YGEN.L Regulatory News (YGEN)

Premaitha Health plc

(formerly ViaLogy plc, the "Company")

Results for 7 months to 30 September 2014

Successful reverse listing on AIM and preparation for launch ofPremaitha non-invasive prenatal test, the IONA® Test in Q1 2015

Manchester, UK - 10 December 2014 - Premaitha Health plc, a molecular diagnostics company employing next generation DNA analysis technology to develop molecular diagnostic products, announces its maiden results for the seven months ended 30 September 2014.

Financial highlights (unaudited)

- Revenues of £83.5k (H1 2013: £42.5k)

- Loss before tax £4.0m, which includes a non-cash loss of £1.2million, (H1 2013: loss of £828k), reflecting preparations for launch and commercialisation of the IONA® test

- Cash and cash equivalents of £5.2m at 30 September 2014 (31 September 2013: £0.03m)

- Successful acquisition of Premaitha by ViaLogy, followed by a listing on AIM in July 2014, raising £7.2m (net) via a Placing and Open Offer at 11p per share

Operational highlights

- Positive feedback on the quality systems and regulatory strategy from potential adopters and regulators

- Ongoing presentation of the test well received by the international fetal medicine and medical genetic community in Europe, US and Australia

- Premarketing to early adopter customers, from both private and publically funded clinical labs progressing

- Anticipated launch on track for Q1 2015

Steve Little, CEO of Premaitha Health, said:

"The past seven months have been very eventful for the Company. The listing on to the AIM Market in London accompanied by a successful fund raising will enable the Company to launch its game-changing, first-in-class non-invasive prenatal test - the IONA® test.

"Preparations for the launch, pre-marketing to the industry, putting systems and sales and marketing teams in place, are on track and in line with budget for Q1 2015."

-Ends-

Notes to Editors

About Premaitha Health

Premaitha Health (AIM: NIPT) is an innovative molecular diagnostics company employing the latest advances in DNA analysis technology to develop tests for non-invasive prenatal screening (NIPT) and other applications. Premaitha's flagship product, the IONA® test is the first non-invasive in vitro diagnostic product for prenatal screening enabling clinical laboratories to offer CE-marked NIPT in-house for the first time. 

The IONA® test estimates the risk of a fetus having Down's syndrome or other serious genetic diseases. The IONA® test has a higher detection rate and lower false positive rate than existing screening tests, giving pregnant women, their families and their doctor's greater confidence in the result and reducing the need for unnecessary invasive follow-up tests and the associated anxiety and stress.

The IONA® test is a complete diagnostic system that is simple and standardised, enabling Premaitha's clinical laboratory customers to perform the test in their own facilities. This supports Premaitha's strategy of accelerating the broad dissemination of NIPT tests to ensure that their benefits are available to pregnant women everywhere. 

Premaitha is listed on the London Stock Exchange (AIM). Its R&D, manufacturing and commercial operation is located at Manchester Science Park, UK.

For further information please visit www.premaitha.com or email iona@premaitha.com.

Overview

In January 2014, the new Board members of Premaitha Health plc (formerly ViaLogy plc, the "Company"), Adam Reynolds and Mark Collingbourne recognised the need for a complete change of strategy and direction for the Company, which had technically become a cash shell. The intention was to find a suitable acquisition target via a reverse takeover that would transform the Company, have growth opportunities and enhance shareholder value over the long term.

In March 2014 negotiations were initiated with Premaitha Health Limited (Premaitha), which culminated in the announcement on 13 June 2014 of the acquisition of the entire issued share capital of Premaitha for £10.5m in equity and a fund raising of £7.2m.

At the General Meeting on 3 July 2014 all resolutions were passed and David Evans, Stephen Little, Peter Collins and Charles Roberts were appointed to the Board of the enlarged group, Premaitha Health plc. The acquisition was a fundamental change in direction for the business. Premaitha is an innovative molecular diagnostics company employing the latest advances in DNA analysis technology to develop tests for non-invasive prenatal screening (NIPT) and other applications. Premaitha's flagship product, the IONA® test, will be the first non-invasive in vitro diagnostic product for prenatal screening enabling clinical laboratories to offer CE-marked NIPT in-house for the first time. The award of the CE mark is expected to take place in January 2015.

The immediate focus since IPO has been the development and regulatory approval of the IONA® prenatal screening product prior to its launch, which is anticipated in early 2015, following the CE mark award.

Financial review

In July 2014, Premaitha was acquired by the Company and the enlarged group was admitted to the AIM market. The issued share capital of the Company on admission to AIM comprised 188,163,709 ordinary shares of 10 pence each. The Company raised £7.2m (before expenses) by way of a placing and open offer at 11p. A significant amount of the funds raised were from institutional investors.

The Company reported a loss for the seven month period (1 March to 30 September 2014) of£3.7 million which includes a non-cash loss of £1.2 million for the adjustments required under IFRS3, reverse acquisition accounting, share based payments and depreciation.

