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Open Orphan plc (ORPH) Demerger Update

Demerger Update

Further to Open Orphan’s announcement on 14 June 2021 in relation to the distribution in specie, the boards of Open Orphan and Poolbeg Pharma are pleased to announce Poolbeg’s intention to seek admission of its shares to trading on AIM, a market of the London Stock Exchange (“Admission”). Funds raised as part of Admission will be used primarily to fund the clinical trial costs associated with the development of the Company’s POLB 001 asset as a treatment for severe influenza and to acquire and develop new portfolio assets.

 

Wide asset portfolio

  • Attractive lead asset  POLB 001:
    • First-in-class, Phase II ready small molecule immunomodulator for severe influenza.
    • Addresses unmet need for effective treatments against severe influenza (c. $800m addressable market)
    • Applications beyond influenza are possible with label extensions (and the Company holds worldwide rights for all uses)
  • Vaccine Discovery Platform harnessing data from the human challenge model to potentially discover new vaccines which the Directors believe could generate significant shareholder value
  • PredictViral™ Biomarker platform for predicting severe disease – potential to transform the way infectious diseases are treated
  • Licensed access to one of the largest infectious disease progression data and bio banks i.e. Open Orphan’s data and biobank, with the potential to interrogate the data with an AI data analysis platform (advanced discussions underway) to accelerate the identification of drug targets / products
  • Pipeline of further assets for acquisition post-IPO

 

Infectious Disease Market

  • Market expected to exceed $250bn by 2025
  • Cumulative costs of the COVID-19 pandemic in terms of lost output & health reduction is equivalent to 90% of US GDP ($16tn)
  • Significant recent M&A and licensing activity in the infectious disease space

 

Capital light business model

  • Enables the Company to develop assets to Phase II quickly with relatively modest investment where they can potentially be monetised / licensed to big pharmaceutical companies
  • Platform for growth with a proven, streamlined method of identifying drugs to acquire / license, access to key data to drive that platform and well protected intellectual property
  • Faster and more cost-effective development model than traditional biotech’s giving potential for multiple value inflection points as each asset is advanced through the pipeline with a view to ultimate monetisation / licensing to big pharmaceutical companies
  • Intend to use contingent payments to fund asset acquisitions therefore minimising / eliminating potential equity dilution

 

Track Record

  • Strong heritage – initial assets from Open Orphan, a well-established, revenue generating business with over 20 years’ experience in infectious diseases and human challenge trials
  • Track record of delivery and creating value for shareholders – management team has completed three IPOs, built revenue generating businesses and achieved significant exits

 

Poolbeg IPO

  • Signal of quality to prospective partners and customers, raising the profile of the business
  • Provides a supportive platform on which to accelerate existing assets through development
  • Funds raised will allow the Company to acquire / license additional assets and technologies as appropriate
  • A portion of the Placing is expected to qualify for EIS and VCT related tax relief in addition to an expected retail offering via PrimaryBid
  • Cathal Friel, Non-Executive Chairman of Poolbeg has committed to participate in the IPO alongside incoming investors on the same terms

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:

“The COVID-19 pandemic has placed the issue of infectious diseases firmly in the public eye; Governments and international organisations are now investing heavily to ensure they are better prepared.

“Poolbeg Pharma is aiming to carve out a leading position in this rapidly evolving and expanding sector. We have an excellent heritage in infectious diseases and a management team with a track record of delivering value creation.

“Our capital light business model is an important differentiator. Through deep biological analysis of disease progression, we believe that it should enable us to reposition existing drug candidates and develop assets to Phase II stage quickly with relatively modest investment where they can then potentially be acquired / licensed to big pharmaceutical companies. We aim to be customer-led and will use our extensive network to become a ‘one stop shop’ for big pharma, developing the assets that they need.”

 

Cathal Friel, Executive Chairman of Open Orphan and Non-Executive Chairman of Poolbeg Pharma commented:

“Poolbeg Pharma is a great opportunity to maximise the potential of some of Open Orphan’s pharma assets which are non-core to our successful human challenge clinical trial business in a focused and capital efficient way.

