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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

Atlantic View – Time To Go Back To The Beach In Spite of Covid-19?


by John Woolfitt, Atlantic Capital Markets

Time To Go Back To The Beach In Spite of Covid-19?

Fundamentals & Statement Summary

With over 20% share of online sales in the short haul beach holiday market, On The Beach (LON: OTB) are one of the UK’s largest online beach holiday retailers. The group’s long-term mission to become Europe’s leading online retailer of beach holidays is fuelled by significant opportunities for growth on the back of innovative technology, low-cost base and a strong customer-value proposition.

On Tuesday June 30th, OTB announced interim results for the 6 months to March 31st, and said that prior to the escalation of COVID-19 in Europe, it had been trading well. In the first four months of FY20 and following the collapse of the Thomas Cook Group, OTB priced its offerings competitively, and saw total holiday sales grew by 29% for Summer 2020 departures. H1 revenue of £21.4m was down 66% on prior year due to COVID-19 related cancellations, with adjusted PBT down £13.4m to £2.3m due to a significant reduction in demand from mid-February when COVID-19 began to spread to Europe. Net debt of £13m excludes £68.8m of customer monies held in a ring-fenced trust account, and following a successful share placing on 22 May 2020, the group cash position was £50.5m, plus a £75m RCF facility which, at 31 May 2020, remained undrawn.

CEO Simon Cooper commented on the excellent progress in the first four months of the financial year, with the Thomas Cook collapse “driving record levels of brand awareness and achieving sales growth of almost 30% for holidays departing in Summer 2020.“

He added “The onset of the COVID-19 pandemic led to a rapid slowdown in demand for foreign travel followed by the total closure of airspace across Europe by mid-March. Our staff responded brilliantly to ensure that the Group delivered the highest possible customer service standards in the most difficult of circumstances”….”The flexibility and asset light nature of our business model together with our recently strengthened balance sheet and the actions we have taken since the middle of March means we are well placed to capitalise on the inevitable structural changes in the market post COVID-19. As a result, the Board continues to look to the future with confidence.”

Chart and Technicals

Source: FactSet and Hargreaves Lansdown

The inevitable ‘Covid cliff fall’ that characterises the charts of many stocks at present started at the end of February 2020, with the group losing 66% of its value during the following 25 or so days. A strong recovery during March saw OTB shares regain the 50-day moving average, currently at 290p, which it has held onto since April 16th. Provided the stock continues to hold the 50-day moving average, there is every reason to expect OTB shares to regain the benchmark 200-day moving average (purple indicator), currently at 358p, by the end of July 2020.

Summary and Atlantic View
While some may view OTB as a contrarian trade, our dealing team are attracted to OTB’s resilient performance before and during the COVID-19 crisis. The group responded strongly and took full advantage of the Thomas Cook collapse, leading to 30% growth in summer holiday sales pre-Covid, largely due to its innovative business model and low cost base. Added to this OTB have a strong cash position, boosted by strong shareholder support for the May 2020 placing.  In summary, Atlantic Capital Markets are backing a long trade position on OTB, governed very much by the technical picture (358p initial target), and while the uncertain backdrop warrants running a tight stop loss, we are of the view that OTB is better placed than its peers to grow market share as the world starts to move again. In this case, it is time to go back to the beach!

To take advantage of this trading idea, speak to a member of our dealing team on 01872 229000 or visit the Atlantic Capital Markets website here

ECR Minerals #ECR – Unaudited Half-Yearly Results for the Six Months Ended 31 March 2020

ECR Minerals plc, the gold exploration and development company, is pleased to announce unaudited half-yearly financial results for the six months to 31 March 2020 for the Company as consolidated with its subsidiaries (the “Group”), along with a review of significant developments during the period and subsequently.

