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Open Orphan (ORPH) Final Results to 31 December 2020

Final Results to 31 December 2020

Important year of transition following the various merger and acquisition activities in 2019 and January 2020

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its audited results for the 12 months to 31 December 2020. Following the acquisition of hVIVO in January of last year, 2020 was a year of transition for the Company with management integrating both businesses and driving improvements in revenue, gross margin and efficient overheads.

This culminated in Q4 2020 proving to be an inflection point for the Company as it successfully generated both an operating profit and positive cashflow. In addition, the Company ended the year with a strong order book of contracted revenue which has been the foundation for the Company’s very strong start to 2021. In the context of the rapidly evolving COVID-19 pandemic and broader growth of the global infectious disease market, this should translate into very strong growth opportunities for the Company going forward.

Operational highlights:

  • Integration of hVIVO and Venn Life Sciences completed with pharmaceutical services business now profitable and poised for strong revenue and EBITDA growth in 2021; growing working capital balance on hand
  • Clearly established as the world leader in the testing of vaccines and antivirals through the use of human challenge study clinical trials
  • Strategy in place to maximise shareholder value via the demerger of non-core assets with first spin-out Poolbeg Pharma Ltd well under way
  • In the last 12 months substantially increased the number of quarantine beds available to Open Orphan:
    • Original 24 quarantine beds in Queen Mary’s BioEnterprises Centre (QMB) in Whitechapel
    • 19 bed additional beds through the conversion of the Whitechapel Hotel
  • Open Orphan has the capacity to screen in >500 volunteers per week to support a growing pipeline of human challenge studies.
    • New state-of-the-art volunteer recruitment screening centre on the ground floor of QMB
    • New standalone regional volunteer recruitment screening centre in Manchester
  • Strategic decision In March 2020 to develop a COVID-19 challenge model:
    • hVIVO was uniquely placed to contribute to a world-first initiative led by the UK government to work as part of the Vaccine Task Force’s Human Challenge project to manufacture a COVID-19 virus, and to collaborate on the design and delivery of a characterization study to understand how to use this virus for vaccine and anti-viral challenge trials, which is ongoing.
    • Collaboration is ongoing with significant progress achieved to enable the Group to test vaccines and therapeutics against COVID-19 in the near future.

Financial highlights

Open Orphan plc Group

(Results as Reported)

hVIVO Ltd

(Proforma results on a stand-alone basis for a full year)

 

Open Orphan plc

(formerly Venn Life Sciences Holdings plc – Proforma results on a stand-alone basis for a full year)

Open Orphan DAC

(Proforma results on a stand-alone basis for a full year)

Open Orphan plc Group

(Proforma results on a combined basis for a full year)

2020

2019

2020

2019

2020

2019

2020

2019

2020

2019

Income Statement

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

£’000

 

Revenue (Incl. other income)

21,995

3,543

14,515

15,092

7,844

8,643

22,359

23,735

Operating (Loss)

(10,442)

(5,130)

(4,854)

(5,893)

(5,604)

(6,385)

(435)

(669)

(10,893)

(12,948)

EBITDA before exceptional items

(6,265)

(3,792)

(2,925)

(3,785)

(3,313)

(4,432)

(431)

(668)

(6,669)

(8,885)

Loss for period

(10,791)

(5,739)

(4,927)

(6,973)

(5,776)

(6,622)

(548)

(899)

(11,251)

(14,494)

 

  • An important year of transition to reverse the proforma losses in 2019 by strengthening business development, restructuring underperforming businesses, driving cross group synergies, eliminating unnecessary layers of management, and integrating support functions across the Group.
  • Significantly improved track record of major contract wins in 2020 (versus 2019) setting the scene for strong revenue growth in 2021
  • Turnaround on track evidenced by an operating profit delivered for Q4 2020 and targeting full year profitability in 2021
  • Cashflow positive in Q4 2020 driven by advanced cash payments on major agreements.
  • Pharmaceutical services business (the combined business of Venn and hVIVO) is operationally profitable and moving into cash generation.
  • Well capitalized following two placings raising a combined total of £17.9m (before expenses)
  • Cash and cash equivalents of £15.1m as at 31 May 2021
  • Proforma revenues of £22.4m (2019: £23.7m), with losses reduced to £11.3m (2019: £14.5m)
  • Reported revenues of £22.0m (2019: £3.5m), with a reported loss for the period of £10.8m (2019: £5.7m)

Outlook:

  • Clinical Science Teams and Laboratory Development Teams continue to address ground-breaking research projects with major pharmaceutical players – strong demand for services expected.
  • Planned demerger strategy is progressing well with further update provided today on Poolbeg Pharma
  • Demergers offer an excellent opportunity for shareholders to maximise value through separate shareholdings in a profitable pharma services company as well as exciting pharma products commercialisation companies.
  • Opportunity to progress Disease in Motion® platform.
  • Targeting delivery of full year profit in 2021 – focusing on enhancing profits and earnings

Cathal Friel, Executive Chairman of Open Orphan plc commented: “The Group is not simply satisfied to have returned to a positive operating position at the end of 2020 and to be targeting to deliver a full year profit in 2021, it is now focused to further enhance the quality of profits and earnings of the Group going forward. Therefore, notwithstanding the strategic investments we are making in new challenge models and the Disease in Motion® platform, we will relentlessly focus on cross selling our services across our broad client base, leveraging technology to drive improved efficiencies, and stripping away unnecessary cost in our operations.”

