Day: September 28, 2021

PHOENIX, Sept. 28, 2021 (GLOBE NEWSWIRE) — WillScot Mobile Mini Holdings Corp. (“WillScot Mobile Mini Holdings” or the “Company”) (Nasdaq: WSC), a North American leader in turnkey modular space and portable storage solutions, today announced that Brad Soultz, Chief Executive Officer, and Tim Boswell, President & Chief Financial Officer, will join Thompson Research Group for a live discussion about the current state of the business on Tuesday, October 5, 2021 at 1:30 p.m. EDT.

About WillScot Mobile Mini Holdings

WillScot Mobile Mini Holdings trades on the Nasdaq stock exchange under the ticker symbol “WSC.” Headquartered in Phoenix, Arizona, the Company is a leading business services provider specializing in innovative flexible workspace and portable storage solutions. WillScot Mobile Mini services diverse end markets across all sectors of the economy from a network of approximately 275 branch locations and additional drop lots throughout the United States, Canada, Mexico, and the United Kingdom.

Additional Information and Where to Find It

Additional information can be found on the company’s website at www.willscotmobilemini.com

Contact Information

Investor Inquiries:

Nick Girardi
nick.girardi@willscotmobilemini.com

Media Inquiries:

Scott Junk
scott.junk@willscotmobilemini.com

Global Telephony Company is one of the most thoroughly due diligenced entities in commercial history, and applies some of the world’s most vigorous KYC and AML processes

ST PETER PORT, Guernsey and NEW YORK, Sept. 28, 2021 (GLOBE NEWSWIRE) — To provide access to its facilities at the same rates and terms worldwide, Global Telephony Provider, Webtel.mobi (“WM”), had to incorporate its business in what is known as a “Third Country” jurisdiction.

A “Third Country” is a country not part of any political or economic union or agreement between countries. Companies operating from Third Country jurisdictions are able to provide their services worldwide, at the same rates and terms, without having to open subsidiaries in other countries.

There are less than 10 Third Country jurisdictions; one of which is Guernsey in the Channel Islands. WM chose to headquarter in Guernsey due to its highly regarded status as one of the most secure, stable and regulatorily robust jurisdictions internationally, as well as its high level of infrastructure and professional services.

Various companies in Guernsey – including WM – are obligated to have their activities supervised by a “Resident Agent” firm at all times. This supervisory role is to closely monitor all activities of a company on behalf of the Guernsey Regulatory authorities, to ensure permanent compliance with all Regulatory and legal requirements. WM’s activities are, therefore, permanently monitored by the nominated personnel of the Resident Agent firm responsible for it.

During WM’s nine years of worldwide operational testing of its Platform 1, the company underwent over 30 due diligence exercises. These included due diligences by Merchant Banks (including the world’s independent Investment Bank), multiple large banks, multiple firms of attorneys, specialist global consultancies, two of the world’s premier Regulatory Agencies, one of the world’s premier Stock Exchanges, and multiple other leading and qualified independent entities worldwide. These due diligences were conducted in multiple countries, over five continents.

WM is one of the most thoroughly due diligenced companies in corporate history, and this high level of scrutiny was specifically accepted and welcomed by WM. The reason for that was and is due to the strategic size and volumes of the markets the WM System would become involved in – and with WM having potentially sector-influencing advantages in each of them. It was therefore part of WM’s strategy to ensure that all legal, regulatory, technical, administrative, logistical, and other aspects were robustly checked and re-verified by credible and qualified external entities, prior to WM commencing unrestricted global operations.

Consequently, although WM’s highly qualified internal personnel signed off on all aspects of WM themselves, no internal sign-offs were ever accepted by WM until multiple qualified and unimpeachable third party entities had also reviewed and signed off on the same aspects.

Since WM’s completion of the rebuild of its Platform 2 – and despite Platform 2 conforming with all legal and regulatory requirements as confirmed by Platform 1 operations and due diligences – WM again agreed to the due diligence of the company and its Platform 2 by a large banking group, a global consultancy, and the Resident Agent in Guernsey.

This was in accordance with WM’s policy that regular and continuous external scrutiny is a Best Practice policy, and that close co-operation between companies and Regulatory Agencies results in a safer and more secure commercial environment for all parties – including for WM and its Members.

Moreover, other than the detailed scrutiny of its own its own legal and regulatory situation and profile, WM also applies a unique and world-leading system of Anti Money Laundering (AML) and Know your Client (KYC) procedures in respect of its Members.

