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Open Orphan #ORPH – Major year-on-year revenue growth and profitable H1 2021 performance following a year of turnaround and transition in 2020

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its unaudited interim results for the six months ended 30 June 2021. These results show a continued pattern of profitability from Q4 2020 to a firmly profitable position delivering a positive EBITDA profit of £2.1 million compared to an EBITDA loss of £4.1 million in H1 2020. We look forward to achieving record revenues in 2021 in our first full year of EBITDA profitability with recent contract wins and exceptional pipeline growth fueling revenues into 2022.

In the past 12 months, the Company has received international recognition and media attention for its excellence in delivering human challenge studies as a partner in the world’s first COVID-19 human challenge characterisation study. The Company now has a broad range of human challenge study models, focusing on leveraging the major growth opportunities presenting in infectious and respiratory disease markets, including RSV, Influenza, Asthma, hRV, COPD and Malaria.

Profitable Financial Performance in H1 2021:

  • Continuing from a profitable Q4 2020, the Company has moved the business to a firmly profitable position with losses consigned to the past
    • 242% reported revenue growth in H1 2021 (£21.9m) versus H1 2020 (£6.4m). Other income grew to £1.2m in H1 2021 from £0.7m in H1 2020
    • EBITDA profit of £2.1m (2020: EBITDA loss of £4.1m)
    • Revenue has more than tripled reflecting six active challenge studies in H1 2021 vs two active challenge studies in H1 2020 and a solid performance in Early Clinical / Biometry Services
    • In H1 2021, non-COVID-19 related work accounted for 75% of revenues
    • Gross margin has grown from 6% to 28% of revenue, reflecting that the Company is driving substantial operating leverage through cross selling, restructuring, functional integration and operational productivity
  • Cash and cash equivalents were £14.9m at 30 June 2021, primarily reflecting the operating cashflow cycle of the business with new contract prepayments expected in H2 2021
  • The Company has executed a share capital re-organisation as an important enabler to progress the monetisation of non-core assets via distribution of dividend in specie. In June, it completed the first distribution in specie back to the shareholders worth £26.2m at 16 September 2021, in relation to the demerging of certain non-core assets into Poolbeg Pharma Limited (“Poolbeg Pharma”)

 

Open Orphan Plc Group

(Results as Reported)

   
Unaudited

6 months ended

30 June 2021

Unaudited

6 months ended

30 June 2020

     
Income Statement £’000 £’000
Revenue (incl. other income) 23,166 7,078
Gross Profit 6,041 390
Operating Profit (Loss) after exceptional items 1,629 (6,340)
EBITDA before exceptional items 2,073 (4,145)

Operational highlights

  • Delivered a strong and growing pipeline of new challenge study contract wins across a broadening range of challenge studies including influenza, RSV, hRV, Asthma, etc. Strong growth from Big Pharma clients which will deliver revenues across H2 2021 and into FY 2022
  • Continued to diversify services offering and associated activities such as virus manufacturing and lab services enabled by CAP and UKAS accreditations which are progressing, as well as the development of new challenge study models (Malaria, COVID-19) as part of its broadening portfolio of challenge models
  • Leveraged its state-of-the-art facilities, including the new 19-bedroom quarantine facility (Whitechapel Clinic) beside the existing 24-bedroom Queen Mary’s BioEnterprises Centre facilities also in Whitechapel (QMB). All COVID-19 characterisation study activities conducted in the 19-bedroom quarantine facility in Royal Free Hospital in London. We have delivered a record volume of quarantine studies on an increasingly cost-efficient basis with ample capacity to further grow the business
  • Increased volunteer recruitment capacity through the opening of a new volunteer screening centre in Manchester and also a new dedicated street level screening facility in QMB increasing screening capacity to 520 visits per week
  • Disease in Motion® launched as a first step towards its spin off as a standalone company, with the intention that the value will be delivered to our shareholders via dividend in specie in the same format as was successfully completed with Poolbeg Pharma plc. This unique data-focused platform has multiple infectious disease applications for a wide variety of end users including big tech, wearables, pharma and biotech companies

