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#POLB Poolbeg Pharma PLC – POLB 001 LPS Trial Data to be Presented at IUIS
16 November 2023 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, announces that an abstract highlighting the potential of POLB 001 as a groundbreaking therapy has been accepted for presentation at the 18th International Congress of Immunology (‘IUIS’), to be held 27 November – 2 December 2023 in Cape Town, South Africa.
IUIS is the world’s leading conference in the field of immunology and attracts immunologists from universities, healthcare providers, independent research organisations and industry leaders. It serves as a premier platform for the exchange of the latest cutting-edge discoveries and advancements in immunological research.
The poster presentation will discuss POLB 001’s positive LPS human challenge trial results. POLB 001 is a potential treatment of severe influenza and Cytokine Release Syndrome (CRS) associated with cancer immunotherapies. CRS is a severe inflammatory response, which may be encountered as a side effect of some therapies, manifesting a range of symptoms that can rapidly progress to a severe life-threatening reaction. An effective therapy for CRS could unlock the benefits of cancer immunotherapies, benefiting patients and healthcare systems alike.
Title: Inhibition of local and systemic inflammatory responses by POLB 001, a novel p38 MAPK inhibitor, following in vivo LPS administration in healthy volunteers
Session Date: 1 December 2023
Presentation Time: 12pm – 1pm SAST
Location: Hall 2
Presenter: Digna de Bruin, The Centre for Human Drug Research
If you would like to meet with Poolbeg Pharma, get in touch at partnering@poolbegpharma.com
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: “The acceptance of this abstract at the upcoming IUIS conference underscores the potential of POLB 001 as a groundbreaking therapy. Severe influenza and Cytokine Release Syndrome associated with cancer immunotherapies are significant problems and an effective drug that can address these issues would have a significant impact on global health.”
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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Cavendish Capital Markets Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Optimum Strategic Communications Nick Bastin, Hana Malik, Vici Rabbetts
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+44 (0) 208 078 4357 |
About Poolbeg Pharma
Poolbeg Pharma plc is focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need. Its model focusses upon developing its exciting clinical assets and commercialising approved and marketed drugs to fund the development of its robust pipeline of innovative products, thereby driving significant value creation.
Poolbeg is led by an experienced leadership team with a history of delivering significant shareholder value. The team and Board have been augmented with strong commercialisation expertise following the appointment of three former members of the Amryt Pharma plc leadership team, with the intention of repeating Amryt’s success and generating near term revenues.
Poolbeg’s clinical programmes target large addressable markets across cancer immunotherapies, infectious disease, and oral GLP-1 agonists for obesity and other metabolic conditions. It uses a cost-effective development philosophy to generate high quality human data to support partnering and further development. Its AI-led infectious disease programmes analyse unique data from human challenge trials to identify clinically relevant drug targets and treatments, leading to faster development and greater commercial appeal.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
#TEK Capital investee company #BELL Belluscura PLC – Orders for over 6,500 DISCOV-R™ received
LONDON, U.K. AND PLANO, TX, U.S. (16 August 2023). Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that it has received purchase orders for over 6,500 of its next-generation DISCOV-R portable oxygen concentrator. This represents approximately $15 million of potential revenue to the Company, with initial production of the DISCOV-R expected to begin by the end of this quarter.
Following the pre-market launch of DISCOV-R and a patient usability study in June 2023, the Company plans a controlled roll out of the DISCOV-R this autumn and into 2024 to meet growing demand for the device amid substantial interest from medical device distributors, retailers, patients and durable medical equipment (DME) providers, among others.
The DISCOV-R is expected to be the world’s first ambulatory two litre continuous flow, eight level pulse dose portable oxygen concentrator when it is released. With the ability to produce two litres of continuous flow and maximum single pulse dose volumes exceeding 110ml, the Company believes that the DISCOV-R will be covered by both CMS E1390 (stationary) and E1392 (portable) reimbursement codes, making the DISCOV-R a better financial option for the thousands of homecare oxygen providers. It will also produce nearly three times as much oxygen by weight than its dual flow competitors.
The recent purchase orders follow the signing of several distribution agreements with medical device distributors and other home healthcare providers, including a distribution agreement with a division of McKesson, one of the largest distributors of pharmaceuticals and medical devices in North America, earlier this month and a marketing agreement with GoodRx®, a leading digital healthcare platform, in February 2023. The Company has received multiple additional requests from leading oxygen homecare providers in the US to distribute the DISCOV-R.