“It has been a remarkable year and I am grateful to our team for their hard work and loyalty. I am also grateful to you, our shareholders for the faith you have placed in the Group. The new financial year has started well and is already very well advanced. We are confident that the actions we are taking now to drive our core CRO business and monetise non-core assets should create significant value for all our stakeholders.”

The Company’s Annual Report and Accounts for the year ended 31 December 2020 will be posted to shareholders in due course together with the notice of the 2021 Annual General Meeting], and will be available on the Company’s website,  https://www.openorphan.com/

Analyst Briefing

An online briefing for Analysts will be hosted by Cathal Friel, Executive Chairman, and Leo Toole, Group Financial Officer, at 11.00am on Thursday 17 June 2021 to review the results and prospects. Analysts wishing to attend should contact Walbrook PR on openorphan@walbrookpr.com or on 020 7933 8780.

Investor presentation

OPEN ORPHAN PLC is pleased to announce that Cathal Friel and Leo Toole will also provide a live presentation relating to Final Results 2020 via the Investor Meet Company platform on 17th Jun 2021 at 6:00pm BST.

The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and add to meet OPEN ORPHAN PLC via:

https://www.investormeetcompany.com/open-orphan-plc/register-investor

Investors who already follow OPEN ORPHAN PLC on the Investor Meet Company platform will automatically be invited.

For further information please contact:

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  

Open Orphan #ORPH – Court Approval to facilitate Distribution in Specie

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, confirms that, following its announcement on 13 April 2021, it has received Court approval for the reduction in capital. The reduction of capital will become effective on registration of the Court order at Companies House, which is expected to occur in the next few days. 

The reduction of capital will give the Company the ability to not only effect the Distribution in Specie, as part of the proposed spin-out of certain non-core Development IP Assets, but also to make other distributions to Shareholders and/or buy back its own Open Orphan Ordinary Shares in the future if and when the Directors may consider that it is appropriate to do so.

As previously announced, the Board has decided that a spin-out and admission to AIM of the wholly owned Development IP Assets may provide the opportunity to secure separate financial resources for the Development IP Assets, with the goal of enabling accelerated development of the asset portfolio and achievement of development and commercial milestones. The Development IP Assets include HVO-001, an orally available, small molecule immunomodulator drug with potential as a treatment for severe influenza and symptoms requiring treatment in hospital with the drug unaffected by viral heterogeneity. It has the potential to treat a broad range of serious unmet needs in patients suffering from severe and fatal respiratory disease.

It is anticipated that a spin-out pursuant to the Demerger would allow the Company’s shareholders to benefit from both the value of the Development IP Assets and the standalone value of the remaining business as it progresses through its own key milestones.

The Company continues to make good progress towards delivering against the potential Demerger and Distribution in Specie and will update shareholders in due course.

Terms defined in the Company’s circular dated 13 April 2021 shall have the same meanings in the announcement.

Cathal Friel, Executive Chairman of Open Orphan plc commented: “We are delighted to have received Court approval of the reduction of capital. The reduction of capital will allow us to return value to shareholders as we go forward either as a distribution in specie as part of the proposed spin-off or through a share buy back or a payment of a dividend, as appropriate. The Company and the entire Open Orphan team have made significant progress in the past year and we remain on target with all of our plans as we continue to build the company going forward.” 

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 / Nick Wright

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 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 – £3m COVID-19 challenge virus manufacturing contract for hVIVO based on new COVID-19 variants

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services 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 a contract with Imperial College London, as part of a Wellcome Trust funded initiative to manufacture a SARS-CoV-2 challenge virus.

The contract is worth £3 million and under this agreement hVIVO will develop a new SARS-CoV-2 challenge virus based on new emerging variants of the virus, which will be used in future hVIVO run human challenge trials to allow direct comparisons of vaccines or antivirals against different COVID-19 variants.

The manufacturing project will begin immediately and is expected to complete before the end of 2021. Following completion of the manufacturing project there is the potential for a follow on characterisation study for this virus to be conducted by hVIVO in partnership with Imperial and Wellcome.

hVIVO has two decades of experience and expertise in challenge agent (virus) manufacture across a range of respiratory viruses including various strains of influenza, Respiratory Syncytial Virus (RSV), human Rhinovirus hRV (common cold virus), as well as a more recently the initial circulating SARS-CoV-2 virus. These challenge agents are then used in controlled human infection studies, an area that hVIVO has focussed on since 2001.

Open Orphan has successfully initiated the development of a number of Coronavirus challenge viruses. The Company has already developed the initial circulating COVID-19 (SARS-CoV-2) virus as part of the Human Challenge Programme in partnership with the UK Government.

