BioNTech’s leadership hires. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

Media Relations

Jasmina Alatovic
+49 (0)6131 9084 1513
[email protected]

Investor Relations

Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
[email protected] 

 



Loop Insights Enters $225B CPG Retail Market With Successful Integration With The Coupon Bureau to Deliver Verified Universal Digital Coupons Through Loop’s Wallet Pass Platform

Power Of Loop’s Real-Time Data Capabilities and Digital Wallet pass solution paired with The Coupon Bureau’s new universal digital 8112 coupons set to revolutionize the Coupon industry and improve the retailer, CPG Brand, and customer experience

VANCOUVER, British Columbia., May 18, 2021 (GLOBE NEWSWIRE) — Loop Insights Inc. (TSX.V: MTRX) (RACMF:OTCQB) (the “Company” or “Loop”), a global leader in providing real-time data analytics through artificial intelligence to drive customer activation and engagement, is pleased to announce that they have completed the integration of the Loop Wallet pass platform and The Coupon Bureau’s new Universal Digital Coupon standard.  The Coupon Bureau (TCB), is a non-profit data exchange helping Retailers and Brands to utilize their new Universal Digital Coupon standard to improve the customer coupon redemption experience and reduce fraud.  Coupon fraud is a serious concern for Consumer Packaged Goods (CPG) brands, with Trend Micro estimating that over $300-600m is lost by these brands each year due to fraud.  

When TCB Digital 8112 Coupons are delivered through Loop’s Wallet pass platform, this will enable users to finally be able to use their mobile phones to redeem coupons in a truly contactless and secure way. Customers will not have to download and install a separate app to redeem their coupons, they can simply redeem them directly through their mobile phone using Loop’s Wallet pass platform which leverages the native wallet that is already built into every iOS and Android smartphone globally.

Just as importantly, Loop will be able to generate significant revenue from this integration. There are revenue models that take into account revenue per active coupon, per impression, per redemption as well as earning revenue from each participating retailer or CPG and quarterly and annual licenses for access to insights and analytics.

Loop Insights CEO Rob Anson states: “As was highlighted in the recent announcement of Loop’s strategic alliance with NielsenIQ, Loop brings the power of personalization at scale and powers “the last inch” in the purchase process in-store, which provides the CPG Brands with real time campaign performance and attribution metrics that don’t exist in today’s market. Combined with NielsenIQ, who works with some of the top global CPG brands and retailers, this integration with TCB will continue Loop’s disruption of the retail sector and position Loop to continue accelerated growth and market disruption. When we look back at the end of 2021, this TCB and Loop integration will be appreciated as a true game-changer for Loop in terms of industry exposure and most importantly its path to revenue.” 

The coupon industry is in dire need of digital standards and Loop & TCB are leading the way

In 2020, according to TCB, there were over 1.3 billion coupons redeemed, and the CPG brands spent more than $225 billion in promotional spending on coupons, which is a huge market.  However, according to Kantar, only 4.2% of all CPG coupons were distributed digitally, and digital coupons only represented 3.4% of the total value of coupons distributed.  Primarily due to the lack of a standardized digital ecosystem, this discrepancy clearly goes against what consumers are demanding both from a convenience and a safety perspective in a post-Covid world.  Consumers want to be able to redeem their coupons on their mobile phones and they want safe, contactless redemption technologies, which is what Loop is helping to deliver with their Wallet pass platform and the new TCB Universal Digital Coupons.

Loop Insights CTO Tamer Shafiq states: “Leveraging The Coupon Bureau’s latest standard AI (8112) provides universal, single-use, real-time validated coupons. Paired with Loop Insights’ blockchain-backed Wallet pass implementation, this results in a fully interoperable solution, where both the authenticity of the coupon, and its validity, can be confirmed in real time by any verifier.”

Brandi Johnson, CEO of TCB states: “The COVID-19 crisis has significantly impacted the coupon and retail industry, especially with the rise in e-commerce sales and online deliveries. To combat this, the retail industry has had to find innovative ways to meet consumers’ changing behavior.  I have been blown away by Loop Insights, their vision, technology, and their innovative approach. The Loop Wallet pass integration with our new coupon standard is truly revolutionary and will significantly improve the customer experience.  If you dig deeper, it goes further, their ability to collect offline and online transactional data, provide insights and then help retailers and brands engage with their customers in real-time through their mobile phones with digital coupons and provide full attribution is truly game-changing for forward-thinking retailers and brands.”    

Forward Thinking Retailers are turning to Loop

Forward-thinking retailers such as Sobeys, Canada’s second-largest grocery chain who Loop is currently working on a POC with are looking to better manage and monetize the entire customer journey from transaction to coupon redemption to personalized real-time promotions and loyalty programs.  These retailers are turning to Loop to help them automate their processes by consolidating all of their offline and online customer transaction data, gaining insights into their customer purchasing habits, and then engaging with their customers providing improved customer service and increasing their share of the customer’s wallet.  Loop’s integration of the TCB Universal Digital Coupon standard is another piece of the complete solution that Loop offers to Retailers and CPG brands to help them connect directly with their customers in real-time.  

