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#ORPH Open Orphan – Omicron human challenge model

  Vaxart becomes the first client of the programme to test its oral COVID-19 vaccine candidate

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that  hVIVO , a subsidiary of Open Orphan, is developing the world’s first Omicron human challenge model. hVIVO has signed an agreement with Vaxart Inc. (“Vaxart”), (NASDAQ: VXRT) to develop the model with the intent to conduct a subsequent Omicron human challenge study in 2023 to test the efficacy of Vaxart’s oral vaccine candidate, VXA-CoV2-1.

 

To develop the model, hVIVO will manufacture a new SARS-CoV-2 (COVID-19) challenge agent based on the Omicron variant. The Good Manufacturing Practice (“GMP”) compliant virus manufacturing activities will commence immediately and are expected to complete by Q4 2022. Following manufacture of the challenge agent, the Company intends to conduct a characterisation study. Subject to the successful completion of the characterisation study and receipt of relevant regulatory approvals, hVIVO expects to conduct Omicron human challenge studies in 2023.

The characterisation study will establish a dose of the Omicron challenge agent that will cause a safe and reliable infection in healthy volunteers. The study will enrol healthy male and female volunteers who have previously been vaccinated against or infected with SARS-CoV-2, with no known risk factors for severe COVID-19 and low levels of serum neutralising antibodies (and therefore still likely to become infected following inoculation).

hVIVO has two decades of experience and expertise in challenge agent manufacture and clinical characterisation across a range of respiratory viruses including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (hRV – common cold virus), as well as the initial circulating SARS-CoV-2 virus and variants which have since emerged. hVIVO leads the Challenge Agent Manufacture Consortium, which has developed international standards that pertain to challenge agent manufacture and storage, to ensure safety, quality and consistency.

Yamin Khan, Chief Executive Officer of Open Orphan, said: “With our leading end-to-end human challenge expertise, we are delighted to be developing the world’s first Omicron human challenge model and to welcome Vaxart as the first client of this programme.

“hVIVO’s fight against the pandemic continues with the development of this new challenge agent. The benefits to Vaxart are immense, and we have already been contacted by a number of biopharma companies looking to test the efficacy of their products using this challenge virus. I have no doubt that the successful completion of the world’s first COVID-19 characterisation, which was published in Nature Medicine earlier this year, has given our customers the confidence to move forward with the less severe yet more infective Omicron challenge model.”

Dr. James Cummings, Chief Medical Officer of Vaxart, said: “A human challenge study of our oral tablet COVID-19 vaccine candidate against the Omicron variant of SARS-CoV-2 is the most rapid and direct way to assess the efficacy of this candidate against a highly prevalent viral strain.

“hVIVO has pioneered COVID-19 characterization and the Omicron human challenge model, and the use of this model in our planned Phase II human challenge trial will rapidly generate robust, controlled data on the ability of our COVID-19 vaccine candidate to prevent infection and the development of symptomatic disease, as well as its effect on viral shedding, which plays a critical role in the spread of infection from one person to another. The results of this study will inform the next steps in the development of our COVID-19 vaccine candidate, which has the potential to transform personal and public health approaches to controlling the global pandemic.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “The team and I at hVIVO are excited to begin work to manufacture an Omicron challenge agent, the follow-on characterisation, and future human challenge trials. We have unparalleled expertise in SARS-CoV-2 challenge agent manufacturing, having completed work on both the original Wuhan strain and the subsequent Delta variant, in addition to our prior experience in successfully conducting the world’s first COVID-19 characterisation study, and our decades of experience in conducting human challenge trials. We are delighted to be working with Vaxart on this programme and look forward to the opportunity to subsequently test the efficacy of their exciting novel vaccine.”

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.

 

For further information please contact:

 

Open Orphan plc

+44 (0) 20 7756 1300

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

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

+44 (0)7747 515393

Open Orphan #ORPH – £7.2m RSV human challenge study contract

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £7.2m contract with an existing top 5 global pharmaceutical company to test its orally administered antiviral product, using hVIVO’s respiratory syncytial virus (“RSV”) Human Challenge Study Model.