Cathal Friel, Executive Chairman of Open Orphan plc commented: “This contract is a great example of how our unique abilities to provide an all encompassing solution for human challenge trials sets us apart. We are able to support our customers from the very beginning of the process by developing challenge study models, including the manufacture of the challenge virus, as well as taking responsibility for full trial recruitment and using our London based quarantine facilities to run the human challenge studies themselves.”

Dr Andrew Catchpole, Chief Scientific Officer, hVIVO commented: “We are delighted to be able to utilise our extensive experience in challenge virus production at hVIVO to aid this important programme in meeting its aims. Production of a SARS-CoV-2 variant challenge virus builds upon our knowledge and learnings from manufacturing and characterising the original Wuhan-like D614G SARS-CoV-2 virus.  The availability of a variant SARS-CoV-2 virus will greatly expand the utility of the SARS-CoV-2 challenge model and allow us to answer a wider range of important scientific questions to aid control of the pandemic as well as facilitate further testing of vaccines designed against COVID-19.”

Dr Chris Chiu, Imperial College London commented: “We are pleased to be embarking on this new phase in development of the SARS-CoV-2 human challenge model with hVIVO. By keeping up with viral evolution, we will be able to address even more relevant scientific questions and test the ability of immune responses after vaccination and infection to protect against different strains of SARS-CoV-2. We are committed to enhancing collaboration through sharing of this virus with academic investigators around the world who have capacity to conduct human infection challenge for academic purposes, thus further enhancing the pandemic response.”

Interested in becoming a volunteer?

Individuals interested in taking part in COVID-19 human challenge study research can learn more at _www.UKCovidChallenge.com.

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.

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 / Benjamin Cryer / Nick Wright
 
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 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.

Wellcome Trust

Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, global heating and infectious diseases.

Open Orphan #ORPH – Potential demerger of certain non-core assets

Open Orphan plc ((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 that it is at an advanced stage in planning for a possible spin-out of certain non-core Development IP Assets. These Development IP Assets are a portfoilio of intellectual property and development assets, including HVO-001 which has potential application in the treatment of respiratory disease. These do not include the equity interests in Imutex Limited and PrEP Biopharm Limited.

The Board believes that to maximise shareholder value that the Development IP Assets are best developed separately from the core services business. Furthermore, such a spin-out transaction could provide the opportunity to secure separate financial resources for these assets, to enable accelerated development of these assets and achievement of commercial milestones. A spin-out transaction would also allow Shareholders to benefit from both the value of the development assets and the standalone value of the core services business, as they progress through their own key milestones.

To this end, a circular (a “Circular”) is being sent to shareholders today providing background to, details of and reasons for, a proposed Reduction of Capital and Distribution in Specie, to facilitate the possible spin-out and admission to AIM of the Company’s non-core Development IP Assets. The reduction in capital will also allow for the Company to pay dividends and distributions to shareholders should the Board deem it appropriate in the future.

The Board has decided to take the necessary preliminary steps in preparation for a potential spin-out, including incorporating a new subsidiary, further details of which are outlined in the Circular.  The Company has decided to proceed in obtaining the approvals necessary for the Reduction of Capital and the Distribution in Specie which are required to implement the demerger. Notwithstanding that the Company is seeking the necessary approvals for the Reduction of Capital and the Distribution in Specie now, these considerations remain at an early stage, and there can be no guarantee that the Reduction of Capital and/or the Distribution in Specie will be completed. HMRC advance clearance for the Demerger has been successfully obtained so any distribution would be exempt for income tax purposes and have no capital gains implications for UK shareholders. Further announcements will be made at the appropriate time. 

Notice of General Meeting

The Circular contains a notice convening the General Meeting to be held at 11 a.m. on 29 April 2021 at which the Resolutions will be proposed.

Full details are outlined in the Circular, which will be posted to Shareholders today and will shortly be available, in accordance with AIM Rule 20, here: https://www.openorphan.com/investors/circulars-and-admission-document

Cathal Friel, Executive Chairman, said: “I am delighted that we are putting in place the first steps needed to enable the monetisation of some of our non-core assets. Over the last year we have been busy transforming Open Orphan into a profitable enterprise with a world leading position testing vaccines and antivirals using human challenge studies. We now have an opportunity to deliver significant further shareholder value by the Demerger of these non-core assets. Their development and commercialisation can be accelerated through the Demerger, which offers the opportunity to access financing as a separate public company listed on AIM and a separate business focussed on the successful commercialisation of pharmaceutical products.

“It is well known in the global  public markets that value is better recognised in the life sciences space when profitable services businesses are viewed separately from pharmaceutical development businesses that have different funding needs. This is now an excellent opportunity for shareholders in Open Orphan to maximise value through separate shareholdings in both a profitable pharma services company as well as an exciting pharma products commercialisation company. I believe that both are well positioned for success as we head into a decade of exponential capital investment across a broad range of infectious disease and respiratory illnesess. This is a sector that has been under-invested in the last thirty years and as such, will be one of the more exciting growth opportunities within the life sciences industry.”

