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TIDMORPH
RNS Number : 8975S
Open Orphan PLC
19 November 2021
19 November 2021
Open Orphan plc
("Open Orphan" or the "Company")
Imutex to present positive Phase I clinical study results for AGS-v PLUS mosquito vaccine candidate
AGS-v PLUS mosquito vaccine candidate shows favourable safety, tolerability, and immunogenicity results
Results to be presented at the American Society of Tropical Medicine and Hygiene Annual Meeting
Open Orphan plc (AIM: ORPH) announces that data from the first-in-human Phase I clinical study evaluating the safety, immunogenicity, and in vitro efficacy of AGS-v PLUS, Imutex Limited's ("Imutex') mosquito saliva vaccine candidate against arboviral diseases, as well as data on the candidate's effect on the reproductive capacity of mosquitoes that fed on vaccinated subjects will be presented on the 20(th) and 21(st) of November 2021. Imutex Limited ("Imutex") is a joint venture with PepTcell Limited ("PepTcell") (the legal name of SEEK Group) in which Open Orphan has a 49% shareholding.
The results will be presented in two virtual sessions at the American Society of Tropical Medicine and Hygiene ("ASTMH") Annual Meeting, held from 17-21 November 2021. The titles and details of the two presentations are as follows:
-- "Blood feeding on humans vaccinated with AGS-v PLUS, a mosquito salivary peptide vaccine, impairs the reproductive capacity of female Aedes albopictus mosquitoes" - Scientific Session 91: Mosquitoes-Vector Biology Epidemiology I, at 8.00 am (ET) on 20 November 2021. To be presented by Joshua Lacsina, M.D., Ph.D. of the Laboratory of Malaria and Vector Research at the National Institute of Allergy and Infectious Diseases.
-- " Safety and immunogenicity of AGS-v PLUS, a mosquito saliva peptide vaccine against arboviral diseases" - Scientific Session 126: Clinical Tropical Medicine: Vector borne Disease, at 8.00 am (ET) on 21 November 2021. To be presented by DeAnna J. Friedman-Klabanoff, M.D. of the University of Maryland School of Medicine.
Following the presentations, Imutex expect to publish the results from the study in a scientific peer-reviewed journal.
Imutex was funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs) to carry out this study.
Data from this study, which was performed at the University of Maryland School of Medicine (Baltimore, Maryland, U.S.) and is related to a collaboration between PepTCell and The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), demonstrated that AGS-v PLUS was well tolerated with no serious adverse events experienced, and that it generated a strong immune response in participants. AGS-v PLUS showed a more robust immune response compared to AGS-v, a first-generation vaccine candidate developed by Imutex. The st
Update on POLB 001 Clinical Development
Rapidly progressing towards LPS challenge study
18 November 2021 - Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the 'Company') a clinical stage infectious disease pharmaceutical company with a capital light clinical model, is pleased to provide an update on the clinical development progress of its lead asset, POLB 001, a small molecule immunomodulator for the treatment of severe influenza.
The Company intends to commence the Phase Ib human challenge study of POLB 001 in June 2022 which will be a key step in the molecule's development. To enable this study, the Company has signed a Letter of Intent to retain the Centre for Human Drug Research (CHDR) to run the challenge study and signed an agreement with SEDA Pharmaceutical Development Services for drug formulation services. A vendor has also been selected for GMP* manufacturing of POLB 001.
In this study, clinical researchers from CHDR will stimulate a healthy volunteer's immune system with bacterial lipopolysaccharide (LPS) in a safe and controlled clinical environment. The study will provide key human data on the efficacy of POLB 001 in dampening the immune response in otherwise healthy volunteers. It will use LPS to simulate the effects of treating severe influenza in the volunteers without the virus itself being present. In cases of severe influenza, the body produces an over-heightened immune response that can cause more damage to the body than the virus itself. POLB 001's mode of action is to reduce this hyper-immune response. The design of the study (the study protocol) is expected to be finalised by the end of Q1 2022.
