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Open Orphan #ORPH – Additional Laboratory Services Contracts Signed with NOBACZ & Nearmedic International

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials is pleased to announce that as part of opening up its hVIVO laboratory services to third parties that it has signed 3 new contracts with third parties; NoBACZ Ltd who are a spin-out company of the University of Cambridge, a new second contract with Nearmedic International Ltd and a contract to run in-vitro testing from its laboratory for a Cambridge, Massachusetts biotech.

NoBACZ Ltd is developing an environmentally friendly antimicrobial, antiviral coating that prevents common-touch surfaces from being a major source of infection transmission during and beyond the COVID-19 outbreak. The innovative, customisable antimicrobial coating has a multitude of applications across public spaces and industries. Applied as a liquid, the NoBACZ product is adhesive and water repellent and sets into a solid but flexible barrier that is robust enough to form a semi-permanent coating on a wide variety of surfaces. The product’s composition can be fine-tuned to produce a thin or thick coating to suit different surfaces and materials, with the ability to adapt the product’s life-span before it naturally degrades such that there is no need to manually remove it.  

NoBACZ Ltd is working with hVIVO, at its state-of-the-art laboratory in East London, to test its products against a range of viruses, including coronaviruses and ultimately, against SARS-CoV-2, the virus strain that causes COVID-19 disease. If successful, the long-lasting coating can be applied to high-touch surfaces in public transport, office buildings, hospitals, gyms, care-homes, and supermarkets.

hVIVO has also recently signed a contract to run in vitro testing from its laboratory for a Cambridge, Massachusetts based biotech company. In addition, hVIVO had also signed another contract with Nearmedic International Ltd, the Company’s second in recent times, to support the development of a RegG3 drug as a treatment for COVID-19 followed by the expansion of this product into several disease areas such as Cystic Fibrosis.

As announced at Open Orphan’s recent fundraise, the group is expanding its virology and laboratory testing services to third parties. This provision of third-party laboratory services is a growth area for the Group as numerous biotechnology companies and small cap pharmaceutical companies around the world do not have their own virology laboratory. hVIVO has a unique state-of-the-art virology laboratory which it needs to run its own clinical trials, however, quite often in the past it was no more than 15% to 20% utilised. Therefore, going forward it makes great business sense to build up the laboratory services to use this underutilised capacity, i.e. our existing staff resources and facilities, to build a more profitable and sustainable business going forward. These contracts are further evidence of the Open Orphan Group executing on its strategy of building out additional and sustainable revenue lines from each of its Group companies going forward and is in line with the strategy of becoming a leading pharma services provider to the viral, and respiratory diseases sector of the pharmaceutical industry.

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are now continuing to sign additional new virology services contracts with third party customers and, as such, this is delivering upon one of our key commitments from when we acquired hVIVO earlier this year that, as part of our growth strategy, we were going to expand the range of our service offerings to third party pharmaceutical and biotech companies. I am excited by this area of growth for Open Orphan as we seek to maximise the value out of our fantastic facilities in East London.”

Jonathan Powell, CEO of NoBACZ said:

“We are delighted to be working with hVIVO, a world-leading virology laboratory and pioneer of viral challenge studies, in our efforts to evaluate NoBACZ’s ground-breaking coating technology and its effectiveness at contact-killing respiratory viruses. hVIVO has the requisite experience and professional commercial focus to execute our pivotal studies rapidly and efficiently, allowing us to move forward in our ambitions to provide a quick-to-market solution for protecting the public against a resurgence of COVID-19 or similar outbreaks.” 

Rupert Holms, Chairman of Nearmedic said:

“hVIVO and Open Orphan have the unique combination of skills which shall help Nearmedic to get its novel ezrin peptide technology to the global pharmaceutical markets and  help in the fight against the COVID-19 pandemic” 

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 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Open Orphan #ORPH – Notice of AGM

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge study models announces that its Annual Report and Accounts for the year ended 31 December 2019 and the notice of the 2020 Annual General Meeting (“AGM”), will be posted to shareholders later today , and will shortly be available on the Company’s website, https://www.openorphan.com/.

The Company’s AGM will be held at the offices of Arden Partners PLC, 125 Old Broad St, London EC2N 1AR on 22 July 2020 at 12 noon.

IMPORTANT NOTICE REGARDING COVID-19

In light of the UK Government’s response to the COVID-19 outbreak, which includes banning most non-essential travel and gatherings of more than two people, the Company and the Executive Chairman have determined that the Resolutions to be proposed at the AGM shall be voted on through a poll rather than on a show of hands. The Company believes that this is the best and fairest way to ensure that the votes of all shareholders can be taken into account, whilst also preventing the Company and shareholders breaching applicable regulations. Accordingly, the Company encourages all shareholders to either submit their Form of Proxy or use the CREST Proxy Voting Service, rather than attend the meeting in person. In accordance with the Company’s articles of association, whilst completion and return of the Form of Proxy or using the CREST Proxy Voting Service would not preclude shareholders from attending, speaking and voting in person at the AGM should they so wish, shareholders are reminded that to do so would potentially be in breach of UK Government regulations in relation to the containment and control of COVID-19 and accordingly shareholders are strongly encouraged to either submit their Form of Proxy or use the CREST Proxy Voting Service, rather than attend the AGM in person.

 

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 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

 

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services group 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. Which 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 Group 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.  In June 2020 hVIVO COVID Clear Test was launched, the most accurate antibody test available to UK employers, helping them to get their people back to work.

Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences, and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. 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, as an integrated drug development consultancy, 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 group broadening the Group’s customer base and with complementary specialist CRO services, widened the range of the Group’s service offerings.

Open Orphan #ORPH – Full Year Results

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge study models is pleased to announce its full year results for the year ended 31 December 2019.

 

Financial Highlights

Open Orphan plc

(As reported)

hVIVO plc

(As reported)

Open Orphan plc

(formerly Venn Life Sciences Holdings plc -proforma results

on a stand-alone basis and excluding any impact of the 28 June 2019 combination)

Open Orphan DAC

(proforma results

on a stand-alone basis

and excluding any

 impact of the

28 June 2019

combination)

Open Orphan plc

(proforma results on a combined basis and including the impact of the 28 June 2019 and 17 January 2020 combinations)

2019

€’000

2018

€’000

2019

£’000

2018

£’000

2019

€’000

2018

€’000

2019

€’000

2018

€’000

2019

€’000

2018

€’000

Revenue (incl. Other income)

4,039

15,092

13,626

9,854

14,291

27,061

29,712

Operating (Loss)

(5,837)

(1,611)

(5,893)

(13,427)

(6,469)

(2,367)

(763)

(1,611)

(14,249)

(19,174)

EBITDA before exceptional items

(4,311)

(1,611)

(3,785)

(8,862)

(5,053)

(1,432)

(763)

(1,611)

(10,130)

(13,072)

Loss for the period

(6,543)

(1,656)

(6,973)

(16,833)

(6,442)

(4,775)

(1,025)

(1,656)

(16,524)

(25,481)

 

Post Period End Highlights

·      Completion of merger of Open Orphan plc and hVIVO plc in January 2020 creating a specialist pharma services group with complementary CRO services