Definitions contained in the Circular have the same meaning as in this announcement.

 

Open Orphan plc

www.openorphan.com

Cathal Friel, Executive Chairman

+353 (0) 1 644 0007 

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Nick Wright

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 /

Lianne Cawthorne

+44 (0)7980 541 893 / +44 (0)7748 651 727 /

+44 (0)7584 391 303

The information provided below includes information contained within the Circular, which should be read as a whole.  

Introduction

Open Orphan is a 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. This was described in the Company’s admission document dated 9 December 2019, following the acquisition of hVIVO by Open Orphan (the “Acquisition”). Since the Acquisition, the enlarged group has pursued a services led strategy centred around its leading position in vaccine and antiviral testing using human challenge clinical trials. The Group further provides a suite of consulting and clinical trial services to pharmaceutical and biotech companies as a leading Clinical Research Organisation (“CRO”).

The Group has continued to develop this services-led strategy since the Acquisition and has completed a post-merger restructuring and integration of its operations to drive efficiency and competitiveness in order to increase profitability. This restructuring, combined with renewed interest and investment in the treatment and prevention of respiratory disease, has resulted in the strong performance of the Group and its CRO services.

Prior to the Acquisition, hVIVO had made significant investments and had developed a portfolio of intellectual property covering the treatment and prevention of respiratory and infectious disease. Having repositioned the Group’s services the Directors have undertaken a review of the Group’s non-core assets. In order for some of these assets to achieve their full commercial potential further investment and deployment of management resource would be required. As a result of having refocused the Group on services, the Directors have taken the strategic decision to demerge certain development assets from the existing CRO business to maximise the future potential and value of both businesses. The Directors are now undertaking the required preliminary steps in order that they may execute a demerger of the Group’s wholly owned Development IP Assets later this year. This demerger would exclude the Group’s equity interests in Imutex Limited and PrEP Biopharm Limited.  Such a demerger would include certain intellectual property surrounding these Development IP Assets. The Company will update Shareholders in due course on its final plans and the timing of an expected demerger. The demerger would allow for any required future investment in the Development IP Assets without consuming existing Group funds or management resource. 

The Development IP Assets include HVO-001 with the Demerger intended to enable accelerated development of this asset utilising an outsourced partnership model and separate management team. It is also intended to provide the financial resources required to rapidly develop this molecule. A spin-out transaction of the Development IP Assets could also allow Shareholders to benefit from both the value of the Development IP Assets including HVO-001 and the standalone value of the remaining business as it progresses through its own key milestones.

The Board is now taking the necessary preliminary steps in preparation for a potential spin-out of its wholly owned Development IP Assets, including the incorporation of a new subsidiary, ORPH Pharma IP, further details of which are set out below.  The Company has decided to proceed with obtaining the approvals necessary for the Reduction of Capital and the Distribution in Specie which are required to implement the Demerger. Notwithstanding that the Company is seeking the necessary approvals for the Reduction of Capital and the Distribution in Specie now, these proposals remain at an early stage and there can be no guarantee that the Reduction of Capital and/or the Distribution in Specie will be completed. Further announcements will be made at the appropriate time. 

Demerger

As announced, the Company has been evaluating its plans for the Development IP Assets, including HVO-001. HVO-001 is an orally available, small molecule immunomodulator drug with potential as a treatment for severe influenza and symptoms requiring treatment in hospital with the drug unaffected by viral heterogeneity. It has the potential to treat a broad range of serious unmet needs in patients suffering from severe and fatal respiratory disease.

Having considered these plans in further detail, the Board has decided that a spin-out and admission to AIM of the wholly owned Development IP Assets may provide the opportunity to secure separate financial resources for the Development IP Assets, with the goal of enabling accelerated development of the asset portfolio and achievement of development and commercial milestones. It is anticipated that a spin-out pursuant to the Demerger would allow the Company’s shareholders to benefit from both the value of the Development IP Assets and the standalone value of the remaining business as they progress through their own key milestones.

The Company has completed various initial steps in anticipation of the implementation of the potential Demerger, including the transfer by HSL to ORPH Pharma IP, the Company’s recently incorporated wholly owned subsidiary, of the intellectual property relating to the Development IP Assets including HVO-001.  Pursuant to the assignment and licence agreement executed by HSL in favour of ORPH Pharma IP, HSL has assigned its interest in certain patents and patent applications to ORPH Pharma IP and licensed to ORPH Pharma IP certain trademarks, know-how, data and challenge agents; and, in addition, HSL has sub-licensed and sub-contracted in favour of ORPH Pharma IP its rights and obligations in relation to certain further intellectual property. As part of the foregoing, HSL will execute in favour of ORPH Pharma IP certain customary documents which will allow ORPH Pharma IP to register itself formally as the proprietor of the transferred intellectual property.

The next steps involve the Reduction of Capital to create distributable reserves to allow the Distribution in Specie to be declared pursuant to which the Demerger will be implemented and the Development IP Assets moved to Newco. 

