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#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 – MicroSalt Operational Update
Tekcapital Plc (AIM: TEK), (OTCQB: TEKCF) the UK intellectual property investment group focused on creating valuable products that can improve people’s lives, is pleased to provide an operationalupdate from Microsalt Ltd (“Microsalt”).
B2C Progress;
· SaltMe Crisps continue to be sold throughout the Kroger group. SaltMe Crisps are currently stocked in Kroger stores with efforts continuing to secure new store placements.
• As announced on 13 March 2023, Hanahreum Group (“H Mart”), one of the fastest growing retailers in United States has agreed to carry MicroSalt’s SaltMe® branded crisps.
• Since launching in September 2022, MicroSalt Shakers are currently stocked in over 500 stores.
• AS announced on 06 February 2023, MicroSalt is currently working with US Salt LLC for in store sales of products across the US Salt system. US Salt LLC is a leading direct supplier of canister salt to the US retail industry.
E-commerce progress;
• First e-commerce sales of MicroSalt Shakers have been encouraging.
• E-commerce sales of SaltMe Crisps have also been increasing.
• Microsalt is preparing to launch its fourth flavour in a 1 oz size to compliment the current product offering and to create a better variety pack.
Medical Outreach campaign progress;
• Direct outreach with free 1 oz shakers samples for the medical community.
• Launched direct marketing campaign for shakers in March 2023 in partnership with the National Pancreas Foundation which includes access to approximately 100,000 medical professionals and 170 hospitals.
B2B progress:
· Successfully completed comprehensive testing of Microsalt with several major food companies. MicroSalt is at varying stages of progress with these company’s respective tasting, procurement, marketing and packaging departments and will keep the market informed of further developments.
About MicroSalt, Ltd
MicroSalt, is the developer and manufacturer of a proprietary low-sodium salt called MicroSalt®. We are passionate about improving peoples’ lives with better-for-you seasonings and snacks by taking the lead in the industry by providing the best low-sodium salt solution, based on the mechanical transformation of the salt particle itself. This solution is the only one that delivers real salt flavour because it is salt. Our new patented technology produces salt crystals that are approximately one hundred times smaller than typical table salt, delivering a powerful saltiness as the micro-grains dissolve in the mouth, with approximately 50% less sodium consumption. Additionally, the ultra-small particle size enhances product adhesion, which reduces waste and provides improved flavour consistency. MicroSalt® and SaltMe® are registered trademarks of MicroSalt Inc. To learn more about MicroSalt please visit www.microsaltinc.com.
To learn more about SaltMe! snacks please visit www.saltme.com
Tekcapital owns 97% of the share capital of MicroSalt Ltd. and 6,034,683 shares (78%) of MicroSalt Inc., its U.S. subsidiary.
About Tekcapital plc
Tekcapital creates value from investing in new, university-developed discoveries that can enhance people’s lives and provides a range of technology transfer services to help organisations evaluate and commercialise new technologies. Tekcapital is quoted on the AIM market of the London Stock Exchange (AIM: symbol TEK) and is headquartered in the UK. For more information, please visit www.tekcapital.com.
LEI: 213800GOJTOV19FIFZ85
For further information, please contact:
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Tekcapital Plc |
Via Flagstaff IR |
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Clifford M. Gross, Ph.D. |
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SP Angel Corporate Finance LLP (Nominated Adviser and Broker) |
+44 (0) 20 3470 0470 |
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Richard Morrison / Charlie Bouverat (Corporate Finance) Rob Rees (Corporate Broking)
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Flagstaff Strategic and Investor Communications Tim Thompson/Andrea Seymour/Fergus Mellon
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+44 (0)207 129 1474 |
#POLB Poolbeg Pharma – POLB 001 Patent Portfolio Strengthened
Key highlights
· Patent granted for use of certain p38 MAP kinase inhibitors for the treatment of hypercytokinaemia
· Allows for use in combination with an antiviral agent
· Patent enhances the robust IP portfolio protecting Poolbeg’s growing pipeline
8 March 2023 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading infectious disease focused biopharmaceutical company, announces that further to its announcement on 4 October 2022, it has been granted a patent by the US Patent and Trademark Office (USPTO) for methods of treating hypercytokinaemia using POLB 001, a small molecule immunomodulator being developed to address the unmet medical need arising from severe influenza and other acute inflammatory conditions.