The IONA® test

Premaitha has made significant progress towards the goal of being the first company to offer laboratory customers a CE marked in vitro diagnostic product to allow them to offer non-invasive prenatal screening tests in their own institutions.

Market strategy

The possibility of a reliable and safe non-invasive prenatal screening test for Down's syndrome and other serious genetic diseases was first suggested in 1997 with the discovery that fetal DNA could be found in the maternal circulation. However, it has only been in the last few years with the development of next generation DNA sequencing technology that this has become a practical proposition.

In the US and Europe there are 11.5 million births per annum, therefore, there is a significant potential market opportunity for a reliable, more accurate and safe prenatal screening test, estimated in the range of c. US$5-10 billion. The new generation of NIPT tests have impressive clinical performance but, unless they are readily available to pregnant women across the world, these benefits are of little value.

The IONA® test is designed to allow clinical laboratories, even without a background in DNA analysis technology, to offer the new NIPT tests thereby ensuring broad uptake and access to pregnant women. The product will initially be available in the EU.

Product development

The priority for the Company has been in preparing the IONA® test for its commercial launch which is anticipated to take place as planned in Q1 2015.

To meet the needs of Premaitha's potential customers, there are a number of key features that the Management team have been focused on since admission in anticipation of launch.

· Ease of Use and Throughput

A typical prenatal screening laboratory will analyse thousands of blood samples from pregnant women in a single year therefore the laboratory process must be as robust and simple as possible.

As set out in the Company's Admission Document published on 13 June 2014, the priority since admission to AIM has been to develop IONA® testing and interpretation system to meet user needs and design verification (Analytical Validation) of the IONA® test and software. The first of these activities is complete as is the second, with the exception of the final verification of the analysis software which will now take place in January 2015. This latter step is not expected to affect the launch timing of the IONA® test.

Premaitha scientists have finalised the first version of the IONA® test so that as much as possible of the workflow is automated, thereby minimising the hands-on time of the laboratory technicians who will operate the test.

· Data analysis

The IONA® test generates a significant amount of DNA sequence data which must be analysed to generate a report on the health of the fetus. In July 2014, Premaitha partnered with Sagentia Group plc, a leading global science, technology and product development company. The aim has been to develop the custom clinical bioinformatics analysis application that performs the test analysis, computes test results and generates test reports. This project has progressed well and the final version of the IONA® software is now available.

· Clinical Performance

It is essential that the IONA® test can correctly identify pregnancies which are either affected or unaffected with Down's syndrome and other genetic diseases. In initial tuning and testing studies of 351 samples, the test was 100% accurate and correctly identified all affected samples with sufficient fetal DNA (99.7%) Further clinical studies are now ongoing to confirm the test performance prior to launch and these will be completed prior to launch of the product with publication of the results to follow.

· Regulatory Status

To allow the sale of the IONA® test as an in vitro diagnostic (IVD) product it must meet the requirements laid down in the European IVD directive. This is ongoing with the first sections of the technical file already submitted to the notified body. The process is expected to be completed in Q1 2015.

· Manufacture and Distribution

The manufacturing process for the IONA® test reagents has been established with Premaitha's suppliers and an order has been placed for the first commercial batch which will be delivered before 31 December 2014.

Technical Support

An important feature of Premaitha's proposition to laboratory customers is the ability to offer training and technical support to laboratories that may not be familiar with the technology used in the IONA® test. To support this activity, Premaitha recently opened a new training suite in close proximity to its original development site and recruited heads of Technical Support and Clinical Testing. Premaitha has a long term commitment to supporting the IONA® test in its customer's laboratories and this function will expand further in the 2015.

Sales and Marketing

The first step in establishing the Sales and Marketing operation was the appointment of Chief Commercial Officer, Peter Collins. He joined Premaitha at the time of the admission to AIM from GlaxoSmithKline where he was Vice President, Head of Diagnostics. He is actively recruiting a sales and marketing team and, last month, the Company announced the appointment of Yves Derveaux who will support in leading business development for the IONA® test in Southern Europe.

Further appointments are planned to strengthen the sales outreach in central Europe and to expand the technical product specialist team in Manchester.

The Company has also begun to promote the forthcoming availability of the IONA® test through its website and by attending and exhibiting at national and international conferences in the field of prenatal screening. There has been a good level of interest in the product, with over 200 expressions of interest from potential customers and distributors.

Outlook

Premaitha has made substantial advances over the past six months and will have the only non-invasive in vitro diagnostic product for prenatal screening enabling clinical laboratories to offer a CE-marked NIPT in-house for the first time. In the short term, the main focus for the management team is finalising preparations - both regulatory and commercial - for the launch of the product as planned in Q1 2015and then winning the first commercial contracts. As set out in the Admission Document, the focus of the R&D team will move to extending applications and platforms to provide customers with additional features and greater ease of use.

