Provexis Regulatory News (PXS)

Prior to publication, the information contained within this announcement was deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). With the publication of this announcement, this information is now considered to be in the public domain.

2 August 2019

Provexis plc

("Provexis" or the "Company")

Collaboration agreement with By-Health Co., Ltd.

Provexis, the business that develops, licenses and sells the proprietary, scientifically-proven Fruitflow® heart-health functional food ingredient, is delighted to confirm it has entered into a collaboration agreement (the 'Agreement') with By-Health Co., Ltd. ('By-Health'), a £3bn listed Chinese dietary supplement business, to support the planned launch of some Fruitflow based products in the Chinese market.

The Agreement has been structured on an open-ended framework basis, enabling the parties to conduct a number of different projects over an unspecified period of time under the one overriding agreement, with all projects envisaged to be at By-Health's sole expense.

It is envisaged that projects conducted under the agreement will be focussed on specific areas of commercial focus for By-Health, and the first project which has been agreed will concentrate on the use of Fruitflow with nitrates in exercise, an area of considerable commercial interest to By-Health in China.

It is envisaged that project work will be managed and conducted by Provexis primarily in the UK, led by Provexis' Chief Scientific Officer Dr Niamh O'Kennedy and supported by outsourced research partners which will be appointed and managed by Provexis.

The Fruitflow with nitrates in exercise project will provide gross income to Provexis in excess of £55k, to include an element of overhead recovery. The project will not affect the ownership of Provexis' existing, substantial intellectual property for the Fruitflow with nitrates formulation, which already has patents granted in the UK and Australia. Further patents for this formulation are being sought in Europe, the US, China and eleven other territories, with potential patent protection out to December 2033. All other commercial terms of the Agreement remain confidential between the two parties.

The Company has previously announced it was working with DSM and By-Health to support the planned launch of some Fruitflow based products in the Chinese market, and in a Trading Update on 31 July 2019 the Company confirmed that:

·; Provexis and By-Health had been working on a proposed new framework research collaboration agreement for Fruitflow, planned to be at By-Health's sole expense.

·; The planned launch by By-Health of a number of Fruitflow based products in the Chinese market, with potential volumes at a significant multiple of existing Fruitflow sales, is progressing well, with activities driven at present by the need to obtain 'blue cap' health claim status for Fruitflow as a dietary supplement with the Chinese State Administration for Market Regulation (SAMR).

·; Clinical studies conducted in China are typically required to obtain blue cap health claim status, and a significant investment in seven separate studies, in support of the Fruitflow based products which By-Health plans to launch in China, is being undertaken at By-Health's expense.

·; Three studies have been successfully completed in China, three studies are currently ongoing at Chinese clinical sites and a further planned human study in 2019 has been confirmed by By-Health.

·; The three completed studies (a human study and two animal studies) showed excellent results in use for Fruitflow, and they provide strong evidence for By-Health in its blue cap and other regulatory submissions to the SAMR for Fruitflow, supported by the Company's existing European Food Safety Authority ('EFSA') health claim for Fruitflow.

·; If a successful blue cap health claim is achieved for Fruitflow it would currently be expected to result in some significant orders for Fruitflow, potentially at a multiple of current total sales values.

The Company's Trading Update on 31 July 2019 stated that completion of a collaboration agreement with By-Health was at that time uncertain, an uncertainty which has been removed by way of this announcement of 2 August 2019.

Ian Ford, CFO and COO of Provexis, commented:

'We are delighted to announce this open-ended collaboration agreement with By-Health, which further strengthens the already close relationship between By-Health and Provexis.

By-Health has already made a substantial investment at its sole expense in the clinical trials which it has been conducting in China, seeking to secure blue cap health claim status for Fruitflow. The Company is very pleased to be able to assist By-Health with its commercialisation plans for Fruitflow in China, by way of this new investment with Provexis in the UK, and it will seek to undertake further projects for By-Health under this flexible framework agreement.

The clinical studies which By-Health has been conducting in China have been progressing well and the completed studies have shown excellent results in use for Fruitflow, providing strong evidence for By-Health in its blue cap and other regulatory submissions to the Chinese SAMR.

If a successful blue cap health claim is achieved for Fruitflow in China it would currently be expected to result in some significant orders for Fruitflow, potentially at a multiple of current total sales values. The Company will provide shareholders with as much information as it can with regard to the timing of this commercially sensitive and potentially transformative process.'

Felix Zhang, MSc PhD, Group Director Science & Technology Centre, and Director, Nutrition & Health Research Centre of By-Health Co., Ltd., commented:

'We are delighted to have entered into this open-ended collaboration with Provexis, and look forward to progressing our work with Fruitflow, in partnership with Provexis, towards future significant commercialisation in China.'

For further information please contact:

Notes for editors

About Provexis plc

AIM-listed Provexis is focused on the development, licensing and sales of its proprietary, scientifically-proven Fruitflow® heart-health functional food ingredient.

Provexis was founded in 1999 and is headquartered in Reading, Berkshire.

Provexis shares are traded on the AIM market of the London Stock Exchange under the ticker symbol PXS.

For further information, please visit www.provexis.com and www.fruitflowplus.com.