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Poolbeg Pharma #POLB licence of Melioidosis vaccine candidate

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 further to the Option Agreement announced in December 2021, Poolbeg has signed an exclusive Licence Agreement with University College Dublin (UCD) through NovaUCD, the University’s knowledge transfer office, for a late preclinical stage vaccine candidate for Melioidosis, a disease for which there is no current approved vaccine available.

The vaccine candidate, which is being developed by Poolbeg as POLB 003, was invented following many years of research by Associate Professor Siobhán McClean, UCD School of Biomolecular and Biomedical Science, and was a recipient of a Wellcome Trust Award to aid its development.

Associate Professor McClean completed some of the original research to identify the antigens associated with the Melioidosis vaccine candidate at TU Dublin. 

Melioidosis, also known as Whitmore’s disease, is caused by the bacterium Burkholderia pseudomallei, Poolbeg identified the disease as an infectious disease of interest because of its rising incidence around the world due to climate change and its resistance to antibiotic treatment. As a US Centres for Disease Control and Prevention (CDC) designated biothreat, there is an increasing global need to develop effective vaccines and antibiotics to prevent and treat this disease.

As part of the Company’s Option Agreement with UCD, Poolbeg continues to evaluate five other potential vaccine candidates being developed by Associate Professor McClean and her team. This includes Escherichia coli (O157); a powerful toxin that can severely harm children and elderly and leave lasting kidney damage and Pseudomonas aeruginosa; a highly antibiotic resistant bacteria which is the leading cause of morbidity and mortality in cystic fibrosis. As well as Klebsiella pneumoniae which is a prevalent issue in US Defence and healthcare settings resulting in burdensome management of complications, Burkholderia cepacia complex; a significant cause of hospital-acquired infections with large impact on health budgets and Acinetobacter baumannii which poses a threat to immuno- compromised patients in care settings such as cystic fibrosis patients.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “Melioidosis presents a growing threat to global health as an infectious disease with no approved vaccine and a high mortality rate. POLB 003 is being developed in line with our capital light approach and represents a significant opportunity for Poolbeg. Combined with the Company’s expertise in infectious diseases it provides the perfect combination to contribute to the global response to this unmet-medical need and potential to generate significant returns for our investors.” 

Siobhán McClean, PhD, Associate Professor, UCD and inventor of MelioVac, said: “This partnership with Poolbeg will enable the further development of this important vaccine candidate. We are pleased to be bringing our technology, and Poolbeg’s vaccine development expertise and industry network together to fight this growing infectious disease.” 

– Ends –

 

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 +44 (0) 20 7183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Sunila de Silva (ECM), Nigel Birks

 

+44 (0) 20 7220 0500

Singer Capital Markets (Joint Broker)

Phil Davies, Sam Butcher

 

+44 (0) 20 7496 3000

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

44 (0) 20 7457 2020

poolbeg@instinctif.com

 

Notes to Editors

About Melioidosis

Caused by the bacterium Burkholderia pseudomallei, commonly found in the soil and surface groundwater of many tropical and subtropical regions, Melioidosis causes a diverse range of symptoms including pneumonia and severe sepsis with multiple organ abscesses. There are an estimated 165,000 cases of Melioidosis each year, of which as many as 89,000 (54%) are estimated to be fatal. It is widespread in South-East Asia, Northern Australia and India, but the warming climate is having a substantial impact on the spread of the disease to new areas such as Brazil and traditionally non-tropical areas. As a US Centres for Disease Control and Prevention (CDC) designated biothreat, there is an increasing global need to develop effective vaccines and antibiotics to prevent and treat this disease.

About POLB 003

Through an extensive characterisation of the protein structures present on the bacteria’s surface, the team at University College Dublin identified a homologue of the common OmpW bacterial antigen specific to this strain, called BpOmpW. Preclinical studies using this antigen showed significant survival benefit when challenged with the Burkholderia pseudomallei, the bacteria which causes Melioidosis. Similarly, so-called correlates of protection, which provide an indication of the protection status of a subject, were much improved including increased IFN-γ production and an enhanced T-Cell response profile, both of which have a proven role in protection against Melioidosis. 

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a unique 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 pharma and biotech 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 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 results from the first programme expected by year end 2022. 

For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma. 