The Company will update the market later this year as it plans its controlled roll out of the DISCOV-R this autumn and into 2024.
Substantial progress on X-PLOR® and proprietary NOMAD biometric app
At the same time, the Company continues to progress its CE and UKCA registration mark application for its X-PLOR® portable oxygen concentrator. Since resources in the US were redirected to completing the development and launch of the DISCOV-R, production of X-PLOR by our Chinese partner, Innomax Medical Technology Ltd (Innomax), has now progressed, with 1,500 units recently being manufactured and shipped to the US for distribution.
The Company recently established a subsidiary and hired its first employees in Shenzhen, China as it prepares for the anticipated registration of the X-PLOR for sale and distribution in China and Hong Kong later this year. The Company and Innomax believe there is a significant market opportunity in China with approximately 100 million people suffering from COPD.
Additionally, the Company continues to drive innovation in telemedicine and artificial intelligence with its proprietary NOMAD biometric app. The NOMAD app will allow users of the DISCOV-R to track performance data on their concentrator and connected devices such as an Apple® or Samsung® Watch, FitBit® device or Nonin® and Masimo® pulse oximeters. The collective information can then be provided to a patient’s healthcare provider in person or remotely.
The Company is already working on the next-generation NOMAD app that will alert patients when their blood oxygen saturation level has varied beyond parameters set by their doctor, which is expected to help patients better monitor their conditions, but also improve the efficiency of the device by delivering supplemental oxygen as needed.
Bob Fary. Sr Vice President of Global Sales, Belluscura plc, commented:
“We are very excited about the overwhelming interest in the DISCOV-R by online retail sellers and other medical equipment providers. Following the pre-market launch of the product and the patient usability study in June, initial feedback suggests we will receive the same or greater level of interest from leading home healthcare providers once it is launched commercially.”
Bob Rauker, Chief Executive Officer, Belluscura plc, commented:
“We believe the DISCOV-R, combined with our proprietary NOMAD app, will be transformational to the portable oxygen industry and patient outcomes. This is reflected by early demand for the product prior to its full commercial launch, which is expected to take place later this year. The significant number of orders received demonstrates the substantial appetite for this product and we anticipate adding several more of these providers to our distribution network as we balance the high demand with production expectations over the next twelve months.
“This marks another exciting development for the Company, delivering on our strategy to design and manufacture highly differentiated, high quality and high margin products. Amid growing sales and continued progress with our X-PLOR device and NOMAD app, we continue to seek further opportunities to improve the quality of life for our end users”.
For further information please contact:
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Belluscura plc |
Tel: +44 (0)20 3128 8100 |
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Adam Reynolds, Chairman |
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SPARK Advisory Partners Limited Nominated Adviser |
Tel: +44 (0)20 3368 3550 |
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Neil Baldwin / Jade Bayat |
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Dowgate Capital Limited Broker |
Tel: +44 (0)20 3903 7715 |
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James Serjeant / Russell Cook |
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MHP Financial PR & Investor Relations |
Tel: +44 (0)20 3128 8100 email: Belluscura@mhpgroup.com |
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Katie Hunt/Matthew Taylor |
#TEK Tekcapital PLC investee co #BELL Belluscura PLC – appoints Senior VP of Global Sales
Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen enrichment technology, announces that Robert (“Bob”) Fary has joined the Company as Senior Vice President of Global Sales.
Bob has thirty-years of experience in the respiratory industry where he has held leadership roles at major oxygen concentrator manufacturers and durable medical equipment companies. During the past two decades, Bob’s industry leading team was directly responsible or contributed to the sale of over 1 million portable oxygen concentrators (“POCs”), generating revenues in excess of $1 billion.
Commenting on the hire, Robert Rauker, Chief Executive Officer, Belluscura plc, said:
“We are very excited that Bob has joined our team as we enter the next stage of growth at Belluscura. His deep knowledge of the portable oxygen concentrator sector and its channels to market will be invaluable as we build on our success to date to bring our latest generation of POCs to market.”
Bob Fary, Senior Vice President of Global Sales, commented:
“I am delighted to have joined Belluscura at this important juncture for the Company as it captures the demand in its markets for its best-in-class products. The planned launch of DISCOV-R will be another exciting step in meeting the needs of patients around the world. I look forward to working alongside the wider executive team to grow the Company’s sales in the US and beyond.”