Post-period end

  • Multiple high value human challenge study contracts signed – £5.7m Influenza study (September 2021), £8.1m asthma study (August 2021), significant hRV & Influenza study (July 2021)
  • Successful Phase 2a RSV human challenge studies completed for a top tier pharma company and for Bavarian Nordic highlight the value of human challenge studies, their role in mainstream clinical trial design, and hVIVO’s industry leading position
  • Successfully monetised the first non-core asset via spin-out and AIM IPO of Poolbeg Pharma plc through a dividend in specie to Open Orphan shareholders, which was non-dilutive to existing shareholdings in the Company
    • As of 16 September 2021, the Open Orphan shareholders’ value in Poolbeg Pharma plc is £26.2
    • Poolbeg Pharma raised £25m in fresh funds from new investors in an IPO in July 2021
    • Created substantial value for Open Orphan shareholders who received these dividend shares in Poolbeg Pharma with no income tax due as part of a HMRC approved statutory demerger
  • Additional 1.3m shares in Open Orphan, valued at £350,000, purchased by Company Directors (Cathal Friel and Prof. Brendan Buckley)

Outlook

  • Post-pandemic, the infectious and respiratory disease market is seeing exponential growth, with an expected global market value of $250bn by 2025. This is resulting in a vastly increased market for Open Orphan to test a new range of infectious and respiratory disease products as the world leader in the provision of human challenge studies
  • The Company is experiencing a major increase in negotiations, contract wins, and repeat contract wins with Big Pharma, while also seeing increased wins from biotech companies with major deals expected to now sign in Q4 2021 driving revenue in 2022
  • Open Orphan is expanding its focus and service offering in providing infectious and respiratory disease challenge studies
  • Full year guidance of c. £40m revenue (incl. other income) with full year EBITDA profitability for FY 2021, with non-COVID-19 work expected to represent c. 70% of FY 2021 revenue mix. While 2021 will represent record revenues for the Company and a return to full year EBITDA profitability, it is somewhat behind analyst expectations as the anticipated COVID-19 challenge studies will now likely commence in 2022 on foot of the successfully completed quarantine phase of the Human Challenge Programme characterisation study
  • Year-end cash balances expected to close in line with the half year position of £14.9m
  • Targeting revenues in the region of £50m for 2022 in non-COVID-19 work, reflecting signed contracts and contracts in advanced negotiations, ongoing momentum in the core business and ongoing market growth. COVID-19 revenue for 2022 will be in addition to this and will depend on the eventual timing of these studies
  • The Company continues to work towards the monetisation of all remaining non-core assets and to hand these back to Open Orphan shareholders via dividend in specie allowing the Company to focus on its core offering
    • These spin-offs / demergers offer an excellent opportunity for shareholders to maximise value in separate shareholdings in both exciting pharma product commercialisation companies, in addition to a profitable and world leading CRO
    • Opportunity to complete spin-off of Disease in Motion® platform along with plans to monetise the other non-core assets, namely the Company’s 62.6% stake in PrEP Biopharm, and 49% stake in Imutex Limited

Cathal Friel, Executive Chairman of Open Orphan plc commented:

Open Orphan has delivered very strong progress both operationally and financially. The Company’s H1 2021 revenues grew by 242% versus H1 2020, which continues a pattern of profitability from Q4 2020 and transitions the business to a firmly profitable position, having delivered a positive EBITDA profit of £2.1 million in H1 2021. The business is now well positioned to capitalise on the significant growth in the infectious disease market, which is expected to grow to in excess of $250bn by 2025 and we have seen our business development pipeline grow accordingly.

“I am delighted and hugely satisfied with the fantastic turnaround and team effort by everyone in the Open Orphan organisation; they have completely transformed the business following the acquisition of both hVIVO and Venn in the past two years. These two companies are now fully integrated and, in the process, we have created the world leader in the testing of vaccines, antivirals and other infectious and respiratory disease products using human challenge studies. With a broadening portfolio of human challenge studies, we are well placed to continue working with Big Pharma and biotechs alike to move their products through the clinic as the infectious disease market experiences one of the largest pharmaceutical growth cycles ever, with the market expected to grow significantly by 2025.  We look forward to further progress and a profitable H2 as the business continues to attract additional clients.

“Additionally, we will look to provide further shareholder value through the monetisation of our non-core assets, as we did post-year end with the successful spin-out, listing and distribution in specie of Poolbeg Pharma plc.”

Analyst Briefing

An online briefing for Analysts will be hosted by Cathal Friel, Executive Chairman, and Leo Toole, Group Chief Financial Officer, at 9.30am (BST) on 20 September 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 H1 2021 Interim Results via the Investor Meet Company platform on 20 September 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:

 

Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)    +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath
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) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus / Louis Ashe-Jepson / Sam Allen +44 (0)7980 541 893 / 07747 515 393 / 07502 558 258

 

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 and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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.