About University College Dublin

UCD is Ireland’s largest and most diverse university and one of Europe’s leading research-intensive universities. Since 1854 UCD has made a unique contribution to the creation of modern Ireland, based on successful engagement with Irish society on every level and across every sphere of activity. As Ireland’s leading university in innovation, knowledge transfer and commercialisation, UCD’s commitment to innovation and entrepreneurship recognises the importance of active participation and collaboration to exploit leading-edge research and development outputs. As set-out in Rising to the Future 2020-2024 UCD’s four strategic theme are; creating a sustainable global society, transforming through digital technology, building a healthy world, and empowering humanity.

 

For further information, visit www.ucd.ie

Poolbeg Pharma #POLB – Interim results for the six months to 30 June 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 its unaudited interim results for the six months to 30 June 2022.

Financial & Operational Highlights

Well capitalised with a strong cash balance of £18.9m as at 30 June 2022

Significant progress made on developing POLB 001, a treatment for severe influenza

LPS human challenge trial commenced in July 2022 with initial results expected by year end 2022

Supply Agreement signed and GMP manufacturing completed

Key US patent granted in May 2022

Continuing to explore further disease indications beyond severe influenza

Two AI programmes commenced to analyse Poolbeg’s unique human challenge trial data

Agreement signed with OneThree Biotech Inc. in February 2022 to identify new drug targets and treatments for Respiratory Syncytial Virus (RSV). The programme is progressing well with the model build and optimisation completed in June 2022, with results expected by the end of 2022

In March 2022 an agreement was signed with CytoReason Ltd. to identify novel drug targets for influenza. Data analysis is ongoing, and results are expected in Q2 2023

Licensed first-in-class broad spectrum RNA-based immunotherapy (POLB 002) for respiratory virus infections from the University of Warwick in January 2022

Key European and US patents granted in April and May 2022 respectively

Diligence completed on POLB 003, an intramuscular vaccine candidate to prevent Melioidosis from University College Dublin. Definitive license agreement being finalised following exclusive option agreement (signed in December 2021)

Licensed AnaBio Technologies’ micro- and nanoencapsulation technology to develop oral vaccines in January 2022

 

Investor presentation

Jeremy Skillington, PhD, Chief Executive Officer, will provide a live presentation via the Investor Meet Company platform on 6 September 2022 at 6:00pm.

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: “I am pleased with the progress that the team has made to advance and expand our portfolio of products and platforms, and we intend to build on and accelerate this rate of progress in the remainder of 2022 and beyond.

“Poolbeg is entering a very exciting phase in its development with a number of near-term value inflection points expected before year end. This includes the initial results from our LPS human challenge trial for our severe influenza treatment, POLB 001, after which we will seek to out-licence to pharma and biotech companies, generating revenues from upfront payment and downstream milestones and royalties. In addition, the outputs from our RSV and influenza Artificial Intelligence Programmes are expected by the end of 2022 and in Q2 2023 respectively.

“We have strong financial resources available to progress our products and platforms and also to capitalise on new opportunities as we identify them which, in addition to our upcoming value inflection points, gives me confidence that we can generate strong returns for shareholders.” 

– Ends –

 Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 +44 (0) 20 7183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Richard Chambers, Sunila de Silva (ECM), Nigel Birks

 

+44 (0) 20 7220 0500

Singer Capital Markets (Joint Broker)

Phil Davies, Sam Butcher

 

+44 (0) 20 7496 3000

 

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

 

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a unique 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 pharma and biotech 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 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 results from the first programme expected by year end 2022.

For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.

 Link here to view the full results and financial statements

Alan Green discusses #WTB Whitbread, #POLB Poolbeg Pharma & #FCM First Class Metals on the Vox Market Podcast

Alan Green discusses #WTB Whitbread, #POLB Poolbeg Pharma & #FCM First Class Metals on the Vox Market Podcast

Listen here

A landmark year for Poolbeg Pharma #POLB – Alan Green talks to CEO Jeremy Skillington

A landmark year for Poolbeg Pharma #POLB – Alan Green talks to CEO Jeremy Skillington, who takes us through what has been a very eventful year since the IPO. At 01:58 we discuss the flagship asset POLB 001, which reached a major milestone last week as it commenced a human challenge trial. At 05:00 Jeremy provides an overview of two collaborations in Artificial Intelligence and how Poolbeg will use these pioneering approaches to identify new treatments for infectious diseases. At 08:57 Jeremy outlines what investors should expect for the remainder of 2022.