For further information, please contact:
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Belluscura plc |
www.belluscura.com |
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Robert Rauker, Chief Executive Officer |
via MHP |
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Anthony Dyer, Chief Financial Officer |
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SPARK Advisory Partners Limited (NOMAD) |
Tel: +44 (0)20 3368 3550 |
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Neil Baldwin |
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Dowgate Capital Limited (Broker) |
Tel: +44 (0)20 3903 7715 |
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James Serjeant / Nicholas Chambers |
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MHP (Financial PR and Investor Relations) |
Tel: +44 (0)20 3128 8100 |
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Katie Hunt / Pete Lambie / Matthew Taylor |
Email: belluscura@mhpgroup.com |
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About Belluscura plc ( www.belluscura.com )
Belluscura is a UK medical device company focused on developing high performing, lightweight and portable oxygen enrichment technology used in a broad range of industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health, mobility and economic outcomes for patients, healthcare providers and insurance organisations.
#TEK TekCapital Plc investee co. #BELL Belluscura Plc – Year-end Trading Update
LONDON, U.K. AND PLANO, TX, U.S. (13 January 2023) Belluscura plc (AIM: BELL), a leading medical device developer focused on lightweight and portable oxygen concentrator (“POC”) technology, provides a trading update for the year ended 31 December 2022.
The Group is pleased to announce that it has made considerable progress this year. Since the launch of the 1st generation X-PLOR in September 2021, the Group is now distributing throughout the US through multiple sales channels: Distributors and Durable Medical Equipment Providers both Online and Bricks and Mortar, Medical Supply Warehouses, Medical Device Intermediaries, Hospitals and Direct to Consumer.
In addition, the collaboration agreement with the VGM Group has already resulted in 17 new distribution agreements in the last 3 months, including the agreement with a leading durable medical equipment provider and distributor in the US, announced in September 2022, which serves nearly 2 million patients both online and through over 1,000 locations.
In December 2022 we also signed our first international distribution agreement, with MedHealth Supplies of South Africa, which sells to one of the world’s leading respiratory device suppliers. We have already received orders for over 1,000 units, with their first shipment sold out within 48 hours.
In December we produced a record 536 units in our in-house facility and with Innomax coming on-line in Q1 this will more than double production of X-PLOR. Of important note, even with the rapid increase in volume, the production quality of our in-house facility has been outstanding, with no units returned due to defects.
By 31 December 2022 the Company had shipped or received orders for 2,850 X-PLOR units with 1,226 units being shipped in 2022 (2021: 377). As at the year end, the Adjusted EBITDA1 loss is anticipated to be in line with market expectations and retained cash balances of $1.8 million, which together with inventory and inventory deposits, amounted to $11.9 million.
The next generation X-PLOR, launched in September 2022, has been well received by the market based upon its performance and reliability. It provides more oxygen by weight than any portable oxygen concentrator in its class and is the first POC with a mobile app that connects to phones, tablets, pulse oximeters and wearables (the NOMAD Biometric App).
The first DISCOV-RTM POCs expect to be launched for pre-market evaluation in Q1 2023, with full commercialisation anticipated in Q2. DISCOV-R is the first ambulatory pulse-dose and two-litre continuous flow POC in the world. Weighing c.40% less than any comparable dual flow oxygen concentrator on the market, the DISCOV-R produces nearly 3 times the oxygen by weight than its competition. Distributors are very excited about DISCOV-R and it is already receiving pre-orders. The DISCOV-R will also include the transformational NOMAD Biometric App.
In March 2022, we signed a manufacturing Master Supply Agreement (“MSA”) with InnoMax Medical Technology, Ltd (“InnoMax”) to manufacture the X-PLOR portable POC in China, more than doubling our manufacturing capacity in 2023 and enabling us to accelerate our international expansion by opening up markets in Asia and beyond. Innomax are anticipated to directly source most of their own components from the second half of 2023, which will also result in a significant margin improvement and reduction in the Company’s inventory levels.
Given the strong demand, the Group took the decision to transfer its US manufacturing in-house, to increase production output at high quality standards, and achieve a significant reduction in production costs. This was successfully completed at the end of July 2022, enabling the achievement of ISO:13485 accreditation. The manufacturing facility is already demonstrating the required product quality to build a significant customer base and repeat orders, underpinning the building of a strong brand reputation for our best-in-class technology.
