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Open Orphan #ORPH – Upcoming Investor Events

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 delighted to be attending and presenting at a series of investor events from the 9th to 11th July 2020.

Cathal Friel, Open Orphan’s Chief Executive Officer, will be in attendance for all of the events and will be presenting to update existing and potential investors on the Company’s business plans for 2020-2021.

No new material information will be disclosed at any event.

A full schedule of the upcoming events is as follows:

Event

Date/Time

Location

Hardman & Co Investor Forum Webinar

July 9th 2020 / 15:00 – 16:30

Virtual Event, further information and registration here: Link

Proactive Investors One2One Investor Forum

July 9th 2020 / 18:00 – 20:00

Virtual Event, further information and registration here: Link

Mello Virtual – Investing in the New World

July 11th 2020 / 9:00 – 17:00

Virtual Event, further information and registration here: Link

 

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 – 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 #ORPH – Major New Contract Win for Venn Life Sciences

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 it has signed a major contract with a leading vaccine developer and one of the top pharmaceutical companies in the world.

The contract with Venn Life Sciences, which is part of Open Orphan, builds on earlier successful contracts between the companies and is to obtain and support market access of newly developed vaccines into the EU and US markets until the end of 2020.

The contact demonstrates Venn Life Sciences’ ability to service leading vaccine developers which in turn benefits hVIVO, also part of Open Orphan, as cross-selling opportunities arise. The contract demonstrates Venn Life Sciences’ unique combination of drug development expertise, clinical trial design and execution services.

This fits with Open Orphan’s strategic aim of becoming a leading pharma services provider globally with particular expertise across the Company in providing services to the rapidly growing vaccines industry.

Cathal Friel, Executive Chairman of Open Orphan, commented:

“We are delighted to have signed this contract with a leading vaccine developer and one of the top pharmaceutical companies in the world. This contract reinforces Open Orphan’s position as one of the leading service providers to the vaccine industry globally. As a result of the Covid-19 pandemic, the vaccine industry is now an increasingly important and rapidly growing sector with many large pharmaceutical companies now directing huge amounts of resources towards their vaccine divisions to progress both Covid-19 and non-Covid-19 vaccines. Open Orphan is ideally positioned to capitalise upon this trend as we build the Company into a growing, profitable pharmaceutical services business.”

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 niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. 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 Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.

Open Orphan comprises of two commercial specialist CRO services businesses (hVIVO and Venn) 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.

Alan Green talks markets, Open Orphan #ORPH, Versarien #VRS & San Leon Energy #SLE on UK Investor Magazine podcast

Alan Green talks markets, Open Orphan #ORPH, Versarien #VRS & San Leon Energy #SLE on the UK Investor Magazine podcast

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

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