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Open Orphan #ORPH – DNDi Phase II trial to support river blindness drug
Open Orphan plc (AIM: ORPH), a rapidly growing specialist clinical research organisation (CRO) which is the world leader in testing vaccines and antivirals using human challenge clinical trials, announces a contract to supply consultancy services to support a Phase II trial in Onchocerciasis Disease, an infectious disease commonly known as river blindness.
Venn Life Sciences (“Venn”), a subsidiary of Open Orphan, will provide Data Management & Biostatistics services to support the Phase II trial of an antibiotic drug candidate for Drugs for Neglected Diseases initiative (“DNDi”), a not-for-profit research organisation developing new affordable and patient-friendly treatments for neglected patients around the world. DNDi was founded in 2003 by Médecins Sans Frontières, the World Health Organisation, and five international research institutions.
The Venn team in the Paris office will provide support for the trial, taking place in the Democratic Republic of Congo, to evaluate the product ABBV-4083, owned by AbbVie and licensed to DNDi, as a potential antibiotic treatment for patients with Onchocerciasis, the second-most common cause of blindness due to infection, after trachoma. ABBV-4083 was identified by a screening of anti-infective compounds led by the pharmaceutical company AbbVie and the anti-Wolbachia consortium A-WOL at the Liverpool School of Tropical Medicine. The study has already commenced.
Venn offers a unique set of high quality, innovative, methodology, data management and biostatistics services utilising the very best technologies and clinical trial expertise to help their clients have access to their data faster and at a lower cost. Venn’s portfolio of services range from design conception, through to data-acquisition and management activities to the analysis, reporting and exploitation of the results and their subsequent presentation for submission to the appropriate regulatory authorities and/or publication. Venn offer a fully standardised and compliant methodology for collating, validating and presenting real-time information to their clinical partners.
Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to announce another contract win for the business which underpins our confidence in the continued growth we expect to see in 2021. Our teams have a unique knowledge of multiple clinical data management systems and our team of biostatisticians have extensive experience to bring to bear on such studies. We’re very proud to be working with DNDi to support their development of what could be a game-changing drug to help people affected by river blindness in some of the world’s poorest nations.”
Sabine Specht, Head of the Filarial Clinical Programme at DNDi, said: “We are delighted that Open Orphan has joined DNDi, AbbVie and multiple partners involved in the development of ABBV-4083 for those at risk or suffering from onchocerciasis. The Democratic Republic of Congo is one of the most affected countries by this debilitating disease, so it is especially important that our clinical trials will take place there, where we will be working with national authorities to test out this potentially innovative treatment.”
For further information please contact
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus / Louis Ashe-Jepson / Sam Allen |
+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258 |
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Notes to Editors
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of eight human challenge study models for infectious and respiratory diseases and is developing a number of other models including the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme.
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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.
Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.
Open Orphan PLC #ORPH – NEJM Opinion Piece
The New England Journal of Medicine (NEJM) publishes editorial relating to Human Challenge Programme
Open Orphan (AIM: ORPH), a rapidly growing specialist clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, confirms that an editorial opinion piece regarding the UK Government’s Human Challenge Programme has been published in the latest edition of the New England Journal of Medicine (NEJM).
The piece, titled ‘Establishing the Model during an Evolving Pandemic’, explores the extensive preliminary review process which was commissioned by the UK Government and delivered by the coalition involved in the COVID-19 Human Challenge Programme to justify the research and manage and minimise the risks associated with the trial, as well as arguments supporting the inclusion of a SARS-CoV-2 human challenge research program as part of the pandemic response.
The Human Challenge Programme, part of the UK Government’s Vaccine Taskforce, is a collaboration between the UK Government, the Royal Free London NHS Foundation Trust, Imperial College London and hVIVO , a subsidiary of Open Orphan, to deliver the world’s first human challenge study for COVID-19.
In human challenge studies, a small number of healthy volunteers in a controlled setting are exposed to an infectious agent, in this instance, COVID-19, for scientists and clinicians to assess how effective vaccines or treatments are against the disease and identify any side effects.