The Board is delighted with the progress of the Company since its admission to AIM in July 2014. The corporate landscape has changed dramatically, which is believed to be to the Company's advantage, witnessed last week by the acquisition of Ariosa Diagnostics by Roche. Premaitha is positioned within a market place that has exponential growth opportunities and the Board is confident of delivering enhanced shareholder value.

David Evans

Chairman

Stephen Little

Chief Executive Officer

Date: 9 December 2014

Consolidated statement of profit or loss and other comprehensive income

For the seven months ended 30 September 2014

Consolidated statement of financial position

As at 30 September 2014

Consolidated cash flow statement

For the seven months ended 30 September 2014

Consolidated statement of changes in equity

For the seven months ended 30 September 2014

1. General information

Premaitha Health plc is a company incorporated and domiciled in England and Wales. Details of the registered office, the officers and advisers to the Company are presented on the Company information page at the end of this report. The Company's offices are in Manchester. The Company is quoted on the AIM market of the London Stock Exchange (ticker: NIPT.L). The Company is a molecular diagnostics company employing next generation DNA analysis technology to develop, manufacture and sell molecular diagnostic products intended to have a major beneficial impact on human health.

2. Basis of preparation

The financial information for the seven months ended 30 September 2014 and period from incorporation to 30 September 2013 is unaudited.

Basis of consolidation

In July 2014 Premaitha Health PLC acquired via s share for share exchange the entire share capital of Premaitha Limited. Under IFRS 3 'Business combinations' the Premaitha Limited share exchange has been accounted for as a reverse acquisition.

Although the consolidated financial information has been issued in the name of the legal parent Premaitha Health Plc, it represents in substance continuation of the financial information of the legal subsidiary Premaitha limited.

The Interim Report has been prepared using the same accounting policies as were applied in the Premaitha Limited audited financial statements to 28 February 2014, which have been prepared in accordance with International Financial Reporting Standards ("IFRS"). The Interim Report for the seven months ended 30 September 2014 was approved by the Directors on 9 December 2014.

The assets and liabilities of the legal subsidiary, Premaitha Health Limited are recognised and measured in the Group financial statements at the pre-combination carrying amounts, without restatement of fair value. The retained earnings and other equity balances recognised in the Group financial statements reflect the retained earnings and other equity balances of Premaitha Health plc immediately before the business combination and the results of the period from 1 March 2014 to the date of the business combination are those of Premaitha Health Limited. However, the equity structure appearing in the Group financial statements reflects the equity structure of the legal parent, Premaitha Health plc, including the equity instruments issued in order to effect the business combination; and comparatives numbers presented in the financial statements are the consolidated numbers of Premaitha Health Limited for the periods ended 30 September 2013 and 28 February 2014.

The aggregate deemed fair value of the consideration paid, assets and liabilities acquired and resulting charge to the income statement in respect of the above acquisition is £965k.

Merger relief reserve

The reserve represents a premium on the issue of the ordinary shares for the acquisition of subsidiary undertakings. The relief is only available to the issuing company securing at least a 90% equity holding in the acquired undertaking in pursuance of an arrangement providing for the allotment of equity shares in the issuing company on terms that the consideration for the shares allotted is to be provided by the issue of equity shares in the other company.

The financial information presented for the period 28 February 2014 is an extraction from Premaitha's audited accounts on which the auditors issued an unqualified report, the information presented does not constitute full accounts for that period.

3. Loss per share

Basic loss per share is calculated by dividing the loss attributable to equity shareholders by the weighted average number of ordinary shares in issue during the period:

Basic and diluted earnings per share are the same, since where a loss is incurred the effect of outstanding share options and warrants is considered anti-dilutive and is ignored for the purpose of the loss per share calculation. The share options outstanding as at 30 September 2014 totalled 30,488,332 (30 September 2013: 33,890,242, 31 March 2014: 261,916,546) and are potentially dilutive.

The weighted average number of ordinary shares for the period ended 30 September 2014 has been restated to reflect the total number of shares arising from the share for share exchange on acquisition and is considered to be in place from the earliest period.

4. Cash and cash equivalents

5. Share capital

The comparative figures for share capital in the financial statements are for Premaitha Health Limited for the period ended 30 September 2013 and for the period ended 28 February 2014.

On 4 July 2014 through an ordinary resolution the Company's share capital was reorganised as follows:

- Every 100 Ordinary shares held by a shareholder was consolidated into 1 Ordinary share of £0.10

The Company issued 95,545,545 new Ordinary shares of £0.10 each at £0.11, 59,090,909 Ordinary shares of £0.10 each at £0.11 by way of a placing and 6,723,651 Ordinary shares of £0.10 each at £0.11 by way of an open offer to acquire the share capital of Premaitha Health Limited.

6. Subsequent events

There are no subsequent events to report.

7. Copy of the Interim Report

Copies of the Interim Report are available to download from the Company's website at www.premaitha.com.