ORPH.L Regulatory News (ORPH)

 11 December, 2018

Venn Life Sciences Holdings Plc

("Venn" or the "Company")

Strategic Collaboration Agreement with Open Orphan DAC and Financing

Venn Life Sciences ("Venn") an Integrated Drug Development Partner offering a combination of drug development expertise and clinical trial design and management to pharmaceutical, biotechnology and medical device organisations announces a strategic collaboration with Open Orphan DAC and the issue of £1m in privately-held loan notes to fund an increased focus of the business into the high growth area of orphan diseases.

Strategic Collaboration

Venn was established with the strategic objective of building a differentiated, full-service clinical research organisation. To date, Venn has managed full service programs and activities across 27 different countries. Much of the work undertaken by Venn is for drugs intended for use in rare diseases, which have been designated "Orphan Drugs". These studies are often complex and challenging, given the limited number of potential trial participants, but fit well with Venn's size and capabilities. Venn can now point to a number of successful programs to underpin its credentials in this area. Therefore the Board believes that it is now the right time to accelerate and prioritise rare diseases as an area of specialisation and to establish the funding and resources to position the Company as a market leader in this arena.

To this end, Venn today announces a strategic collaboration with Open Orphan DAC. The principals of Open Orphan DAC have significant experience of clinical research and regulatory consulting for companies developing products under the auspices of the various Orphan Drug frameworks in the US and EU.

As part of this agreement both parties will commit to resource sharing and joint marketing and seek to achieve a stronger commercial position in this well-defined market segment.

Financing

Following a review of the available funding options, including consultation with the Company's principal shareholder, Venn's Board, in collaboration with the principals of Open Orphan, has identified a group of private individuals which, in the Board's view, represents the best source of funds for the anticipated increase in working capital relating to this initiative.

This group of private individuals has subscribed for a two year loan note with a principal of £1m and a 10% coupon. The interest on the notes will be paid biannually. In addition, the holders of the loan notes will receive warrants to purchase such number of ordinary shares of the fully diluted share capital of Venn as is permitted under Venn's existing authority conferred by its shareholders at it's AGM on 27th June 2018 on an as-converted basis, in return for (a) nominal consideration as regards 2,141,854 ordinary shares (i.e. 3%) and (b) consideration of 2.2p per share, being equal to the average close price per share over the five trading days prior to completion, as regards 3,908,146 ordinary shares.

In conjunction with this loan facility and in order to deepen the orphan drug expertise in Venn it has been agreed that certain boad changes will be made, with immediate effect. Cathal Friel a subscriber to £108,642 loan notes (and associated warrants over 657,285 shares); a principal of Raglan Capital Limited (the arranger of the loan notes) and principal of Open Orphan will join the board of Venn as Chairman. In addition Professor Brendan Buckley, a principal of Open Orphan, will join the board of Venn as a Non-Exective Director. Allan Wood, Chairman and Mary Sheahan, Non-Executive Director, retire from the Venn board and Michael Ryan remains on the board as a Senior Independent Director.

Cathal Friel has 30 plus years of corporate experience and is the Managing Director and founder of Raglan Capital. Cathal was a Co-founder and Director of Amryt Pharma plc, a leading European Orphan Drug Company listed on the London and Dublin Stock Exchanges. His is also Director and one of the founders of Open Orphan, was previously Executive Chairman and co-founder of Fastnet Oil & Gas plc and was one of the founding directors of Merrion Stockbrokers. Cathal has an MBA from the University of Ulster.

Prof Brendan Buckley was the Chief Medical Officer of ICON plc until 2017, prior to which he co-founded Firecrest Clinical, a company which focused on improving the performance of clinical trial sites. A medical graduate of University College Cork (UCC) and a doctoral graduate in Biochemistry of Oxford University, Brendan has over 30 years' experience in clinical research. Brendan is a Director and one of the founders of Open Orphan as well as of a number of other developmental stage biopharma companies. He was a Director of the Health Products Regulatory Authority of Ireland between 2004 and 2011 and was a member of the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) from 2000-2003 and the EMA Scientific Advisory Committee on Diabetes and Metabolism until 2011.

Commenting on this development Tony Richardson CEO of Venn said "The development of areas of specialisation is critical if we are to position Venn as a higher value business relative to our peers. We envisage the development of a number of areas of specialisation and orphan and rare technologies represent a logical starting point for us. I would like to thank Allan Wood and Mary Sheahan for their guidance and assistance in helping us to build our current platform and business base. I welcome Cathal and Brendan to the team and look forward to working together to develop a commercial business in this well-defined market segment.

The following information regarding the appointment of Cathal Friel, aged 54, is disclosed under Schedule 2(g) of the AIM Rules for Companies:

The following information regarding the appointment of Brendan Buckley, aged 68, is disclosed under Schedule 2(g) of the AIM Rules for Companies:

Save for the disclosures above, there are no further disclosures to be made in accordance with Rule 17 and Schedule 2(g) of the AIM Rules.

Enquiries:

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

About Venn Life Sciences: Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management to pharmaceutical, biotechnology and medical device organisations. Venn have dedicated operations in France, Germany, the Netherlands, the UK, Ireland with partners across Europe and the US.

About Open Orphan DAC: Open Orphan is a recently established European and Middle East Focused Orphan Drug, Rare Disease and Specialty Pharma Platform. Open Orphan is led by an experienced Board and management team with expertise in orphan drug regulatory approval, market access and reimbursement, commercialisation and launch optimisation.

Further information in relation to Venn Life Sciences www.vennlifesciences.com