To utilize some of WM’s services and facilities – and despite WM providing a Members-Only Closed-Loop service and not a public service – WM Members need to:

1. Upload KYC Documents certified by an attorney or notary (according to specific guidelines).
2. Have the Certifying Attorney or Notary Re-verify the Certified documents once they have been uploaded.
3. The Certified and Re-verified KYC documentation is then checked by WM personnel for completeness.
4. The Certified and Re-verified KYC documentation is then checked by the Resident Agent against Sanctions Lists and other lists of prohibited Persons or Entities issued by international agencies.
5. WM’s Artificial Intelligence Complex System additionally constantly checks the Re-verifications carried out by Attorneys and Notaries to monitor for any anomaly in respect of physical distance between Certifier and the person or entity being certified, the frequency and numbers of persons or entities being certified by an Attorney or Notary, and other anomalies.
6. There are additional KYC and especially AML procedures applied and carried out within – and by – the WM System that are not made publicly available, in order to maintain process security and confidentiality.

The in-house KYC and AML process of WM has been described as one of – if not the – most comprehensive KYC and AML systems in the world.

Consequently, in respect of its own compliance and the compliance procedures applied by it, WM is one of the most robustly compliant companies in operation today.

Notes: WM has recently released a video of an interview on the regulatory environment in Guernsey and WM’s regulation, provided by its supervising Resident Agent in Guernsey. This video of the interview is available for public review, and a url to the video of the interview is provided in the Resources section of this release.

Resources:

Media Contact:
Nick Lambert: wm@thoburns.com

Video Interview:
The Guernsey Regulatory Regime and WM’s Regulatory Compliance
https://youtu.be/u522lVsGIJI

Video Interview:
The Capacities and Reach of the WM System and TUV Digital Currency
https://youtu.be/XYBrCikUhn8

Research Reports:
The Capacities and Reach of the WM System and TUV Digital Currency
https://tinyurl.com/TUVresearch

Characteristics of WM’s TUV Digital Currency:
https://tinyurl.com/TUVdata

WM’s urls:
https://webtel.mobi/pc (Tablets / Laptops / Desktops)
https://webtel.mobi (Smart Phones)
https://webtel.mobi/wap (Pre-Smart Mobile Phones)

— ENA Respiratory engages PPD, Inc. for Phase 2 COVID-19 post-exposure prophylaxis study and hVIVO for influenza challenge study to assess the efficacy of fast-acting nasal spray designed to boost innate immunity

SYDNEY, Australia, Sept. 28, 2021 (GLOBE NEWSWIRE) — ENA Respiratory, a biotechnology company developing a first-in-class nasal spray for the prevention of COVID-19 and other respiratory viral infections, announced today that it has engaged research partners PPD, Inc. and hVIVO, a division of Open Orphan, to conduct its Phase 2 studies. The self-administered nasal spray, INNA-051, is being developed to stimulate the innate immunity in the nose, where most respiratory viral infections begin. This announcement follows encouraging preliminary results from the ongoing Phase 1 study which supports decision to progress INNA-051 development to Phase 2 studies.

In partnership with PPD, Inc., ENA Respiratory will conduct a Phase 2, randomised COVID-19 post-exposure antiviral prophylaxis study, to determine whether INNA-051 reduces the incidence and severity of symptomatic COVID-19 following close contact with COVID-19 positive individuals. The study will also evaluate whether the nasal spray reduces the magnitude and duration of SARS-CoV-2 nasal shedding, to understand potential broader public health benefits. The study will be conducted in several countries and will initially recruit adults ages 18 to 55 who have had recent exposure to someone with confirmed COVID-19. Recruitment is expected to begin in January 2022.

“We are pleased that Ena Respiratory has entrusted us with helping develop its Phase 2 studies for this important therapeutic,” said Elisha Talley-Roithner, senior vice president of development operations and portfolio management for PPD. “Our early, direct and ongoing experience managing COVID-19 trials enables us to continue providing customers with innovative solutions to support development of therapies and vaccines to address the global pandemic.”

Additionally, in partnership with hVIVO (part of Open Orphan plc), ENA Respiratory will begin an influenza challenge pre-exposure prophylaxis study in adults ages 18 to 55. The study will evaluate the safety and efficacy of INNA-051 in reducing the total viral load of treated participants versus placebo. The study will be conducted in the United Kingdom and is expected to begin in January 2022.