The Phase 2a double-blinded placebo-controlled human challenge study will take place at the Company’s specialist quarantine facilities in Whitechapel and will evaluate the safety and efficacy profile of the antiviral against RSV. The study will commence in June 2022, with the revenue being recognised in 2022 and 2023. As part of the study, hVIVO will recruit healthy volunteersvia the Company’s dedicated volunteer recruitment arm, FluCamp.

The client’s antiviral is presently in Phase III clinical trials for another infectious disease indication and the client will use human challenge to assess the efficacy of their antiviral drug candidate against RSV quickly and efficiently, highlighting the value that human challenge studies can bring within the drug development process. The repeat business from this top 5 global pharmaceutical company underlines the Company’s world leading expertise and its ability to attract additional contracts from its existing Big Pharma clients.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “We’re delighted to be working with this top 5 global pharmaceutical client again to test their antiviral candidate using the hVIVO RSV Human Challenge Study Model. I am especially proud that our world-class offering and customer service has secured repeat business from another Big Pharma client, and that we are seen as the ‘go-to’ partner for an increasing number of global drug developers. The client’s drug has already been shown to be an effective antiviral in certain disease indications, and we’re pleased to now test its efficacy against RSV infection. RSV continues to be a serious global health threat causing an estimated 100,000 annual deaths in children under the age of five.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a strong example of where human challenge studies can provide significant value. With a drug that has existing safety data and has been approved for one indication, human challenge studies can provide fast, cost-effective efficacy data within a new indication. The data will then indicate whether the candidate is viable for a wider Phase II study, providing substantial time and financial savings compared to traditional field-based studies.”

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

Yamin ‘Mo’ Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

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

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

Notes to Editors 

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

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

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

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

About RSV

RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50-million people annually, leading to 4 million hospitalisations and an estimated 100,000 deaths in children under the age of 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.

Alan Green covers Cobra Resources #COBR & Open Orphan #ORPH on this week’s Stockbox Research Talks

Alan Green covers Cobra Resources #COBR & Open Orphan #ORPH on this week’s Stockbox Research Talks

#ORPH Open Orphan – Board appointment

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces the appointment of Martin Gouldstone as an Independent Non-Executive Director of the Company with effect from 8 June 2022.Martin will also Chair the Audit & Risk Committee and will be a member of the Nominations Committee and the Remuneration Committee.

Martin brings 30 years of corporate development experience in the CRO, healthcare and pharmaceutical sectors, holding a number of senior roles at healthcare AI businesses. Martin has expertise in executing multi-billion dollar deals across Europe and the US, architecting end-to-end portfolio out-sourcing deals, and negotiating multi-year research partnerships.

Martin is currently Global SVP, Business Development at Owkin, a French-American start-up using artificial intelligence to discover and develop better treatments for unmet medical needs. Previously, Martin has held the roles of Chief Business Officer at both BenevolentAI and Sensyne Health and was a Partner at Results Healthcare, an international M&A advisory firm, where he co-led the company’s healthcare practice. Prior to this, Martin was Head of Life Sciences for BDO UK LLP, Senior Director responsible for M&A and joint venture opportunities in Europe for Quintiles (now IQVIA), and Business Development and Licensing Lead at Confirmant Ltd, Pharmacopeia Inc, Sareum Ltd.

Martin holds a BSc in Genetics and has completed a range of post graduate management courses.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to welcome Martin to the Board of Open Orphan. Martin has extensive corporate development experience in the CRO, healthcare and pharmaceutical sectors and held a number of senior roles in healthcare AI businesses. I look forward to working closely with Martin as we drive further growth across the business.”

Martin Gouldstone, Non-Executive Director, said: “I am delighted to join the Board of Open Orphan at what is an exciting time for the Company and the infectious disease market as it continues to grow significantly post pandemic. I am delighted to bring my previous three decades of experience in the CRO, healthcare and pharmaceutical industry to the Company as it continues to build and expand on partnerships with leading global biopharma companies.”

Regulatory Disclosures

Save for the information set out above and below, there are no further disclosures to be made in accordance with Rule 17, Schedule Two (g) of the AIM Rules for Companies in respect of the appointment of Mr Martin John Gouldstone, aged 55, Martin does not hold an interest in the Company’s share capital.

Current Directorships

Past Directorships

Novara Therapeutics Limited

n.a.