HIGHLIGHTS

  • Victoria, Australia continues to enjoy a gold exploration boom and interest from third parties in ECR’s projects in Victoria is strong, with several discussions taking place in respect of potential commercial transactions over our Bailieston and Creswick projects.
  • Announced results from exploration activities in Victoria included positive findings of an alteration study on RC drill cuttings from the Creswick project (March 2020), and confirmation of very high grade gold mineralisation at Creswick by the completion of ‘full bag’ testing (November 2019).
  • In January 2020, MGA, ECR’s 100% owned Australian subsidiary, received a research and development expenditure refund of A$555,212 (approximately £295,515) from the Australian government.
  • The Company completed the sale of its Argentine subsidiary Ochre Mining SA in February 2020 and retains an NSR royalty of up to 2% to a maximum of USD 2.7 million in respect of future production from the SLM gold project.
  • Post-period end, the Company sold licences comprising the Avoca, Moormbool and Timor gold exploration projects in Victoria, Australia to Fosterville South Exploration Ltd for total potential cash consideration of up to A$2.5 million announced in April 2020.
  • Post-period end, the Company’s cash position was strengthened by a £500,000 equity financing and the receipt of A$500,000 from Fosterville South Exploration Ltd in April 2020.
  • Group comprehensive expense of £1,846,202 for the six months ended 31 March 2020 (£480,368 for the six months ended 31 March 2019) and net assets of £2,206,211 at 31 March 2020 (£3,876,921 at 31 March 2019).
  • The Group Operating Loss for the six months ended 31 March 2020 reduced to £369,102, compared with £438,145 for the six months ended 31 March 2019.
  • Despite the effect of the COVID-19 pandemic on the global economy, the Directors’ believe ECR is in a robust financial position and continues to provide shareholders with exposure to an exciting range of gold projects.

FINANCIAL RESULTS
For the six months ended 31 March 2020 the unaudited financial statements of the Group record a total comprehensive expense of £1,846,202, including, a one off exceptional item of (£1,602,539) which pertains to the disposal of the Company’s Argentine subsidiary Ochre Mining SA. This amount cannot remain capitalised under applicable accounting standards, although this amount could be recovered from future royalty payments in relation to the SLM gold project in Argentina, which is owned by Ochre Mining SA, if they progress to production.

The Group’s net assets were £2,275,479 at 31 March 2020, compared with £3,876,921 at 31 March 2019. The reduction in net assets has occurred largely due to the disposal of Ochre Mining SA, as explained above.

The Group held £166,852 of cash and cash equivalents at 31 March 2020, compared with £622,457 at 31 March 2019. The current cash position of the Group today is £742,379.

In January 2020, Mercator Gold Australia Pty Ltd (“MGA”), ECR’s 100% owned Australian subsidiary, received a research and development (R&D) refund of A$555,212 (approximately £295,515) from the Australian government. This refund relates to qualifying expenditure incurred by MGA in the year ended 30 September 2019. The qualifying R&D activities pertain to research into turbidite-hosted gold deposits within MGA’s exploration licences in Victoria. Post the period end, the Group’s cash position benefited from a £500,000 equity financing completed by the Company and the receipt of AUD$500,000 from the sale of licences in April 2020.

The financial information included in the 31 March 2019 announcement have been restated due to a change in the accounting treatment of the R&D refunds received by MGA. As well as the refund noted above, a refund of A$318,971.73 (approximately £175,188) was received in May 2019. This was previously categorised as other income in the interims to 31 March 2019. The amount received has been offset against exploration assets following the restatement.

REVIEW OF PRINCIPAL DEVELOPMENTS DURING THE PERIOD AND SUBSEQUENTLY

Sale of Avoca, Moormbool and Timor gold exploration projects (the “Licences”) in Victoria, Australia to Fosterville South Exploration Ltd

In April 2020, ECR announced that Fosterville South Exploration Ltd, which listed on the TSX Venture Exchange that same month, had agreed to acquire MGA’s 100% ownership of the Licences by way of Currawong Resources Pty Ltd, a wholly owned subsidiary of Fosterville South, for total potential cash consideration of up to A$2.5 million, as follows:

  1. A$500,000 in cash, which was paid to MGA immediately;
  2. A further payment of A$1 for every ounce of gold or gold equivalent of measured resource, indicated resource or inferred resource estimated within the area of one or more of the Licences in any combination or aggregation of the foregoing, up to a maximum of A$1,000,000 in aggregate;
  3. A further payment of A$1 for every ounce of gold or gold equivalent produced from within the area of one or more of the Licences, up to a maximum of A$1,000,000 in aggregate.