The USPTO granted a patent for the use of POLB 001 and related p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of hypercytokinaemia (or “cytokine storm”), including hypercytokinaemia that occurs due to viral infection such as an influenza virus, cancer or an autoimmune response, through the modulation of the immune response (reducing the body’s hyperinflammatory response).
Poolbeg has a worldwide license for POLB 001 for all uses in humans and is developing a strong IP portfolio with US patent protection in place covering the use of a wide range of p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of symptoms of severe influenza and hypercytokinaemia and a European patent for the class of p38 MAP kinase inhibitors for use in the treatment of severe influenza.
In January 2022, the Company filed a patent application to seek class protection for the novel use of p38 inhibitors in CAR T cell treatment. This opens up a significant new market opportunity for POLB 001 beyond severe influenza. Poolbeg continues to explore opportunities to expand its IP around this asset to cover new disease areas which could enhance the value of the asset.
The Company continues to work with its patent advisors to broaden and expand its patent families.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:
“We are expanding our IP portfolio across the globe, allowing us to continue advancing and protecting our programmes for the treatment or prevention of severe influenza and hypercytokinaemia. Enhanced IP protection of our assets across key markets, such as the US, increases the overall value and attractiveness of these products to potential partners. This is particularly important in the light of the recent favourable results from our POLB 001 LPS human challenge trial announced 2 March 2023.”
About POLB 001
POLB 001 is a small molecule immunomodulator for the treatment of symptoms of severe influenza, and hypercytokinaemia which may occur due to exposure to a pathogen or be triggered by cancer or an autoimmune response. Poolbeg continues to discover new indications for POLB 001 in other acute inflammatory conditions. POLB 001 selectively inhibits overwhelming inflammation that may be triggered by viral infections, such as severe influenza, while leaving the necessary immune functions intact to fight the infection. This contrasts with other immunomodulatory approaches, such as steroids, which affect both beneficial and damaging immune responses. Due to its mode of action it is strain agnostic and unaffected by seasonal variants which is a significant advantage over treatments available on the market. In addition, as a shelf stable oral drug it is an ideal stock piling candidate for both seasonal and pandemic outbreaks. Therefore, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment.
Cytokines, originally intended to optimise immunity, when overexpressed can sweep throughout the body re-programming white blood cells causing tissue damage, shutting down circulation and other essential organs leading to death and in certain circumstances cytokine storm or cytokine release syndrome (CRS). Such excessive cytokine responses can be seen in diseases as diverse as severe influenza and in response to chimeric antigen receptor T cell therapy (CAR T cell) treatment of cancers. Poolbeg continues to evaluate POLB 001’s potential in additional indications to fully unlock the potential value of the molecule.
p38 MAP kinase (p38 MAPK) is a master regulator of immunity, ubiquitously expressed in all white blood cells where it is poised to unleash inflammation. Poolbeg’s clinical approach, inhibiting p38 MAP kinase hypothesised that it’s a prime suspect in driving the cytokine storm and its consequences in patients whose immune responses do not resolve normally, without intervention. This has now been demonstrated as a concept in a human clinical model of infectious disease and endotoxin mediated inflammation administering LPS as the endotoxin to healthy volunteers. LPS is a bacterial product that mimics infection and is used to capture the hallmarks of both local and systemic inflammation typical of a cytokine storm in humans, but in a safe, controlled and quantifiable manner – it’s one step removed from the infected critical care patient. Treatment with POLB 001 resulted in a highly significant reduction in p38 MAP kinase driven cytokines and exhibited a marked reduction in multiple markers of systemic and local inflammation compared with placebo. Read more here.
