ORPH.L Regulatory News (ORPH)

10 August 2020

Open Orphan plc

("Open Orphan" or the "Company")

Major New Contract Win with Top 3 Pharma Company

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials is pleased to announce a new contract, valued at £4m, with a top 3 global pharmaceutical company to be the sponsor of and provide a respiratory syncytial virus (RSV) human challenge study trial.

This new £4m contract represents continued conversion of Open Orphan's substantial pipeline and generation of significant cash flow. The contract further validates Open Orphan's position as the world leader in the provision of viral challenge study clinical trials and laboratory services supporting both biotech and Big Pharma in developing antivirals, vaccines and respiratory therapeutics.

This study will take place in hVIVO's unique London-based quarantine unit and is expected to be completed by the end of quarter one 2021. The hVIVO unit is Europe's only commercial 24-bed quarantine clinic with on-site virology laboratory. hVIVO is the only company globally offering the capability to conduct an RSV human challenge study.

Cathal Friel, Executive Chairman, Open Orphan, said:

"This is another exciting new contract win with a new customer for Open Orphan's subsidiary hVIVO as we convert the substantial pipeline that is building up within the Company. This contract, with a top 3 global pharmaceutical company, is evidence of the high regard hVIVO is held in within the industry and reinforces our position as the world leader in the testing of vaccines and antivirals using human challenge clinical trials. As a group we are focused on winning and delivering high-quality, profitable contracts and this is another example of our delivery against that strategy."

The information contained within this announcement is 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 via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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Notes to Editors - Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility which offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.    In June 2020  hVIVO COVID Clear Test  was launched, the most accurate antibody test available to UK employers, helping them to get their people back to work.

Open Orphan comprises of two commercial specialist CRO services businesses; hVIVO  and  Venn Life Sciences and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company's customer base and with complementary specialist CRO services, widened the range of the Company's service offerings.