·      Continued action to reduce the cost base with annualised savings of €2.0m in hVIVO and €3.0m in Venn respectively removed since the merger in January 2020 and further annualised cost savings of €2.5m in the merged entity are expected to be implemented by 31 December 2020

·      Developing the world’s first challenge study model clinical trial in order to be able to test the efficacy of the large number of Covid-19 vaccines that are in development

·      Developing an antibody testing service with capacity for up to 3,000 tests per day using the Quotient testing instruments which is one of the few able to offer 100% accuracy

·      Expanded the Group’s pipeline of opportunities and converting pipeline of contracts across the whole Group, including:

o  provision of an RSV human challenge study projected to deliver £3.2m in revenue all of which is expected to be recognised in 2020 with potential for additional follow-on £7m Pivotal challenge study delivering significant further revenue

o  A contract with a US Biotech company for the provision of an RSV human challenge study projected to deliver £3.5 million in revenue all of which is expected to be recognised in 2020

o  Expansion of laboratory service with offerings to third party biotech companies and small cap pharma companies with new contracts already completed and this is anticipated to be an important new revenue generating stream for the Group

o  Venn’s traditional pharma consulting business continues to perform well and a significant contract was announced in recent weeks to obtain and support market access of newly developed vaccines into the EU and US markets for one of the top pharmaceutical companies in the world

·      Increased liquidity and strong balance sheet through placings of £5.3m in January 2020 and £12.6m in May 2020 to allow the Group to complete its transition and leverage a broader service offering to an enlarged and combined customer base

Outlook

·      Unprecedent growth opportunities as pharma focuses funding on Covid-19 and respiratory diseases resulting the development of a strong pipeline of opportunities, for both Covid-19 and non-Covid-19 challenge studies along with the wider CRO services offered by the Group

·      Strong pipeline of work to build H2 2020 revenue, targeting operational profitability by Q3 2020

·      A further €2.5m of cost to be removed from the business in H2 2020

·      Right management team in place, with a clear strategy, targeting the high margin pharma services sector, to deliver significant shareholder value

·      A strategic review is underway in order to seek to monetise the 49% stake in Imutex and our other non-core investments such as the 62.5% in PrEP Biopharm and our 100% stake in an immunomodulator

Cathal Friel, Executive Chairman of Open Orphan, said:

“Since the reverse takeover of Venn in June 2019 we have been building the foundations of a soon to be profitable business in Q3 and a rapidly growing CRO pharmaceutical services Group with all loses in both companies confined to the past. The merger with hVIVO, post period end, has given us a full-service business, with world class facilities, motivated colleagues and a strong pipeline of work and transforms out business into the world leader in the testing of vaccines and anti-virals through human challenge model clinical trials.

Traditionally, the testing of vaccines and antivirals had been somewhat of a Cinderella industry, however, following the advent of the Covid-19 pandemic it is clear that for the months and years ahead the development of new and novel vaccines and also the testing of such vaccines and antivirals will be one of the fastest growing areas of the pharmaceutical industry. In recent decades, governments and pharma companies around the world completely underinvested in new vaccines and the onset of Covid-19 caught them significantly off-guard and as such there is a huge capital investment program underway around the world to roll out an extensive range of Covid-19 and importantly non-Covid-19 vaccines to ensure that the world is not caught unprepared in future pandemics.

We have substantially reduced overheads and rightsized the management team including combining the CEO and other senior roles in both Venn and hVIVO. We have also brought forward some long-serving and excellent line managers and heads of departments flattening the organisation structure and giving them more autonomy and responsibility to successfully run their own areas and this is proving very effective both for the company but also most importantly for the individual managers as well. In turn, this has completely transformed the culture of the enlarged business to one of vastly more open communications, sharing of knowledge and a much faster decision-making process.

I am very excited for the year ahead and I am confident that we have created a soon to be profitable, fast-growing business which is creating value for all our stakeholders.”

Conference call for sell-side analysts and investors

The Company will hold a conference call for sell-side analysts and investors at 09:30 today.

Participant dial-in numbers

 

Dial-in numbers:

IE: +353 1 526 0106

UK: +44 33 0606 1122

ITFS:  International Access Numbers

 

Room number:

 

430863

 

Participant PIN:

 

5880

A corporatepresentation is available to shareholders on the Group’s website at: https://www.openorphan.com/investors/reports-and-presentations/year/2020

 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 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Open Orphan #ORPH – Positive Phase 1 study results published in The Lancet

Monday 15th June, 2020

Positive results from the Phase I study of the AGS-v vaccine developed by an Open Orphan joint venture, Imutex Limited, have been published in the peer reviewed journal The Lancet

AGS-v is a first-in-class mosquito saliva, standalone, vaccine candidate designed to protect against mosquito-borne diseases carried in the saliva such as Zika, Malaria, Dengue Fever and West Nile Virus

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge study models is pleased to announce that the results of a randomised, placebo-controlled, double-blind, phase 1 trial of AGS-v have been published in The Lancet. AGS-v has been developed by Imutex Limited, in which Open Orphan owns a 49% stake in conjunction with the SEEK Group.

Highlights:

·    The first trial of AGS-v, a first-in-class “mosquito saliva vaccine” in humans

·    The trial indicated that the vaccine is safe and induces a strong immune response in healthy volunteers

·    These positive findings suggest that AGS-v is now ready to advance to Phase II

Numerous studies have shown that protection from diseases carried in saliva is possible if you alter the immune response to saliva. Using natural saliva to achieve this not viable. AGS-v is designed as a transformational vaccine, the first ever mosquito synthetic saliva vaccine designed in to protect against mosquito-borne diseases carried in the saliva such as Zika, Malaria, Dengue Fever, West Nile Virus etc. AGS-v is designed to provoke an immune response against mosquito saliva, rather than any specific parasites, viruses, or bacteria the mosquito might transmit making it an important tool in the fight against mosquito-borne diseases.

In the new study published in The Lancet, NIAID scientists describe the results of the Phase 1 trial of the vaccine as “encouraging and worthy of further study”.

The Trial Results

The double-blind study, which began in 2017 at the NIH Clinical Center in Bethesda, Maryland, was the first trial of this so-called “mosquito saliva vaccine” in humans.

The volunteers’ blood tests showed that the vaccine in combination with the adjuvant produced a significant immune response to mosquito salivary peptides. Further, this immune response was not accompanied by a worse reaction to mosquito bites.

The study’s results are promising and suggest that further research to test the vaccine’s efficacy against individual pathogens, followed by larger field studies, would be worthwhile.  A widely available “universal” vaccine could provide protection against emerging and re-emerging mosquito-borne diseases as they arise, allowing public health officials to quickly respond to new outbreaks and epidemics without waiting for new treatments or vaccines to be developed.

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are delighted with the results of this very important and successful trial of Imutex’s universal vaccine for mosquito-borne diseases. This further confirms and reinforces our belief that our 49% shareholding in Imutex has a lot of unrealised potential value and we look forward to working closely with Gregory Stoloff and his team in SEEK to see how we can commercialise and monetise the true value of Imutex over the coming months.”