The NEJM is recognised as the world’s leading medical journal and website. Published continuously for over 200 years, the NEJM delivers high-quality, peer-reviewed research and interactive clinical content to physicians, educators, researchers, and the global medical community. The publication’s mission is to publish the best research and information at the intersection of biomedical science and clinical practice and to present this information in understandable, clinically useful formats that inform health care practice and improve patient outcomes.
Cathal Friel, Executive Chairman of Open Orphan plc, commented: “We are delighted to see support for the COVID-19 Human Challenge Programme in a publication such as the New England Journal of Medicine. The piece articulates the considerable review process commissioned by the UK Government and delivered by hVIVO, in collaboration with the Royal Free London NHS Foundation Trust , and Imperial College London. We believe the UK Government’s COVID-19 Human Challenge Programme will play a vital role in trialling the vaccines and antivirals which continue support our effective pandemic response in the UK and abroad. “
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus / Louis Ashe-Jepson / Sam Allen |
+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258 |
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Poolbeg Pharma #POLB – Admission to AIM and First day of trading
Poolbeg Pharma (AIM: POLB), a clinical stage infectious disease pharmaceutical company with a capital light clinical model , is pleased to announce that admission of its entire issued share capital to trading on the AIM market of the London Stock Exchange will become effective and dealings will commence at 8.00 a.m. today under the ticker “POLB” and with the ISIN GB00BKPG7Z60 (“Admission”).
The full Admission Document is available to view on the Company’s website at www.poolbegpharma.com
IPO highlights
· Shares priced at 10p per share equating to a market capitalisation at Admission of £50m
· Oversubscribed fundraise which resulted in an increased raise from £20m to £25m despite some investor scale back
· Funds raised to be used primarily:
o to fund clinical trial costs associated with development of the Company’s POLB 001 asset as a treatment for severe Influenza and potentially other areas with label extensions
o work on advancing other portfolio assets to monetisation
o to acquire and develop other infectious disease assets
Company investment case
· Attractive lead asset – POLB 001 – A first-in-class, Phase II ready small molecule immunomodulator for severe influenza, addressing a significant unmet need for effective treatments (c. $800m addressable market)
· Wide asset portfolio – lead product has applications beyond Influenza plus PredictViral™ Biomarker platform for early prediction of severe disease (which has the potential to transform the way that infectious diseases are treated) and the Vaccine Discovery Platform harnessing data from the human challenge model
· Valuable Data Access – licensed access to one of the largest infectious disease progression data and bio banks i.e. Open Orphan’s data and biobank, with the potential to interrogate the data with an AI data analysis platform (advanced discussions underway) to accelerate the identification of drug targets / products
· Rapidly expanding market – focused on infectious diseases, particularly Influenza and other viral diseases. The market is expected to exceed $250bn by 2025
· Capital light and scalable business model – enables the Company to develop assets to be Phase II-ready quickly with modest investment where they can be monetised / licenced to big pharmaceutical companies
· Strong heritage – initial assets from Open Orphan plc (AIM: ORPH), a well-established, revenue generating business with more than 20 years of experience in infectious diseases and human challenge trials
· Experienced team – management team has a track record of delivery and creating value for shareholders
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:
“The IPO and funds raised have provided a strong platform to begin our rapid growth plan. With experienced management on board and the exciting assets acquired from Open Orphan, we look forward to delivering value to our shareholder base and generating innovation in the previously overlooked infectious disease space which is now one of the fastest growing markets and is expected to exceed $250bn by 2025.
“Our capital light model versus conventional biotech has been well received by investors and the life sciences industry at large. We intend to drive business development through product in-licensing and acquisitions, which will provide continued momentum and value creation for our shareholders. At the core of our business, we are patient-focused and customer-led and plan to use our extensive network to become a ‘one-stop shop’ for big pharma, developing and partnering the infectious disease assets that they need.”
Cathal Friel, Chairman of Poolbeg Pharma commented:
“The listing of Poolbeg Pharma is a great opportunity to maximise the potential of some of Open Orphan’s key pharma assets and we have had excellent support from current and new shareholders.