In advance of the Phase Ib study commencing, the Company has completed the manufacturing of a non-GMP* batch of POLB 001 which is on hand for any non-clinical (not administered to humans) requirements, such as formulation. This is also an important step in validating the manufacturing process. On this basis, manufacturing can now be scaled up as required as the clinical development phase progresses. The Company will now move towards manufacturing GMP* grade POLB 001 material needed for the LPS challenge study and has similarly selected a vendor for this work.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:
"We are delighted to be progressing our POLB 001 asset as planned, with preparatory steps in motion in advance of the LPS human challenge study clinical trial. We have selected experienced partners in SEDA to formulate the product, and CHDR to run our LPS human challenge study. The clinical study is expected to commence in June 2022, as detailed at IPO. With our capital light and early monetisation model, we are actively developing infectious disease assets with modest investment where they can be monetised / licenced to Big Pharma. We will continue to provide updates as we progress the programme."
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan, has signed a GBP5.1m contract with a biopharmaceutical company to test its Investigational Medicinal Product (IMP) using hVIVO's respiratory syncytial virus (RSV) Human Challenge Study Model.
The study is due to commence in H2 2022, with the revenue from the contract being recognised across 2021 and 2022. hVIVO will conduct this study on behalf of this biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection.
RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan said: "We are pleased to have signed this contract to test our client's product using our RSV Human Challenge Study Model. It is testament to our position as the world leading provider of Phase IIa human challenge study clinical trials that innovative biopharmaceutical companies, as well as Big Pharma, are actively and regularly engaging us to test their novel vaccine and antiviral candidates.
"RSV is one of several infectious and respiratory disease areas of unmet need that we are seeing rapidly growing interest in from drug developers. We look forward to working with more companies across the world to test their antivirals and vaccines, as Phase IIa human challenge studies increasingly become part of mainstream clinical trial design."
DOMAIN.
28 October 2021
Supply@ME Capital plc
(The "Company" or "SYME")
Appointment of new Chair:
Supply@ME appoints James ("Jim") Coyle as new independent Non-executive Chairman
Supply@ME Capital plc, the fintech business which provides an innovative Platform for use by manufacturing and trading companies to access Inventory Monetisation solutions enabling their businesses to generate cashflow, is pleased to announce the appointment of Jim Coyle as its new independent non-executive chairman with effect from 28 October 2021.
The Company conducted a rigorous and wide-ranging selection process to ensure that it appoints the strongest possible candidate to lead the business through its next stage of growth. Mr Coyle succeeds Dominic White, who stepped down from the role in July of this year.
Mr Coyle is a highly respected, strategic leader who brings over four decades of both executive and non-executive financial services experience to the role. After a thirty-year career at some of the UK's largest institutions, including BP, Bank of Scotland and Lloyd's Banking Group Plc, where he served most recently as Group Financial Controller and Deputy Group Finance Director, Mr Coyle has been appointed to a number of Board roles mainly across the financial services industry. He currently serves as a Non-Executive Director and Audit Chair of HSBC UK Bank Plc and M&S Bank Plc and chairs other M&S group subsidiaries, as well as serving as Senior Independent Director on the board of Honeycomb Investment Trust Plc and Audit and Risk Chair at Scottish Water. He has previously held the role of Chair at international payments business World First.
Mr Coyle qualified as a Chartered Accountant with KPMG.
SYME Chief Executive, Alessandro Zamboni said:
"I am very pleased to welcome Jim to Supply@ME. He brings vast experience and an exceptional track record gained at some of the UK's largest financial institutions. His counsel, expertise and network of contacts will be invaluable as we embark on an exciting new stage in Supply@ME's growth."
SYME Chair, Jim Coyle said:
"I am delighted to be joining Supply@ME as its new chair. This is a great opportunity to work with a business with a unique model and brilliant leadership team. The growth strategy and opportunity for Supply@ME are clear and I believe we are well positioned for the years ahead. I am looking forward to working with Alessandro and the team to drive the business forward, providing a much-needed financing solution to SMEs globally."