Cathal Friel, executive chairman of Open Orphan plc said, “We are pleased to partner with ENA Respiratory to carry out this Phase 2a trial, using hVIVO’s Influenza human challenge study model. As the world leading provider of human challenge trials, we have significant experience in successfully conducting these types of trials, and we look forward to working alongside the ENA Respiratory team to investigate the efficacy of this candidate.”

“In recent months, SARS-CoV-2 variants including the Delta variant have continued to spread around the world, at the same time other respiratory viruses like RSV have seen a resurgence in some countries. There continues to be an urgent need for treatments that will work alongside vaccines, especially for those at high risk of complications or those who do not mount an adequate immune response to vaccines, such as the elderly, patients with chronic respiratory diseases and the immunocompromised,” said Christophe Demaison, Ph.D., co-founder and CEO of ENA Respiratory. “These Phase 2 studies will take us closer to understanding whether our nasal spray can prevent illness and reduce the risk of community spread of common respiratory viruses.”

The Phase 1 study of INNA-051, designed to investigate safety and tolerability of single and multiple administrations of INNA-051 in healthy adults aged 18 -85, is expected to be completed in Q1 2022, with interim results available in late Q4 2021. It is being conducted at Scientia Clinical Research in Randwick, New South Wales, Australia.

Notes to Editors

If you would like to arrange an interview, please contact:

• Glenn Silver, Finn Partners, +1 973 818 8198, glenn.silver@finnpartners.com

About ENA Respiratory and INNA-051

ENA Respiratory is aiming to transform the treatment and prevention of respiratory viral infections in at-risk populations. The company is based in Melbourne and Sydney, Australia.

INNA-051 is a potent innate immune agonist that targets the receptor TLR2/6. It is being developed for intranasal delivery to target the primary entry site of viral respiratory infections as most respiratory viruses, including SARS-CoV-2 and influenza, initially infect and replicate in nasal mucosa epithelial cells. Fast acting and inducing a durable biologic response supporting weekly administration, INNA-051 works by recruiting innate immune cells and priming epithelial cells of the nasal mucosa to respond more quickly to infections, rapidly eliminating viruses and other pathogens before they spread throughout the body.^1,2 INNA-051 and close analogues have been shown in preclinical studies to be effective against to multiple respiratory viruses, including SARS-CoV-2³, influenza (H1N1 and seasonal H3N2)^2&4 and rhinovirus¹.

Key features of INNA-051 intranasal administration include limited minimal or no systemic bioavailability, minimal or no systemic pro-inflammatory cytokine release, no direct type I interferon upregulation, durable immune response supporting weekly administration and compatibility with vaccine⁵ and intranasal corticosteroids. ¹

For more information, please visit https://enarespiratory.com

References:

1. Girkin, J et al. TLR2-mediated innate immune priming boosts lung anti-viral immunity. European Respiratory Journal. 2020. 2001584; DOI: 10.1183/13993003.01584-2020
2. Deliyannis, G. et al. TLR-mediated activation of innate responses in the upper airways confers antiviral protection of the lungs. JCI Insight. 2021. 6(5):e140267. https://doi.org/10.1172/jci.insight.140267
3. Proud PC et al. Prophylactic intranasal administration of a TLR2/6 agonist reduces upper respiratory tract viral shedding in a SARS-CoV-2 challenge ferret model. EBioMedicine. 2021 Jan;63:103153. doi: 10.1016/j.ebiom.2020.103153. Epub 2020 Dec 3.
4. Tan A.C., Mifsud E.J., Zeng W., Edenborough K., McVernon J., Brown L.E., Jackson D.C. (2012). Intranasal administration of the TLR2 agonist Pam2Cys provides rapid protection against influenza in mice. Mol Pharm. 49:2710-2718.
5. Mifsud, E.J., Tan, A.C., Brown, L.E., Chua, B.Y., Jackson, D.C. (2015). Generation of adaptive immune responses following influenza virus challenge is not compromised by pre-treatment with the TLR-2 agonist Pam2Cys. Front Immunol. 6:290.

U.S. Polo Assn.

U.S. Polo Assn.

WEST PALM BEACH, Fla. & POOLE, England, Sept. 28, 2021 (GLOBE NEWSWIRE) — U.S. Polo Assn., the official brand of the United States Polo Association (USPA), in collaboration with its U.K. licensee, Brand Machine Group, was the Official Apparel Partner for the British Beach Polo Championship 2021, played September 17-18 at Sandbanks Beach in Poole, England.