Gregory Stoloff, Chief Executive Office, Imutex Ltd, said:

“We all know too well today the cost of pandemics to society and mosquitoes have been causing these problems for many countries for too long. It has been known for some time that injecting saliva in a particular way from an insect provides protection from the disease carried in that saliva. Harvesting natural saliva however, was not practical. We are very excited that our synthetic made saliva produced an immune response and was safe in humans. This makes a vaccine that can protect people against  so many diseases that plague the world, a step closer to reality. We are excited that we now are a step closer to making a vaccine that could deal with these issues.”

 

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 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Experts seek approval for COVID-19 trials – China Daily

By ANGUS McNEICE in London

Medical community divided on issue of exposing humans to deadly virus

A laboratory in the United Kingdom is hoping to become the first in the world to intentionally infect volunteers with novel coronavirus in order to test the efficacy of COVID-19 vaccines.

Half of the participants in these so-called human challenge trials would be given a candidate vaccine for COVID-19, the other half would get a placebo, and all of them would then be exposed to novel coronavirus via a nasal spray.

The volunteers, aged 18 to 30, would then spend weeks quarantined at a private clinic, frequently checked on by researchers in hazmat suits running tests to determine if the vaccine provides protection against the disease. Those who display symptoms would be treated with antivirals or immunotherapeutics.

The human challenge model is a tried and tested way to assess vaccine efficacy. Such trials have previously been used in the study of influenza, malaria, typhoid, dengue fever, and cholera inoculations. Challenge studies have an advantage over traditional field trials when levels of a pathogen are low in the general population, as is the case with novel coronavirus during lockdown.

The method is also highly controversial, and the lab in question, London-based hVIVO, will have to navigate an ethical minefield to achieve its goal during this pandemic.

“We are the only place in the world that is well down the road to development for COVID-19 human challenge studies,” Cathal Friel, chief executive of hVIVO parent company Open Orphan, told China Daily. “We will be able to very quickly guarantee to any pharma company in the world if their vaccine works.”

Friel is currently in talks over running challenge trials for a dozen COVID-19 vaccine developers in Europe, North America, and Asia, three of which are from China. Before commencing the trials, hVIVO must gain approval from the ethics committee at the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency.

Among a host of considerations, the committee will attempt to answer two core questions: is COVID-19 too dangerous for a challenge trial, and are existing treatments effective enough if and when volunteers fall ill.

Challenge trials generally involve around 100 volunteers and are typically used to test vaccines against non-lethal illnesses, such as the common cold, or diseases for which highly effective treatments exist, such as malaria. The trials are not considered for lethal diseases for which existing treatments are limited, such as Ebola or Marburg virus.

While severe cases of COVID-19 are rare among healthy young people, some in the medical community warn that not enough is yet known about the disease to run such trials, and doing so would be extremely risky. Others argue that this risk can be mitigated with well-designed trials, which would in turn greatly accelerate vaccine development, potentially saving hundreds of thousands of lives.

Vaccine developers are faced with a conundrum during this stage of the pandemic. Field trials involving tens of thousands of volunteers are most efficient when a pathogen is thriving in the general population. But lockdown measures in some regions have been so effective that there is not enough COVID-19 going around to challenge a vaccine’s efficacy.

Link here to the original story

Open Orphan plc #ORPH – Launch of Covid-19 Antibody Testing

Open Orphan plc      (“Open Orphan” or the “Company”)

Launch of Covid-19 Antibody Testing

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge study models, announces the launch of hVIVO COVID Clear Test, the Company’s antibody testing service, following the successful completion of installation, testing and training.

The antibody tests, which utilise the Quotient MosaiQ™ system and MosaiQ COVID-19 Antibody Microarray, offer best in class COVID-19 antibody testing performance and will require a full blood draw. hVIVO COVID Clear Test will be offered to large employer groups and channel partners including GP networks, nursing services, health clinics and private hospitals. Samples will be tested in the Company’s London laboratory with results returned within 48 hours.

The Company is hosting a press event at its clinic in East London at 11am today details of which can be found at: https://hvivo.com/news-media/companynews/.

Cathal Friel, Executive Chairman of Open Orphan, said: “hVIVO is a world class company with best in class scientists and facilities. We are very excited to be offering this service and I am confident our work will help large companies and clinics in the UK test their staff and patients to ensure the safety of all employees. I look forward to updating everyone on our progress in due course.”

Franz Walt, Chief Executive Officer, Quotient, said: “Antibody testing is crucial for guidance on immunity, development of vaccinations and potential revaccinations, as well as helping to answer outstanding epidemiological questions about the spread of the virus. We are incredibly proud to be collaborating with hVIVO and Open Orphan in this project and can assure them that we will provide top of the line services alongside our excellent products.”

 

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 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Open Orphan #ORPH – Results of Fundraising

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, announces that, further to its announcement at 7.00 a.m. today (the “Fundraising Announcement”), it has successfully completed the oversubscribed Fundraising which is now closed.

The Fundraising has raised approximately £12 million (net of expenses) through the placing of 109,549,098 new Ordinary Shares, an offer for subscription conducted by PrimaryBid Limited of 4,545,454  new Ordinary Shares and subscription of 727,272 new Ordinary Shares, all at an Issue Price of 11 pence per share.

The net proceeds of the Fundraising will be used to

  • Maximise available Covid-19 opportunities including accelerating the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon Group’s inbound demand from Covid-19 vaccine developers globally. These challenge study models have the ability to speed up the development of a vaccine by 2-3 years;
  • Ramp up Covid-19 antiviral testing to the Group’s current capacity for 3,000 tests per day;
  • Expand existing laboratory testing services to 3rd party pharmaceutical and biotech companies in line with our strategy of becoming a leading services provider to the growing viral, and respiratory   diseases sector of the pharmaceutical industry; and
  • Strengthen the balance sheet to enable the Group to take advantage of the significant and growing opportunities the Board believes are available.

First Admission and Total Voting Rights

The Firm Fundraise of 44,496,864 new Ordinary Shares is conditional on First Admission, and is being carried out within the Company’s existing share authority to issue Ordinary Shares for cash.

It is expected that the Firm Fundraising Shares will be admitted to trading on AIM and Euronext Growth at 8.00 a.m. on or around 29 May 2020 (or such later date as may be agreed between the Company and Arden, but no later than 30 June 2020).

Following the First Admission of the Firm Fundraising Shares, the total number of Ordinary Shares in the Company in issue will be 593,535,138. 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 FCA’s Disclosure and Transparency Rules.

Second Admission and Total Voting Rights

The Second Admission of 70,324,960 new Ordinary Shares is conditional upon (amongst other things) the Placing Agreement not having been terminated, First Admission occurring, the passing of the Resolutions at the General Meeting and Second Admission occurring on or before 8.00 a.m. on 12 June 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Conditional Fundraise).

It is expected that the Conditional Fundraising Shares will be admitted to trading on AIM and Euronext Growth at 8.00 a.m. on or around 12 June 2020 (or such later date as may be agreed between the Company and Arden, but no later than 30 June February 2020).