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.

LINK HERE FOR FULL FINANCIAL STATEMENTS

Open Orphan #ORPH – £5.7m Influenza human challenge study contract win

Open Orphan (AIM: ORPH), a rapidly growing specialist clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed a £5.7m contract with a specialist biotechnology company developing therapeutics for respiratory viral infections, to test its antiviral product using the hVIVO Influenza human challenge study model.

The human challenge study is expected to commence in Q1 2022 and will be conducted at hVIVO’s state-of-the-art facilities in London. The Company expects the revenue from the contract to be recognised across 2021 and 2022.

The client’s influenza antiviral product has demonstrated effectiveness in animal preclinical models of respiratory viruses and has several clinical and commercial advantages with respect to convenience, resistance, durability and compatibility when compared to similar products.

The Company expects to sign more contracts in this area as attention switches to potential future Influenza outbreaks. Influenza is expected to be a major global issue due to low level population immunity caused by reduced infection rates over the last 18 months, which is the result of COVID-19 mitigation measures such as social distancing and mask wearing. After a solidly EBITDA profitable H1, this contract will help ensure the Company enters a period of sustained growth and profitability across a whole range of challenge studies.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus), malaria, asthma. In October 2020, this expanded to include the SARS-CoV-2 virus. 

Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to be working with this biotechnology company to test their exciting antiviral product against our Influenza human challenge study model. As a result of social distancing, hand washing and other COVID-19 mitigation measures, there has been extremely low levels of population immunity to Influenza. As such, there is an increasing concern that in the year ahead Influenza outbreaks could spike considerably and therefore this type of therapeutic could form part of an effective defence against future outbreaks of Influenza due to its compelling array of clinical and commercial advantages.

“This contract is also a further demonstration of our expertise and capabilities testing therapeutics across the infectious disease and respiratory market, which is due to grow exponentially to over $250 billion by 2025, as pharmaceutical companies around the world look to restock the medicine cabinets with novel vaccines and antivirals. With this in mind, we expect that moving into 2022, our work will continue to come from a broad range of infectious and respiratory diseases, as we see rapid growth in those spaces. 

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:

 

Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)    +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath
 
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) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus/ Sam Allen/ Louis Ashe-Jepson +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 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 and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been an explosion in the growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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.

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 – Notice of Results, Analyst Briefing and Investor Presentation

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that its interim results for the six-month period ended 30 June 2021 will be released on Monday, 20 September 2021.

Analyst Briefing

A briefing open to analysts will take place remotely via video conference call on Monday 20 September at 9.30am (BST). If you would like the details of this call, please contact Walbrook PR on openorphan@walbrookpr.com. 

Investor Presentation

Cathal Friel, Executive Chairman, and Leo Toole, Chief Financial Officer, will provide a live presentation relating to the interim results via the Investor Meet Company platform on Monday, 20 September 2021 at 6.00pm (BST).

The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9am the day before the meeting or at any time during the live presentation.

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:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath

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)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 

 

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 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 #ORPH – £8.1m Asthma Human Challenge Study Contract Win

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed an £8.1m contract with a major global pharmaceutical company to test its inhaled human rhinovirus (hRV) antiviral product using the hVIVO Asthma Human Challenge Study Model, which uses a hRV challenge agent (common cold virus).

Asthma is a long-term condition that is characterised by inflammation and narrowing of the small airways of the lungs, which causes coughing, shortness of breath and chest tightness. 5.4 million people in the UK currently receive treatment for asthma. Illnesses such as the common cold, which is most commonly caused by HRV, can worsen symptoms.    

This antiviral study will be conducted by hVIVO and is expected to commence in H1 2022. The Company expects the bulk of the revenue from this contract to be recognised across 2021 and 2022. This new contract further underlines the increased international focus and investment into respiratory and infectious diseases following the outbreak of COVID-19, in areas such as the common cold, Influenza, and many other areas which were previously underserved by the pharmaceutical industry.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious disease viruses, including various strains of influenza, RSV, HRV, Asthma and Malaria, etc.

Cathal Friel, Executive Chairman of Open Orphan, said: “We are pleased to sign this contract with this top five European pharmaceutical company to test its inhaled hRV antiviral product using our Asthma Human Challenge Study Model. This contract demonstrates how our broad range of challenge study models can support our clients’ varied infectious and respiratory disease product pipelines, and adds to our exciting pipeline of RSV, hRV, Influenza, Malaria, and Asthma challenge study contracts.

