YGEN.L Regulatory News (YGEN)

Premaitha Health Plc

("Premaitha" or the "Company")

UK High Court grants appeal against UK First Instance Judgment

Manchester, UK - 24 January 2018 - Premaitha Health PLC (AIM: NIPT), a leading international molecular diagnostics group focused on prenatal testing, announces that it has secured the right to appeal a First Instance Judgment in its ongoing litigation with Illumina Inc. and others.

At a Form of Order hearing in the UK High Court yesterday (the "Hearing"), the Judge accepted Premaitha's application for leave to appeal against the First Instance Judgment handed down on 21 November 2017. The key outcomes of the Hearing are:

· Illumina had no standing to bring the claim for infringement of the Lo I patent in the first action HC-2015-001175 as it was not an exclusive licensee of the Lo I patent. Most of the claims of the Lo I patent were, in any event, found to be invalid and Illumina was ordered to pay Premaitha's costs in relation to this exclusive licence issue. Sequenom, as the owner of the Lo I patent, was entitled to 50% of its costs of the Lo I action due to the November finding that the IONA® test infringed a dependent claim limited to sex determination.

· Premaitha was granted leave to appeal against the Court's first instance findings of infringement and validity on a range of grounds, including obviousness, lack of priority and two alternative processes for carrying out the IONA test that Premaitha considers to be non-infringing.

· Illumina was granted leave to appeal against the Court's first instance findings that various claims of the Lo I patent are invalid and that Illumina is not an exclusive licensee under the Lo I patent.

· Premaitha was ordered to pay interim costs to Illumina of an amount in the region of £1.5m. This payment will be met from the escrow facility announced on Monday. These costs will be repaid in the event that the appeal is successful.

· Premaitha agreed to pay 10% of UK revenues earned from the Hearing date into an escrow facility for the duration of the appeal cycle as a reasonable reserve for potential future damages if the appeal is unsuccessful.

· Illumina had sought an immediate injunction against the IONA® test in the UK but this was stayed until the resolution of the appeal.

Dr Stephen Little, CEO of Premaitha, commented: "The Court was refreshingly pragmatic in granting us leave to appeal all aspects of the November judgment, with which we still strongly disagree. We had anticipated an interim costs award and had taken steps to prepare the necessary facility to meet that, for which we are very appreciative of Thermo Fisher's recent financial support. We anticipate the appeal cycle will take at least 12 months and the costs will be significantly lower than those we have incurred to date. We remain hopeful that the Courts will in time agree with us on the patent issues at hand.

"We have attempted to engage Illumina into meaningful settlement discussions both before and since the November judgment. We will continue to pursue such discussions as we believe these are firmly in the best interests of patients, clinicians, the NHS and the companies involved. We are open to terms that are financially viable for us to offer IONA® within the UK without the negative drag on the whole market that this litigation engenders.

"In the meantime, our business remains firmly on course to expand its international footprint. The UK market now represents less than 15% of our revenue run rate and overall the Group is seeing sizeable growth on a quarterly basis. Within the UK market place, we will continue to provide exceptional service to our customers and will continue to innovate in the field of NIPT and other applications of NGS technology globally."

The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2014 and has been arranged for release by Barry Hextall, Chief Financial Officer of the Company.

-Ends-

About Premaitha

Premaitha is an international molecular diagnostics group which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved genetic screening tests. The Group's primary focus is on non-invasive prenatal tests (NIPT) for pregnant women - an emerging, multi-billion dollar global market.

Premaitha's IONA® test was launched in 2015 as the first CE-IVD NIPT test in Europe. It enables laboratories and healthcare practitioners to offer a complete CE-marked NIPT system in-house. The IONA® test is performed on a maternal blood sample - which contains traces of fetal DNA - and estimates the risk of a fetus being affected with Down's syndrome or other genetic conditions.

Unlike existing prenatal screening methods, due to its high level of accuracy, the IONA® test can significantly reduce the number of women subjected to unnecessary invasive follow up diagnostic procedures, such as amniocentesis, which are costly, resource intensive and carry a risk of miscarriage.

In March 2017, Premaitha acquired Yourgene Bioscience, a specialist next generation sequencing and bioinformatics company based in Taiwan, with its own NIPT screening test that operates on the same Thermo Fisher next-generation sequencing platform as Premaitha's IONA® test. Yourgene brings significant benefits to the Group through expanded market access in Asia - the world's fastest growing NIPT market - as well as opportunities for cross-selling and the ability to jointly develop expanded test content both within NIPT and beyond.

Premaitha is headquartered in Manchester, England, with Yourgene offices in Taipei and Singapore. Its shares trade on the AIM market of the London Stock Exchange (AIM: NIPT). For further information, please visit www.premaitha.com. Follow us on twitter @PremaithaHealth.