Following the Second Admission of the Conditional Fundraising Shares, the total number of Ordinary Shares in the Company in issue will be 663,860,098. 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 FCA’s Disclosure and Transparency Rules.

Cathal Friel, Executive Chairman of Open Orphan, said:

“Open Orphan is now a fast growing, and soon to be profitable, specialist CRO pharmaceutical services business with a market leading position in the rapidly expanding market of testing vaccines and antivirals. We are delighted by the heavily oversubscribed fundraise which has brought many new leading blue-chip institutional shareholders to our share register.

As a result of Covid-19, we are seeing unprecedented growth opportunities as pharma, biotech and governments around the world focus funding on finding solutions to Covid-19 and other respiratory diseases. As such, we’re developing several new revenue streams including by speeding up the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon the Company’s inbound demand from Covid-19 vaccine developers globally. We have also opened up our laboratory services offering to third party pharma and biotech companies, as in the case of the recently announced Nearmedic contract, and from our state-of-the-art viral laboratory have launched a transformational Covid-19 antibody testing service which, unlike the home and online testing kits, offers 100% accuracy and the potential to complete up to 3,000 tests per day on a single machine. We believe that the Company has the pipeline to potentially sign up to six Covid-19 related challenge study contracts in 2020 with a further six potential contracts in 2021.

It is an exciting time at Open Orphan, and we are looking to capitalise on the opportunity to deliver rapid growth in the near term by converting some of our c. £160m pipeline of revenue opportunities.”

Capitalised terms in this Announcement shall have the meanings given to such terms in the Group’s announcement at 7.00 a.m. today.

For further information please contact

Open Orphan plc 

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 / Dan Gee-Summons (Corporate Finance)

Fraser Marshall / Simon Johnson (Equity Sales)

finnCap plc (Joint Broker)                                                                                                                          +44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Charlie Beeson (Corporate Finance)

Richard Chambers (ECM)

Davy (Euronext Growth Adviser and Joint Broker)                                                              +353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)                                                                                                              +44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

Open Orphan #ORPH – Proposed Fundraising to raise up to £12 million and PrimaryBid.com Offer

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, today announces its intention to raise up to £12 million (net of expenses) (the “Fundraising”) via a placing of new Ordinary Shares (“Placing Shares”) to institutional and other investors (the “Placing”), subscription of new Ordinary Shares (“Subscription Shares”) to certain investors and an offer subscription for new Ordinary Shares by PrimaryBid (“PrimaryBid Shares”) all at a price of 11 pence per new Ordinary Share (the “Issue Price”).

Fundraising Highlights:

  • The Group intends to conduct a Fundraising to raise up to £12 million (net of expenses) via the Placing of the Placing Shares, Subscription of the Subscription Shares and an offer for subscription of the PrimaryBid Shares all at the Issue Price.
  • The Placing is to be conducted by way of an accelerated bookbuild process which will commence immediately following this Announcement and will be subject to the terms and conditions set out in Appendix I to this Announcement.
  • The Company has conditionally raised approximately £80,000 (before expenses) through the Subscription of 727,272  Subscription Shares.
  • The Group also intends to launch an offer for subscription to be conducted by PrimaryBid on behalf of the   Company  (the “PrimaryBid Offer”) on a “first come, first served” basis.
  • The net proceeds of the Fundraising will be used to
    • Maximise available Covid-19 opportunities including accelerating the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon Group’s inbound demand from Covid-19 vaccine developers globally. These challenge study models have the ability to speed up the development of a vaccine by 2-3 years;
    • Ramp up Covid-19 antiviral testing to the Group’s current capacity for 3,000 tests per day;
    • Expand existing laboratory testing services to 3rd party pharmaceutical and biotech companies in line with our strategy of becoming a leading services provider to the growing viral, and respiratory diseases sector of the pharmaceutical industry; and
    • Strengthen the balance sheet to enable the Group to take advantage of the significant and growing opportunities the Board believes are available.
  • The Issue Price represents a premium of 3.8 per cent. to the closing price of 10.6 pence per Ordinary Share on 7 May 2020 being the date immediately before the announcement of the Quotient partnership on 11 May 2020. It represents a discount of approximately 26.4 per cent. to the closing middle market price of 14.95 pence per Ordinary Share on 21 May 2020, being the latest practicable date prior to the publication of this Announcement.

The Fundraising

The Fundraising comprises a proposed placing, an offer for subscription through PrimaryBid and subscription of new Ordinary Shares to be effected in two tranches. The first tranche of up to 44,824,000 new Ordinary Shares (the “Firm Fundraising Shares”) will utilise the Company’s existing shareholder authorities to issue the Firm Placing Shares and the Firm PrimaryBid Shares on a non-pre-emptive basis for cash (the “Firm Fundraising”). The second tranche of approximately 70,000,000 new Ordinary Shares (the “Conditional Fundraising Shares”) will be conditional (amongst other things) on the passing of resolutions to grant authority to the Directors to allot the Conditional Placing Shares, Conditional PrimaryBid Shares and Subscription Shares for cash and to disapply statutory pre-emption rights at a General Meeting. 

The Placing is subject to the satisfaction of certain conditions set out in this announcement and the appendices hereto (the “Appendices”) (together, this “Announcement”) and is being conducted by way of an accelerated bookbuild, which will be launched immediately following the publication of this Announcement. Arden Partners plc (“Arden”) and finnCap Ltd (“finnCap” and, together with Arden, the “Joint Brokers”) are acting as Joint Brokers in connection with the Placing and Arden as nominated adviser.

The Company intends to publish and send a circular (the “Circular”) to shareholders convening the General Meeting in connection with the issue of the Conditional Fundraising Shares on or around 26 May 2020. The Circular will also be available on the Company’s website: www.OpenOrphan.com .

An updated corporate presentation will be made available on the Company’s website.

A further announcement will be made following the close of the Bookbuild, confirming final details of the Placing.

For further information please contact

Open Orphan plc                                                                                                

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 / Dan Gee-Summons (Corporate Finance)

Fraser Marshall / Simon Johnson (Equity Sales)

finnCap plc (Joint Broker)                                                                                                   +44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Charlie Beeson (Corporate Finance)

Richard Chambers (ECM)

Davy (Euronext Growth Adviser and Joint Broker)                                                       +353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)                                                                                                        +44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

 

Additional information

 

Expected timetable of principal events

2020

Announcement of the Fundraising

22 May

Announcement of the results of the Fundraising

22 May

Circular and Form of Proxy posted to Shareholders

26 May

First Admission of the Firm Fundraising Shares to trading on AIM and Euronext Growth and commencement of dealings

8.00 a.m. on 29 May

Expected date for CREST accounts to be credited in respect of Firm Fundraising Shares in uncertified form

29 May

Where applicable, expected date for despatch of definitive share certificated for Firm Fundraising Shares in certified form

within 14 days

Latest time and date for receipt of Forms of Proxy

11.00 a.m. on 9 June

General Meeting 

11.00 a.m. on 11 June

Second Admission and dealings in the Conditional Fundraising Shares

8.00 a.m. on 12 June

Expected date for CREST accounts to be credited in respect of Conditional Fundraising Shares in uncertified form

12 June

Where applicable, expected date for despatch of definitive share certificated for Conditional Fundraising Shares in certified form

within 14 days

 

Information on Open Orphan

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the provision of viral laboratory services and the testing of vaccine and antivirus using human challenge study models. Open Orphan comprises of two commercial specialist CRO services businesses; hVIVO and Venn Life Sciences, and Open Orphan Genomic Health Data.

hVIVO is the world leader in testing the efficacy of vaccines, antivirals and respiratory disease agents using human challenge study models. hVIVO has the world leading portfolio of challenge study such models including flu, RSV, asthma, HRV, COPD and cough which have a replacement cost in excess of £25million. These studies are run from the Group’s 24-bedroom quarantine clinic in London, which can be made into three zones to run three different vaccine company’s challenge studies at the same time. hVIVO also has a state of the art viral laboratory that is utilised in connection with its challenge studies and on contract with third parties, including for anti-body testing.