ECR considered the Avoca, Moormbool and Timor licences to be high-potential but non-core to the Company, and the Company maintains exposure to upside from the projects as a result of future resource estimation or production, through a royalty arrangement as set out above.

Alteration Study – Creswick Gold Project
In February 2020, MGA commissioned Dr Dennis Arne to carry out an alteration study of cuttings (chips) generated by the RC drilling at the Creswick project in 2019. Dr Arne is a preeminent consulting geochemist in Victoria, whose experience includes previous and on-going reviews of geochemistry at the highly successful Fosterville gold mine in Central Victoria owned by Kirkland Lake Gold.

The results of the study were announced on 27 March 2020, and showed good indications of hydrothermal fluid flow related to gold mineralisation in a number of drill holes at Creswick. Importantly, the variation in the results, with some areas ‘lighting up’ and others not, is potentially useful for identifying gold-bearing shoots.

‘Full Bag’ Sampling – Creswick Gold Project
In February 2019 MGA completed a total of 1,687 metres of reverse circulation (RC) drilling in 17 holes at Creswick, targeting multiple quartz vein orientations within the Dimocks Main Shale (“DMS”). The drilling identified more extensive quartz than anticipated, in a zone exceeding 60 metres in width (more than twice the 25 metres expected), with quartz identified in more than one third of the 1,687 metres drilled. Gold mineralisation was identified in the majority of holes, with grades in nine holes ranging from 0.6 g/t gold to 44.63 g/t gold (1.44 oz/t).

MGA’s geologists hypothesised an extreme nuggety distribution of gold based on the results of drilling and other observations, including capturing a small 0.27 g nugget in gravity tests conducted on a single sample bag. In order to assess the significance of this effect, MGA’s consultants devised a testing program using gravity and electrostatic concentration (GEC) on full bags of RC drill cuttings, which would constitute the whole sample recovered from each metre of drilling (less sub-samples obtained at the time of drilling via a splitter mounted on the drill rig). In nuggety gold systems, increasing sample size increases the chance of nuggets being captured in the sample, and thus being appreciated as part of the gold endowment of the system.

Using the GEC method on the full bags, MGA was able to subject larger, more representative sample sizes to analysis. A total of 129 ‘full-bag’ samples were analysed using the GEC process. In parallel, 74 duplicate sub-samples obtained at the time of drilling via the rig-mounted splitter were analysed by the Leachwell method at Gekko Systems. This was done to enable comparison with the assay results (obtained by the same method) for the first set of sub-samples, to assist in classifying the nugget effect as extreme, major or minor.

Grade variability due to the nugget effect was demonstrated by the results of the exercise, which were announced in November 2019, but some consistency between results was also seen, and indicates the nugget effect may be less severe than initially thought. Overall, the programme confirmed the presence of nuggety gold mineralisation in the Dimocks Main Shale (DMS) at Creswick, some of which is very high grade.

MGA’s tenement position at Creswick covers approximately 7 kilometres of the DMS trend, and the 2019 drilling only tested approximately 300 metres of this. ECR therefore believes there is significant potential upside in the project.

Sale of SLM Gold Project
In February 2020, the Company sold its wholly owned Argentine subsidiary Ochre Mining SA, which holds the SLM gold project in La Rioja, Argentina, to Hanaq Argentina SA (“Hanaq”). The sale allows ECR to focus on its core gold exploration activities in Australia.

Hanaq is a Chinese-owned company engaged in lithium, base and precious metals exploration in Northwest Argentina including Salta, Jujuy and La Rioja, with a highly experienced management team.