The Directors believe that the Development IP Assets have the potential to deliver significant upside value for Shareholders. The Directors are therefore exploring funding options for that business, including equity funding, and the Directors intend on conducting initial market soundings in order to assist them in determining the feasibility of Newco being admitted to trading on AIM should the Demerger take place. Further announcements will be made at the appropriate time. 

The value of the proposed Distribution in Specie (the “Value”) has not yet been determined and the number of Newco Ordinary Shares (the “Ratio”) that each Shareholder would receive pursuant to the proposed Distribution in Specie has not yet been determined. If the results of the market sounding exercise for Newco are positive, the Board intends to declare the Distribution in Specie shortly prior to completion of the Fundraising and subsequent Admission, at which point the Value and the Ratio will be determined and announced to Shareholders via an RIS. The distribution in specie of the entire issued share capital of ORPH Pharma IP by the Company to Newco will be in return for Newco allotting and issuing Newco Ordinary Shares to Open Orphan Shareholders who are registered on the Open Orphan register of members at the specified demerger record date at a time and date to be determined by the Company and notified to the Shareholders in due course, on the basis of the determined Ratio (save that fractions of a Newco Ordinary Share will not be issued). 

The Company plans to use an external agent to establish a trust over the legal interest in the Newco Ordinary Shares allotted and issued pursuant to the Demerger, from the allotment and issue of such shares until the end of the Lock-In Period, pursuant to a nominee arrangement. The intention is that, following the end of the Lock-In Period, the agent will transfer legal title to the Newco Ordinary Shares to those beneficially entitled to them.  Shareholders should therefore be aware that if the Demerger is implemented they will not be able to sell, transfer or deal in the Newco Ordinary Shares they receive for a period to be determined by the Board and expected to be up to nine months following Admission. During the period of such nominee arrangements, and except as follows, such nominee will exercise the voting rights attaching to the Newco Ordinary Shares held by it in accordance with the wishes, if any, of the underlying beneficial owners of such shares. However, prior to Admission it will be necessary for Newco to re-register as a public limited company and, in order to facilitate the passing of the necessary resolution(s), it is intended that, on the basis that the Resolutions would already have been passed, the Board will instruct such nominee to vote all of the Newco Ordinary Shares held by it in favour of such resolution(s).

As mentioned above, Shareholders should note that the Board does not intend to declare the Distribution in Specie until the Fundraising for Newco process is near conclusion. The Fundraising process is in its early stages and so the Fundraising and Admission of Newco may or may not occur. The Distribution in Specie therefore may or may not occur. In the event that the Distribution in Specie does not occur ORPH Pharma IP will remain within the Open Orphan Group and continue to be operated as a subsidiary of the Company. The reserves created by the Reduction of Capital which were intended to be used in the implementation of the Distribution in Specie will be used, as with the balance of the reserves, to facilitate the future consideration of payment of dividends to Shareholders and the possible redemption or buy back of the Company’s shares where desirable. However, no assurance can be given that any such dividend would be declared or redemption or buy-back implemented. 

Reduction of Capital

The Act only permits a company to make distributions to its shareholders out of its profits available for that purpose. In addition, a public company may only fund a purchase of its own shares out of distributable profits. Such profits are, broadly, a company’s accumulated realised profits so far as not previously utilised by distribution or capitalisation, less its accumulated realised losses. The Company does not currently have distributable profits and is therefore unable to make any distributions to its Shareholders or fund a purchase of its own Open Orphan Ordinary Shares out of distributable profits. 

As at 31 December 2019, the Company had an accumulated retained earnings deficit on its statement of financial position of €3,513,000. At the same date, there was €19,041,000 standing to the credit of the Company’s share premium account.  In addition, the nominal value of the Deferred Shares (which are non-voting), which the Directors consider to be effectively worthless due to the extremely restricted rights which the shares confer on their holders, was £62,833.34. 

Since 31 December 2019, the Company’s share premium account has increased following the issue by the Company of Open Orphan Ordinary Shares at the following prices: (i) 207,040,800 Open Orphan Ordinary Shares at a price of £0.05775 per Open Orphan Ordinary Share; (ii) 86,885,253 Open Orphan Ordinary Shares at a price of £0.061 per Open Orphan Ordinary Share; (iii) 1,383,741 Open Orphan Ordinary Shares at a price of £0.001 per Open Orphan Ordinary Share; (iv) 2,524,860 Open Orphan Ordinary Shares at a price of £0.022 per Open Orphan Ordinary Share; (v) 114,821,824 Open Orphan Ordinary Shares at a price of £0.11 per Open Orphan Ordinary Share; and (vi) 2,172,565 Open Orphan Ordinary Shares at a price of £0.02 per Open Orphan Ordinary Share. 

As at 31 December 2020, there was £44,494,997 standing to the credit of the Company’s share premium account and the accumulated retained earnings deficit on the Company’s statement of financial position had also increased.

The Directors therefore feel it is appropriate to seek shareholder approval to effect the Reduction of Capital and, subject to the approval of the Shareholders and of the Court, to:

2.1

cancel the Company’s share premium account; and

2.2

cancel all of the Deferred Shares.

