Provexis Regulatory News (PXS)

27 September 2017

Provexis plc

Study publication - consumption of Fruitflow® lowers blood pressure

Provexis plc ('Provexis' or the 'Company'), the business that develops, licenses and sells the proprietary, scientifically-proven Fruitflow® heart-health functional food ingredient, is pleased to confirm the publication of an important pilot study for Fruitflow® in the International Journal of Food Sciences and Nutrition.

The study, titled 'Consumption of Fruitflow® lowers blood pressure in pre-hypertensive males: a randomised, placebo controlled, double blind, cross-over study' concerns the research undertaken by the Company and the University of Oslo into the relationship between Fruitflow® and blood pressure regulation, and it is expected to be a strong opportunity to promote Fruitflow® further across scientific, trade customer and consumer channels.

The study is available to view on the Company's website at: www.provexis.org/wp-content/uploads/2017/09/IJFSN-Fruitflow-blood-pressure-study-Sep-17.pdf

The study reflects the outcome of the research work undertaken by the Company and the University of Oslo, following a collaboration agreement between the parties which was signed in 2014.

In December 2016 the Company announced that the second stage of the collaboration work with the University of Oslo had been completed, which had seen the parties conduct a small clinical trial in Oslo by way of a proof of principle study. The study examined the acute effects of different amounts of Fruitflow® in powder format on parameters relating to blood pressure, such as systolic and diastolic blood pressure, mean arterial pressure, pulse pressure and heart rate. These blood pressure related parameters were monitored over a 24-hour period using ambulatory blood pressure monitoring. Platelet function was also measured. The trial subjects, who were healthy with no underlying cardiovascular disease or other conditions likely to affect blood pressure, received both placebo and Fruitflow® supplements in a blinded crossover design.

Results from the pilot study indicated that a 150mg dose of Fruitflow® in powder format significantly lowered the average 24-hour systolic blood pressure compared to placebo. When the monitoring time was split into waking and sleeping periods, both systolic and diastolic blood pressure were significantly lower after 150mg Fruitflow® treatment than after placebo treatment during the waking period; systolic pressure was also significantly lower during the sleeping period. Platelet response to ADP agonist was significantly reduced 24 hours after consumption of Fruitflow®. The supplements were given in a single dose at the start of the 24-hour monitoring period; further work is likely to be required to understand the optimal dosage pattern.

Raised blood pressure is estimated to cause more than 7 million premature deaths throughout the world each year, and 4.5% of the disease burden. Treating raised blood pressure by way of achieving systolic blood pressure < 140 and diastolic blood pressure < 80 has been associated with a 35-40% reduction in the risk of stroke and at least a 16% reduction in the risk of heart attack (WHO 2007). These pilot study results therefore show that Fruitflow® may have clinically relevant effects in blood pressure control.

Provexis signed its collaboration agreement with the University of Oslo in November 2014, alongside which it also signed a related option agreement with Inven2 AS ('Inven2'), the technology transfer office at the University of Oslo ('the University') which is responsible for commercialising the University's research.

The Company has provided primary funding for the collaboration work and the associated patent filings on a tightly managed budget, with the results from the collaboration being jointly owned by the Company and the University. The option agreement between the Company and Inven2 gives the Company an exclusive opportunity to license the University's existing background intellectual property and any new joint intellectual property developed as part of the collaboration.

The Company expects that these encouraging study results will be of relevance to a large number of consumers and patients, and the publication of this study in a peer-reviewed scientific journal is expected to drive further commercial interest from existing and potential future brand owner trade customers.

An increasing number of further commercial projects have been initiated by the Company's commercial partner DSM with prospective customers, including some prospective customers which are part of global businesses, with good prospects for these projects to be launched as consumer products.

The Company reported in its preliminary results on 7 September 2017 that the Company and DSM had seen an encouraging increase in brand awareness and customer interest in Fruitflow® in recent months, with the total projected annual sales value of the prospective sales pipeline for Fruitflow® continuing to increase and standing at a new all-time high level.

The University of Oslo's research team was led by Professor Asim K Duttaroy, Group Leader of Chronic Disease at the Faculty of Medicine, who was the original inventor of Fruitflow®. Provexis' work under the collaboration was led by Dr Niamh O'Kennedy, a research chemist specialising in the field of natural products chemistry who played a key role in the development of Fruitflow®, and the health claim for Fruitflow® which was adopted by the European Food Safety Authority ('EFSA').

Professor Asim Duttaroy commented:

'The pilot study clearly shows the beneficial effects of Fruitflow® on two important cardiovascular risk factors, high blood pressure and platelet hyperactivity. From a public health standpoint, it has been reported that every 1 mmHg reduction in systolic blood pressure could prevent approximately 10,000 CVD deaths each year in the USA alone. Thus, Fruitflow® supplementation could be a promising dietary approach to achieve and maintain healthy blood pressure.'