This Press Release Is Available On the Loop Insights website, and also on the Verified Forum On AGORACOM For Shareholder Discussion And Management Engagement

ABOUT THE COUPON BUREAU

The Coupon Bureau is an open-market platform connecting all stakeholders to the new Universal Positive Offer File. We help support smarter promotions and enable the ongoing growth of the industry. This allows all current stakeholders to maintain their current business functions and expand those by utilizing The Coupon Bureau connectivity. For more information, visit http://www.thecouponbureau.org/

ABOUT LOOP INSIGHTS

Loop Insights Inc. is a Vancouver-based Internet of Things (“IoT”) technology company that delivers transformative artificial intelligence (“AI”) automated marketing, contact tracing, and contactless solutions to the brick and mortar space. Its unique IoT device, Fobi, enables data connectivity across online and on-premise platforms to provide real-time, detailed insights and automated, personalized engagement. Its ability to integrate seamlessly into existing infrastructure, and customize campaigns according to each vertical, creates a highly scalable solution for its prospective global clients that span industries. Loop Insights operates in the telecom, casino gaming, sports and entertainment, hospitality, and retail industries, in Canada, the US, the UK, Latin America, Australia, Japan, and Indonesia. Loop’s products and services are backed by Amazon’s Partner Network.

For more information, please contact:

Loop Insights Inc.   LOOP Website: www.loopinsights.ai
Rob Anson, CEO   Facebook: @ LoopInsights
T : +1 877-754-5336 Ext. 4   Twitter: @ LoopInsights
E: [email protected]   LinkedIn: @ LoopInsights

This news release contains certain statements that constitute forward-looking statements or information, including statements regarding Loop’s business and technology; the ability of Loop to engage with industry participants to achieve its goals; the development of Loop’s technology; and the viability of Loop’s business model. Such forward-looking statements are subject to numerous risks and uncertainties, some of which are beyond Loop’s control, including the impact of general economic conditions, industry conditions, competition from other industry participants, stock market volatility, and the ability to access sufficient capital from internal and external sources. Although Loop believes that the expectations in its forward-looking statements are reasonable, they are based on factors and assumptions concerning future events which may prove to be inaccurate. Those factors and assumptions are based upon currently available information. Such forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that could influence actual results or events and cause actual results or events to differ materially from those stated, anticipated, or implied in the forward-looking statements. As such, readers are cautioned not to place undue reliance on the forward-looking statements, as no assurance can be provided as to future results, levels of activity, or achievements. The forward-looking statements contained in this news release are made as of the date of this news release and, except as required by applicable law, Loop does not undertake any obligation to publicly update or to revise any of the included forward-looking statements, whether as a result of new information, future events or otherwise. The forward-looking statements contained in this document are expressly qualified by this cautionary statement. Trading in the securities of Loop should be considered highly speculative. There can be no assurance that Loop will be able to achieve all or any of its proposed objectives.

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

 



Rubicon Organics Reports First Quarter 2021 Financial Results and Operational Milestones

VANCOUVER, British Columbia, May 18, 2021 (GLOBE NEWSWIRE) — Rubicon Organics Inc. (TSXV: ROMJ) (OTCQX: ROMJF) (“Rubicon Organics” or the “Company”), a licensed producer focused on cultivating and selling organic certified and premium cannabis, today reported its financial results for the first quarter ended March 31, 2021 (“Q1 2021”). All amounts are expressed in Canadian dollars.

“Rubicon Organics has maintained its market share leadership position in the organic cannabis segment and remains a top selling premium brand in all major Canadian provinces. We remain focused on superior product quality and we have rapidly implemented efficiencies to our production process that position us to maximize our profitability. Our unique expertise in cultivating and marketing premium cannabis remains a significant competitive advantage and we firmly believe we have the right team and the right strategy to deliver long-term value for our shareholders,” said Jesse McConnell, Chief Executive Officer.

Q1 2021 Highlights:

  • Earned $4.1 million of net revenue, an increase of $3.7 million versus the prior year;
  • Received a Health Canada license amendment which authorizes the direct sale of cannabis topical, edible and concentrate products to provincially authorized distributors/retailers and registered patients;
  • Closed a bought deal offering of 6,052,631 units for aggregate gross proceeds of $23.0 million;
  • Entered into an agreement with The Valens Company (TSX:VLNS) for organic certified extraction services;
  • Received purchase orders from distributors in Ontario, British Columbia, Alberta and Saskatchewan for Wildflower CBD Relief Sticks and Wildflower CBD Cool Sticks; and
  • Fully repaid a $5.0 million first mortgage loan that had matured.

Highlights Subsequent to Q1 2021:

  • Announced a Cannabis Purchase and Sale Agreement with the YCL for the distribution of its portfolio of cannabis products to consumers in Yukon territory;
  • Fully repaid a $3.4 million second mortgage loan that had matured; and
  • Fully repaid a $5.0 million second mortgage loan originally due on May 27, 2021.

Q1 2021 Select Financial and Operational Results:

  Three months ended
March 31, 2021


$
Three months ended
March 31, 2020


$
Three months ended
December 31, 2020


$
Net revenue 4,110,563   454,043   4,774,488  
Other income   131,173    
Loss from continuing operations (3,987,316 ) (3,696,245 ) (4,805,606 )
Loss from discontinuing operations   (111,926 ) (237,096 )
Net loss for the period (3,987,316 ) (3,808,171 ) (5,042,702 )
Adjusted EBITDA* (3,375,368 ) (3,036,260 ) (2,958,525 )
       
Cash 20,213,416   1,650,313   12,136,459  
Working Capital 20,534,187   2,476,598   4,166,180  

* Adjusted EBITDA is a non-GAAP measure that is calculated as earnings (losses) from operations before interest, tax, depreciation and amortization, share-based compensation expense, and fair value changes. See Selected Financial Information in the Q1 2021 Management’s Discussion & Analysis for details on the Adjusted EBITDA calculation.

In Q1 2021, Rubicon Organics earned $4.1 million of net revenue, an increase of $3.7 million from Q1 2020, which is attributable to an increased product offering, including the launch of new brands, and expanded distribution channels across Canada. Net revenue declined $0.7 million from Q4 2020 due to ongoing restrictions by provincial governments on retail store operations.

