Tuesday 02 June 2020
Here is our summary of the day's hottest RNS alerts from across London's Alternative Investments Market (AIM).
Novacyt S.A. (NCYT.LSE)
Novacyt, an international specialist in clinical diagnostics, provided an update on its polymerase chain reaction (PCR) test for COVID-19, developed by Primerdesign, the Company's molecular diagnostics division.
As of 1 June 2020, sales of the Primerdesign COVID-19 test are €45 million (£40 million). In addition, Primerdesign has received orders for, or been contracted to deliver, a further €90 million (£80 million) of its COVID-19 test. Therefore, currently the total sales and confirmed orders are €135 million (£120 million).
During the second half of the year, additional COVID-19 related sales are expected from the Company's new products, Exsig™ Direct and Exsig™ Mag, and from the Company's mobile testing solution (see further detail below).
Novacyt is now selling its COVID-19 test into more than 130 countries, with the top two countries being the UK and Germany. Novacyt is also pleased with the progress it is making in the US market and expects to update the market in due course.
Zimbabwe tender win
Following completion of a formal evaluation of the Primerdesign COVID-19 test by the Medicines Control Authority of Zimbabwe and a successful tender process, Zimbabwe's Ministry of Health and Child Care has awarded Primerdesign with a contract for the supply of 1.5 million tests. Outside the UK, this is the largest contract secured by Novacyt to date. The initial purchase order for the first 500,000 tests has been received and will be shipped immediately. The remaining one million tests will be shipped over the coming weeks.
Regulatory - France
Following several months of discussions with the Haute Autorité de Santé (HAS), which advises the French government on medical reimbursement, the Company reports that HAS has not approved Primerdesign's COVID-19 test for reimbursement in France. This decision by HAS is despite clinical approval from the Institut Pasteur,an internationally renowned centre for biomedical research with a goal of improving public health in France, which the Company received on 6 April 2020. HAS stated it will not authorise reimbursement because the COVID-19 test has been developed with one single gene target.Novacyt can still sell the test in France for private patient testing.
Regulatory - other territories
During the last few weeks, Novacyt has secured registrations and regulatory approvals in the following new markets for its COVID-19 test: Panama, Ecuador, Columbia, Peru, Paraguay and the UAE.
As announced on 14 May 2020, the Company is working on further innovations to support laboratories during the pandemic. Exsig™ Direct is an innovative and proprietary RNA extraction reagent that removes the need for complex, automated magnetic extraction systems. Exsig™ Mag is Novacyt's RNA extraction reagent containing magnetic beads to be used in laboratories which still wish to run their automated RNA extraction systems. The mobile COVID-19 testing solution is a combination of Exsig™ Direct and the COVID-19 test optimised to run on the Company's proprietary q16 and q32 instrumentation. Both Exsig™ extraction reagents are on track to launch during June 2020 and the mobile COVID-19 system will launch in July 2020.
Ascent Resources Plc (AST.LSE)
Slovenia Court Ruling
Ascent Resources plc, the onshore Caribbean, Hispanic American and European energy and natural resources company, announced that the Administrative Court of the Republic of Slovenia has published its decision in relation to Ascent's JV partner Geoenergo d.o.o's appeal against the Slovenian environmental agency ARSO's decision to require an Environmental Impact Assessment ('EIA') in order to re-stimulate the PG-10 and PG-11A wells. The Court has ruled that an EIA is required.
The Company is in the process of beginning preparations for submission of an EIA, alongside the stimulation and field development planning which was initiated recently.
The Court decision, along with earlier action by the State, will constitute important evidence to support the claim the Company intends to bring against the Republic of Slovenia under the Energy Charter Treaty.
Further updates will be released as necessary.
For full RNS details, see: https://www.investegate.co.uk/ascent-resources-plc--ast-/rns/slovenia-court-ruling/202006020700026023O/
ValiRx Plc (VAL.LSE)
Collaboration Agreement Signed
ValiRx announced that it has entered into a collaboration agreement with Oncolytika Limited and Black Cat Bio Limited to explore the use of VAL201 in a combination treatment for patients suffering a hyperimmune response to Coronavirus SARS-CoV2 infection. Dr Suzanne Dilly is proposed to be the chairman of the Project steering committee. As announced on 1 May 2020, the Company intends to appoint Dr Suzanne Dilly as a director of the Company subject to the completion of satisfactory background checks which are ongoing at present.
Many patients infected with Coronavirus SARS-CoV2 exhibit more severe symptoms, with significant damage believed to be caused by an excessive response of the immune system, even after the viral infection has reduced. This is known as a hyperimmune response.
Oncolytika, a private UK based technical consultancy, has proposed a combination therapy which includes a selective SRC kinase inhibitor (which inhibits a potential oncogenic pathway), alongside one or two complementary treatments to treat the excessive response of the immune system. Oncolytika and Black Cat have filed a patent to protect the proposed use of the combination therapy.
ValiRx's contribution to the collaboration is to provide samples of its proprietary SRC kinase inhibitor, VAL201, for preclinical testing, and provide access to safety and tolerability data collected in the recently completed clinical trial in men with prostate cancer. No cash funding is committed to the project by ValiRx under this agreement.
Subject to successful out-licencing, ValiRx will receive 40% of all licensing income generated. The collaboration addresses an emergent and immediate unmet medical need, and details the commencement of a short term experimental plan, with the agreement covering a maximum of two years.
This additional use for VAL201, being explored through the collaboration does not impact ValiRx's intellectual property rights, or the progress or commercial potential of the oncology or endometriosis applications of using for VAL201 or VAL301.
There is no guarantee that the Project will be successful and that ValiRx will generate any licensing income from the Project.
For full RNS details, see: https://www.investegate.co.uk/valirx-plc--val-/rns/collaboration-agreement-signed/202006020741066521O/