UK Investor Magazine Podcast – Covering Royal Mail #RMG Poolbeg Pharma #POLB & GreenX Metals #GRX

investor

Alan Green joins the Podcast for an in-depth discussion around the current market conditions and a selection of UK equities.

We break down the current market dynamics and question whether we have seen a bottom in markets as investor sentiment improves.

Royal Mail has changed their name after a torrid period of trading and a rather challenging outlook. Pressures from unions and falling volumes create a potentially toxic cocktail for the company and this has been reflected in the share price.

Poolbeg Pharma have announced a bug step forward in their flagship project in the commencement of a trial for POLB 001, a strain agnostic, small molecule immunomodulator.

GreenX Metals is creating a portfolio of metals with applications in clean technology. Their shares popped higher today as they begin a field program at their copper project in Greenland.

 

Improving Sentiment, Royal Mail, and Copper with Alan Green

Poolbeg Pharma #POLB – Major milestone reached as POLB 001 human challenge clinical trial ready to commence

20 July 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, has received ethics and competent authority approval to commence its Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a strain agnostic, small molecule immunomodulator which aims to address the unmet medical need for a treatment for severe influenza.

Key Highlights:

Clinical trial activities will formally commence on 22 July 2022

The trial will assess the efficacy of POLB 001 in dampening the robust immune response to LPS which acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases

Start of the trial demonstrates significant delivery on commitment at IPO

Initial results expected in Q4 2022 at which point the Company intends to rapidly monetise by out-licensing / partnering with pharma and biotech companies for further development of POLB 001

Trial success would also pave the way for potential applications beyond severe influenza

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “This is a major milestone for Poolbeg as we are ready to commence the LPS human challenge trial of POLB 001, our severe influenza treatment. Significant preparatory work has been completed in order to reach this stage with the completion of GMP* manufacturing, formulation, trial protocol design amongst other vital regulatory requirements. We look forward to receiving the valuable, broad-ranging data and insights that this trial is expected to generate by the end of 2022. We stated at our IPO in July 2021 that we intended to bring POLB 001 into the clinic for this LPS trial in the summer of 2022 and are happy to have achieved this stated objective and demonstrate our ability to effectively execute on our strategy.

“The unmet need for new treatments for severe influenza presents a significant opportunity to improve outcomes for patients as well as to potentially rapidly monetise our lead asset. The unique mode of action of POLB 001 to reduce hyperinflammatory response in the body means that it is agnostic to the strain of virus and has the potential to expand to other disease indications and as such, could provide further opportunities to create significant value beyond severe influenza for the Company and our shareholders.” 

*Good Manufacturing Practice

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

 

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson
Richard Chambers, Sunila de Silva (ECM), Nigel Birks

 

+44 (0) 207 220 0500

Arden Partners PLC (Joint Broker)

John Llewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

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 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 will commence its LPS human challenge trial imminently, with results expected by year end 2022. A first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections. (POLB 002); and a vaccine for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) drug discovery programmes to accelerate the power of its human challenge model data and biobank.

For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma 

Further detail on the LPS trial, POLB 001 and the Influenza opportunity and beyond

Rigorous randomised, double-blind, placebo-controlled, multiple dose, LPS human challenge trial in 36 healthy volunteers to assess efficacy of POLB 001 in treating the dangerous effects of severe influenza. As part of the trial, researchers will stimulate the immune systems of healthy volunteers with LPS across three cohorts. LPS triggers a robust immune response and acts as a surrogate for the hyperinflammatory effects associated with severe influenza infection, as well as other diseases. Each cohort will receive escalating doses of POLB 001 to evaluate its effectiveness in suppressing the body’s harmful inflammatory response to both intradermal (a shallow injection) and intravenous (an injection in a vein) administered LPS.

The Principal Investigator is Dr. Matthijs Moerland and the trial will be conducted at the Centre for Human Drug Research in The Netherlands and has received all relevant regulatory and ethics approvals. POLB 001 has previously been proven to be safe and well tolerated in a successful Phase I clinical trial. The first results of this LPS human challenge trial are expected before the end of the year, and the Company expects to be in a position to rapidly monetise POLB 001 thereafter by partnering or out-licensing to Pharma for further development and commercialisation.