“We have been deliberate in creating a company with a capital light model that can create excellent returns and value for its shareholders with substantially less risk than the traditional biotech model, which is why I was so excited to invest £500,000 personally in the IPO alongside incoming investors. We have assembled a leading management team with the tools and funding in place to deliver and are excited to now accelerate all our activities. At the heart of Poolbeg is the desire to improve infectious disease treatments for patients and provide valuable assets big pharma needs to improve patient care. It’s a win-win.”
– Ends –
Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+353 (0) 1 644 0007 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson
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+44 (0) 20 7220 0500 |
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Arden Partners PLC (Joint Broker) John Lewellyn-Lloyd, Richard Johnson, Oscair McGrath
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+44 (0) 207 614 5900 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Lewis Hill |
+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 licence 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. It already has a Phase II ready repositioned small molecule immunomodulator for severe influenza and a portfolio of other exciting assets. The Company plans to broaden this portfolio further going forward and is in active discussions with AI data analysis platforms to help accelerate the power of its human challenge model data and biobank.
For more information, please go to www.poolbegpharma.com
Open Orphan #ORPH – Exec Chairman Cathal Friel & Non Exec Director Prof. Brendan Buckley purchase shares
The Company announces that it has received notification that, on 14 July 2021, Cathal Friel, Executive Chairman of the Company, purchased 1,132,075 ordinary shares of 0.1 pence each in the capital of the Company (“Shares”) at a price of 26.5 pence per Share and that Prof. Brendan Buckley, Non-Executive Director of the Company, purchased 188,679 Shares at a price of 26.5 pence per Share.
Following this purchase Cathal Friel is interested in 47,087,086 Shares, representing approximately 7.0 per cent. of the Company’s issued ordinary share capital, and Brendan Buckley is interested in 8,034,539 Shares, representing approximately 1.2 per cent. of the Company’s issued ordinary share capital.
Cathal Friel, Executive Chairman, Open Orphan, said: “I am delighted to have now had the opportunity to increase my personal stake in Open Orphan plc by today purchasing additional shares, and am equally pleased that Brendan is joining me in doing likewise. These share purchases further demonstrates my and the Board’s commitment to the Company, and reiterates my confidence in Open Orphan’s future prospects as we enter a period where the infectious disease market is rapidly expanding and expected to grow to in excess of $250bn per annum by 2025.
“We continue to roll out new contract wins and having signed and announced this week and last week, two significant challenge study contract wins for our London office and earlier today a €900k contract win for our Breda, Netherlands office. In the past week I was also delighted to confirm that we were solidly EBITDA profitable in H1 2021 and remain on target for a profitable and successful 2021.
“Likewise, earlier today Poolbeg Pharma plc filed its Schedule One confirming that it had successfully raised £25m in fresh funds on a pre-money valuation of £25m, thus when it completes its IPO in the coming week it should be listing with a market cap of c. £50m. This is an excellent start to our strategy of spinning off and montizing our non-core assets. We plan and expect to spin off the other three non-core assets between now and year end; namely our 49% stake in Imutex, our 62.6% stake in PrEP Biopharm and Disease in Motion platform business. Thus, we have a very exciting year ahead for Open Orphan.”
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath |
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finnCap Ltd (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson / Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus / Louis Ashe-Jepson / Sam Allen |
+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258 |
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Notes to Editors
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.
Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts .
Open Orphan #ORPH – New Contract win for Open Orphan’s Breda office
Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a new contract win of c. €900,000 with an existing customer for clinical trial management by our Breda, Netherlands office.
Cathal Friel, Executive Chairman of Open Orphan, said: “This new contract win demonstrates the ongoing and continued success of our Breda office which continues to sign multiple contracts and only those close to £1 million and above are announced. Our Breda office is getting more and more integrated with our London business, and the entire Open Orphan group is excelling as the global leader in the testing of vaccines, anti-virals and other infectious disease therapeutics.”