The Company reported an Adjusted EBITDA loss of $3.4 million in Q1 2021, as compared to a loss of $3.0 million in Q4 2020 and $3.0 million in Q1 2020. The sequential change in Adjusted EBITDA is attributable to the decline in net revenue described above and the variance over the prior year is due to higher operating costs incurred to support the ramp up of the Company’s operations.

The Company reported a net loss of $4.0 million in Q1 2021, as compared to a net loss of $5.0 million in Q4 2020 and $3.8 million in Q1 2020. The sequential change in profitability reflects fair value changes in the Company’s cannabis assets and the year-over-year variance reflects higher net revenue offset by increased production and overhead costs, as well as a foreign currency translations benefit in the prior year.

Outlook

In Q1 2021, the Company maintained significant market share in the premium and organic product categories with its Simply Bare Organic™ brand1. The Company held a top six position in premium in each of Ontario, Alberta and Quebec and remained the #1 premium brand in BC1. Consistent with industry trends and guidance, the shutting of stores in Q1 2021 had a significant impact on sales to provincial distributors relative in forecast, particularly in Ontario and Alberta. This trend of decreased sales in Ontario and Alberta has continued with the ongoing lock-downs and store closures where sales are limited to “click and collect” shopping in those markets. In the few weeks that stores in Ontario were open to in-store shopping, Rubicon saw significant in-store sales increases. The government restrictions on retail operations remains challenging for revenue growth, but the results of the few weeks being open indicated a strong consumer demand in the premium segment for our Simply Bare Organic™ brand.

As a proactive measure to an uncertain outlook for store re-openings, Rubicon Organics is undergoing a company-wide restructuring and has already achieved an annualized savings of $2.6 million. Rubicon is also accelerating the launch of additional products and brands in the coming months which we expect will drive revenue within more segments of the premium flower category and with cannabis 2.0 product launches.

COVID-19 related store closures will impact Rubicon Organics’ ability to achieve its previously disclosed Adjusted EBITDA and operating cash flow targets in Q2 2021. The Company’s current expectation for the achievement of such milestones has been delayed to Q3 2021, subject to the impact of further provincial restrictions on retail store openings and distributor buying patterns. We remain confident in our product appeal and plan to win in the premium market given the additional SKU’s being added in various markets across the country.

On March 31, 2021, the Company fully repaid the $5.0 million first mortgage on the Delta Facility.  On April 23, 2021, the Company fully repaid two tranches of second mortgages totaling $8.4 million in principal and $2.1 million in accrued interest.  In Q2 2021, the Company expects to enter into a mortgage financing facility at more favourable terms.

Conference Call

The Company will be hosting a conference call to discuss Q1 2021 results on May 18, 2021. Conference call details are as follows:

Date and time: 7:00 AM PT / 10:00 AM ET
Conference ID: 2699002
Local dial-in:         (833) 900-2238
International dial-in: (647) 689-5136
Webcast: https://onlinexperiences.com/Launch/QReg/ShowUUID=C4504707-166F-4539-B5A1-E58E4DEF03BE  

ABOUT RUBICON ORGANICS INC.

Rubicon Organics Inc. is becoming the global brand leader in organic cannabis products. Through its wholly owned subsidiary Rubicon Holdings Corp, a licensed producer, the Company cultivates, processes and sells organic certified, sustainably produced, super-premium cannabis products from its state-of-the-art hybrid greenhouse located in Delta, BC, Canada. Rubicon Organics is focused on achieving industry leading profitability through a focus on innovation and the development of brands and cannabis 2.0 products, including its flagship super-premium brand Simply Bare™ Organic, its super-premium concentrate brand LAB THEORY™ and its premium flower and hash brand 1964™.

CONTACT INFORMATION

Margaret Brodie
Chief Financial Officer
Phone: +1 (437) 929-1964
Email: [email protected]

The TSX Venture Exchange, its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) does not accept responsibility for the adequacy or accuracy of this press release.

Cautionary Statement Regarding Forward Looking Information

This press release contains forward-looking information within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, statements regarding Rubicon Organics’ proposed brand launches and path to market are “forward-looking statements”. Forward-looking information can be identified by the use of words such as “will” or variations of such word or statements that certain actions, events or results “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. The forward-looking information in this press release is based upon certain assumptions that management considers reasonable in the circumstances, including the launch of new brands and cannabis products, the timing of becoming Adjusted EBITDA and cash flow positive, and the Company’s ability to refinance its debt. Risks and uncertainties associated with the forward looking information in this press release include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, local or other licenses and any inability to obtain all necessary governmental approvals licenses and permits for construction at its facilities in a timely manner; regulatory or political change such as changes in applicable laws and regulations, including bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; Rubicon Organics’ limited operating history and lack of historical profits; reliance on management; and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with customers and suppliers; and the effects of the COVID-19 pandemic. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. Although Rubicon Organics has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. Rubicon Organics assumes no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.

Non-GAAP Financial Measures

This press release contains certain financial performance measures that are not recognized or defined under IFRS (“Non-GAAP Measures”) including, but not limited to, “Adjusted EBITDA”. As a result, this data may not be comparable to data presented by other cannabis companies. For an explanation and reconciliation of these measures to related comparable financial information presented in the financial statements prepared in accordance with IFRS for the 3 months ended March 31, 2021, please refer to the “Selected Financial Information” section in the MD&A for the 3 months ended March 31, 2021. The Company believes that these Non-GAAP Measures are useful indicators of operating performance and are specifically used by management to assess the financial and operational performance of the Company.

1 Based on information from industry data sources including the Ontario Cannabis Stores and Buddi data during the period from January 1, 2021 to March 31, 2021.