Influenza is a viral pathogen that infects approximately one-eighth of the world’s population each year, an estimated 1 billion people infected globally, attacking the respiratory system leading to between 5 and 10 million hospitalisations and as many as 500,000 influenza related deaths. Survivors of severe influenza can suffer organ damage, leading to chronic and life-changing injuries. Given POLB 001’s mode of action, it is strain agnostic meaning that it treats the body’s reaction to infection rather than targeting the virus directly and, as such, POLB 001 is unaffected by the seasonal variants of influenza that arise each year which is a significant advantage over treatments available on the market. Therefore, POLB 001 has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment. POLB 001 has patent protection until 2038 and is a shelf-stable oral drug which makes it ideal as a stockpiling candidate for both seasonal outbreaks and pandemic preparedness.

POLB 001 also has potential therapeutic applications beyond severe influenza, due to its mode of action of reducing hyperinflammation (cytokine storm). This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage which is linked with many diseases. POLB 001 has the potential to block this by interrupting the positive feedback loop of inflammatory mediators. Poolbeg is currently investigating new potential uses and in due course hopes to expand its IP around this asset to cover new disease areas thereby increasing the value of the asset.

News Poolbeg Pharma AI model of respiratory syncytial virus starts analysis

Poolbeg featured in the @MorningstarInc following yesterdays announcement on the completion of build 7 optimisation of our #AI model for RSV #data, the first time AI used to model #RSV with complete longitudinal #disease data.

Link below to read in full:

https://www.morningstar.co.uk/uk/news/AN_1656323268845373200/poolbeg-pharma-ai-model-of-respiratory-syncytial-virus-starts-analysis.aspx

Poolbeg Pharma #POLB – Article

The @McKinsey’s #biotech #investment themes article highlights “insufficient number of high-quality data”a limitation to AI #drugdiscovery #POLB‘s #AI programmes have access the world’s largest data & #biobank of high-dimensional #disease progression data

 

Open Orphan #ORPH – Final results Reveal Record revenues and EBITDA-profitability accompanied by significant operational progress

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces its audited final results for the 12 months ended 31 December 2021.

Financial highlights

·       Record revenues of £39.0m (2020: £22.2m) achieved representing 76% growth

·       £9m improvement in EBITDA generating £2.9m (2020: £(6.1)m)

·       Cash and cash equivalents as at 31 December 2021 of £15.7m (2020: £19.2m)

·       Significant EPS improvement in 2021 to (0.01)p per share (2020: (1.80)p)

·       Order book growth of 11% to £46m future contracted revenue as at 31 December 2021 (2020: £41.6m)

Operational highlights

·     Delivered a strong and growing pipeline of new challenge study contract wins

Served four of the top 10 global biopharma companies in 2021 among a growing client base of over 60 clients

·     Substantially expanded the Group’s offering into the respiratory market signing an asthma study with a top three global pharma company

·     Completed the world’s first COVID-19 characterisation study which was proven to be safe and well tolerated

·     Contract signed to manufacture a SARS-CoV-2 Delta variant challenge agent with Imperial College London, as part of a Wellcome Trust-funded initiative

·     Opened a new quarantine clinic on a capital efficient basis to facilitate the growing demand for human challenge studies. This new facility, The Whitechapel Clinic, added 19 quarantine bedrooms for future challenge studies 

·     FluCamp screened c. 84,000 volunteers for human challenge studies in 2021 (2020: c.68,000); supported by the cost-efficient expansion of volunteer recruitment centre

New London FluCamp volunteer recruitment centre – converted former coffee shop adjacent to the existing QMB facility

New Manchester FluCamp volunteer recruitment centre

·     Significant CRO experience added to the Board with the appointment of Yamin ‘Mo’ Khan as Non-Executive Director, who was appointed CEO post period end

·     In June 2021, completed a distribution in specie to the Company’s shareholders, through the demerger of certain non-core assets into Poolbeg Pharma

Post-period end highlights

·     Commenced development of a new influenza challenge model for an existing top five global pharmaceutical client and signed a £14.7m contract for the characterisation and challenge trial to follow

·     £7.3m influenza challenge trial and £5m RSV challenge trial contracts signed

·     Launched a new Malaria human challenge model and was awarded by an existing Big Pharma client to act as a vaccination site for a Phase II field study

·     Opened a new primary FluCamp volunteer recruitment facility in Whitechapel, increasing bed capacity by 44% from 43 beds to 62 beds, and opened a new Manchester volunteer recruitment centre at the same cost as the old facility, but with four times the floor space, doubling the Group’s volunteer screening capacity to 1,000 per week

Facilities expansion enables the Group to broaden the scope of the business to offer additional clinical trial services outside of its traditional core challenge study offering

Current trading and outlook

As at 1 June 2022, Open Orphan had an order book of signed contracts worth £64.2m which is expected to be recognised across 2022, 2023 and 2024.