“The COVID-19 pandemic has highlighted that for the past 30 years there has been very little investment into the infectious disease and respiratory products space. As such, when the pandemic arrived the world discovered that the medicine cabinet of infectious disease products to deal with COVID-19 was virtually empty. Post-pandemic, most governments across the world, all of the Big Pharma companies and many of the smaller pharma companies are now investing hugely in new infectious and respiratory disease products and as such, this market is expected to grow from $20bn in 2019 to $250bn by 2025. This restocking of the pharmaceutical industries medicine cabinet of infectious disease products around the world is now leading to an enormous expansion of investment into the infectious disease and respiratory product market and will be seen as one of the biggest growth opportunities in the history of the pharmaceutical industry.

“Having recently launched our Malaria Human Challenge Study Model, adding to our world leading portfolio of challenge study models, Open Orphan is now ideally situated to be one of the few companies in the world that can quickly and efficiently test a broad range of these new infectious and respiratory disease products in our human challenge clinical trial studies. Open Orphan is well placed to work with Big Pharma and biotechs alike to move their products through the clinic as human challenge becomes a part of mainstream clinical trial design.”

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:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath

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)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393  

 

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 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 #ORPH – Development of Controlled Human Malaria Infection Human Challenge Study

Open Orphan plc (AIM: ORPH), a rapidly growing specialist clinical research organisation (CRO) and world leader in testing vaccines and antivirals using human challenge clinical trials, announces that its subsidiary, hVIVO, has developed a Controlled Human Malaria Infection (“CHMI”) challenge model, both strengthening and further diversifying the Company’s world leading portfolio of viral challenge study models. The Malaria challenge model will assist in the advancement of antimalarial drug and vaccine candidates from November 2021. Results from CHMI modelling of drug and vaccine efficacy have previously shown good translation into the field.

Malaria is a serious and life-threatening disease prevalent across much of tropical and sub-tropical Asia, South America and Sub-Saharan Africa. Due to increasing resistance to current antimalarial regimens, new drugs are required as both stand-alone and partner therapies to address a growing unmet medical need. In addition, novel combinations of existing drugs may be required to fill the gap until pipeline candidates can be safely progressed to market. New drugs and combination therapies are required to not only reduce mortality and morbidity in susceptible, primarily paediatric populations, but also to help the move towards a greater goal of malaria elimination.

hVIVO has secured access to a unique, GMP-manufactured P. falciparum sporozoite challenge agent (“PfSPZ Challenge”) for use in its malaria challenge studies. PfSPZ Challenge has been used in multiple clinical trials in the United Kingdom, United States, Europe, Indonesia and Africa. As of June 2021, 1,204 volunteers have received 2,011 doses of PfSPZ Challenge (NF54) with no unresolved serious adverse event, sequelae, or deaths to date. Controlled Human Malaria Infection by Direct Venous Inoculation has largely replaced the traditional method of CHMI (mosquito bite), owing to its superior predictability and safety profile. Reported symptoms are mostly mild to moderate and include headache, fever, nausea and fatigue.

Cathal Friel, Executive Chairman of Open Orphan, said: “Malaria is a disease of huge unmet need around the world, with 229 million cases and 409,000 deaths caused in 2019. Its prevention and cure is a designated World Health Organization target. We are pleased to have formally announced today the latest addition to our portfolio of human challenge models namely the Malaria Human Challenge Study Model. The safety profile of PfSPZ is impressive, and we are optimistic that it will enable us to assist in the advancement of antimalarial drug and vaccine candidates from November. This also adds a new challenge model to our already world leading portfolio of viral challenge study models and continues to build on our global infectious disease expertise.”

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.

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 (“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

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell / Oscair McGrath

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)

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

Paul McManus / Louis Ashe-Jepson / Sam Allen

+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258  

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 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 #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

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

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)

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

Paul McManus / Louis Ashe-Jepson / Sam Allen

+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258  

 

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:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

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)

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

Paul McManus / Louis Ashe-Jepson / Sam Allen

+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258

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:

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

work on advancing other portfolio assets to monetisation

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

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+353 (0) 1 644 0007

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson 

 

 

+44 (0) 20 7220 0500

Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Richard Johnson, Oscair McGrath

 

 

+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, 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:

  Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

finnCap Ltd (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)

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

Paul McManus / Louis Ashe-Jepson / Sam Allen

+44 (0)7980 541 893 / 07747 515 393 / 07502 558 258 

 

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:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

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)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

+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 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.

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