Notes
Supply@ME Capital PLC and its operating subsidiaries (together th
Sorry should be 23.65p
1 million trade yesterday, timed at 5.36 at 33.65p
RNS Number : 2260M
Open Orphan PLC
20 September 2021
This announcement contains inside information
for the purposes of Article 7 of Regulation (EU) No 596/2014 as it forms part of UK law
by virtue of the European Union (Withdrawal) Act 2018 ("MAR")
OPEN ORPHAN PLC
("Open Orphan" or the "Company")
Interim Results for six months ended 30 June 2021
Major year-on-year revenue growth and profitable H1 2021 performance following a year of turnaround and transition in 2020
Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its unaudited interim results for the six months ended 30 June 2021. These results show a continued pattern of profitability from Q4 2020 to a firmly profitable position delivering a positive EBITDA profit of GBP2.1 million compared to an EBITDA loss of GBP4.1 million in H1 2020. We look forward to achieving record revenues in 2021 in our first full year of EBITDA profitability with recent contract wins and exceptional pipeline growth fueling revenues into 2022.
In the past 12 months, the Company has received international recognition and media attention for its excellence in delivering human challenge studies as a partner in the world's first COVID-19 human challenge characterisation study. The Company now has a broad range of human challenge study models, focusing on leveraging the major growth opportunities presenting in infectious and respiratory disease markets, including RSV, Influenza, Asthma, hRV, COPD and Malaria.
Profitable Financial Performance in H1 2021:
-- Continuing from a profitable Q4 2020, the Company has moved the business to a firmly profitable position with losses consigned to the past
o 242% reported revenue growth in H1 2021 (GBP21.9m) versus H1 2020 (GBP6.4m). Other income grew to GBP1.2m in H1 2021 from GBP0.7m in H1 2020
o EBITDA profit of GBP2.1m (2020: EBITDA loss of GBP4.1m)
o Revenue has more than tripled reflecting six active challenge studies in H1 2021 vs two active challenge studies in H1 2020 and a solid performance in Early Clinical / Biometry Services
o In H1 2021, non-COVID-19 related work accounted for 75% of revenues
o Gross margin has grown from 6% to 28% of revenue, reflecting that the Company is driving substantial operating leverage through cross selling, restructuring, functional integration and operational productivity
-- Cash and cash equivalents were GBP14.9m at 30 June 2021, primarily reflecting the operating cashflow cycle of the business with new contract prepayments expected in H2 2021
-- The Company has executed a share capital re-organisation as an important enabler to progress the monetisation of non-core assets via distribution of dividend in specie. In June, it completed the first distribution in specie back to the shareholders worth GBP26.2m at 16 September 2021, in relation to th
TIDMORPH
RNS Number : 2114M
Open Orphan PLC
20 September 2021
Open Orphan plc
("Open Orphan" or the "Company")
GBP5.7m Influenza human challenge study contract win
Open Orphan plc (AIM: ORPH), a rapidly growing specialist clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan plc, has signed a GBP5.7m contract with a specialist biotechnology company developing therapeutics for respiratory viral infections, to test its antiviral product using the hVIVO Influenza human challenge study model.
The human challenge study is expected to commence in Q1 2022 and will be conducted at hVIVO's state-of-the-art facilities in London. The Company expects the revenue from the contract to be recognised across 2021 and 2022.
The client's influenza antiviral product has demonstrated effectiveness in animal preclinical models of respiratory viruses and has several clinical and commercial advantages with respect to convenience, resistance, durability and compatibility when compared to similar products.
The Company expects to sign more contracts in this area as attention switches to potential future Influenza outbreaks. Influenza is expected to be a major global issue due to low level population immunity caused by reduced infection rates over the last 18 months, which is the result of COVID-19 mitigation measures such as social distancing and mask wearing. After a solidly EBITDA profitable H1, this contract will help ensure the Company enters a period of sustained growth and profitability across a whole range of challenge studies.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus), malaria, asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said : "We are delighted to be working with this biotechnology company to test their exciting antiviral product against our Influenza human challenge study model. As a result of social distancing, hand washing and other COVID-19 mitigation measures, there has been extremely low levels of population immunity to Influenza. As such, there is an increasing concern that in the year ahead Influenza outbreaks could spike considerably and therefore this type of therapeutic could form part of an effective defence against future outbreaks of Influenza due to its compelling array of clinical and commercial advantages.
"This contract is also a further demonstration of our expertise and capabilities testing therapeutics across the infectious disease and respiratory market, which is due to grow exponentially to over $250 billion by 2025, as pharmaceutical companies around the world look to restock the medicine cabinets with n
Thank you
Does anyone know what this means ?