Venn Life Sciences is an integrated drug development business which offers phase I & II clinical trials design and execution, post-trial data management, statistics, trial randomisation and regulatory expertise.

Background to and Reasons for the Fundraising

On 31 January 2020, the World Health Organisation declared a global pandemic due to the Covid-19 virus that has spread across the globe, causing different governments and countries to enforce restrictions on people movements, a stop to international travel, and other precautionary measures. This has had a widespread impact economically and a number of industries have been heavily impacted. As well as the challenges faced by other industries this has presented Open Orphan with some unique opportunities as a specialist provider to pharmaceutical companies.

There is now a global urgency to quickly and effectively develop and subsequently demonstrate effective Covid-19 vaccines, in May 2020 the World Health Organisation backed Covid-19 human challenge studies to speed up Covid-19 vaccine approvals. On 9 March 2020 the Group announced that it had commenced the development of a commercial human coronavirus challenge study model, also known as a Controlled Human Infection Model (CHIM) utilising seasonal coronavirus strains such as OC43 and 229E which are from the same family of viruses as the Covid-19 virus. Following this announcement, the Group has continued development of its Covid-19 challenge study and has opened discussions with 12 of the leading Covid-19 vaccine developers around the world. hVIVO is also now developing an attenuated Covid-19 virus challenge study model. The Group has decided to self-fund the investment to develop both of these models to ensure that it retains ownership and control of the resulting challenge model. In addition to the testing of potential vaccines and antivirals, it is expected that the challenge study models will facilitate a greater understanding of the type and durability of the immune response coronavirus infections elicit. The Board believes that, based on current discussions, the Group has as potential pipeline of up to six Covid-19 related challenge study contracts in 2020 with a further potential six contracts in 2021.

Challenge Studies

Challenge studies involve, in a controlled setting, using small numbers of volunteers removed from community exposure to other infections, the inoculation of volunteers with known doses of the challenge virus and the monitoring of the disease time course. All subjects are inoculated with virus but with some receiving a placebo and others the experimental drug to test the efficacy of the drug and obtain proof of concept data much quicker than can be achieved in the field. Challenge studies can be carried out for novel therapeutics, including vaccines, immunomodulators and antivirals, as well as new diagnostics. Challenge study models can potentially speed up vaccine development and approval by 2-3 years by testing the efficacy on human volunteers over a short period of time in a quarantine clinic.

By splitting the hVIVO 24 bed quarantine clinic into 3 zones the Group is able to run up to 3 different vaccine challenge studies concurrently. The Group typically expects a complete challenge study trial to deliver project revenues of approximately £7 million with the revenue dependent in part on the size of the trial and the number of volunteers.

Open Orphan plans to have a growing, clinical trial challenge study business and also a testing capability. The challenge study business will provide third-party laboratory services whilst also providing actual testing capability of human population groups.

The fundraising will allow the Group to provide virology and laboratory testing services to third parties, such as its recent contract with Nearmedic International Ltd. This provision of third-party laboratory services is a growth area for the Group as numerous biotechnology companies across Europe do not have their own virology laboratory. This revenue stream is in line with our strategy of becoming a leading pharma services provider to the viral, and respiratory diseases sector of the pharmaceutical industry.

Use of Proceeds

It is as a result of the recent expansion of the Group’s pipeline and other recent commercial developments that the Group is looking to raise up to £12 million net of expenses. The proceeds of the Fundraising will be used to:

a.     Maximise available Covid-19 opportunities including accelerating the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon Group’s inbound demand from Covid-19 vaccine developers globally. These challenge study models have the ability to speed up the development of a vaccine by 2-3 years;

b.     Ramp up Covid-19 antiviral testing to the Group’s current capacity for 3,000 tests per day;

c.     Expand existing laboratory testing services to 3rd party pharmaceutical and biotech companies in line with our strategy of becoming a leading services provider to the growing viral, and respiratory diseases sector of the pharmaceutical industry; and

d.     Strengthen the balance sheet to enable the Group to take advantage of the significant and growing opportunities the Board believes are available.

Current trading and prospects

All results provided are preliminary and subject to completion of the 2019 audit. The audit is substantially complete and Open Orphan’s audited accounts for the year ended 31 December 2019 are expected to be published in late June 2020.

The Company confirms that on a proforma basis including the full year of Open Orphan and hVIVO, the Group generated revenue of €27.1 million for the year ended 31 December 2019, gross profit of €4.2 million and a normalized LBITDA of €10.1 million adjusting for depreciation, amortization, one-time and non-recurring expenses / charges.

The Group’s cash and cash equivalents at 30 April 2020 was €2.6 million and debt at 30 April 2020 was €1.6 million which related to loans arranged previously by Raglan Capital.

Since the merger of Open Orphan and hVIVO, the group has successfully integrated hVIVO and Venn Life Sciences, has reduced the Group’s cost base by an annualised 5.0 million (in an addition to the €3.8 million of savings realised in 2019). Further annualised cost savings of €2.5m are expected to be implemented by year end. We have also expanded hVIVO’s laboratory services and converted the hVIVO pipeline of contracts, including:

–       a new contract with a European Biotech Company for the provision of a RSV human challenge study projected to deliver £3.2m in revenue all of which is expected to be recognised in 2020. If successful, it is anticipated that an additional follow-on larger pivotal challenge study will commence end Q4 2020, delivering significant further revenue and expected to be a minimum of £7m; and

–       a contract with a US Biotech company for the provision of an RSV human challenge study projected to deliver £3.5 million in revenue all of which is expected to be recognised in 2020.

The Group’s pipeline of potential new contracts is now in excess of £160 million and includes c.£110 million of near-term contracts within hVIVO and Venn Life Sciences along with new opportunities arising post Covid-19. This includes the delivery of Covid-19 related challenge studies, third party testing and laboratory services, and the roll out of Covid-19 antibody testing utilising the Quotient Limited system. The MosaiQ Covid-19 Antibody Microarray machine is expected to have capability to undertake up to 3,000 tests a day once fully operational, in line with expected performance as stated by Quotient Limited. The MosaiQ COVID-19 Antibody Microarray machine has demonstrated a 100% sensitivity to detect Covid-19 antibodies and a 99.8% ability to rule out the presence of Covid-19 antibodies. The Group’s plan is to develop this pipeline with channel partners to secure testing volumes.