Orthopaedic Research UK

Sempiternum Ltd

For further information please contact:

 

Open Orphan plc

+44 20 7756 1300

Yamin ‘Mo’ Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer / Edward Mansfield / Phil Walker / Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

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

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

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

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

Financial highlights

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

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

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

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

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

Operational highlights

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

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

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

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

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

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

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

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

New Manchester FluCamp volunteer recruitment centre

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

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

Post-period end highlights

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

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

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

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

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

Current trading and outlook

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

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

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

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

 

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

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

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

Interested in becoming a volunteer?

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

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

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin ‘Mo’ Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

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

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

+44 (0)7747 515393

Notes to Editors

Open Orphan plc 

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

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

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

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

Link here for full financial statements

#ORPH Open Orphan – GBP14.7m influenza contract signed

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed a £14.7m contract for an influenza characterisation study and a follow on influenza human challenge study with an existing top five global pharmaceutical client. Revenue from the contract will be recognised across 2022 and 2023.

This follows a challenge virus manufacturing contract signed with the same client, announced on 4 May 2022. Following completion of the challenge agent manufacturing, the characterisation study will identify a dose of the flu challenge agent that causes a safe and reliable infection in healthy volunteers. The study, which is sponsored by hVIVO, is expected to start in Q3 2022, subject to the relevant regulatory approvals, and will enrol volunteers recruited from the Company’s clinical trial volunteer recruitment arm,FluCamp.

 

As part of the study, hVIVO Labs will develop and validate challenge agent specific assays for the new flu challenge agent to US Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards. This includes quantitative polymerase chain reaction (qPCR) for viral load determination, viral infectivity assay and serological assays for antibody level determination.

 

Following completion of the characterisation study, hVIVO will conduct a human challenge study, expected to commence in Q1 2023. The study will enable the Company to determine the efficacy of a number of different vaccine candidates for the reduction in incidence of symptomatic flu infection and disease severity in healthy volunteers. This will help select which of the candidates to progress further into later stage clinical trials. The vaccine study can be initiated, subject to receipt of the relevant regulatory approvals, as soon as the Company completes the infectivity and safety data review from the characterisation study and establishes the best challenge agent dose for safe volunteer inoculation.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said:  “This is another important milestone for hVIVO in that, in addition to the previously announced manufacture of a bespoke challenge agent, we have now been contracted to conduct the characterisation and the challenge studies with this big pharma customer. Moreover, we will also be providing full recruitment and laboratory services. This highlights hVIVO’s unique full-service offering in running complex human challenge studies. Our team has a long history of manufacturing challenge agents and conducting human challenge studies. In regard to challenge studies our experience is unrivalled, our scientific expertise unmatched, and our operational delivery in a class of its own.”

 

Alex Mann, Senior Director of Clinical Science of hVIVO, Sponsor Representative and Scientific Design Lead, commented: “This major contract win solidifies hVIVO’s position in the market in offering the full spectrum of support to clients, from start to finish of the vaccine and drug discovery process. Furthermore, the development of challenge agent specific assays underlines the skill and expertise of our experienced lab scientific team to validate bespoke assays to international standards for use in good clinical practice (GCP) clinical trials.

The threat of influenza has never been greater, with an estimated one billion cases per year. Our continued work to support our clients’ vaccine and antiviral programme’s will support the quick, efficient and cost-effective development of these lifesaving medicines.”

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.

 

For further information please contact:

 

Open Orphan plc

+44 (0) 20 7756 1300

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

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

+44 (0)7747 515393

#ORPH Open Orphan – Completion of Nominated Adviser due diligence

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that further to the appointment of Liberum Capital Limited (“Liberum”) as its Nominated Adviser and Joint Broker on 28 April 2022, Liberum has confirmed that is has completed its due diligence .

 

For further information please contact:

 

Open Orphan plc

+44 20 7756 1300

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

  +44 (0) 20 3100 2000

Ben Cryer / Edward Mansfield / Phil Walker / Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

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

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

Open Orphan #ORPH – Notice of results

 

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials , announces that it will release its full year results for the year ended 31 December 2021 on Tuesday 7 June 2022. 

Investor Presentation 

Yamin ‘Mo’ Khan, Chief Executive Officer, and Leo Toole, Chief Financial Officer, will be hosting a live online presentation relating to the final results via the Investor Meet Company platform at 6pm on Tuesday 7 June 2022. The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and register for the presentation here.