Amdocs’ BriteBill Modernizes and Streamlines BT Group’s Customer Billing

BriteBill’s customer experience management platform provides tens of millions of BT Group’s customers with a leading billing experience, offering personalized upsell opportunities for new services and reduced call center engagements

ST. LOUIS, May 18, 2021 (GLOBE NEWSWIRE) — Amdocs (NASDAQ: DOX), a leading provider of software and services to communications and media companies, today announced that BT, one of the world’s leading communications services companies, has implemented Amdocs’ BriteBill billing communications platform. BriteBill has empowered the BT Group, including mobile brand EE, to customize billing communications for customers with an engaging design and the flexibility to personalize with recommendations for relevant new services or notify customers if a promotional contract period is coming to an end. Together, Amdocs and BT Group are delivering clear, easy-to-understand billing communications that are personalized and give greater clarity to customers.

The project, which produces tens of millions of bills for customers each month both digitally and on paper, has transformed the presentation of BT & EE’s bills. The bills’ easy-to-understand itemization provides a visually engaging view of all charges, with explanations for any new changes. This has reduced calls to BT Group’s call centers and supported company initiatives and offerings, such as the provision of free mobile data to NHS workers during the pandemic.

“As providing excellent customer service is central to BT Group’s business, it’s important to communicate with our customers in the most effective way possible,” said a BT spokesman. “This means providing billing communications that are engaging and provide a clear representation of the customer’s services. We are delighted to have chosen and implemented Amdocs BriteBill’s customer billing platform, and the results are speaking for themselves.”

“Determining the most effective monetization relationships with customers is key for providing leading customer service and growing loyalty,” said Anthony Goonetilleke, group president of Media, Network and Technology, Amdocs. “We are proud to be working alongside BT Group to provide a superior billing communications system to its tens of millions of customers across the United Kingdom.”

Supporting Resources

About Amdocs

At Amdocs, we enrich lives and progress society. With our creativity and technology, we help make a better connected world. Amdocs and its 27,000 employees serve the leading players in the communications and media industry, enabling next-generation experiences in 80 countries. Our cloud-native, open and dynamic portfolio of digital solutions, platforms and services brings greater choice, faster time to market and flexibility to better meet the evolving needs of our customers as they take their business to the cloud. Listed on the NASDAQ Global Select Market, Amdocs had revenue of $4.2 billion in fiscal 2020. For more information, visit Amdocs at www.amdocs.com.

Amdocs’ Forward-Looking Statement

This press release includes information that constitutes forward-looking statements made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995, including statements about Amdocs’ growth and business results in future quarters. Although we believe the expectations reflected in such forward-looking statements are based upon reasonable assumptions, we can give no assurance that our expectations will be obtained or that any deviations will not be material. Such statements involve risks and uncertainties that may cause future results to differ from those anticipated. These risks include, but are not limited to, the effects of general economic conditions, Amdocs’ ability to grow in the business markets that it serves, Amdocs’ ability to successfully integrate acquired businesses, adverse effects of market competition, rapid technological shifts that may render the Company’s products and services obsolete, potential loss of a major customer, our ability to develop long-term relationships with our customers, and risks associated with operating businesses in the international market. Amdocs may elect to update these forward-looking statements at some point in the future; however, the Company specifically disclaims any obligation to do so. These and other risks are discussed at greater length in Amdocs’ filings with the Securities and Exchange Commission, including in our Annual Report on Form 20-F for the fiscal year ended September 30, 2020 filed on December 14, 2020 and our Form 6-K furnished for the first quarter of fiscal 2021 on February 16, 2021 and for the second quarter of fiscal 2021 on May 12, 2021.

Media Contacts:

Nick Boulton
Amdocs Public Relations
Tel: +44 (0)7896 931 335
E-mail: [email protected]

Paul Campbell
Babel PR for Amdocs
Tel: +44 (0)20 7434 5552
E-mail: [email protected]



Amdocs Provides Business Continuity for BT’s Mobile Customers to Enjoy Secure Remote Digital Engagement

An Amdocs and Lightico joint solution enables BT’s mobile customers to complete sales journeys remotely and securely, without the need for physical paperwork; solution is an expansion to existing multi-year managed services agreement

ST. LOUIS, May 18, 2021 (GLOBE NEWSWIRE) — Amdocs (NASDAQ: DOX), a leading provider of software and services to communications and media companies, and BT, one of the world’s leading communications services companies, today announced that in addition to their existing multi-year managed services agreement, BT has implemented Amdocs’ and Lightico’s real-time digital interaction platform across its contact centers, to enable business operations to be conducted digitally and remotely in the cloud. The platform is designed to allow BT’s customers to conduct self-care and sign contracts online, alleviating the need for customers to physically visit BT stores, and drive towards a seamless digital society.

Through the project, BT has digitized its sales systems, removing paperwork for customers purchasing via BT’s website and enabling BT to bring greater choice, faster time to market and improved flexibility. At BT’s contact centers, hundreds of thousands of sales and service customer journeys are now completed more efficiently due to an intuitive interface.

Paul Greig, director of Contact Centre Sales at BT and EE, said: “The solution has been remarkable in terms of driving both compliance and business benefits. Following the quick and simple integration, we’ve seen a remarkable uptick in our sales and a step-change in our compliance abilities. The Amdocs and Lightico solution drives ROI and improves our day-to-day interactions for our customers and advisers, making it easier to continue improving business operations during times when customers are unable to visit us in-store. Partnering with Amdocs and Lightico enables us to digitize and accelerate customer interactions across the board, and we are proud to be able to provide the seamless digital experience our customers expect, while empowering our teams to better serve them.”

“Organizations that focus on customer experience outperform the market by a significant margin,” said Anthony Goonetilleke, group president of Media, Network and Technology, Amdocs. “Together with Lightico, we are enabling BT to provide completely digital and compliant customer journeys from wherever their customers feel most comfortable. Working hand-in-hand with BT, we are enriching customer interactions on critical business processes and are proud to be driving significant business value for millions of BT customers across multiple channels.”