Following this transition and having achieved ISO13485 accreditation, we are confident in having both the quality of manufacturing facilities and the inventory levels to increase production commensurate with market demand, as we expand our sales channels and are able to apply to distribute products internationally.
Robert Rauker, CEO of Belluscura plc, commented: “During the year we have made considerable progress. We have enhanced our production, quality accreditation and supply chain, positioning us well to deliver on the demand we are seeing for our devices, as we expand our distribution partners and geographical reach. Market reception for the next generation X-PLOR and Nomad App has been extremely positive, with an encouraging level of forward orders. We are very excited about the upcoming launch of the DISCOV-R, which we believe will be a transformational product, and we look to the future with confidence.”
Adjusted EBITDA is earnings before interest, tax, depreciation, amortisation, share-based payment expense, foreign exchange movements and non-recurring items.
For further information please contact:
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Belluscura plc |
www.belluscura.com |
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Robert Rauker, Chief Executive Officer |
via MHP |
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Anthony Dyer, Chief Financial Officer |
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SPARK Advisory Partners Limited (NOMAD) |
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Neil Baldwin |
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Dowgate Capital Limited (Broker) |
Tel: +44 (0)20 3903 7715 |
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James Serjeant / Nicholas Chambers |
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MHP (Financial PR and Investor Relations) |
Tel: +44 (0)20 3128 8100 |
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Katie Hunt / Pete Lambie / Matthew Taylor |
Email: belluscura@mhpgroup.com |
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About Belluscura plc (www.belluscura.com)
Belluscura is a UK medical device company focused on developing oxygen enrichment technology spanning broad industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health and economic outcomes for the patients, healthcare providers and insurance organisations.
#POLB Poolbeg Pharma PLC – Poolbeg identifies novel RSV drug candidates
Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading infectious disease focused biopharmaceutical company, announces that it has successfully identified potential new drug candidates from its Respiratory Syncytial Virus (‘RSV’) artificial intelligence (‘AI’) Programme with OneThree Biotech, Inc.
Since initiating the collaboration in February 2022, Poolbeg’s scientific team has worked closely with OneThree to build a tailored AI approach that leverages Poolbeg’s unique RSV human challenge trial data in order to identify disease-relevant biological pathways and potential drug targets. Based on those newly discovered drug targets, the collaboration has now identified a number of promising drug candidates to rapidly bring forward to lab-based validation to determine the full potential of these assets.
The Company has prioritised compounds with existing Phase I clinical data and which could, if successfully validated, be repositioned as novel treatments for RSV infection. Candidates with solid safety and pharmacodynamic data in humans are well positioned to rapidly enter a clinical trial to generate early human efficacy data for RSV. This is in line with Poolbeg’s efficient, capital light clinical development strategy that is at the core of its ambitious growth model.
RSV, which inflames the smallest airways of the lungs, usually sends an average of 58,000-80,000 children under the age of 5 to hospital each year in the US alone, according to the US Centers for Disease Control and Prevention (CDC). RSV can also be dangerous for adults over the age of 65, resulting in around 177,000 hospitalisations per year in the United States alone. The current cold and flu season commenced about two months earlier than anticipated and already rivals some of the worst seasons on record with RSV hospitalising young children in the United States and Europe at an alarming rate. Public health officials have been warning for weeks that a “tripledemic” of SARS-CoV-2, influenza and RSV would strain an already weary healthcare system. RSV has made so many young children ill this fall that weekly paediatric hospitalisations in the US are the highest recorded.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “In the past few months, RSV has been sending children to hospital at alarming rates in the United States and Europe. As paediatric units fill beyond capacity, and our healthcare systems contend with a ‘tripledemic’ of RSV, influenza and SARS-CoV-2, the need for better treatments has never been so urgent.
We’re impressed with the quality of work executed so far with OneThree leveraging their AI expertise to present new drug potential candidates from our unique human challenge trial data which Poolbeg will now optimise for further development in RSV, the only one of the three main respiratory illnesses for which there are not yet any approved vaccines and where treatment options are limited.”