Dawson Buck, Chairman of Provexis, commented:

'We are delighted to announce the publication of this study, which shows that a standard dose of Fruitflow® in powder format significantly lowered average 24-hour systolic blood pressure compared to placebo. Both systolic and diastolic blood pressure were shown to be significantly lower whilst trial subjects were awake, a clinically relevant reduction in blood pressure which is expected to be of interest to a large number of consumers and patients with a wide range of cardiovascular conditions.

The Company expects that the encouraging blood pressure results detailed in this study will have a positive effect on current and future commercial negotiations for Fruitflow, and the Company will seek to maximise the commercial opportunities arising from this important development for Fruitflow and the Provexis business.'

This announcement contains inside information.

ends-

For further information please contact:

Provexis plc Tel: 07490 391888

Dawson Buck, Chairman enquiries@provexis.com

Ian Ford, Finance Director

Cenkos Securities plc Tel: 020 7397 8900

Bobbie Hilliam

Notes for editors

About Provexis plc

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

In May 2009, the Company's Fruitflow® technology was the first to be substantiated by the European Food Safety Authority ('EFSA') under the new Article 13(5) for proprietary and emerging science. In December 2009 the European Commission authorised the health claim 'Helps maintain normal platelet aggregation, which contributes to healthy blood flow', which was the first wording to be authorised under Article 13(5).

In June 2010 it was announced that the Company had entered into a long-term Alliance Agreement with DSM Nutritional Products to commercialise Fruitflow®, and in June 2015 the Company confirmed it had agreed significantly enhanced financial terms for its Alliance Agreement with DSM for Fruitflow®.

The Company's Alliance partner DSM Nutritional Products has developed the market actively for the Company's novel, patented Fruitflow® heart-health ingredient in all global markets, with over 50 regional consumer healthcare brands now having been launched by direct customers of DSM, and with a number of further regional brands having been launched through DSM's distributor channels.

An increasing number of further commercial projects have been initiated by DSM with prospective customers, including some prospective customers which are part of global businesses, with good prospects for these projects to be launched as consumer products. Interest in the technology exists in all major global markets.

The Company reported in its preliminary results on 7 September 2017 that the Company and DSM had seen an encouraging increase in brand awareness and customer interest in Fruitflow® in recent months, with the total projected annual sales value of the prospective sales pipeline for Fruitflow® continuing to increase and standing at a new all-time high level.

In June 2016 the Company launched a high quality dietary supplement product containing Fruitflow® and Omega-3 which is being sold from a separate, dedicated website www.fruitflowplus.com on a mail order basis.

The Company conducted a Key Opinion Leaders' roundtable event for Fruitflow® in London on 29 September 2016, focussed on raising awareness of the importance of blood flow in cardiovascular health, and the effectiveness of dietary antiplatelets. The roundtable was attended by key scientists from Provexis and DSM, along with a number of interested health care professionals with close links to the media. The event was recorded and a video for Fruitflow® + Omega-3 capsules targeting prospective consumers can be seen here www.youtube.com/watch?v=P3HCSdyupEY&t=48s

The Company and DSM are keen to secure greater medical advocacy for Fruitflow® and the roundtable event forms part of this strategy.

The roundtable event is being supported by a broader consumer PR campaign, and the Company's Fruitflow® + Omega-3 dietary supplement product has featured in a number of recent articles in the UK national press which can be seen here www.fruitflowplus.com/fruitflow-in-the-media

The Company has been engaged in a two stage collaboration agreement with the University of Oslo to undertake further research into the relationship between Fruitflow® and blood pressure regulation. In December 2016 the Company announced the results from the second stage of the collaboration, a pilot study which indicated that a standard dose of Fruitflow® in powder format significantly lowered average 24-hour systolic blood pressure compared to placebo. Both systolic and diastolic blood pressure were shown to be significantly lower whilst trial subjects were awake, a clinically relevant reduction in blood pressure which is expected to be of interest to a large number of consumers and patients with a wide range of cardiovascular conditions.

In April 2017 the Company announced that it had entered into a memorandum of understanding with BY-HEALTH Co., Ltd ('BY-HEALTH') which is intended to result in a research and collaboration agreement with BY-HEALTH for Fruitflow®. The Company also confirmed separately that Provexis and DSM are working with BY-HEALTH to support the planned launch of some Fruitflow® based products in the Chinese market, with the first launch envisaged in the second half of 2017.

BY-HEALTH is a substantial Chinese listed dietary supplement business which is currently valued in excess of £2bn.

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