Completion of CHIMagents acquisition
Separately, and further to the Company’s announcement of 15 July 2020, Open Orphan announces that it has completed its acquisition of CHIMagents Limited. CHIMagents was established to assist in the design, manufacture and testing of challenge agents for use in challenge studies. The CHIMagents team have been working alongside the Open Orphan team since July 2020 supporting the design, manufacture and testing of both new challenge agents and the Company’s industry leading portfolio of existing challenge study agents.
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.
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus/ Sam Allen/ Louis Ashe-Jepson |
+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
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Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.
Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.
Open Orphan #ORPH – World’s first Covid-19 human challenge study to expand
Open Orphan (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, is continuing to work with the UK Government to inoculate up to 20 further volunteers as part of the world’s first COVID-19 characterisation study.
As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that causes a safe and reliable infection in unvaccinated COVID-19 naïve volunteers. The UK Government has decided to expand the Human Challenge Programme to answer further questions that can help in the fight against COVID-19.
The study expansion will commence as soon as appropriate regulatory approvals and clinical preparations are complete. The study is funded by the UK Government who have commissioned Imperial College London to act as the clinical study sponsor. The study is conducted by hVIVO at the Royal Free Hospital, under the supervision of our highly trained scientists and medics.
The virus being used in the characterisation study has been produced under hVIVO’s supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London.
The data from this study is already providing valuable insight into the biology of the virus which causes COVID-19. This knowledge will improve the ability to manage the virus and deliver a range of treatment options in the future.
The revenue from the contract is expected to be recognised in the current financial year.
Cathal Friel, Executive Chairman of Open Orphan, said: “At Open Orphan we are committed to helping the UK Government in partnership with two great institutions, Imperial College London and the Royal Free Hospital, to discover effective treatments for COVID-19. This study expansion further illustrates the effectiveness and importance of this study.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “We are delighted to announce this study expansion with the UK Government. This will enable 20 furthervolunteers to participate in this next phase of the world’s first study of its kind which will help scientists better understand and treat COVID-19.
“Open Orphan, through its subsidiary hVIVO, is proud to be working with the UK Government’s Human Challenge Programme in this initiative to help control and minimise the spread of the virus and we will look to provide updates on the study with further announcements in due course.”
Caroline Clarke, Royal Free London group chief executive, said: “We are excited to enter this next phase of this study with our partners from hVIVO, Imperial College London and the government’s Vaccine Taskforce. Ultimately, we hope this research will give us more information about vaccines, as well as its impact on infection rates, and enable us to provide better treatments in the future for patients with COVID-19.”
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.
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.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus/ Sam Allen/ Louis Ashe-Jepson |
+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
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Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.
Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.
Open Orphan #ORPH – Significant HRV & Influenza human challenge study contract win
Open Orphan (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 capabilities as an antiviral prophylaxis and therapeutic. The ability to do a human challenge trial using HRV and Influenza allows us to test in humans Ampligen’s potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses.”
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.
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.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus/ Sam Allen/ Louis Ashe-Jepson |
+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
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Notes to Editors
Open Orphan plc
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.
Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.
Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.
AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.
The Times – Our flu drug is not to be sniffed at, says Poolbeg Pharma chief Jeremy Skillington
The course of Jeremy Skillington’s year took a fateful turn in March when he took a call from Cathal Friel, chairman of Open Orphan, a clinical trials company listed on the Alternative Investment Market (AIM). At the time Skillington was tidying up the loose ends of the landmark €380 million sale of Irish biotech company Inflazome to Roche, a Swiss pharmaceutical multinational, and plotting three months of leisure.
Donegal deal-maker Friel dangled the dizzying prospect of heading an Irish biotech company that would list on the stock market within three to six months.
Link here for the full article
Open Orphan plc (ORPH) Demerger Update
Demerger Update
Further to Open Orphan’s announcement on 14 June 2021 in relation to the distribution in specie, the boards of Open Orphan and Poolbeg Pharma are pleased to announce Poolbeg’s intention to seek admission of its shares to trading on AIM, a market of the London Stock Exchange (“Admission”). Funds raised as part of Admission will be used primarily to fund the clinical trial costs associated with the development of the Company’s POLB 001 asset as a treatment for severe influenza and to acquire and develop new portfolio assets.