Supporting Resources

About Amdocs

At Amdocs, we enrich lives and progress society. With our creativity and technology, we help make a better connected world. Amdocs and its 27,000 employees serve the leading players in the communications and media industry, enabling next-generation experiences in 80 countries. Our cloud-native, open and dynamic portfolio of digital solutions, platforms and services brings greater choice, faster time to market and flexibility to better meet the evolving needs of our customers as they take their business to the cloud. Listed on the NASDAQ Global Select Market, Amdocs had revenue of $4.2 billion in fiscal 2019. For more information, visit Amdocs at www.amdocs.com.

About Lightico

Lightico is an award-winning SaaS platform for customer interactions, that digitally transforms millions of connections between businesses and their customers. With Lightico, sales and service agents can instantly collect customer documents, eSignatures, payments, and verify ID in real-time – straight from the customers’ cell phones. Hundreds of enterprise businesses rely on Lightico to accelerate sales cycles and service their customers effortlessly, earning customer’s trust and loyalty, translating to higher profits.
For more information, please visit www.lightico.com

Amdocs’ Forward-Looking Statement

This press release includes information that constitutes forward-looking statements made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995, including statements about Amdocs’ growth and business results in future quarters. Although we believe the expectations reflected in such forward-looking statements are based upon reasonable assumptions, we can give no assurance that our expectations will be obtained or that any deviations will not be material. Such statements involve risks and uncertainties that may cause future results to differ from those anticipated. These risks include, but are not limited to, the effects of general economic conditions, Amdocs’ ability to grow in the business markets that it serves, Amdocs’ ability to successfully integrate acquired businesses, adverse effects of market competition, rapid technological shifts that may render the Company’s products and services obsolete, potential loss of a major customer, our ability to develop long-term relationships with our customers, and risks associated with operating businesses in the international market. Amdocs may elect to update these forward-looking statements at some point in the future; however, the Company specifically disclaims any obligation to do so. These and other risks are discussed at greater length in Amdocs’ filings with the Securities and Exchange Commission, including in our Annual Report on Form 20-F for the fiscal year ended September 30, 2020 filed on December 14, 2020 and our Form 6-K furnished for the first quarter of fiscal 2021 on February 16, 2021 and for the second quarter of fiscal 2021 on May 12, 2021.

Media Contacts:

Nick Boulton
Amdocs Public Relations
Tel: +44 (0)7896 931 335
E-mail: [email protected]

Paul Campbell
Babel PR for Amdocs
Tel: +44 (0)20 7434 5552
E-mail: [email protected]



LGBTQ Loyalty Holdings Launches LGBTQ + ESG100 ETF

New offering is one of the first funds to enable investing in companies committed to the LGBTQ+ community

WEST HOLLYWOOD, Calif., May 18, 2021 (GLOBE NEWSWIRE) — LGBTQ Loyalty Holdings, Inc. (OTC PINK: LFAP) (“LGBTQ Loyalty” or “the Company”), a diversity-and inclusion-driven financial methodology and data company, announces through its wholly owned subsidiary, Loyalty Preference Index, Inc., the launch of the LGBTQ + ESG100 ETF (NASDAQ: LGBT) today.

“I am thrilled that the launch of the LGBTQ + ESG100 ETF has arrived. Today is an important day for advancing equality, as we showcase companies that align and support the LGBTQ community through this announcement. Seeing the trading symbol ‘LGBT’ listed on Nasdaq is truly historic,” said Martina Navratilova, former Hall of Fame professional tennis player and member of the LGBTQ Loyalty board of directors.

The LGBTQ + ESG100 ETF is one of the first funds designed to serve the principles and values of the LGBTQ community and its allies. The fund provides investors with the methodology and results related to performance of the top corporations that embrace ESG principles in the workplace and advance equality. The LGBTQ + ESG100 ETF offers investors access to U.S. large-cap equity securities of companies that have demonstrated a commitment to LGBTQ diversity and inclusion, along with ESG compliance, as part of their corporate social responsibility fundamental mandate.

“I’m very proud to be part of this doubly beneficial effort: it provides supporters of LGBTQ equality with access to investments that reflect their values, while simultaneously rewarding businesses that demonstrate that ethical behavior and profitability are fully compatible,” said Barney Frank, Former U.S. Congressman, Chairman of the House Financial Services Committee and member of the LGBTQ Loyalty board of directors.

The fund will track the LGBTQ100 ESG Index (Ticker: LGBTQ100), powered by Fuzzy Logix, which identifies the top 100 corporations that most align with the LGBTQ community across America. It is the first-ever index to incorporate LGBTQ community survey data into the methodology, generating a benchmark of the nation’s highest-performing companies that are most committed to advancing equality.

For the 18-month period from November 2019 to April 2021, the Index generated a 43.84% return versus a 37.65% return for the S&P 500, while keeping volatility lower by 66 basis points of the benchmark. The Index was most recently reconstituted in March 2021.

“The launch of the much-anticipated LGBTQ + ESG100 ETF, is at a consequential time for the LGBTQ community and our supportive allies, and a monumental time for advancing equality. We are proud to provide investors with the means to invest in top corporations that align with their interests, and embrace equality, diversity and ESG principles in the workplace.” said Bobby Blair Executive Chairman of the Board.

Investors can learn more about the LGBTQ + ESG100 ETF at: www.PALETFs.com

About LGBTQ Loyalty Holdings, Inc.

