Friday 22 May 2020
Here is our summary of the day's hottest RNS alerts from across London's Alternative Investments Market (AIM).
Genedrive Plc (GDR.LSE)
Genedrive® 96 SARS-CoV-2 Kit receives CE-IVD Mark
Genedrive plc, the near patient molecular diagnostics company, announced that the Genedrive® 96 SARS-CoV-2 Kit is now CE-IVD marked and is available for commercial sale across the European Union, including the UK, whilst also accelerating market access to countries that accept the CE-IVD mark.
The Genedrive® 96 SARS-CoV-2 Kit is a novel Polymerase Chain Reaction (PCR) assay designed to detect active infection in COVID-19 patients. genedrive's PCR bead format eliminates the need for the time consuming and error-prone reagent preparation required in all other open-platform test kits. The proprietary format streamlines laboratory workflow, allowing more tests to be performed in a day. Patient samples are simply mixed with the PCR beads, and are then analysed on a variety of existing third-party real time PCR platforms. During CE-IVD evaluations on 180 randomised specimens, the Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 98.2% specificity, placing it in a top tier performance table for COVID-19 PCR tests.
The test has been co-developed with Cytiva (formerly GE Healthcare Life Sciences). The scalable manufacturing process uses Cytiva's Lyo-Stable™ validated manufacturing method, capable of producing 10,000 PCR beads per hour. The Genedrive® 96 SARS-CoV-2 kit is stable at ambient temperatures which eliminates the need for cold storage, making the test very practical for global export markets.
Following CE-IVD marking, the Company can commence commercial sales in the UK and across the EU immediately. The Company will now begin distribution to potential customers for initial clinical evaluations, and aims to record first commercial sales in June.
The Company continues to develop a point-of care version of the SARS-CoV-2 test for use with its Genedrive® platform, which will enable decentralised testing.
Ideagen PLC (IDEA.LSE)
Partnership with the World Health Organisation
Ideagen PLC, a leading supplier of Information Management software to highly regulated industries, announced a partnership with the World Health Organisation (WHO) to support its vital collaboration and policy making work with member states and other interested bodies during the coronavirus pandemic.
The 73rd annual World Health Assembly took place earlier this week (May 18/19). In normal times there would be more than 60 items on the agenda for discussion, but this year there were only two, with the main one, unsurprisingly, being coronavirus and the global response to it.
The Assembly was due be attended by delegations from the 194 Member States of the WHO, as well as NGOs, philanthropic organisations and other interested parties. This year many delegations were led by Heads of States and the number of people attending was expected to be around 4,000. Normally this meeting would involve face to face gatherings and discussions in the Palais de Nation in Geneva, but social distancing measures required meant that was impossible this year.
Ideagen's leading document collaboration and governance software, PleaseReview, provided the WHO with a solution to their problems. PleaseReview allows for the real-time collaboration on documents, offers a secure means of capturing comments and provides a full audit trail of responses, changes and agreements. When each word is poured over and debated by thousands of people and the outcome of those debates has such global significance, getting it right is of paramount importance to the WHO.
A spokesperson for the WHO, said:
"PleaseReview is working with the World Health Organization in support of WHO's COVID-19 outbreak response by providing services to WHO on a pro bono basis to allow WHO to conduct its first-ever digital World Health Assembly".
Adopting PleaseReview meant the WHO could invite member states to conduct a first review of policy documents, that would normally be conducted face to face, in a secure, online environment. As well as ensuring social distancing was maintained, this also saved a huge amount of time, which is incredibly valuable during this uncertain period.
Open Orphan Plc (ORPH.LSE)
Primary Bid Offer
Open Orphan Plc, a rapidly growing specialist 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, announced 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 May2020. The Placing, Subscription and PrimaryBid Offer are 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.
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 2020and 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.
For full RNS details, see: https://www.investegate.co.uk/open-orphan-plc--orph-/rns/primarybid-com-offer/202005220701057392N/