ECR retains an Net Smelter Return (“NSR”) royalty of up to 2% to a maximum of USD 2.7 million in respect of future production from the SLM gold project. ECR believes that Hanaq has the operational capabilities and access to Chinese investment capital necessary to put the SLM project into production, subject to the usual prerequisites such as further exploration and feasibility studies being successfully completed (if deemed necessary by Hanaq) and to the necessary permits for production being obtained.

The founder and CEO of Hanaq Group, of which Hanaq Argentina SA is part, is Mr Xiaohuan (Juan) Tang, who has a substantive track record in Latin America, including responsibility for the successful permitting of the Pampa de Pongo iron ore project in Peru in his former capacity as General Manager of Jinzhao Mining Peru. Pampa de Pongo is one of the largest iron ore deposits in Latin America. Mr Tang has degrees from Tsinghua University in China, and Imperial College, Cambridge University and Oxford University in the UK.

Outlook, Future Prospects and COVID 19
The Directors’ of ECR Minerals plc are very positive regarding the outlook for the Company, gold and the prospectively of the Company’s projects in Victoria, Australia.

As a consequence of COVID 19, governments around the world have imposed restrictions on international travel; restrictions have also been imposed on domestic travel within Australia. These restrictions have meant that the board have been unable to visit the assets. However, the team on the ground in Australia continue the work at site without interruption. Accordingly, there has been no significant negative impact on the Group from the coronavirus.

FOR FURTHER INFORMATION, PLEASE CONTACT:

ECR Minerals plc

Tel: +44 (0)20 7929 1010

David Tang, Non-Executive Chairman

Craig Brown, Director & CEO

Email: info@ecrminerals.com

Website: www.ecrminerals.com

WH Ireland Ltd

Tel: +44 (0)161 832 2174

Nominated Adviser

Katy Mitchell/James Sinclair-Ford

SI Capital

Tel: +44 (0)1483 413500

Broker

Nick Emerson

FORWARD LOOKING STATEMENTS
This announcement may include forward looking statements. Such statements may be subject to a number of known and unknown risks, uncertainties and other factors that could cause actual results or events to differ materially from current expectations. There can be no assurance that such statements will prove to be accurate and therefore actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward looking statements. Any forward looking statements contained herein speak only as of the date hereof (unless stated otherwise) and, except as may be required by applicable laws or regulations (including the AIM Rules for Companies), the Company disclaims any obligation to update or modify such forward looking statements as a result of new information, future events or for any other reason.

ABOUT ECR MINERALS PLC
ECR is a mineral exploration and development company. ECR’s wholly owned Australian subsidiary Mercator Gold Australia Pty Ltd has 100% ownership of the Bailieston and Creswick gold projects in central Victoria, Australia.

Following the sale of the Avoca, Moormbool and Timor gold projects in Victoria, Australia to Fosterville South Exploration Ltd (TSX-V: FSX), ECR has the right to receive up to A$2 million in payments subject to future resource estimation or production at those projects.

ECR has earned a 25% interest in the Danglay gold project, an advanced exploration project located in a prolific gold and copper mining district in the north of the Philippines, and holds a royalty on the SLM gold project in La Rioja Province, Argentina.

Link here for financial statements

Monetary Stimulus = Currency Devaluation = Increasing Gold Demand

As the world starts to emerge from the first wave of the COVID-19 crisis, the implications for the unprecedented monetary stimulus measures employed by Governments around the globe to support citizens in lockdown are becoming ever clearer.

As stock markets roar back from the coronavirus-led rout, advisers to the world’s wealthy are urging them to hold more gold, questioning the strength of the rally and the long-term impact of global central banks’ cash splurge, Reuters writers commented.

In a note for Kitco News, Allen Sykora noted Gold had started a new week on firmer footing amid worries about the rising number of COVID-19 cases. “The price of gold jumped to its highest in more than a month this morning ($1,757), after surging coronavirus cases heightened concerns over a delay in global economic recovery,” said a research note from commodities brokerage SP Angel. Analysts cited news reports showing that while social distancing in March and April slowed the spread of the virus, reopening in a number of U.S. states and European nations has coincided with a new wave of infections.