Investors who already follow Open Orphan on the Investor Meet Company platform will automatically be invited.

Questions can be submitted pre-event via your IMC dashboard or in real time during the presentation, via the “Ask a Question” function. Whilst the Company may not be in a position to answer every question it receives, it will address the most prominent within the confines of information already disclosed to the market through regulatory notifications. A recording of the presentation and a PDF of the slides used will be available on the Investor Meet Company platform and the Company’s website afterwards.

 

UK Investor Magazine Podcast, we discuss #stagflation, Burberry #BRBY Open Orphan #ORPH & Tertiary Minerals #TYM

investor

 

The UK Investor Magazine is joined by Alan Green for a rundown of key market themes and Uk equities.

We start by looking at Stagflation at the implications for the UK economy and markets. Stagflation is a period of rising inflation, economic contraction, and rising unemployment.

The UK satisfies the first two of these, however, unemployment remains robust. We look at whether rising inflation will soon hit jobs activity and what it could mean for equities.

We also discuss the relationship between the FTSE 100 and US indices and how this may develop if we see recession in the US.

Burberry has posted a respectable set of results and is proving a possible choice for income investors. Margins have improved with sales as the luxury brand jumps back from COVID.

Open Orphan’s valuation is worth attention. One could argue the current market cap doesn’t pay justice to their revenue growth and forecast profitability.

We update on the latest from Tertiary Minerals and their portfolio of assets including a selection in Nevada and Nambia.

Stagflation, Burberry and Open Orphan with Alan Green

Open Orphan #ORPH – £7.3m Influenza human challenge study contract win

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £7.3m influenza human challenge study (“Study”) contract with a leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. 

The randomised, double-blinded, placebo-controlled study will test and assess the antiviral prophylactic and post-inoculation treatment activity of the antiviral in healthy adult volunteers enrolled through the Company’s specialist, tech-enabled volunteer recruitment arm,FluCamp. The Study will be conducted by hVIVO’s team of medics at its state-of-the-art quarantine facilities in London and is expected to commence next year. Revenue from the contract is expected to be recognised across FY23 and FY24.

The Company’s specialised virology laboratories, hLAB, will determine the viral load of the influenza challenge agent used to inoculate volunteers, hLAB will also provide serology services and virology services (viral infectivity assay) for the study. 

Influenza is a contagious respiratory illness caused by influenza viruses that affect the nose, throat and the lungs. It can cause mild to severe illness, and occasionally lead to death. According to Financial Times1 analysis of official data in England, since the development of effective vaccines and the emergence of the less severe Omicron variant, influenza is now more lethal than COVID-19. For every 100,000 Omicron infections, 35 will result in death, while the equivalent number of flu infections will lead to around 40 fatalities.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to sign a contract with this leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. hVIVO has seen a steady increase in flu studies, a reflection of the shift in market sentiment following recent scrutiny of infectious disease data that has outlined the significant threat of flu and the potential of human challenge studies to the advancement of drug development candidates.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “We are excited to test the antiviral prophylactic and post inoculation treatment activity against flu infection using the hVIVO Influenza Human Challenge Study Model. hVIVO has pioneered influenza human challenge studies for decades, with our history dating back to the Salisbury Common Cold Clinic.

“Since the advent of effective vaccines and treatments for COVID-19, there has been renewed focus on influenza and official data shows flu is now a more lethal threat. After completing the study, we hope to provide positive data and early proof of concept for our client’s product, in order to accelerate its development into a Phase II programme.” 

1‘Vaccines and Omicron mean Covid now less deadly than flu in England’, The Financial Times, by Burn-Murdoch, John, and Barnes, Oliver. Link: https://www.ft.com/content/e26c93a0-90e7-4dec-a796-3e25e94bc59b

 

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

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

  +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

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

 

Notes to Editors 

Open Orphan plc

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

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

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

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

hVIVO has a long history of testing influenza vaccines and treatments, with its history dating back to the Common Cold Unit in Salisbury. The Common Cold Unit was established following the end of the Second World War to investigate the microorganisms which cause typical cold symptoms. It was through this research that the first human coronavirus was discovered in 1960.

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