MR04(ef)
Company Name: OPEN ORPHAN PLC Company Number: 07514939
Received for filing in Electronic Format on the: 17/09/2021 Details of Satisfaction
Charge created (or property acquired) on or after 6th April 2013. Charge code: 0751 4939 0001
Satisfaction of In full charge:
XAD80R9W
Details of the person delivering this statement and their interest in the charge
Name: Address: Interest:
CAROLINE MCNICHOLAS
6 WOODVIEW COMMONS ROAD DUBLIN 18 IRELAND D18Y426 GROUP FINANCIAL CONTROLLER OF COMPANY
Authentication of Form
This form was authorised by: a person with an interest in the registration of the charge.
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Electronically filed document for Company Number: 07514939 Page: 1
Poolbeg Pharma plc
Poolbeg Pharma to present at investor conferences
13 September 2021 - Poolbeg Pharma (AIM: POLB), 'Poolbeg' or the 'Company', a clinical stage infectious disease pharmaceutical company with a capital light clinical model, today announces that members of its management team will be attending four upcoming investor events across September and October.
· Proactive Investors One2One Forum (virtual) on 16 Sep 2021. Registration Link: click here
· Small Company Champion Investor Presentation on 17 Sep 2021 at The Menphys Hub, Bassett Street South, Wigston, Leicester LE18 4PE. Registration Link: click here
· Shares Magazine Investor Webinar (virtual) on 5 Oct 2021. Registration link will be available on the Poolbeg Pharma website: click here
· London South East Webinar (virtual) on 19 Oct 2021. Registration link will be available on the Poolbeg Pharma website: click here
The above event details may be subject to change. Further information and any updates will be on the events section of the Poolbeg Pharma website.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma , said:
"Following continuing demand after an oversubscribed AIM listing in July and a share price above the IPO price, I am looking forward to sharing how our capital light model and a scalable platform for growth will deliver value creation for our shareholders. Poolbeg Pharma is targeting a rapidly expanding market of infectious diseases, which is expected to exceed $250B by 2025. These events will be an opportunity to discuss our attractive, Phase II ready lead asset (POLB 001) tackling the inflammatory response to severe influenza, and our special access to a unique data bank of 20 years of infectious disease data in humans which we will mine to identify new, compelling therapeutics."
Poolbeg Pharma plc
Poolbeg Pharma to present at investor conferences
13 September 2021 - Poolbeg Pharma (AIM: POLB), 'Poolbeg' or the 'Company', a clinical stage infectious disease pharmaceutical company with a capital light clinical model, today announces that members of its management team will be attending four upcoming investor events across September and October.
· Proactive Investors One2One Forum (virtual) on 16 Sep 2021. Registration Link: click here
· Small Company Champion Investor Presentation on 17 Sep 2021 at The Menphys Hub, Bassett Street South, Wigston, Leicester LE18 4PE. Registration Link: click here
· Shares Magazine Investor Webinar (virtual) on 5 Oct 2021. Registration link will be available on the Poolbeg Pharma website: click here
· London South East Webinar (virtual) on 19 Oct 2021. Registration link will be available on the Poolbeg Pharma website: click here
The above event details may be subject to change. Further information and any updates will be on the events section of the Poolbeg Pharma website.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma , said:
"Following continuing demand after an oversubscribed AIM listing in July and a share price above the IPO price, I am looking forward to sharing how our capital light model and a scalable platform for growth will deliver value creation for our shareholders. Poolbeg Pharma is targeting a rapidly expanding market of infectious diseases, which is expected to exceed $250B by 2025. These events will be an opportunity to discuss our attractive, Phase II ready lead asset (POLB 001) tackling the inflammatory response to severe influenza, and our special access to a unique data bank of 20 years of infectious disease data in humans which we will mine to identify new, compelling therapeutics."
Been a rns this morning
20th sept
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan plc, has signed an GBP8.1m contract with a major global pharmaceutical company to test its inhaled human rhinovirus (hRV) antiviral product using the hVIVO Asthma Human Challenge Study Model, which uses a hRV challenge agent (common cold virus).