“Poolbeg’s approach to asset development should result in good licensing opportunities and excellent returns in a relatively short period of time with substantially less risk than the traditional biotech model and allow for regular investor newsflow. In addition, in Poolbeg we have assembled a leading management team, generated an exciting pipeline of potential acquisitions and entered advanced discussions with leading AI data analysis platforms to increase the attractiveness of the Company and its offering. Thus, I am confident and excited in the Company’s prospects going forward and will be personally investing alongside incoming investors as part of the potential IPO.

“We are extremely proud that this is now the third life science IPO from the Raglan Capital stable after Amryt Pharma plc and Open Orphan plc, and we are excited to have Jeremy Skillington joining as CEO, bringing his valuable experience and  successful track record with Inflazome to the team.”

– Ends –

 

Open Orphan plc

Cathal Friel, Executive Chairman

 

+353 (0) 1 644 0007

Arden Partners PLC (Nominated Adviser & Joint Broker)

John Llewellyn-Lloyd, Richard Johnson, Oscair McGrath

 

+44 (0) 207 614 5900

finnCap Ltd (Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson 

 

+44 (0) 20 7220 0500

Davy (Euronext Growth Adviser and Joint Broker)

Anthony Farrell

 

+353 (0) 1 679 6363

Walbrook PR (Financial PR & IR)

Paul McManus / Louis Ashe-Jepson / Sam Allen

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

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

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 – Proposed Distribution in Specie & Notice of Results

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, further to previous announcements, it proposes to make a distribution in specie of the entire issued share capital of its wholly-owned subsidiary Orph Pharma IP Company Limited (“Orph Pharma”) to Poolbeg Pharma Limited (“Poolbeg”), in return for the issue of new shares by Poolbeg (“Poolbeg Shares”) to shareholders of Open Orphan on the register at close of business on 17 June 2021 (“Relevant Shareholders“). 

The approval of Open Orphan shareholders to such distribution in specie was granted at Open Orphan’s general meeting held on 29 April 2021. 

It is expected that Open Orphan ordinary shares will be marked “ex rights” at 8.00 a.m. on 16 June 2021.

It is also expected that the board of Open Orphan will convene formally to make such distribution in specie on 18 June 2021 and that Relevant Shareholders will receive one Poolbeg Share for every 2.98 ordinary shares held in the Company, with resultant entitlements rounded down to the nearest whole number. Prior to the making of the distribution in specie, Open Orphan and Poolbeg intend to enter into a demerger agreement providing for the issue of the Poolbeg Shares to Relevant Shareholders in return for the distribution in specie of the entire issued share capital of Orph Pharma to Poolbeg.

Further to the Company’s announcement of 13 April 2021, the board of Open Orphan has determined that if and when the Poolbeg Shares are admitted to trading on AIM (“Admission”) Relevant Shareholders who receive Poolbeg Shares will not be permitted to sell, transfer or deal in such Poolbeg Shares for a period of 9 calendar months (the “Lock-up Period”). Accordingly, Open Orphan and Poolbeg have appointed Croft Nominees Limited (“Croft”) to hold the legal title to the Poolbeg Shares from the date on which the distribution in specie is effected until the date which is 9 months from Admission.

Croft has agreed to hold on trust on behalf of Relevant Shareholders, the beneficial owners of the Poolbeg Shares, an omnibus share certificate representing all the Poolbeg Shares until the end of the Lock-up Period and to take certain limited actions with respect to the Poolbeg Shares. Following the expiry of the Lock-up Period Croft will deliver the share certificate to Poolbeg’s registrar and will execute stock transfer forms to transfer the Poolbeg Shares to Relevant Shareholders based on a schedule to be provided to Croft by Poolbeg, and upon the registration of such Relevant Shareholders (or their respective personal representative, nominee or successor in title) as legal holders of such shares, Croft will be released from its obligations in relation to such trust arrangements.

In the event of a general meeting of Poolbeg during the Lock-up Period, Poolbeg will arrange for its registrar to contact Relevant Shareholders to ascertain how (if at all) they wish to vote. Croft will then complete a proxy form reflecting the voting intentions as so communicated to Poolbeg’s registrar. However, following the issue of the Poolbeg Shares to Relevant Shareholders, and given the passing of the resolutions at the general meeting of the Company on 29 April 2021, the board of Open Orphan intends to instruct Croft to vote the Poolbeg Shares in favour of resolutions to re-register Poolbeg as a public limited company and adopt appropriate public company articles of association.