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Neel S. Madhukar, PhD, co-founder and CEO of OneThree Biotech, said: “We are very pleased to be working with Poolbeg and to have the opportunity to deploy the ATLANTIS platform to complete the first ever AI-driven analysis of RSV disease progression data. I am delighted that Poolbeg’s unique dataset combined with OneThree’s externally validated platform have now delivered new actionable insights surrounding disease biology and drug discovery that can bring much needed treatment options for both the young and the elderly; the most vulnerable to RSV infection.”
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Optimum Strategic Communications Mary Clark, Nick Bastin, Manel Mateus, Vici Rabbetts
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+44 (0) 208 078 4357 |
About Poolbeg Pharma
Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in prevalent and emerging infectious diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, and in-license near or in the clinic medicines, leading to faster development and greater commercial appeal.
The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.
With its initial assets from hVIVO plc (formerly Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has completed its LPS human challenge trial with full data read-out expected in Q2 2023; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing two Oral Delivery Programmes and is progressing two Artificial Intelligence (AI) Programmes to add promising new assets to its pipeline.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
About OneThree Biotech
OneThree Biotech is a private, clinically validated, biology-driven artificial intelligence (AI) company focused on using its proprietary ATLANTIS AI platform in combination with systems biology to understand the mechanisms that drive drug-target-disease relationships. This approach has been used not only to generate a pipeline of first-in-class programs, but also in partnerships with other biopharmaceutical companies. OneThree Biotech’s proven technology platform integrates chemical, biological, and clinical data with cutting-edge computational tools to answer complex questions surrounding disease biology and drug discovery. The company’s AI platform has shown success in identifying new targets for the treatment of various cancers and optimizing early-stage drug discovery and development by quickly and accurately generating new, testable insights and hypotheses. The OneThree platform has been validated across early-stage drug discovery through multiple partnerships, clinical trials, and more than 20 peer-reviewed publications. OneThree Biotech is based in New York City.
For more information, please go to https://onethree.bio/
Twitter: @onethreebiotech
#HVO Hvivo – Imutex Phase I data published
hVIVO plc (AIM & Euronext: HVO) (formerly Open Orphan plc), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces publication of previously reported positive data from a first-in-human Phase I clinical study evaluating the safety and immunogenicity of AGS-v PLUS. The data has been published in eBioMedicine,1 a peer-reviewed open access biomedical journal part of The Lancet Discovery Science.
AGS-v PLUS is a vaccine candidate against arboviral diseases that targets the saliva of the mosquito rather than the pathogens carried by the mosquito. AGS-v PLUS is owned by Imutex Ltd, a joint venture with PepTcell Limited (the parent company of ConserV Bioscience Ltd), in which hVIVO has a 49% shareholding.
AGS-v PLUS vaccine candidate has a novel proposed dual action mechanism of preventing infection in humans whilst controlling the mosquito population through affecting reproduction. AGS-v PLUS contains five synthetic peptides that originate from proteins found in the saliva of mosquitoes. The published manuscript shows data from the study conducted at the University of Maryland School of Medicine and sponsored by NIAID-NIH, demonstrating that all AGS-v PLUS formulations evaluated (non-adjuvanted or adjuvanted in alhydrogel or Montanide ISA-51) were well tolerated with no serious adverse events experienced, and that they generated a robust cellular and humoral immune response in participants, the formulation in Montanide ISA-51 being the most immunogenic. Moreover, the immune response mounted against AGS-v PLUS was shown to reduce infectivity of Zika virus in vitro.
Mosquito-borne diseases include Zika, West Nile, chikungunya, dengue, yellow fever, and malaria amongst others. There are ~360 million cases of and more than 600,000 deaths from mosquito-borne diseases annually, although the true burden is likely underestimated. A vaccine efficacious against multiple mosquito-borne diseases could significantly impact public health.
Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, said: “It is encouraging to see the results from Imutex’s first-in-human Phase 1 trial for AGS-v PLUS published in eBioMedicine. The data demonstrated that AGS-v PLUS was well tolerated and generated a robust immune response in participants, with no serious adverse events. The next steps will be to determine if these findings translate into clinical efficacy against mosquito-borne diseases, which inflict a severe burden on public health systems around the world.”