The Directors believe that the increased investment in testing capability will result in companies, such as Open Orphan, benefitting as a provider of testing services.

The Directors believe that the recent conversion of the Group’s pipeline coupled with additional annualised savings of 2.5 million referred to above, and strong pipeline of work for the second half of 2020 should allow the Company to achieve its goal of being operationally profitable by Q3 2020.

The Subscription

Under the Subscription, the Company has conditionally raised approximately £80,000 (before expenses) by way of the subscription at the Issue Price of 727,272 new Ordinary Shares. 

The Subscription is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated, the passing of the Resolutions at the General Meeting and Second Admission occurring on or before 8.00 a.m. on 12 June 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Conditional Fundraise).

PrimaryBid Offer

PrimaryBid intends to conduct an offer for subscription for PrimaryBid Shares on behalf of the Company on the terms set out in a separate announcement to be made by the Company immediately after this announcement.

The Firm PrimaryBid Offer is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated and First Admission occurring on or before 8.00 a.m. on 29 May 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Firm Placing).

The Conditional PrimaryBid Offer is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated, the passing of the Resolutions at the General Meeting and Second Admission occurring on or before 8.00 a.m. on 12 June 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Conditional Fundraise).

The Placing and Subscription Agreement

Pursuant to the Placing and Subscription Agreement, the Joint Brokers, as agents for the Group, have conditionally agreed to use reasonable endeavours to procure subscribers at the Issue Price for the Placing Shares.

The Joint Brokers intend to conditionally place the Placing Shares with certain institutional and other investors at the Issue Price. The Firm Placing is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated and First Admission occurring on or before 8.00 a.m. on 29 May 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Firm Placing).

The Conditional Placing is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated, the passing of the Resolutions at the General Meeting and Second Admission occurring on or before 8.00 a.m. on 12 June 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Conditional Placing).

The Placing and Subscription Agreement contains customary warranties from the Company in favour of the Joint Brokers in relation to, inter alia, the accuracy of the information in this Announcement and other matters relating to the Group and its business. In addition, the Company has agreed to indemnify the Joint Brokers in relation to certain liabilities that they may incur in respect of the Placing, Subscription and PrimaryBid Offer.

The Joint Brokers (together acting in good faith) have the right to terminate the Placing and Subscription Agreement in certain circumstances prior to Second Admission, including (but not limited to): in the event that any of the warranties in the Placing and Subscription Agreement were untrue or inaccurate in any material respect, or were misleading in any respect when given or in the event of a material adverse change affecting the business, financial trading position or prospects of the Company. The Brokers shall also have a further right to terminate the Placing and Subscription Agreement, following consultation with the Company to the extent practicable, if, at any time before Second Admission there occurs any change, or development involving a prospective change, in national or international, military, diplomatic, monetary, economic, political, financial, industrial or market conditions or exchange rates or exchange controls, or any incident of terrorism or outbreak or escalation of hostilities or any declaration by the UK, the US or in any member or associate member of the European Union or elsewhere of a national emergency or war or pandemic, epidemic or any other calamity or crisis (including a significant worsening of the Covid-19 crisis in the United Kingdom) (amongst other things).

The Placing and Subscription Agreement also provides for the Company to pay all agreed costs, charges and expenses of, or incidental to, the Placing and Admission including all legal and other professional fees and expenses up to the specified amounts stipulated in the Placing and Subscription Agreement.

Fundraising Shares

The Fundraising Shares, when issued, will be fully paid and will rank pari passu in all respects with the existing Ordinary Shares in issue, including the right to receive all dividends and other distributions declared, made or paid after the date of issue.

Applications will be made to the London Stock Exchange for admission of the Firm Fundraising Shares and the Conditional Fundraising Shares to trading on AIM.

Application will be made to Euronext Dublin for admission of the Firm Fundraising Shares and the Conditional Fundraising Shares to trading on Euronext Growth.

It is expected that First Admission of the Firm Fundraising Shares (“First Admission”) will take place on or before 8.00 a.m. on 29 May 2020 and that dealings in the Firm Fundraising Shares on AIM will commence at the same time. It is expected that Second Admission of the Conditional Fundraising Shares (“Second Admission” and, together with First Admission “Admission”, as the context may require) will take place on or before 8.00 a.m. on 12 June 2020 and that dealings in the Conditional Fundraising Shares on AIM will commence at the same time.

General Meeting

The General Meeting will be held at 11.00 a.m. on 11 June 2020, at which the Resolutions will be proposed for the purposes of implementing the Second Admission as follows:

Resolution 1 – an ordinary resolution to grant the Directors authority to allot shares in the Company and to grant right to subscribe for, or convert or exchange any security into shares in the Company.

Resolution 2 – a special resolution to disapply statutory pre-emption rights otherwise applicable to the Company in respect of resolution one.

IMPORTANT INFORMATION

This Announcement has been issued by, and is the sole responsibility, of the Group. No representation or warranty express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the Joint Brokers or by any of their respective affiliates or agents as to or in relation to, the accuracy or completeness of this Announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed.

NOTICE TO OVERSEAS PERSONS

This Announcement does not constitute, or form part of, a prospectus relating to the Group, nor does it constitute or contain any invitation or offer to any person, or any public offer, to subscribe for, purchase or otherwise acquire any shares in the Group or advise persons to do so in any jurisdiction, nor shall it, or any part of it form the basis of or be relied on in connection with any contract or as an inducement to enter into any contract or commitment with the Group. In particular, the Fundraising Shares have not been, and will not be, registered under the United States Securities Act of 1933 as amended or qualified for sale under the laws of any state of the United States or under the applicable laws of any of Canada, Australia, New Zealand, the Republic of South Africa or Japan and, subject to certain exceptions, may not be offered or sold in the United States or to, or for the account or benefit of, US persons (as such term is defined in Regulation S under the Securities Act) or to any national, resident or citizen of Canada, Australia, New Zealand, the Republic of South Africa or Japan.

The distribution or transmission of this Announcement and the offering of the Fundraising Shares in certain jurisdictions other than the UK may be restricted or prohibited by law or regulation. Persons distributing this Announcement must satisfy themselves that it is lawful to do so. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction. No action has been taken by the Group that would permit an offering of such shares or possession or distribution of this Announcement or any other offering or publicity material relating to such shares in any jurisdiction where action for that purpose is required. Persons into whose possession this Announcement comes are required by the Group to inform themselves about, and to observe, such restrictions. In particular, this announcement may not be distributed, directly or indirectly, in or into the United States, Canada, Australia, New Zealand, the Republic of South Africa or Japan. Overseas Shareholders and any person (including, without limitation, nominees and trustees), who have a contractual or other legal obligation to forward this Announcement to a jurisdiction outside the UK should seek appropriate advice before taking any action.