LGBTQ Loyalty is a diversity- and inclusion-driven financial methodology and data company that quantifies corporate equality alignment with the LGBTQ community and minority interest groups. The Company has benchmarked the first-ever U.S. Loyalty Preference Index, which it believes empowers the LGBTQ community to express their preferences for the nation’s high-performing corporations most dedicated to advancing equality. The Loyalty Preference Index, branded as LGBTQ100 ESG Index, is an environmental, social and governance (ESG) Index, offering an added perspective for those seeking to align with equality-driven, ESG-responsible corporations. LGBTQ Loyalty’s leadership includes seasoned authorities in the financial industry and LGBTQ community. For more information, please visit www.lgbtqloyalty.com.

About Fuzzy
Logix

We accelerate analytics. We use it to deliver high-impact business outcomes in Banking, Finance and Healthcare. Our state-of-the-art tool – FastINDX – allows 10-100x faster creation and turnkey management of Indexes and alpha-seeking Portfolios using a global database of 100K+ financial instruments. You can find us at www.fuzzylogix.com and www.fastindx.com.

Please consider the Fund’s investment objectives, risks, and charges and expenses carefully before you invest. This and other important information is contained in the Fund’s summary prospectus and prospectus, which can be obtained by visiting


www.PALETFs.com


or call 1-866-690-3837. Read carefully
before you invest.

Investing involves Risk. Principal loss is possible. Shares of any ETF are bought and sold at market price (not NAV), may trade at a discount or premium to NAV and are not individually redeemed from the funds. Brokerage commissions will reduce returns. Additional Fund risks include: Technology Sector Risk, Healthcare Sector Risk, Finance Sector Risk, Concentration Risk, Cyber Security Risk, and Liquidity Risk. For additional information please see the prospectus.

This information should not be relied upon as research, investment advice, or a recommendation regarding any products, strategies, or any security in particular. This material is strictly for illustrative, educational, or informational purposes and is subject to change.

A strategy or emphasis on environmental, social and governance factors (“ESG”) may limit the investment opportunities available to a portfolio. Therefore, the portfolio may underperform or perform differently than other portfolios that do not have an ESG investment focus. A portfolio’s ESG investment focus may also result in the portfolio investing in securities or industry sectors that perform differently or maintain a different risk profile than the market generally or compared to underlying holdings that are not screened for ESG standards.

Past performance is no guarantee of future results. Volatility is measured by standard deviation which is a statistical measurement of variations from the average. One basis point is equal to 1/100th of 1%, or 0.01%.


Please read the prospectus and its risk disclosure before investing.


Certain statements may constitute a forward-looking statement, including those identified by the expression “expect” and similar expressions (including grammatical variations thereof). The forward-looking statements are not historical facts but reflect the author’s current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. These and other factors should be considered


carefully and readers should not place undue reliance on such forward looking statements. These forward-looking statements are made as of the date hereof and the authors do not undertake to update any forward-looking statement that is contained herein, whether as a result of new information, future events or otherwise, unless required by applicable law.

Distributed by Quasar Distributors LLC

MEDIA CONTACT:

Sam Marinelli
[email protected]
610-246-9928



Organigram Launches Big Bag o’ Buds Indoor-grown, Strain-specific Dried Flower in 28g Value Format

Organigram Launches Big Bag o’ Buds Indoor-grown, Strain-specific Dried Flower in 28g Value Format

Big Bag o’ Buds strains include both celebrated and new cultivars, including Organigram’s industry-leading Ultra Sour

MONCTON, New Brunswick,–(BUSINESS WIRE)–
Organigram Holdings Inc. (“Organigram” or the “Company”) (TSX: OGI) (NASDAQ: OGI), the parent company of Organigram Inc., a leading licensed producer of cannabis, is pleased to announce the launch of Big Bag o’ Buds, a lineup of dried flower products featuring a roster of well-known genetics and an exciting rotation of one-time offerings (OTO) in a 28g format.

“Customers across the country continue to express the importance of large formats and new genetic offerings at an appealing price point,” says Tim Emberg, Senior Vice President of Sales and Commercial Operations at Organigram. “Without a doubt, Big Bag o’ Buds delivers on all of those points but also offers Canadian consumers a continuous pipeline of new cultivars reflecting our team’s ongoing search for and development of new terpene profiles and phenotypic expressions.”

Big Bag o’ Buds offers a minimum of 17% THC and a rich cultivar selection that includes Ultra Sour, a pungent, sativa-leaning sour featuring the tartness of Meyer lemon and the diesel and pungent notes from the cultivar’s Kush undertones. Organigram currently leads the pack with the #1 Ultra Sour brand in Canada. The Big Bag o’ Buds OTO cultivar selection will include Grapefruit GG4, Original Glue, and Lemon Tree strains.

Every Big Bag o’ Buds strain benefits from being grown in strain-specific, climate-controlled indoor grow rooms to optimize each cultivar’s flavour. Variables including humidity, temperature, light and plant density can be customized to enhance the growth and output of each plant.

Big Bag o’ Buds is available at select retailers across Canada.

About Organigram Holdings Inc.

Organigram Holdings Inc. is a NASDAQ Global Select Market and TSX listed company whose wholly owned subsidiaries include: Organigram Inc., a licensed producer of cannabis and cannabis-derived products in Canada and The Edibles and Infusions Corporation, a cannabis infused soft chew and confectionary manufacturer in Canada.

Organigram is focused on producing high-quality, indoor-grown cannabis for patients and adult recreational consumers in Canada, as well as developing international business partnerships to extend the Company’s global footprint. Organigram has also developed a portfolio of legal adult use recreational cannabis brands including The Edison Cannabis Company, Indi, Bag o’ Buds, SHRED and Trailblazer. Organigram’s facility is located in Moncton, New Brunswick with another leased manufacturing facility in Winnipeg, Manitoba. The Company is regulated by the Cannabis Act and the Cannabis Regulations (Canada).