- “Safety and immunogenicity of AGS-V plus, a mosquito saliva peptide vaccine against arboviral diseases: A randomized, double-blind, placebo-controlled phase 1 trial,” by Friedman-Klabanoff, D.A.J. et al. (2022) is available in eBioMedicine, part of The Lancet, 86, p. 104375. DOI: https://doi.org/10.1016/j.ebiom.2022.104375
- Institute for Health Metrics and Evaluation (IHME). Global Burden of Disease 2019 Cause and Risk Summary: Malaria, Dengue, Yellow Fever, Zika; 2020. Accessed April 6, 2021.
For further information please contact:
| hVIVO plc | +44 (0) 20 7756 1300 | ||
| Yamin ‘Mo’ Khan, Chief Executive Officer
Stephen Pinkerton, Chief Financial Officer |
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| Liberum Capital (Nominated Adviser and Joint Broker) | +44 (0) 20 3100 2000 | ||
| Ben Cryer, Edward Mansfield, Phil Walker, Will King | |||
| finnCap plc (Joint Broker) | +44 (0) 20 7220 0500 | ||
| Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM) | |||
| Davy (Euronext Growth Adviser and Joint Broker) | +353 (0) 1 679 6363 | ||
| Anthony Farrell, Niall Gilchrist | |||
| Walbrook PR (Financial PR & IR)
Stephanie Cuthbert / Phillip Marriage / |
+44 (0) 20 7933 8780 or hvivo@walbrookpr.com
+44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
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Notes to Editors
hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.
The Group’s fast-growing services business includes a unique portfolio of 10+ human challenge models to test a broad range of infectious and respiratory disease products, world class challenge agent manufacturing, specialist drug development and clinical consultancy services via its Venn Life Sciences brand, and a lab offering via its hLAB brand, which includes virology, immunology biomarker and molecular testing. The Group offers additional clinical field trial services such as patient recruitment and clinical trial site services.
hVIVO runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester.
About PepTcell Limited
PepTcell brings safe, effective, and low-cost treatments to patients, in the shortest time possible, to radically improve human health in major disease areas. Through its subsidiary ConserV Bioscience Limited, PepTcell develops vaccines to a broad range of infectious diseases. ConserV Bioscience is a late-stage vaccine development company focused on advancing safe and effective vaccines that protect against endemic and emergent infectious diseases. They use a novel in silico proprietary platform to identify highly conserved regions in the proteome that contain a high number of reactive T-cell epitopes with extensive HLA coverage. These regions are then used as antigens and are delivered using the most appropriate method for the combination of antigens and the disease, for example, as synthetic peptides or encoded in mRNA. This approach has consistently identified promising vaccine candidates which have demonstrated immunogenic responses in pre-clinical validation studies and have achieved mid- and late-stage clinical milestones.
#POLB Poolbeg Pharma PLC – Metabolic diseases oral delivery licence signed
Clinical trial to demonstrate technology can safely deliver GLP-1 to commence in H1 2023
Prof Brendan Buckley joins Poolbeg’s Scientific Advisory Board to guide clinical development of technology
Licence expands Poolbeg’s existing exclusive licence to AnaBio’s oral vaccine delivery technology
Investor Meet Company presentation on 14 December 2022 at 5:30pm
Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading infectious disease focused biopharmaceutical company, announces that it has acquired an exclusive licence from InsuCaps Limited (“InsuCaps”), a sister company of AnaBio Technologies (“AnaBio”), to use InsuCaps’ patented microencapsulation and nanoencapsulation oral delivery technologies in metabolic syndrome related diseases including obesity, pre-diabetes and diabetes. Obesity alone costs the US healthcare system c. $173bn a year.
Following the licence, in H1 2023 Poolbeg will rapidly commence a proof-of-technology clinical trial to determine that a Glucagon-like Peptide 1 receptor (GLP-1) agonist can be safely delivered orally in humans. GLP-1 agonists, which are used to treat diabetes and obesity, represent an extremely large, fast-growing opportunity estimated to grow to c.$22bn per annum by 2025. At present, all but one GLP-1 products are injectables, which are more onerous for patients than oral delivery.
The upcoming trial is designed to provide data confirming that the patented microencapsulation and nanoencapsulation technologies can safely deliver GLP-1 orally, with results expected to be announced later next year. In line with its rapid-partnering model, Poolbeg then intends to licence the technology to pharma and biotech for use in obesity and / or diabetes, as well as other active molecules in metabolic syndrome related diseases.
This oral GLP-1clinical trial rapidly follows the completion of Poolbeg’s LPS challenge trial for POLB 001 and, like the LPS challenge study, is in line with Poolbeg’s efficient, capital light approach to clinical development at the core of the Poolbeg model.