 

The Directors then propose to apply the reserve arising on the Reduction of Capital to eliminate the Company’s accumulated retained earnings deficit on its statement of financial position and, as to the balance, to create distributable profits on the balance sheet of the Company of approximately £39,388,000.  

As mentioned above, the Directors are planning to effect the Demerger by way of the Distribution in Specie.  However, in order to do this the Company first needs to create realised profits of the requisite amount which is the purpose of the Reduction of Capital. 

In addition, the Board believes that, subject to the future performance of the Company, the creation of realised profits will give the Company the ability to not only effect the Distribution in Specie but also to make distributions to Shareholders and/or buy back its own Open Orphan Ordinary Shares in the future if and when the Directors may consider that it is appropriate to do so. However, the Directors cannot give any guarantee either that the Company will make the Distribution in Specie or make any distributions or purchases of its own Open Orphan Ordinary Shares or as to the size of any distributions or purchases of its own Open Orphan Ordinary Shares which may be made.

The rights attaching to the Deferred Shares as set out in the articles of association of the Company (“Articles”) mean that the proposed cancellation of such shares does not involve a variation of such rights for any purpose and therefore the Company is authorised at any time to reduce its share capital (subject to the provisions of the Act) by cancelling the Deferred Shares without obtaining the consent of the holders of such Deferred Shares. Once the Reduction of Capital has been confirmed by the Court no further communication will be received by the holders of the Deferred Shares from the Company and all share certificates (if any) held in respect of such Deferred Shares can be destroyed. 

Cancellation of the share premium account and the Deferred Shares 

The cancellation of the Company’s share premium account and the Deferred Shares will only become effective if (in the following order): (i) Resolution 1 as set out in the Notice of General Meeting is approved by Shareholders at the General Meeting; (ii) confirmation is given by the Court; and (iii) the Court order and a statement of capital are delivered to and registered by Companies House.

As noted above, the cancellation of the Company’s share premium account and the Deferred Shares should enable the Directors to eliminate the current retained earnings deficit on the Company’s statement of financial position and create distributable profits. 

Notice of General Meeting

The Reduction of Capital and Distribution in Specie are conditional upon, inter alia, the Shareholders approving the Resolutions at the General Meeting.

In accordance with the UK Government’s response to the COVID-19 outbreak, and to minimize public health risks, it is strongly recommended that shareholders do not physically attend the General Meeting, and instead appoint the Chairman of the meeting as a proxy to exercise their right to vote.

The Circular contains a notice convening the General Meeting to be held at 11 a.m. on 29 April 2021 at which the Resolutions will be proposed.

Shareholders should note that, unless the Resolutions are approved at the General Meeting, the spin-out of the Development IP Assets cannot take place.

Recommendation

The Directors consider that the Resolutions are in the best interests of the Company and would promote the success of the Company for the benefit of its Shareholders as a whole. Accordingly, the Directors unanimously recommend that Shareholders vote in favour of the Resolutions to be proposed at the General Meeting as they and their immediate families and connected persons (within the meaning of section 252 of the Act) intend to do in respect of their aggregate holdings of 53,810,871 Open Orphan Ordinary Shares representing approximately 8.04 per cent. of the existing issued share capital of the Company.

ENDS

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.

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 .

Open Orphan #ORPH – Launch of Disease in Motion platform

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan, has officially launched its Disease in Motion® platform. This unique data-focused platform includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has multiple infectious disease applications that are applicable to a wide variety of end users including big tech, wearables, pharma and biotech companies.  

hVIVO has been at the forefront of running human challenge studies for more than 20 years and has built up one of the most comprehensive, multi-parametric bio and databanks ever created for infectious diseases. This dataset from the Disease in Motion platform is continuously gathered throughout the onset, progression and resolution of an infection which is enabled by hVIVO’s challenge study model. The Company is committed to volunteer patient data privacy and data is only collected from fully consented volunteers in accordance with all relevant privacy guidelines.

For more information on the platform, please visit www.hvivo.com/DiseaseInMotion  

Cathal Friel, Executive Chairman said: The Disease in Motion platform includes data from cutting edge wearables that are applicable to a wide variety of end users including big tech, wearables, pharma and biotech companies. As volunteers remain under close observation prior to viral challenge, during disease progression and until resolution, data is captured across the full time-course of the infection, yielding possible insights into the body’s response to infection. The Disease in Motion platform currently spans several conditions with plans to expand this going forward.  

As a recognised global leader in supporting the development of therapeutics and vaccines, hVIVO and our team of virological, clinical and regulatory experts are actively in discussion with potential partners to help address the next set of challenges facing humanity.” 

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 #ORPH – £7.5m Human Challenge Study Contract

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan, has entered into a contract with a  biotechnology company to run a human viral challenge study for a respiratory syncytial virus (“RSV”) prophylactic and treatment.  