This news release contains forward-looking information. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “estimates”, “intends”, “anticipates”, “believes” or variations of such words and phrases or state that certain actions, events, or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results, events, performance or achievements of Organigram to differ materially from current expectations or future results, performance or achievements expressed or implied by the forward-looking information contained in this news release. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information include factors and risks as disclosed in the Company’s most recent annual information form, management’s discussion and analysis and other Company documents filed from time to time on SEDAR (see www.sedar.com) and filed or furnished to the Securities and Exchange Commission on EDGAR (see www.sec.gov). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. The forward-looking information included in this news release are made as of the date of this news release and the Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

For Investor Relations enquiries:

Amy Schwalm

Vice President, Investor Relations

[email protected]

(416) 704-9057

For Media enquiries:

Marlo Taylor

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Alternative Medicine Health

MEDIA:

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FAT BRANDS BEEFS UP SENIOR MANAGEMENT TEAM

Three additions to executive suite bring decades of experience and expertise as global restaurant franchise company moves to make further acquisitions

Los Angeles, May 18, 2021 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., parent company of Fatburger, Johnny Rockets and seven other restaurant concepts, has added additional depth to its senior management team with three new hires: Allen Sussman, General Counsel; Ken Kuick, Chief Financial Officer; and Rob Rosen, EVP Capital Markets.

“FAT Brands has experienced remarkable growth in spite of the pandemic, opening new restaurants around the world, and we’re not done yet,” said Andy Wiederhorn, CEO of FAT Brands. “Bringing these three talented professionals on-board will bring additional intellectual capital and practical expertise to our executive team as we explore new opportunities and consider other acquisitions.”

Although Allen Sussman is newly appointed as General Counsel, he has worked with FAT Brands for several years and shepherded the company through its IPO and multiple acquisitions. He joins FAT from Loeb & Loeb LLP in Los Angeles, where he was a partner in the Capital Markets and Corporate Practice Groups. “I’m very excited to be joining FAT Brands in-house at this key juncture in the company’s evolution,” he said. “The company has a compelling story to tell, and I am eager to help build upon the impressive growth the company has achieved, in particular, over the last several years.”

Chief Financial Officer, Ken Kuick, most recently served as Chief Financial Officer for Noodles & Company (NASDAQ: NDLS). Prior to that, he was Chief Accounting Officer for VICI Properties (NYSE: VICI), a real estate investment trust. Ken also served as Chief Accounting Officer for Caesars Entertainment (NASDAQ: CZR) from 2014 to 2017 and as Vice President, Assistant Controller beginning in 2011.

Commenting on his appointment, Mr. Kuick said, “I am thrilled to join Andy and the entire FAT Brands team and play a role in helping to lead the organization as it continues its growth strategy. FAT Brands has an impressive portfolio of brands, tremendous growth potential and a dedicated team. Along with joining the strong FAT Brands team, I am equally looking forward to working with the amazing franchisees and serving as a resource for them.”

Rob Rosen, EVP Capital Markets, is a Wall Street veteran with over 30 years of experience in structured finance, banking, lending and on the portfolio management buy-side. Rob has worked on the banking side for Fleet Bank, Kidder Peabody and Bank of Tokyo and has spent over 20 years working with Black Diamond Capital Management in a variety of management, board level and advisory capacities.

“FAT Brands’ multi-brand platform has reached a critical mass in terms of quality holdings and infrastructure to enable additional brand acquisitions and internal growth to be significantly accretive from day one,” explained Rob Rosen. “A large component of executing FAT’s organic growth strategy as well as the acquisition roll up plan is effective use of the credit and capital markets and a disciplined approach to future purchases. I look forward to working with the group on all of these aspects.”


About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets and develops fast casual and casual dining restaurant concepts around the world. The Company currently owns nine restaurant brands: Fatburger, Johnny Rockets, Buffalo’s Cafe, Buffalo’s Express, Hurricane Grill & Wings, Elevation Burger, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises approximately 700 units worldwide. For more information, please visit www.fatbrands.com.


Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to our future financial and operating results and future acquisitions and growth. Forward-looking statements generally use words such as “expect,” “foresee,” “anticipate,” “believe,” “project,” “should,” “estimate,” “will,” “plans,” “forecast,” and similar expressions, and reflect our expectations concerning the future. Our future performance may differ materially from current expectations expressed in these forward-looking statements. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies including, but not limited to, uncertainties surrounding the severity, duration and effects of the current COVID-19 pandemic, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results expressed or implied in such forward-looking statements. We refer you to the documents we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other risks and uncertainties that could cause our actual results to differ materially from our current expectations and from the forward-looking statements contained in this press release. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

MEDIA
C
ONTACT
:

Erin Mandzik, JConnelly
[email protected]
862-246-9911



Western Union to Present at the J.P. Morgan Global Technology, Media and Communications Conference

Western Union to Present at the J.P. Morgan Global Technology, Media and Communications Conference

DENVER–(BUSINESS WIRE)–
The Western Union Company (NYSE: WU), a global leader in cross-border, cross-currency money movement and payments, today announced that the Company will present at the J.P. Morgan Global Technology, Media and Communications Conference on Tuesday, May 25, 2021. The presentation will begin 2:10 p.m. Eastern time and will include comments from Hikmet Ersek, CEO, and Raj Agrawal, CFO.

Investors and interested parties will be able to listen to the investor presentation via webcast from https://www.westernunion.com, under the investor relations section. The archived webcast will be available shortly after the conclusion of the presentation.