It is intended that Relevant Shareholders will receive a letter informing them of their beneficial holdings of Poolbeg Shares shortly after the issue of the Poolbeg Shares.

Following the Lock-up Period, Relevant Shareholders (or their respective personal representative, nominee or successor in title) will receive individual registrations in respect of their Poolbeg Shares.

The anticipated timetable for the proposed Open Orphan distribution in specie is:

 

Open Orphan ordinary shares marked as ex rights

8.00 a.m. on 16 June 2021

Record date for the distribution in specie

Close of business on 17 June 2021

Distribution in specie effected

18 June 2021

Registration of Poolbeg Shares in the name of Croft Nominees Limited

Upon issue on 18 June 2021

 

A copy of the undertaking in relation to Croft Nominees Limited acting as legal holder of the Poolbeg Shares will be made available in due course via the investor section of the Company’s website.

Notice of Results

The Board expects to release the Company’s audited results for the year ended 31 December 2020 on 17 June 2021. It also expects, at the same time, to update shareholders on the progress of the anticipated admission to trading on AIM of Poolbeg.

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0)20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

finnCap Ltd (Joint Broker)

+44 (0)20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

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

Paul McManus / Sam Allen

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

 

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 – Exercise of Warrants & TVR

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 , has received notice of exercise of warrants by investors, who participated in the Venn loan note financing in December 2018, over 404,806 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 143,312 Ordinary Shares and at a price of 2.2 pence per share for 261,494 Ordinary Shares. The gross proceeds of this exercise received by the Company amount to £5,896.18.

Following this exercise, the warrants issued to investors in connection with the 2018 Venn loan note have been substantially exercised with only the Chairman’s 657,285 warrants outstanding.

The total outstanding warrants over Ordinary Shares are as follows:

Number of Ordinary Shares

Exercise Price per share

Date awarded

Expiry Date

Beneficiary

232,696

0.1 pence

11 December 2018

10 December 2023

Venn loan note investor

424,589

2.2 pence

11 December 2018

10 December 2023

Venn loan note investor

1,607,142

5.6 pence

28 June 2019

27 June 2024

An advisor


The Company has made application for 404,806 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 16 June 2021.

Total Voting Rights

Following the admission of the 404,806 new Ordinary Shares, the Company’s total issued ordinary share capital will consist of 670,855,002 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

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 / Richard Johnson / Oscair McGrath

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

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

Paul McManus / Sam Allen /

Lianne Cawthorne

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

+44 (0)7584 391 303

 

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) Investor Presentation June 2021

Open Orphan (ORPH) Investor Presentation June 2021.

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 PLC #ORPH – Result of General Meeting

Result of General Meeting

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 all resolutions proposed at the General Meeting held earlier today were duly passed.

Further announcements regarding the proposed Distribution in Specie will be made in due course.

For further information, please contact:

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

Alan Green talks Watches of Switzerland #WOSG, Open Orphan #ORPH & Union Jack Oil #UJO on Vox Markets podcast

Alan Green discusses Watches of Switzerland #WOSG, Open Orphan #ORPH & Union Jack Oil #UJO on Vox Markets podcast. Interview is 18 minutes 35 seconds in.

Alan Green talks Coinbase & Mast Energy #MAST IPOs and markets, plus ECR Minerals #ECR, Blencowe Resources #BRES & Open Orphan #ORPH on UK Investor Magazine podcast

Alan Green joins the UK Investor Magazine Podcast as we await trading in Coinbase, the cryptocurrency dealing platform which could be valued at $100bn.

The Coinbase IPO marks the move of cryptocurrencies to the mainstream and we question what it could mean for assets such as Bitcoin if investors view Coinbase’s listing as a ‘buy the rumour, sell the fact’ moment.

Major investment banks and institutional investors have changed their stance on Crypto with this IPO, many who warned against investing in the assets, or even called them a Ponzi scheme, are now showing interest and working them into their business models.

After the busiest quarter for IPOs on the London Stock Exchange since 2007, we touch on Mast Energy Developments who began trading today, changing hands at 15p having set an IPO price of IPO.

The three UK equities we explore in this episode are ECR Minerals (LON:ECR), Open Orphan (LON:ORPH) and Blencowe Resources (LON:BRES)

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