Wide asset portfolio
- Attractive lead asset – POLB 001:
- First-in-class, Phase II ready small molecule immunomodulator for severe influenza.
- Addresses unmet need for effective treatments against severe influenza (c. $800m addressable market)
- Applications beyond influenza are possible with label extensions (and the Company holds worldwide rights for all uses)
- Vaccine Discovery Platform harnessing data from the human challenge model to potentially discover new vaccines which the Directors believe could generate significant shareholder value
- PredictViral™ Biomarker platform for predicting severe disease – potential to transform the way infectious diseases are treated
- Licensed access to one of the largest infectious disease progression data and bio banks i.e. Open Orphan’s data and biobank, with the potential to interrogate the data with an AI data analysis platform (advanced discussions underway) to accelerate the identification of drug targets / products
- Pipeline of further assets for acquisition post-IPO
Infectious Disease Market
- Market expected to exceed $250bn by 2025
- Cumulative costs of the COVID-19 pandemic in terms of lost output & health reduction is equivalent to 90% of US GDP ($16tn)
- Significant recent M&A and licensing activity in the infectious disease space
Capital light business model
- Enables the Company to develop assets to Phase II quickly with relatively modest investment where they can potentially be monetised / licensed to big pharmaceutical companies
- Platform for growth with a proven, streamlined method of identifying drugs to acquire / license, access to key data to drive that platform and well protected intellectual property
- Faster and more cost-effective development model than traditional biotech’s giving potential for multiple value inflection points as each asset is advanced through the pipeline with a view to ultimate monetisation / licensing to big pharmaceutical companies
- Intend to use contingent payments to fund asset acquisitions therefore minimising / eliminating potential equity dilution
Track Record
- Strong heritage – initial assets from Open Orphan, a well-established, revenue generating business with over 20 years’ experience in infectious diseases and human challenge trials
- Track record of delivery and creating value for shareholders – management team has completed three IPOs, built revenue generating businesses and achieved significant exits
Poolbeg IPO
- Signal of quality to prospective partners and customers, raising the profile of the business
- Provides a supportive platform on which to accelerate existing assets through development
- Funds raised will allow the Company to acquire / license additional assets and technologies as appropriate
- A portion of the Placing is expected to qualify for EIS and VCT related tax relief in addition to an expected retail offering via PrimaryBid
- Cathal Friel, Non-Executive Chairman of Poolbeg has committed to participate in the IPO alongside incoming investors on the same terms
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:
“The COVID-19 pandemic has placed the issue of infectious diseases firmly in the public eye; Governments and international organisations are now investing heavily to ensure they are better prepared.
“Poolbeg Pharma is aiming to carve out a leading position in this rapidly evolving and expanding sector. We have an excellent heritage in infectious diseases and a management team with a track record of delivering value creation.
“Our capital light business model is an important differentiator. Through deep biological analysis of disease progression, we believe that it should enable us to reposition existing drug candidates and develop assets to Phase II stage quickly with relatively modest investment where they can then potentially be acquired / licensed to big pharmaceutical companies. We aim to be customer-led and will use our extensive network to become a ‘one stop shop’ for big pharma, developing the assets that they need.”
Cathal Friel, Executive Chairman of Open Orphan and Non-Executive Chairman of Poolbeg Pharma commented:
“Poolbeg Pharma is a great opportunity to maximise the potential of some of Open Orphan’s pharma assets which are non-core to our successful human challenge clinical trial business in a focused and capital efficient way.
“Poolbeg’s approach to asset development should result in good licensing opportunities and excellent returns in a relatively short period of time with substantially less risk than the traditional biotech model and allow for regular investor newsflow. In addition, in Poolbeg we have assembled a leading management team, generated an exciting pipeline of potential acquisitions and entered advanced discussions with leading AI data analysis platforms to increase the attractiveness of the Company and its offering. Thus, I am confident and excited in the Company’s prospects going forward and will be personally investing alongside incoming investors as part of the potential IPO.