Through this partnership, U.S. Polo Assn. outfitted the polo players, provided staff outfitting, branded caps for attendees, and global promotion of the event across various digital platforms. This is the first year U.S. Polo Assn. has partnered with the British Beach Polo Championship tournament.

Now in its 14th year, The British Beach Polo Championships, also known as Sandpolo, is the largest beach polo event in the world. Sandpolo is a unique way to watch and play the sport of polo on the stunning shores of Sandbanks Beach, a world-famous destination known for its luxury properties and pristine sand. A twist on traditional polo, Sandpolo is played with an oversized orange ball designed not to get lost in the sand but still move at a high speed.

In the sold-out Sandbanks Beach Arena, thousands of Sandpolo fans were close enough to the action to see all the fast-paced competition between Team Whispering Angel and Team Lightning Commercial Finance during the two-day event. In the end, it was Whispering Angel (Chris Gregory, Hazel Jackson & Adolfo Casabal) that took the British Beach Championships 2021 title with a 19-14 victory against Team Lightning Commercial Finance (Garrie Renucci, Ollie Cork & Nick Van Open).

“With the U.K. being one of U.S. Polo Assn.’s most loyal and fastest-growing markets, we were proud to be part of the exciting British Beach Polo Championships,” said J. Michael Prince, President and CEO of USPA Global Licensing, which manages the global, multi-billion-dollar U.S. Polo Assn. brand. “We love that Sandpolo is yet another opportunity to expose new polo fans and global consumers to the sport and this brand in such a unique and fun way.”

In advance of the event, there were sweepstakes opportunities for fans to win unique prizes and “a piece of the sport,” including a hospitality tent VIP experience and more than five hundred dollars’ worth of U.S. Polo Assn. brand gear and apparel.

“This year’s event received great exposure, thanks in part to U.S. Polo Assn.,” says Johnny Wheeler, the director of Sandpolo. “As the official brand of the United States Polo Association, this partnership for the 14th Annual British Beach Polo Championships was a win-win for everyone involved.”

About U.S. Polo Assn. and USPA Global Licensing Inc. (USPAGL)

U.S. Polo Assn. is the official brand of the United States Polo Association (USPA), the nonprofit governing body for the sport of polo in the United States and one of the oldest sports governing bodies, having been founded in 1890. With a multi-billion-dollar global footprint and worldwide distribution through some 1,100 U.S. Polo Assn. retail stores, department stores, sporting goods channels, independent retailers and e-commerce. U.S. Polo Assn. offers apparel for men, women and children, as well as accessories, footwear, travel and home goods in 180 countries worldwide. Recently ranked the fifth largest sports licensor in License Global magazine’s 2020 list of “Top 150 Global Licensors,” U.S. Polo Assn. is named alongside such iconic sports brands as the National Football League, the National Basketball Association and Major League Baseball. Visit uspoloassnglobal.com.

USPA Global Licensing Inc. (USPAGL) is the for-profit subsidiary of the USPA and its exclusive worldwide licensor. USPAGL manages the global, multi-billion-dollar U.S. Polo Assn. brand and is the steward of the USPA’s intellectual properties, providing the sport with a long-term source of revenue. Through its subsidiary, Global Polo Entertainment (GPE), USPAGL also manages Global Polo TV, the world’s leading production entity for global polo broadcasts and polo lifestyle content. Learn more at globalpolo.com.

Brand Machine Group – United Kingdom

The Brand Machine Group (BMG) is an international fashion brand owner and licensing specialist, housing a diverse and industry-leading portfolio of fashion, sports and outdoor brands including U.S. Polo Assn., across adults and childrenswear clothing and accessories. With more than 35 years of experience, Brand Machine Group specialises in global licensing, and partners with recognized market leaders to manage a seamless and collaborative process of designing, manufacturing and delivering quality product whilst championing the DNA of its brands. Visit Brand Machine Group.

###

For further information contact: 
Shannon Stilson – AVP, Marketing
Phone +001.561.227.6994 – Email: sstilson@uspagl.com

Stacey Kovalsky – Senior Director, Global Communications
Phone +001.561.790.8036 – Email: skovalsky@uspagl.com

Related Images

Image 1: U.S. Polo Assn.

U.S. Polo Assn
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Attachment

• U.S. Polo Assn.

