ORPH.L Regulatory News (ORPH)

24 September 2020

Open Orphan plc

("Open Orphan" or the "Company")

Statement re price movement and press speculation

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 notes the recent share price movement and press speculation regarding UK government-funded Coronavirus human challenge studies.

The Company confirms that it is in advanced negotiation with the UK Government and other partners for a Coronavirus challenge study in the UK. While negotiations continue, it is expected that in the event that a contract is agreed revenue will be in excess of £7 million, being the approximate anticipated revenue for a Coronavirus challenge study as indicated by the Company on 22 May 2020. However, there can be no certainty that these discussions will lead to a new contract until final negotiations are concluded. The Company will update the market in due course as appropriate.

Further to its announcements of 9 March 2020 and 22 May 2020 regarding the development by the Company of a Coronavirus challenge study model the Company remains in ongoing discussions with potential vaccine developers regarding Coronavirus challenge studies.

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.

ENDS

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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.