Commerzbank believes the U.S. economic recovery is “hanging in the balance” with a likelihood of “increasing calls for the U.S. government to implement further stimulus measures, especially as [Federal Reserve Chair Jerome] Powell had already called for more fiscal stimulus during his virtual testimony before the U.S. Congress last week,” Commerzbank also believes the U.S. Fed is “likely to keep the pedal to the metal – i.e. to expand its balance sheet”… and thus the issue of currency debasement/inflation ..”will remain high in the minds of market participants.”

Geologists speculating with fees for professional services

This ‘pedal to the metal’ approach to monetary easing and the conseqential strength in gold continues to drive investor interest in junior gold explorers. Increasingly this sector is seeing mining geologists taking fees for their work in shares as well as cash, as armed with knowledge and experience, a successful drilling campaign can have a transformational effect the valuations of small cap explorers with quality projects, meaning that professional fees can potentially multiply in value. The majority of small mining companies however only have one or two key projects in their asset portfolio, so micro-cap explorers that own a broad spread of assets are particularly sought after.

AIM listed ECR Minerals (AIM: ECR) is firmly in the latter category. The company 100% owns the Bailieston and Creswick projects in Central Victoria, Australia, and also has financial interests in the Avoca, Moormbool and Timor projects following the sale of those licenses, detailed below. In addition ECR has earned a 25% interest in the Danglay epithermal gold project in the north of the Philippinesand and holds a net smelter royalty on the SLM gold project in Argentina.

Creswick

Creswick has long been viewed as a potential pivot project for ECR after the highest grade duplicate result of 80.97 g/t gold came from a 1 metre interval that originally assayed 44.63 g/t, confirming the original findings announced on 8 May 2019. Referred to by ECR as ‘nuggety gold mineralisation’, a study by pre-eminent consulting geochemist Dr Dennis Arne, whose experience includes extensive consultancy at the highly successful Fosterville gold mine in Central Victoria, underlined the significant gold exploration potential at Creswick

Bailieston

Bailieston is also at the centre of the current gold exploration boom in Victoria, located close to the highly successful Fosterville mine owned by Kirkland Lake Gold. The project potential was underlined by the arrival of mining giant Newmont Exploration with a license application for ground immediately to the north of ECR’s Black Cat prospect. The Fosterville mine is located approximately 50km west of the Bailieston project.

Flagship Projects Set to Deliver Value

The focus on Creswick and Bailieston prompted the board decision in April 2020 to sell three further Victoria licences (the Avoca, Moormbool and Timor gold exploration projects) to TSX-V listed Fosterville South Exploration Ltd for an upfront cash payment of A$500,000, plus additional potential of a further A$2 million based on resource estimates and gold production.

This, added to the two recent R&D cash refunds and the GB£500,000 placing at 0.5p mean that ECR are fully funded and ready to spend on further developing the two flagship assets.

And with external parties currently reviewing data on the Bailieston and Creswick gold projects with a view to potential commercial transactions and joint venture opportunities, the ECR board believes that both projects “hold considerable potential and inherent value for the Company.”

Currently valued at just GB£3.9m, there are great expectations for ECR in the coming months despite the restrictions resulting from the COVID-19 lockdown. Given the compelling backdrop in the Gold market and the ‘pedal to the metal’approach to monetary easing by Governments around the world, ECR shareholders could be set for a bonanza if Creswick and Bailieston come good.

References:

Reuters: https://www.reuters.com/article/us-health-coronavirus-gold-wealth-analys/worlds-ultra-wealthy-go-for-gold-amid-stimulus-bonanza-idUSKBN23P253

Kitco: https://www.kitco.com/news/2020-06-22/Gold-prices-trade-to-one-month-high-on-COVID-19-concerns-analysts.html?sitetype=fullsite

 

 

 

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.

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