This exclusive licence is in addition to Poolbeg’s exclusive license to AnaBio’s microencapsulation and nanoencapsulation technologies which underpins Poolbeg’s Oral Vaccine Platform. As recently announced, a Poolbeg-led consortium was awarded €2.3m in non-dilutive funding by the Irish Government’s Disruptive Technologies Innovation Fund to progress the Oral Vaccine Platform.
Addition to Poolbeg’s Scientific Advisory Board
Poolbeg has also added Prof Brendan Buckley to its Scientific Advisory Board. He is the former Chief Medical Officer at ICON plc, a medical graduate of University College Cork and a doctoral graduate in Biochemistry in the Faculty of Medicine at Oxford University. Prof Buckley has advised Poolbeg since inception and has deep experience in metabolic diseases including over 40 years’ experience in clinical practice as a Consultant Physician in endocrinology, diabetes and in academic clinical pharmacology. In addition, Brendan has sat on the European Medical Agency (EMA)’s Scientific Advisory Group for Diabetes and Endocrinology. He has published over 150 scientific papers, mainly on metabolic disease, as well as the recent key opinion-leading book ‘Re-Engineering Clinical Trials’.
Investor Meet Company presentation – 14 December 2022 at 5:30pm
Jeremy Skillington, PhD, Chief Executive Officer, and Professor Brendan Buckley will provide a live presentation via the Investor Meet Company platform on 14 December 2022 at 5:30pm. Click here to register.
The presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and add to meet Poolbeg Pharma plc here. The presentation and recording will be available on the Company’s website after the event here.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “Poolbeg saw the potential for microencapsulation and nanoencapsulation oral delivery technologies in vaccines, and this has been further validated by the grant from the Irish Government’s Disruptive Technologies Innovation Fund. Drawing on our growing understanding of this technology from our Oral Vaccine Platform, we believe that there is significant opportunity in other adjacent areas, such as metabolic diseases. Diabetes and obesity are extremely fast growing markets and the ability to administer drugs orally, rather than through injection, will improve access and quality of life for millions of patients. We are really excited to be moving swiftly to a proof-of-concept trial in H1 2023 to test the oral delivery of GLP-1 in humans, with the results to be announced later in the year.”
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Dr Sinéad Bleiel, Founder & Chief Scientific Officer of InsuCaps said: “We are excited to be expanding our working relationship with Poolbeg and believe that the trial commencing in H1 2023 will deliver meaningful data showing our ability to orally deliver GLP-1 safely and efficiently. As the world is beginning to realise, GLP-1 and similar metabolic peptides have life changing effects for diabetics and are becoming the obesity management drug of choice for the years ahead. We believe that our microencapsulation and nanoencapsulation oral delivery technologies can potentially deliver significant quality of life benefits to patients suffering from these long-term metabolic syndrome conditions.”
-Ends-
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Optimum Strategic Communications Mary Clark, Nick Bastin, Manel Mateus, Vici Rabbetts
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+44 (0) 208 078 4357 |
#TEK Tek Capital PLC – Investee Company #BELL Belluscura PLC
Belluscura, a leading medical device developer focused on lightweight and portable oxygen enrichment technology, is pleased to announce it has entered into its first international distribution agreement outside of the US, with MedHealth Supplies of South Africa (“MedHealth”).
Following the distribution agreement, MedHealth has placed orders for both 2022 and 2023, with deliveries to commence immediately.
MedHealth is a leading durable medical equipment provider in South Africa distributing durable medical equipment throughout South Africa and neighboring countries, and was recently awarded oxygen supply contracts based on the ability to deliver Belluscura’s X-PLOR portable oxygen concentrator.
Robert Rauker, CEO of Belluscura plc, said:
“This is a big step in Belluscura’s expansion outside the US. MedHealth’s founders have a long history in the supplemental oxygen space and we are excited to work with them moving forward.”