“We are extremely proud that this is now the third life science IPO from the Raglan Capital stable after Amryt Pharma plc and Open Orphan plc, and we are excited to have Jeremy Skillington joining as CEO, bringing his valuable experience and successful track record with Inflazome to the team.”
– Ends –
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Open Orphan plc Cathal Friel, Executive Chairman
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+353 (0) 1 644 0007 |
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Arden Partners PLC (Nominated Adviser & Joint Broker) John Llewellyn-Lloyd, Richard Johnson, Oscair McGrath
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+44 (0) 207 614 5900 |
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finnCap Ltd (Joint Broker) Geoff Nash, James Thompson, Charlie Beeson
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+44 (0) 20 7220 0500 |
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Davy (Euronext Growth Adviser and Joint Broker) Anthony Farrell
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+353 (0) 1 679 6363 |
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Walbrook PR (Financial PR & IR) Paul McManus / Louis Ashe-Jepson / Sam Allen |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / 07747 515 393 / 07502 558 258 |
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Open Orphan (ORPH) Final Results to 31 December 2020
Final Results to 31 December 2020
Important year of transition following the various merger and acquisition activities in 2019 and January 2020
Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its audited results for the 12 months to 31 December 2020. Following the acquisition of hVIVO in January of last year, 2020 was a year of transition for the Company with management integrating both businesses and driving improvements in revenue, gross margin and efficient overheads.
This culminated in Q4 2020 proving to be an inflection point for the Company as it successfully generated both an operating profit and positive cashflow. In addition, the Company ended the year with a strong order book of contracted revenue which has been the foundation for the Company’s very strong start to 2021. In the context of the rapidly evolving COVID-19 pandemic and broader growth of the global infectious disease market, this should translate into very strong growth opportunities for the Company going forward.
Operational highlights:
- Integration of hVIVO and Venn Life Sciences completed with pharmaceutical services business now profitable and poised for strong revenue and EBITDA growth in 2021; growing working capital balance on hand
- Clearly established as the world leader in the testing of vaccines and antivirals through the use of human challenge study clinical trials
- Strategy in place to maximise shareholder value via the demerger of non-core assets with first spin-out Poolbeg Pharma Ltd well under way
- In the last 12 months substantially increased the number of quarantine beds available to Open Orphan:
- Original 24 quarantine beds in Queen Mary’s BioEnterprises Centre (QMB) in Whitechapel
- 19 bed additional beds through the conversion of the Whitechapel Hotel
- Open Orphan has the capacity to screen in >500 volunteers per week to support a growing pipeline of human challenge studies.
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- New state-of-the-art volunteer recruitment screening centre on the ground floor of QMB
- New standalone regional volunteer recruitment screening centre in Manchester
- Strategic decision In March 2020 to develop a COVID-19 challenge model:
- hVIVO was uniquely placed to contribute to a world-first initiative led by the UK government to work as part of the Vaccine Task Force’s Human Challenge project to manufacture a COVID-19 virus, and to collaborate on the design and delivery of a characterization study to understand how to use this virus for vaccine and anti-viral challenge trials, which is ongoing.
- Collaboration is ongoing with significant progress achieved to enable the Group to test vaccines and therapeutics against COVID-19 in the near future.
Financial highlights
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Open Orphan plc Group (Results as Reported) |
hVIVO Ltd (Proforma results on a stand-alone basis for a full year)
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Open Orphan plc (formerly Venn Life Sciences Holdings plc – Proforma results on a stand-alone basis for a full year) |
Open Orphan DAC (Proforma results on a stand-alone basis for a full year) |
Open Orphan plc Group (Proforma results on a combined basis for a full year) |
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2020 |
2019 |
2020 |
2019 |
2020 |
2019 |
2020 |
2019 |
2020 |
2019 |
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|
Income Statement |
£’000
|
£’000
|
£’000
|
£’000
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£’000
|
£’000
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£’000
|
£’000
|
£’000
|
£’000
|
|
|
Revenue (Incl. other income) |
21,995 |
3,543 |
14,515 |
15,092 |
7,844 |
8,643 |
– |
– |
22,359 |
23,735 |
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Operating (Loss) |
(10,442) |
(5,130) |
(4,854) |
(5,893) |
(5,604) |
(6,385) |
(435) |
(669) |
(10,893) |
(12,948) |
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EBITDA before exceptional items |
(6,265) |
(3,792) |
(2,925) |
(3,785) |
(3,313) |
(4,432) |
(431) |
(668) |
(6,669) |
(8,885) |
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Loss for period |
(10,791) |
(5,739) |
(4,927) |
(6,973) |
(5,776) |
(6,622) |
(548) |
(899) |
(11,251) |
(14,494) |
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- An important year of transition to reverse the proforma losses in 2019 by strengthening business development, restructuring underperforming businesses, driving cross group synergies, eliminating unnecessary layers of management, and integrating support functions across the Group.