FORWARD-LOOKING STATEMENTS

This Announcement includes statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “plans”, “projects”, “anticipates”, “expects”, “intends”, “may”, “will”, or “should” or, in each case, their negative or other variations or comparable terminology. These forward-looking statements include matters that are not historical facts. They appear in a number of places throughout this Announcement and include statements regarding the Directors’ current intentions, beliefs or expectations concerning, among other things, the Group’s results of operations, financial condition, liquidity, prospects, growth, strategies and the Group’s markets.

By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Actual results and developments could differ materially from those expressed or implied by the forward-looking statements.

Forward-looking statements may and often do differ materially from actual results and are not guarantees of future performance. Any forward-looking statements in this Announcement are based on certain factors and assumptions, including the Directors’ current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group’s operations, results of operations, growth strategy and liquidity. Whilst the Directors consider these assumptions to be reasonable based upon information currently available, they may prove to be incorrect. Save as required by law or by the AIM Rules or the Euronext Growth Rules, none of the Group, Arden, finnCap, Davy nor their respective directors undertakes any obligation to publicly release the results of any revisions to any forward-looking statements in this Announcement that may occur due to any change in the Directors’ expectations or to reflect events or circumstances after the date of this Announcement.

GENERAL

Arden, which is authorised and regulated by the FCA in the United Kingdom, is acting as Nomad and Joint Broker to the Group in connection with the Fundraising. Arden will not be responsible to any person other than the Group for providing the protections afforded to clients of Arden or for providing advice to any other person in connection with the Fundraising. Arden is not making any representation or warranty, express or implied, as to the contents of this Announcement. Arden has not authorised the contents of, or any part of, this Announcement, and no liability whatsoever is accepted by Arden for the accuracy of any information or opinions contained in this Announcement or for the omission of any material information.

finnCap, which is authorised and regulated by the FCA in the United Kingdom, is acting as Joint Broker to the Group in connection with the Fundraising. finnCap will not be responsible to any person other than the Group for providing the protections afforded to clients of finnCap or for providing advice to any other person in connection with the Fundraising. finnCap is not making any representation or warranty, express or implied, as to the contents of this Announcement. finnCap has not authorised the contents of, or any part of, this Announcement, and no liability whatsoever is accepted by finnCap for the accuracy of any information or opinions contained in this Announcement or for the omission of any material information.

The Fundraising Shares will not be admitted to trading on any stock exchange other than AIM and Euronext Growth.

Nothing in this Announcement shall be effective to limit or exclude any liability for fraud or which otherwise, by law or regulation, cannot be so limited or excluded.

Neither the content of the Group’s website (or any other website) nor the content of any website accessible from hyperlinks on the Group’s website (or any other website) is incorporated into, or forms part of, this Announcement.

INTERPRETATION

Certain terms used in this Announcement are defined under the heading “Definitions” in Appendix II of this Announcement.

All times referred to in this Announcement are, unless otherwise stated, references to London time.

All references to legislation in this Announcement are to the legislation of England and Wales unless the contrary is indicated. Any reference to any provision of any legislation or regulation shall include any amendment, modification, re-enactment or extension thereof.

Words importing the singular shall include the plural and vice versa, and words importing the masculine gender shall include the feminine or neutral gender and vice versa.

Link here to view the full  Prospectus

 

Open Orphan Plc (LON: ORPH) is also pleased to announce a conditional offer for subscription via PrimaryBid(the “PrimaryBidOffer”) of new ordinary shares (“New Ordinary Shares”) at an issue price of 11 pence per New Ordinary Share (the “Issue Price”), a premium of 3.8 per cent. to the closing price of 10.6 pence per Ordinary Share on 7 May 2020 being the date immediately before the announcement of the Quotient partnership on 11 May 2020. It represents a discount of approximately 26.4 per cent. to the closing middle market price of 14.95 pence per Ordinary Share on 21 May 2020, being the latest practicable date prior to the publication of this Announcement. The Company is also conducting a placing of new Ordinary Shares to institutional and other investors at the Issue Price by way of an accelerated bookbuild process by Arden Partners plc (“Arden”) and finnCap Ltd (“finnCap” together with Arden, the “Joint Brokers”) (the “Placing”), and a subscription (the “Subscription”), as announced on 22 May 2020. The Placing, Subscription and PrimaryBid Offerare expected to raise up to £12 million (net of expenses).

  • The net proceeds of the Fundraising will be used to
  • Maximise available Covid-19 opportunities including accelerating the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon Group’s inbound demand from Covid-19 vaccine developers globally. These challenge study models have the ability to speed up the development of a vaccine by 2-3 years;
  • Ramp up Covid-19 antiviral testing to the Group’s current capacity for 3,000 tests per day;
  • Expand existing laboratory testing services to 3rd party pharmaceutical and biotech companies in line with our strategy of becoming a leading services provider to the growing viral, and respiratory diseases sector of the pharmaceutical industry; and
  • Strengthen the balance sheet to enable the Group to take advantage of the significant and  growing  opportunities the Board believes are available.

PrimaryBid Offer

The Company values its retail investor base and is therefore pleased to provide private and other investors the opportunity to participate in the PrimaryBid Offer by applying exclusively through the www.PrimaryBid.com platform and the PrimaryBid mobile app available on the Apple App Store and Google Play. PrimaryBid does not charge investors any commission for this service.

The PrimaryBid Offer will comprise of two tranches. The first tranche will comprise of new Ordinary Shares (the “Firm PrimaryBid Shares”), which will be issued pursuant to the Company’s existing share authorities, which were granted to the directors at the general meeting of the Company held on 6 January 2020. The second tranche will comprise new Ordinary Shares (the “Conditional PrimaryBid Shares”) and together with the Firm PrimaryBid Shares, the “PrimaryBid Shares”. which will be issued pursuant to and conditional upon the granting of new share authorities at the General Meeting to be held on 11 June 2020.

The PrimaryBid Offer, the Placing  and the Subscription are conditional on the new Ordinary Shares to be issued pursuant to the PrimaryBid Offer, the Placing and the Subscription being admitted to trading on AIM (operated by the London Stock Exchange) (“Admission”). Admission of the Firm PrimaryBid Shares is expected to be take place at 8.00 a.m. on 29 May 2020. Admission of the Conditional PrimaryBid Shares is expected to be take place at 8.00 a.m. on 12 June 2020, subject to the passing of granting of new share authorities at the General Meeting to be held on 11 June 2020. The PrimaryBid Offer will not be completed without the Placing also being completed. The PrimaryBid Offer, via the PrimaryBid.com platform, will be open to individual and institutional investors from 7.00 a.m. on 22 May 2020 and will close at the same time as the bookbuilding process is completed. The PrimaryBid Offer may however close early.

Subscriptions under the PrimaryBid Offer will be considered by the Company on a “first come, first served” basis, subject to conditions, which are available to view on PrimaryBid.com.

The Company in consultation with PrimaryBid reserves the right to scale back any order at its discretion. The Company and PrimaryBid reserve the right to reject any application for subscription under the Offer without giving any reason for such rejection.

No commission is charged to investors on applications to participate in the PrimaryBid Offer made through PrimaryBid.  It is vital to note that once an application for New Ordinary Shares has been made and accepted via PrimaryBid, an application cannot be withdrawn.