ENDS
For further information, please contact:
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Belluscura plc |
www.belluscura.com |
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Robert Rauker, Chief Executive Officer |
via MHP |
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Anthony Dyer, Chief Financial Officer |
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SPARK Advisory Partners Limited (NOMAD) |
Tel: +44 (0)20 3368 3550 |
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Neil Baldwin |
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Dowgate Capital Limited (Broker) |
Tel: +44 (0)20 3903 7715 |
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James Serjeant / Nicholas Chambers |
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MHP (Financial PR and Investor Relations) |
Tel: +44 (0)20 3128 8100 |
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Katie Hunt / Pete Lambie / Matthew Taylor |
Email: belluscura@mhpgroup.com |
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About Belluscura plc ( www.belluscura.com )
Belluscura is a UK medical device company focused on developing high performing, lightweight and portable oxygen enrichment technology used in a broad range of industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health, mobility and economic outcomes for patients, healthcare providers and insurance organisations.
Glossary
X-PLOR® is a lightweight portable oxygen concentrator with user replaceable oxygen enrichment cartridges and direct-charge batteries. Weighing only 3.75 lbs, its AirgonomicTM Design ensures user-friendly experience and maximum comfort. It has multiple Pulse Flow Settings including X-PLORATIONTM Mode (750mL for 10 mins).
DISCOV-R™ will deliver 2000mL of continuous flow oxygen and have 8 Pulse Flow Settings. Weighing only 6.5 lbs, it will be the first ambulatory 2L portable oxygen concentrator, producing more oxygen per pound than others in its class.
About Reach announcements
Reach is an investor communication service aimed at assisting listed and unlisted (including AIM quoted) companies to distribute media only / non-regulatory news releases such as marketing messages, corporate and product information into the public domain. An RNS Regulatory announcement is required to be notified under the AIM Rules for Companies.
#POLB Poolbeg Pharma Plc- Capital Markets Day
17 November 2022 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces that it will be holding a Capital Markets Day for analysts and institutional investors on Wednesday 30 November between 10am – 12:45pm.
The event, which will be chaired by Jeremy Skillington, Chief Executive Officer, will provide insights into a number of the Company’s growing pipeline of infectious disease vaccines and treatments and one of its innovative artificial intelligence programmes which is unlocking the power of human challenge trial data. In addition, attendees will gain a greater understanding of how Poolbeg’s unique model and business development strategy can drive growth from the infectious disease market. A networking lunch will follow at the end of the session.
There will be an opportunity for attendees to take part in a Q&A with Poolbeg’s management team including Ian O’Connell, Chief Financial Officer and David English, VP of Business Development as well as a number of guest speakers:
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Dr Tal Almog of CytoReason, one of Poolbeg’s artificial intelligence partners; a world leader in AI which to date has worked with five of the world’s top ten pharma companies |
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Derek Gilroy, Head of the Centre for Clinical Pharmacology and Professor of Immunology at University College London and has pioneered research examining the molecular and biochemical pathways that regulates the resolution of acute immune reactions |
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Professor Brendan Buckley, co-founder of Minerva Medical, acquired by IQVIA and Firecrest Clinical, acquired by ICON plc where he held the position of Chief Medical Officer. Brendan has over thirty years of experience in clinical research and has published over 150 scientific papers |
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Further speakers will be announced in advance of the event |
Analysts, institutional investors and media are welcome to attend the event in the City of London. Due to restrictions on numbers, it will not be possible for all interested parties to attend in-person. However, a live webcast will be available for retail investors and others to view the presentations here.
To register your interest to attend the in-person event, please RSVP to poolbeg@instinctif.com.
A recording of the presentation will be made available on the Company’s website after the event here.
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson
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+44 (0) 207 220 0500 |
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Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
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+44 (0) 207 496 3000 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020 |
About Poolbeg Pharma
Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for Big Pharma seeking mid-stage products to license or acquire.
The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.
With its initial assets from hVIVO plc (formerly named Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has commenced its LPS human challenge trial with initial results expected by year end 2022; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) programmes to accelerate the power of its human challenge model data and biobank, with outputs from the first programme expected by year end 2022.
#HVO hVIVO plc- Share Price
hVIVO plc (AIM: HVO) (formerly Open Orphan plc), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, saw the share price rise which was then picked up in the Daily Mail Stock Watch this morning
For further information please contact:
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hVIVO plc |
+44 (0) 20 7756 1300 |
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Yamin ‘Mo’ Khan, Chief Executive Officer Stephen Pinkerton, Chief Financial Officer |
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Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
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Ben Cryer, Edward Mansfield, Phil Walker, Will King |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM) |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell, Niall Gilchrist |
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Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0) 20 7933 8780 or hvivo@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
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