#TEK Tek Capital PLC investee co. Microsalt Ltd- MicroSalt Expands Low Sodium Shakers Distribution
Tekcapital Plc (AIM: TEK), (OTCQB: TEKCF) the UK intellectual property investment group focused on creating valuable products that can improve people’s lives, is pleased to announce that MicroSalt has today announced that both sizes of its new line of low sodium salt shakers are now available through UNFI and KeHE Foods, two of the U.S.’s largest retail food distributors.
United Natural Foods, Inc. (NYSE: UNFI) is the largest publicly traded wholesale distributor delivering healthier food options to people throughout the United States and Canada.
KeHE Distributors is one of the nation’s top wholesale food distributors with 16 distribution centers across North America. KeHe partners with grocery stores, supermarkets, natural retailers, online eCommerce drop shippers to access a curated assortment of innovative products via a one-truck delivery.
Additionally, as a result of its recent trade show attendance, MicroSalt has received orders from Pete Markets in Illinois and Busch’s Market in Michigan for the new MicroSalt low sodium salt shakers. Delivery will be executed through KeHE Foods.
Pete’s Market currently has 17 upscale stores in Chicago and its suburbs and Busch has 16 stores in southeastern Michigan with headquarters in Ann Arbor.
“Excess sodium intake is one of the world’s greatest health concerns, and partnerships like these are the best way to make a difference in our efforts to address the sodium challenge. We are proud to have our shakers available at both UNFI and KeHe and truly believe that working together we can make a difference.” Said Rick Guiney, CEO of MicroSalt®”
To learn more about Pete Market visit: https://www.petesfresh.com/our-company
To learn more about Busch’s Market visit: https://www.buschs.com/whatisbuschs
About MicroSalt, Ltd
MicroSalt, is the developer and manufacturer of a proprietary low-sodium salt called MicroSalt®. We are passionate about improving peoples’ lives with better-for-you seasonings and snacks by taking the lead in the industry by providing the best low-sodium salt solution, based on the mechanical transformation of the salt particle itself. This solution is the only one that delivers real salt flavour because it is salt. Our new patented technology produces salt crystals that are approximately one hundred times smaller than typical table salt, delivering a powerful saltiness as the micro-grains dissolve in the mouth, with approximately 50% less sodium consumption. Additionally, the ultra-small particle size enhances product adhesion, which reduces waste and provides improved flavor consistency. MicroSalt® and SaltMe® are registered trademarks of MicroSalt Inc.
To learn more about MicroSalt please visit www.microsaltinc.com
To learn more about SaltMe! snacks please visit www.saltme.com/
Tekcapital owns 97% of the share capital of MicroSalt Ltd. and 6,034,683 shares (78%) of MicroSalt Inc., its U.S. subsidiary.
About Tekcapital plc
Tekcapital creates value from investing in new, university-developed discoveries that can enhance people’s lives and provides a range of technology transfer services to help organisations evaluate and commercialise new technologies. Tekcapital is quoted on the AIM market of the London Stock Exchange (AIM: symbol TEK) and is headquartered in the UK. For more information, please visit www.tekcapital.com.
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LEI: 213800GOJTOV19FIFZ85
For further information, please contact:
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Tekcapital Plc |
Via Flagstaff IR |
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Clifford M. Gross, Ph.D. |
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SP Angel Corporate Finance LLP (Nominated Adviser and Broker) |
+44 (0) 20 3470 0470 |
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Richard Morrison / Charlie Bouverat (Corporate Finance) Rob Rees (Corporate Broking)
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Flagstaff Strategic and Investor Communications Tim Thompson/Andrea Seymour/Fergus Mellon
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+44 (0)207 129 1474 |
#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) |
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 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.”
-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 |
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.
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