For further information on PrimaryBid.com or the procedure for applications under the PrimaryBid Offer, visit www.PrimaryBid.com or call PrimaryBid.com on +44 20 3026 4750. 

The new Ordinary Shares will be issued free of all liens, charges and encumbrances and will, when issued and fully paid, rank pari passu in all respects with the Company’s existing Ordinary Shares.

Open Orphan Plc

Cathal Friel, Executive Chairman

 

 

+353 (0)1 644 0007

PrimaryBid Limited

Kieran D’Silva / James Deal

 

+ 44 (0) 203 026 4750

Arden Partners plc (Nominated Adviser and Joint Broker)

John Llewellyn-Lloyd / Benjamin Cryer (Corporate Finance)

Fraser Marshall / Simon Johnson (Equity Sales)

 

+44 (0)20 7614 5900

finnCap plc (Joint Broker)

Geoff Nash /James Thompson/Richard Chambers

 

 +44 (0)20 7220 0500

Davy (Euronext Growth Adviser and Joint Broker)

Anthony Farrell

 

 +353 (0)1 6796363

Camarco (Financial PR)

Tom Huddart / Daniel Sherwen

+44 (0)20 3757 4980

Details of the Offer

The Company highly values its retail investor base which has supported the Company alongside institutional investors. Given the longstanding support of retail shareholders, the Company believes that it is appropriate to provide retail and other interested investors the opportunity to participate in the Offer. The Company is therefore making the Offer available exclusively through PrimaryBid.com.

The Offer is offered under the exemptions against the need for a prospectus allowed under the Prospectus Rules. As such, there is no need for publication of a prospectus pursuant to the Prospectus Rules, or for approval of the same by the Financial Conduct Authority in its capacity as the UK Listing Authority. The Offer is not being made into any Restricted Jurisdiction or any other jurisdiction where it would be unlawful to do so.

There is a minimum subscription of £100 per investor under the terms of the Offer which is open to existing shareholders and other investors subscribing via PrimaryBid.com. This allocation will be filled on a “first come first served” basis.

For further details please refer to the PrimaryBid.com website at www.PrimaryBid.com. The terms and conditions on which the Offer is made, including the procedure for application and payment for New Ordinary Shares, is available to all persons who register with PrimaryBid.com.

Investors should make their own investigations into the merits of an investment in the Company. Nothing in this announcement amounts to a recommendation to invest in the Company or amounts to investment, taxation or legal advice.

It should be noted that a subscription for New Ordinary Shares and investment in the Company carries a number of risks. Investors should consider the risk factors set out on PrimaryBid.com before making a decision to subscribe for New Ordinary Shares. Investors should take independent advice from a person experienced in advising on investment in securities such as the New Ordinary Shares if they are in any doubt. d, sold, or acquired, directly or indirectly, within those jurisdictions;

Open Orphan #ORPH – Update on antibody test agreement and recent share price movement

Open Orphan plc (ORPH) the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, notes the increase in the Company’s share price and media comment regarding its collaboration with Quotient Limited. Furthermore, it also notes the substantial increase in interest in antibody testing for Covid-19 following recent announcements by the UK Government.

The Company confirms that the MosaiQ COVID-19 Antibody Microarray machine is on site at hVivo’s laboratory in East London and is undergoing testing. It is expected to be fully operational within two weeks following which it will have capability to undertake up to 3,000 tests a day, in line with expected performance as stated by Quotient Limited. The Company intends to enter into discussions with channel partners to secure testing volumes with pricing to be determined as part of these negotiations. It is not the company’s intention to deal directly with consumers and while there can be no certainty on pricing until such time as terms are agreed, the Company notes current market prices ranging from c.£70 for home testing kits and upwards towards c.£150. It is the intention to supply testing capability to channel partners, who will in turn deal with the end users and the final price points. The Company will update shareholders in due course.

Further information on the Company’s approach to Covid-19 antibody testing and vaccine trials is available on the Company’s website

 

ENDS

For further information please contact

Open Orphan plc

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

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

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Notes to Editors:

Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of Covid-19 in 2020. The Company also 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 Coronavirus challenge study model and expects to be very active with many companies in the development of a Covid-19 vaccine. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. 

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. 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, as an integrated drug development consultancy, 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.

Open Orphan #ORPH – Quotient Limited & hVIVO Partnership to Support Wide-Spread COVID-19 Antibody Testing in the UK

Open Orphan plc (ORPH) the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, is pleased to announce that Quotient has entered into an exclusive contract with hVIVO to support COVID-19 antibody testing in the UK.

The MosaiQ™ by Quotient system and MosaiQ COVID-19 Antibody Microarray will be used by hVIVO to screen for SARS-CoV-2 antibodies (COVID-19). The MosaiQ COVID-19 Antibody Microarray was CE marked (certified to meet EU requirements) as of 01 May 2020 based on testing that demonstrated 100% sensitivity (ability to detect COVID-19 antibodies) and 99.8% specificity (ability to rule out the presence of COVID-19 antibodies). The test is designed as a serological disease screen specific to COVID-19. It detects the IgG and IgM antibodies that humans develop when infected by SARS-CoV-2.

Quotient is a Nasdaq listed, commercial-stage diagnostics company delivering diagnostic solutions. MosaiQ is Quotient’s proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities.

Cathal Friel, Executive Chairman of Open Orphan, said:

“We are delighted to exclusively partner with Quotient Limited to bring fast and accurate COVID-19 antibody testing to the UK. Open Orphan plc, via our subsidiary hVIVO, has industry leading scientific and laboratory capability and the MosaiQ™ system’s best in class COVID-19 antibody testing performance makes the system a natural addition to our state-of-the-art virology laboratory in London. There is a clear demand for COVID-19 antibody testing and we will be making testing available both as a standalone offering and will also utilize the testing capability to screen volunteers for our industry leading range of human challenge studies to ensure no disruption to our clients.”

Franz Walt, Chief Executive Officer of Quotient, said:

“This collaboration marks a major milestone for our company, and we are proud to collaborate with an industry leader like hVIVO. Quotient has developed what we believe is a gold standard antibody microarray to help combat the COVID-19 pandemic. This collaboration is uniquely positioned to leverage our combined expertise, and helps address the large need for antibody testing in the U.K. and beyond.” said Franz Walt, Chief Executive Officer of Quotient.”

Separately, Open Orphan plc (AIM: ORPH) announces the appointment of finnCap Ltd as its joint broker with immediate effect.

ENDS

For further information please contact

Open Orphan plc

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

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

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of Covid-19 in 2020. The Company also 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 Coronavirus challenge study model and expects to be very active with many companies in the development of a Covid-19 vaccine. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. 

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. 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, as an integrated drug development consultancy, 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.

Notes to Editors – Quotient Limited:

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial-stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced. MosaiQ, Quotient’s proprietary multiplex microarray technology, offers the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ is designed to be a game-changing solution, which Quotient believes will increase efficiencies, improve clinical practice, deliver significant workflow improvements, and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins, Switzerland, Edinburgh, Scotland and Newtown, Pennsylvania.

The Quotient logo and MosaiQ™ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions.

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