GHENT, Belgium, Sept. 28, 2021 (GLOBE NEWSWIRE) — MRM Health, a biopharmaceutical company developing next-generation live microbiome consortia therapeutics, announced today that they have received regulatory approval from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium to start a Phase 1b/2a trial with the novel next-generation optimized consortium therapy, MH002, in patients with mild-to-moderate ulcerative colitis (UC).

MH002 is the first rationally-designed consortium therapy, in which key disease-driving mechanisms guide therapeutic microbial strain selection, to enter clinical studies in patients. Developed through MRM Health’s proprietary Microbiome Optimization Technology, MH002 consists of 6 well-characterized commensal strains that are optimized to form a synergistic microecosystem driving differentiated potency, resiliency, and engraftment. Combining rational selection of disease-modifying strains with consortium optimization to ensure live delivery, engraftment, and durability is expected to result in greater efficacy than conventional microbiome therapeutics.

MH002 is produced using MRM Health’s breakthrough scalable, robust, and standardized cGMP manufacturing platform, overcoming past microbiome challenges in manufacturing multi-strain consortia of uniform composition. MRM Health’s standardized platform allows the manufacturing of complete consortia as a single drug substance, expected to provide both key regulatory and patient compliance advantages.

Preclinical studies in inflammatory bowel disease (IBD) models showed that MH002 repairs gut microbiome dysbiosis, heals the dysfunctional intestinal barrier, and restores immune homeostasis with its differentiated mechanism targeting multiple key disease pathways. MH002 has demonstrated excellent safety and superior preclinical efficacy as compared to conventional, non-optimized microbiome therapeutics as well as mesalamine, the current first-line standard of care in UC.

MRM Health’s Phase 1b/2a study is a multi-center, double-blind, randomized, placebo-controlled trial which will enroll 45 mild-to-moderate UC patients. The trial is designed to evaluate safety, mechanistic effects, and initial efficacy of MH002 on disease activity (EUDRACT Number: 2020-004355-33).

Substantial clinical unmet need persists in UC as many patients remain refractory to standard of care and current treatments (e.g., anti-inflammatory, immunosuppression approaches) primarily provide symptomatic relief. MH002’s disease-modifying mechanism is anticipated to induce remission via immunomodulation, rather than immunosuppression, resulting in superior safety with no elevated risks associated with reduced immune system functioning.

“There is definitely an important medical need for an effective and safe new medicinal product for the treatment of mild-to-moderate UC. MH002 has all the characteristics and potential to fill that need and may become a novel tool in the first-line treatment of UC,” said Prof. Séverine Vermeire (MD, PhD), IBD expert at the Gastroenterology Department of the University Hospitals Leuven, Belgium, and coordinating investigator of the trial.

“Reaching this milestone is the start of an exciting period of clinical development that is expected to provide the first clinical Proof-of-Concept of our differentiating consortia optimization platform and breakthrough single-process manufacturing technology,” said Sam Possemiers (PhD), Chief Executive Officer and Co-Founder of MRM Health. “We are eager to work with our investigators to bring this first-in-class, rationally-designed bacterial consortia therapeutic product into patients.”

About MRM Health

MRM Health NV, Ghent, Belgium, is a biopharmaceutical company focused on the development of next-generation optimized consortium therapeutics based on the human microbiome. The company has built a diversified pipeline with its proprietary platform to design, optimize, and manufacture bacterial consortia as single drug substances. Its most advanced program MH002 is an optimized consortium of 6 rationally-selected and well-characterized commensal strains. MH002 is entering a Phase 1b/2a study in patients with mild-to-moderate ulcerative colitis in Q4 2021. Additional pipeline development includes a preclinical program in Parkinson’s disease, two preclinical programs in metabolic disease (partnered with IFF Nutrition Biosciences, previously DuPont), and a discovery program in autoimmune disease, including spondyloarthritis.

About IBD and UC

Ulcerative colitis (UC) is a chronic, autoimmune, inflammatory bowel disease (IBD) characterized by mucosal inflammation of the rectum and colon resulting in debilitating diarrhea, abdominal pain, and rectal bleeding. Current treatments include symptomatic anti-inflammatory therapies and immunosuppressants. In many cases, these therapies fail to induce enduring remission and/or cause potentially severe adverse events.

For further information please contact:

Dr Sam Possemiers – CEO
Christiane Verhaegen – CFO
Phone: +32.9.241.11.88
info@mrmhealth.com