This US biotechnology company is developing a product for the prevention and treatment of acute and chronic respiratory syncytial virus infections. RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness. There is currently no prophylactic or specific treatment on the market for RSV. 

The total contract value is £7.5m and the study is due to commence in Q4 2021, with the majority of revenues being recognised in 2021. hVIVO will conduct this study on behalf of its client to demonstrate the efficacy of their lead candidate against RSV infection.  The product is expected to have substantial advantages with respect to potency, safety, tolerability and convenience while fully maintaining efficacy when compared to other similar products.

Cathal Friel, Executive Chairman, said: “This is another substantial and significant contract win for hVIVO and Open Orphan. Through signing these deals, we continue to reinforce our position as the clear world leader in human challenge studies. Over the past year, Open Orphan has fully restructured, reorganised, and integrated our London, Paris and Breda operations to become a fast-growing, profitable provider of human challenge clinical trials in a manner required by the global pharmaceutical and biotechnology companies. We have expanded from one clinic to multiple clinics, and it is our stated objective to continue to invest and expand our global capability to ensure our position as the world leader in testing vaccines, antivirals, and monoclonal antibodies through the use of human challenge studies well into the future.

 With the ongoing expansion of our clinical footprint, we can now provide any pharmaceutical company, anywhere in the world, rapid access to challenge study clinical trials to gather data on their product in a relatively short time period. In the past, human challenge studies suffered from the perception that it was difficult to find a provider and that it may take a long period of time to complete, however, Open Orphan is transforming this view. We are delighted to see human challenge clinical trials now becoming an increasingly important part of pharmaceutical product testing and commercialisation.

hVIVO is currently the only company worldwide that can facilitate RSV challenge studies and we are in advance negotiations with all the significant RSV vaccine and drug developers globally. Our multiple state-of-the-art East London quarantine facilities are well equipped to carry out this study in a safe and controlled clinical environment.”

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 / Benjamin Cryer / Dan Gee-Summons

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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

Notes to Editors

Open Orphan plc

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

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

Open Orphan #ORPH – COVID-19 Human Challenge Programme update

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces an update in the world’s first COVID-19 characterisation study. Following Research Ethics Committee approval on 17 February 2021, hVIVO, a subsidiary of Open Orphan, began the study at the Royal Free London NHS Foundation Trust earlier this month.

The first three volunteers have now successfully completed the quarantine phase of their study participation with no safety concerns presented and have been discharged from the unit. The study will now progress to the next group of volunteers. The first three volunteers will continue their study participation with follow up visits and monitoring for a period of up to one year. As is normal practice during any clinical trial, none of the partners in the study will be identifying any of the volunteers.

The virus characterisation study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2) infection in a safe and controlled environment. The study is funded by the UK Government and Imperial College London is the clinical study sponsor. The study is conducted by hVIVO at the Royal Free Hospital, under the scrutiny of highly trained scientists and medics. The virus being used in the characterisation study has been produced under hVIVO’s supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London.

Individuals interested in taking part in this research can visit www.UKCovidChallenge.com to learn more.

Chief Scientific Officer at hVIVO, Dr Andrew Catchpole, said : “We are pleased to announce that the first three volunteers in this world’s first study have now successfully completed the quarantine phase, these volunteers will continue to be monitored post-study for up to 1 year. Throughout their stay at the Royal Free Hospital in London, the volunteers are closely monitored by our highly trained team of clinicians.

“We would like to thank these volunteers for their participation in this important study and look forward to welcoming the following cohorts. We expect that this study will greatly assist our understanding of this disease and provide insights into its progression, natural immune response, and transmission. We look forward to publishing the study’s results in due course and moving forward with vaccine challenge studies later this year.”

Dr Chris Chiu,  Chief Investigator and Reader in Infectious Disease at Imperial College London said: “We’re pleased to confirm the first group of three healthy volunteers has now successfully completed the first stage of the trial, with no unexpected issues. The volunteers are in good health. It would be premature to discuss further details at this early stage.”  

Group Chief Executive at the Royal Free London, Caroline Clarke, said:We are incredibly proud to be working with our partners from hVIVO, Imperial College London and the government’s Vaccine Taskforce on this important research. We’re delighted that the first stage of the study has been completed successfully and we look forward to continuing our close collaboration as this research moves forward.”

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 / Benjamin Cryer / Dan Gee-Summons

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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

Notes to Editors

Open Orphan plc

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

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

Open Orphan #ORPH – Journal for Clinical Studies article publication

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that an article has been written and published in the Journal for Clinical Studies (“JCS”). The article, entitled “Hot Topics – Vaccine Solutions for Tropical Diseases” is written by Adrian Wildfire, Director of Scientific and Business Strategy and Bruno Speder, VP of Regulatory Affairs and Consultancy Services at hVIVO, a subsidiary of Open Orphan plc.

The article explores the issue of vaccine development for tropical diseases for low and middle income countries and the barriers to effective treatments. In the article, hVIVO discuss how challenge study models can be used in the development of vaccines for tropical diseases. They further discuss the importance of Chemistry, Manufacturing & Control (CMC) development in relation to storage conditions, stress tests for tropical regions and the importance of non-clinical development.