- Significantly improved track record of major contract wins in 2020 (versus 2019) setting the scene for strong revenue growth in 2021
- Turnaround on track evidenced by an operating profit delivered for Q4 2020 and targeting full year profitability in 2021
- Cashflow positive in Q4 2020 driven by advanced cash payments on major agreements.
- Pharmaceutical services business (the combined business of Venn and hVIVO) is operationally profitable and moving into cash generation.
- Well capitalized following two placings raising a combined total of £17.9m (before expenses)
- Cash and cash equivalents of £15.1m as at 31 May 2021
- Proforma revenues of £22.4m (2019: £23.7m), with losses reduced to £11.3m (2019: £14.5m)
- Reported revenues of £22.0m (2019: £3.5m), with a reported loss for the period of £10.8m (2019: £5.7m)
Outlook:
- Clinical Science Teams and Laboratory Development Teams continue to address ground-breaking research projects with major pharmaceutical players – strong demand for services expected.
- Planned demerger strategy is progressing well with further update provided today on Poolbeg Pharma
- Demergers offer an excellent opportunity for shareholders to maximise value through separate shareholdings in a profitable pharma services company as well as exciting pharma products commercialisation companies.
- Opportunity to progress Disease in Motion® platform.
- Targeting delivery of full year profit in 2021 – focusing on enhancing profits and earnings
Cathal Friel, Executive Chairman of Open Orphan plc commented: “The Group is not simply satisfied to have returned to a positive operating position at the end of 2020 and to be targeting to deliver a full year profit in 2021, it is now focused to further enhance the quality of profits and earnings of the Group going forward. Therefore, notwithstanding the strategic investments we are making in new challenge models and the Disease in Motion® platform, we will relentlessly focus on cross selling our services across our broad client base, leveraging technology to drive improved efficiencies, and stripping away unnecessary cost in our operations.”
“It has been a remarkable year and I am grateful to our team for their hard work and loyalty. I am also grateful to you, our shareholders for the faith you have placed in the Group. The new financial year has started well and is already very well advanced. We are confident that the actions we are taking now to drive our core CRO business and monetise non-core assets should create significant value for all our stakeholders.”
The Company’s Annual Report and Accounts for the year ended 31 December 2020 will be posted to shareholders in due course together with the notice of the 2021 Annual General Meeting], and will be available on the Company’s website, https://www.openorphan.com/
Analyst Briefing
An online briefing for Analysts will be hosted by Cathal Friel, Executive Chairman, and Leo Toole, Group Financial Officer, at 11.00am on Thursday 17 June 2021 to review the results and prospects. Analysts wishing to attend should contact Walbrook PR on openorphan@walbrookpr.com or on 020 7933 8780.
Investor presentation
OPEN ORPHAN PLC is pleased to announce that Cathal Friel and Leo Toole will also provide a live presentation relating to Final Results 2020 via the Investor Meet Company platform on 17th Jun 2021 at 6:00pm BST.
The presentation is open to all existing and potential shareholders.
Investors can sign up to Investor Meet Company for free and add to meet OPEN ORPHAN PLC via:
https://www.investormeetcompany.com/open-orphan-plc/register-investor
Investors who already follow OPEN ORPHAN PLC on the Investor Meet Company platform will automatically be invited.
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Paul McManus / Louis Ashe-Jepson / Sam Allen |
+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258 |
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