Asthma is a long-term condition that is characterised by inflammation and narrowing of the small airways of the lungs, which causes coughing, shortness of breath and chest tightness. 5.4 million people in the UK currently receive treatment for asthma. Illnesses such as the common cold, which is most commonly caused by HRV, can worsen symptoms.
This antiviral study will be conducted by hVIVO and is expected to commence in H1 2022. The Company expects the bulk of the revenue from this contract to be recognised across 2021 and 2022. This new contract further underlines the increased international focus and investment into respiratory and infectious diseases following the outbreak of COVID-19, in areas such as the common cold, Influenza, and many other areas which were previously underserved by the pharmaceutical industry.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious disease viruses, including various strains of influenza, RSV, HRV, Asthma and Malaria, etc.
Cathal Friel, Executive Chairman of Open Orphan, said : "We are pleased to sign this contract with this top five European pharmaceutical company to test its inhaled hRV antiviral product using our Asthma Human Challenge Study Model. This contract demonstrates how our broad range of challenge study models can support our clients' varied infectious and respiratory disease product pipelines, and adds to our exciting pipeline of RSV, hRV, Influenza, Malaria, and Asthma challenge study contracts.
"The COVID-19 pandemic has highlighted that for the past 30 years there has been very little investment into the infectious disease and respiratory products space. As such, when the pandemic arrived the world discovered that the medicine cabinet of infectious disease products to deal with COVID-19 was virtually empty. Post-pandemic, most governments across the world, all of the Big Pharma companies and many of the smaller pharma companies are now investing hugely in new infectious and respiratory disease products and as such, this market is expected to grow from $20bn in 2019 to $250bn by 2025. This restocking of the pharmaceutical industries medicine cabinet of infectious disease products around the world is now leading to an enormous expansion of investment into the infectious disease and respiratory product market and will be seen as one of the biggest growth opportunities in the history of the pharmaceutical industry.
"Having re
Artical
Articulate also says Open Orphan has significant growth potential
Hi, could anybody tell me what this Open Orphan company filing means
07 Aug 2021 Resolutions
Resolution of removal of pre-emption rights
Authority to make market purchases 21/07/2021
Resolution of allotment of securities
This document is being processed and will be available in 10 daya
RNS Number : 6879E
Open Orphan PLC
09 July 2021
9 July 2021
Open Orphan plc
("Open Orphan" or the "Company")
Significant HRV & Influenza human challenge study contract win
Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO, a subsidiary of Open Orphan plc, has signed a significant contract with AIM ImmunoTech Inc ("AIM IT") to test its antiviral candidate, Ampligen, using both the human Rhinovirus HRV (common cold virus) and Influenza human challenge study models as part of a single study.
This antiviral study will be conducted by hVIVO. AIM IT will be the study sponsor of the Phase 2 human challenge trial, which is expected to commence in Q4 2021. The Company expects the majority of revenue from the contract to be recognised in the current financial year. The AIM IT contract demonstrates the breadth of Open Orphan's service offering and its ability to test multiple pathogens at once in its state-of-the-art zoned unit, reinforcing its status as the world leader in its field. The Company expects to sign more contracts in this area due to the increased international focus on respiratory and infectious diseases following the outbreak of COVID-19 and as attention turns to potential future outbreaks of other viral diseases.
hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus). In October 2020, this expanded to include the SARS-CoV-2 virus.
Cathal Friel, Executive Chairman of Open Orphan, said : "We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product against both HRV and Influenza human challenge study models as part of a single study. Being able to test our client's product against multiple pathogens in a single study demonstrates our capability of our state-of-the-art London unit, our industry leading experience, and our position as the go to provider of human challenge studies for biotech and pharmaceutical companies globally. Fortunately, with our access to three challenge study clinics in London, we were able to find a small gap in our schedule later this year to slot this particular study in at short notice.
"Likewise, as previously confirmed to the market, our London facilities are comprehensively prebooked throughout this year and into next year. As such, I am also delighted to confirm that we were solidly EBITDA profitable in H1 2021 and we remain on target for a profitable and successful 2021."
Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech Inc., said: "It is our belief that Ampligen's mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum
On companies house website Open Orphan have posted interim accounts up to to 31st May 2021 and these will be available to view in 10 days.
Is there any significance in this ?