The full article can be found here https://hvivo.com/hot-topics-vaccine-solutions-for-tropical-diseases/

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 / Benjamin Cryer / Dan Gee-Summons

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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

 

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 – Ethics approval – COVID-19 Human Challenge Study

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces the world’s first COVID-19 characterisation study has received approval from a specially convened Research Ethics Committee (“REC”). This news follows the announcement on 20 October 2020 of Open Orphan subsidiary hVIVO’s contract with the UK Government to develop a COVID-19 human challenge study model.  

The initial virus characterisation study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2)infection in a safe and controlled environment. The study is set to commence shortly and is funded by the UK Government. Imperial College London is the clinical study sponsor and the study will be conducted by hVIVO at the Royal Free London NHS Foundation Trust’s specialist clinical research unit, under the scrutiny of highly trained scientists and medics. The virus being used in the characterisation study has been produced under hVIVO’s supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London,  with support from virologists at Imperial College London.

The REC approval completes all the independent external body approvals required before the study can commence.   

Individuals interested in taking part in this research can visit  www.UKCovidChallenge.com to learn more. 

Chief Scientific Officer, hVIVO, Dr Andrew Catchpole, said: “Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the COVID-19 challenge model. COVID-19 Human Challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic. 

“This study is a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required.  Data from this study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection.” 

Dr Chris Chiu, Clinical Reader, Honorary Consultant and Chief Investigator of this study said: “The recent worsening of the pandemic and urgent need to vaccinate people quickly and effectively have raised new questions about COVID-19 and how to best protect ourselves against it. This study will immediately tell us about mild and asymptomatic infection, which is a major driver of continuing transmission. While the first wave of vaccines are being rolled out, human challenge studies could also be pivotal in helping to shape the timings and doses of existing vaccines, finding out how long one dose is protective for, and if they are effective against new variants of the virus.”

“The Research Ethics Committee has provided detailed independent scrutiny. Their favourable opinion is a crucial step towards getting this study open and running, and greatly helps us in our efforts to minimise risks and enhance the quality of the research.”

Cathal Friel will be presenting at a Mello event on Monday, 22 February. To register for this, please follow the link: https://melloevents.com/mellomonday-22nd-february-2021/

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 / Benjamin Cryer / Dan Gee-Summons

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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

 

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.

Health Research Authority (HRA)

Before commencing a clinical study, researchers must submit an application for Health Research Authority (HRA) approval which brings together the assessment of governance and legal compliance, with the independent Research Ethics Committee (REC) opinion to confirm whether a research study has all the necessary approvals in place from the relevant bodies to proceed. The HRA, as the body responsible for running the UK Research Ethics Service, brought together a group of experienced REC members from around the UK to review the COVID-19 challenge study. The specially convened committee was made up of 12 members, a mixture of lay people and experts as required by law and has been recognised by UKECA (The United Kingdom Ethics Committee Authority).

Open Orphan #ORPH – Exercise of Investor Warrants by Investors, Issue of Shares and TVR

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organization (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials , has received notice of exercise of warrants by investors who participated in the Venn loan note financing in December 2018 over 1,349,349 ordinary shares of  0.1 pence each in the capital of the Company (“Ordinary Shares”) at a price of 0.1 pence per share for 477,703 Ordinary Shares and at a price of 2.2 pence per share for 871,646 Ordinary Shares. The gross proceeds of this exercise received by the Company amounts to £19,653.91.

Following this exercise the warrants issued in connection with the 2018 Venn loan note have been substantially exercised with 1,062,111 warrants outstanding. In addition, the 2018 Venn loan note has now been fully repaid, and as such, the current outstanding debt and loans owed by the Company is £319,000.

The total outstanding warrants over Ordinary Shares are as follows:

Number of Ordinary Shares

Exercise Price per share

Date awarded

Expiry Date

Beneficiary

166,666

30 pence

7 June 2011

6 June 2021

An advisor

376,008

0.1 pence

11 December 2018

10 December 2023

Venn loan note investors

686,083

2.2 pence

11 December 2018

10 December 2023

Venn loan note investors

1,607,142

5.6 pence

28 June 2019

27 June 2024

An advisor


The Company has made application for 1,349,349 new Ordinary Shares, to be issued and allotted as a result of the warrant exercise set out above, to be admitted to trading on AIM and Euronext Growth. Admission is expected to occur at 8.00 a.m. on 8 February 2021.

Total Voting Rights

Following the admission of 1,349,349 new Ordinary Shares, the Company’s total issued ordinary share capital will consist of 669,401,610 Ordinary Shares. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

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.

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details 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 / Benjamin Cryer / Dan Gee-Summons

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

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

About Open Orphan  ( www.openorphan.com )

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility.  hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at  www.FluCamp.com The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.  Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.  hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its  COVID Clear  offering.  

Open Orphan comprises of two commercial specialist CRO services businesses,  hVIVO    and    Venn Life Sciences  and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteers via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.

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