Open Orphan’s pipeline of new opportunities continues to grow with a number of further challenge study opportunities at advanced negotiations across influenza, asthma, RSV, malaria and COVID-19. This growth is driven by the increased success and awareness of human challenge trials, and the development of new challenge models. A significant portion of our pipeline includes returning Big Pharma customers, in addition to a wider group of new clients who have observed the benefits of human challenge trials.

Our Venn Life Sciences subsidiary continues to deliver specialist drug development consultancy services across non-clinical and clinical development, pharmacology, CMC and biometry services, acting as a trusted partner to an extensive range of clients.

These developments reaffirm the Board’s expectations of a profitable growing business with revenues in the region of £50m in 2022.The Group is now well positioned and well capitalised to deliver sustainable long-term profitability.

 

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “2021 was a milestone year for Open Orphan; the Group achieved record revenues, and recorded full year EBITDA-profitability for the first time – a significant turning point for the business. 

“The Group won a record number of human challenge study contracts, serving four of the top 10 global biopharma companies and more than 60 clients in total. We were proud to make a significant contribution to the UK Government’s response to the pandemic by completing the world’s first COVID-19 characterisation study, which furthered our understanding of COVID-19 disease progression. Importantly, the Group accomplished this whilst investing in operational improvements, with volunteer screening and quarantine capacities expanded during the year.

“Post-period end, we have continued our momentum from 2021 into a strong start to trading and significant contract wins. We increased our bed count from 43 to 62, doubled our volunteer screening capacity, and also expanded the scope of our business to offer additional clinical trial services, where we have already signed our first contracts, establishing new revenue streams for the business. We also launched our new Malaria Human Challenge Model, which I believe has further consolidated our position as the leading provider of human challenge trials in infectious and respiratory disease. In my new role as CEO, I look forward to driving further growth across the business this year and converting this substantial progress into value for our shareholders.” 

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses. 

1 Source: Citeline Trialtrove, Jan. 2022 and Pharma R&D Annual Review; IQVIA Institute, Global Trends in R&D – Overview Through 2021; Global Data; Evaluate Pharma; Edison Investment Research; Pitchbook

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin ‘Mo’ Khan, Chief Executive Officer

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 / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /

+44 (0)7747 515393

Notes to Editors

Open Orphan plc 

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan 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 newly opened 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. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

Link here for full financial statements

#POLB Poolbeg Pharma – TR-1: Notification of major interest in shares

POLB

TR-1: S tandard form for notification of major holdings

 

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii :

Poolbeg Pharma PLC

1b. Please indicate if the issuer is a non-UK issuer   (please mark with an “X” if appropriate)

Non-UK issuer

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:

3. Details of person subject to the notification obligation iv

Name

Schroders PLC

City and country of registered office (if applicable)

London , United Kingdom

4. Full name of shareholder(s) (if different from 3.) v

Name

City and country of registered office (if applicable)

5. Date on which the threshold was crossed or reached vi :

18/05/2022

6. Date on which issuer notified (DD/MM/YYYY):

19/05/2022

7. Total positions of person(s) subject to the notification obligation

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights held in issuer vii

Resulting situation on the date on which threshold was crossed or reached

5.128388%

5.128388%

25,641,941.00

Position of previous notification (if

applicable)

Below Reportable Threshold

Below Reportable Threshold

 



 

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

GB00BKPG7Z60

25,641,941.00

5.128388%

SUBTOTAL 8. A

25,641,941.00

5.128388%

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date
 x

Exercise/
Conversion Period
 xi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date
 x

Exercise/
Conversion Period
 xi

Physical or cash

settlement xii

Number of voting rights

% of voting rights

 

SUBTOTAL 8.B.2



9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entity
 xiv (please add additional rows as necessary)

X

Name xv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Schroders PLC

Schroder Administration Limited

Schroder Wealth Holdings Limited

Schroder & Co. Limited

Schroders PLC

Schroder Administration Limited

Schroder International Holdings Limited

Schroder Investment Management Limited

 

10. In case of proxy voting, please identify:

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional information xvi

Place of completion

London

Date of completion

19/05/2022

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