About Western Union

The Western Union Company (NYSE: WU) is a global leader in cross-border, cross-currency money movement and payments. Western Union’s platform provides seamless cross-border flows and its leading global financial network bridges more than 200 countries and territories and over 130 currencies. We connect businesses, financial institutions, governments, and consumers through one of the world’s widest reaching networks, accessing billions of bank accounts, millions of digital wallets and cards, and over half a million retail locations. Western Union connects the world to bring boundless possibilities within reach. For more information, visit www.westernunion.com.

WU-G

Media Relations:

Pia De Lima

+1 (954) 260-5732

[email protected]

Investor Relations:

Brendan Metrano

+1 (720) 332-8089

[email protected]

KEYWORDS: Colorado United States North America

INDUSTRY KEYWORDS: Professional Services Retail Technology Other Technology Specialty Finance Banking

MEDIA:

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CytoDyn to Submit Newly Completed Topline Report of CD12 Trial Results to Regulatory Agencies in Multiple Countries including India and Philippines

Finalized data analysis shows CD12 trial reached almost all of its major secondary 

endpoints in a subpopulation (62 patients) of critically ill COVID-19

VANCOUVER, Washington, May 18, 2021 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it intends to submit the results of its newly completed topline report of its CD12 Phase 3 clinical trial data for severe to critically ill COVID-19 patients to various regulatory agencies including but not limited to agencies in India and the Philippines.

A summary of the new key findings from the data of the CD12 Phase 3 clinical trial results, included in the newly completed topline report, consists of the following:


Efficacy
 
Safety
Leronlimab mortality better than placebo   No safety issues in CD12 or CD10 clinical trials
CD12: Critically ill population (7-day) 78 %   CD12: LL arm 21% less AE/patients (AE/all patients)
CD12: Critically ill population (14-day) 82 %   CD12: LL arm 3% less SAE/patients (SAE/all patients)
CD12: Critically ill population (21-day) 50 %   CD10: LL arm 59% less AE/patients (AE/all patients)
CD12: Critically ill population (28-day) 31 %   CD10: LL arm 64% less SAE/patients (SAE/all patients)

Patients in the CD12 trial were administered only two doses of leronlimab, the first dose at day zero and the second dose at day seven, while results were measured for 28 days (every 7 days). The results in the table above indicate that from day zero to day seven, critically ill patients receiving leronlimab (on day zero) experienced a mortality rate 78% lower than patients receiving placebo. Further, patients receiving the second dose of leronlimab achieved maximum benefit of 82% less mortality. However, the effects diminished from day 14 to day 21 and from day 21 to day 28, as the mortality rate decreased to 50% and 31%, respectively. This, we believe, was due to patients not being administered leronlimab past day 7.

The secondary endpoints met with statistically significant p-values for the critically ill subpopulation (62 patients) were:
      1)   All-cause mortality at day 14 (p =0.0233)
      2)   Proportion of patients achieving a category of 6 or higher on a 7-point ordinal scale at days 14 and 28 (p=0.036 & 0.038)
      3)   Change in clinical status of subject at day 14 on a 7-point ordinal scale (p=0.02)
      4)   Length of hospital stay in days (p=0.005)

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very thankful for the opportunity to be able to conduct two very crucial clinical trials in Brazil for severe and critically ill COVID-19 patients, which we believe could result in a statistically significant p-value of our primary endpoint leading the way to a potential approval. Although we did not meet our primary endpoint in our CD12 clinical trial in the mITT population, we were still very pleased that we did meet almost all of our secondary endpoints in the critically ill subpopulation of COVID-19 patients. To the best of our knowledge, we are unaware of another drug or therapeutic which has reported results in the critically ill population, in a randomized controlled trial, remotely close to what we reported for the CD12 trial. We are very excited for the opportunity to receive our first approval in multiple countries in great need of leronlimab. We are very confident this approval will happen this year.”

About Leronlimab (PRO 140)

The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH (nonalcoholic steatohepatitis). Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients). 

Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies. 

Cancer research has shown CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. As a result, CytoDyn is conducting two Phase 2 human clinical trials, one in mTNBC, which was granted Fast Track designation by the FDA in 2019, and a second in a basket trial which encompasses 22 different solid tumor cancers.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers. This trial will evaluate the effect of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC. It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term sequelae. Common symptoms include fatigue, cognitive impairment, sleep disorders, and shortness of breath. If this trial is successful, CytoDyn plans to pursue clinical trials to evaluate leronlimab’s effect on immunological dysregulation in other post-viral syndromes, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis. Preclinical studies revealed a significant reduction in NAFLD and a reduction in liver fibrosis using leronlimab. There are currently no FDA approved treatments for NASH. NASH is a leading cause of liver transplant. About 30 to 40 percent of adults in the U.S. live with NAFLD, and 3 to 12 percent of adults in the U.S. live with NASH. There have been no strong safety signals identified in patients administered leronlimab in multiple disease spectrums, including patients with HIV, COVID-19 and Oncology.

About CytoDyn

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH.

CytoDyn successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to refile its Biologics License Application (“BLA”) for this HIV combination therapy since receiving a Refusal to File in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the filing. CytoDyn expects to refile its BLA in the first half of the calendar year 2021 or shortly thereafter.

CytoDyn also completed a Phase 2/b3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension approval. Several patients on leronlimab’s Phase 2b/3 monotherapy extension arm have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 2 clinical trial with leronlimab in mTNBC, a Phase 2 basket trial in solid tumor cancers (22 different cancer indications), Phase 2 investigative trial for post-acute sequelae of SARS COV-2, also known as COVID-19 Long-Haulers, and a Phase 2 clinical trial for NASH. CytoDyn has already completed two trial in COVID-19 patients (a Phase 2 and a Phase 3). More information is at www.cytodyn.com

Forward-Looking Statements 

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to provide positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTS

Investors:

Cristina De Leon
Office: 360.980.8524
[email protected]