ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

Trading Update

Volunteer Recruitment and Laboratory Facilities Expansion

New facilities doubles volunteer recruitment screening capacity

Changes allow for expanded business scope and laboratory services offering

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, provides a trading update for the year ended 31 December 2021. The Company also announces it will be opening a new primary FluCamp volunteer recruitment screening facility in Plumbers Row, London ("Plumbers Row Facility") and a secondary FluCamp recruitment facility in Manchester.

Trading Update

Subject to completion of the audit, the Company expects both revenues and EBITDA to be in line with the expectation detailed at the time of the interim results. Accordingly the Company expects 2021 to be EBITDA positive with revenues of approximately £40m. Cash and cash equivalents as of 31 December 2021 was £15.6m (30 June 2021: £14.9m). The Company further expects to be in line with management expectations for year-ending 31 December 2022, targeting revenues in the region of £50m in non-COVID-19 work. COVID-19 revenue for 2022 will be in addition to this and will depend on the eventual timing of these studies.

Facilities Expansion

The new facilities will double the Company's previous volunteer screening capacity, significantly boosting its ability to identify and enrol study volunteers and patients and further strengthening its world leading human challenge capabilities.

As part of the opening of a new specialised volunteer recruitment facility in London, the Whitechapel quarantine clinic and the Queen Mary's Bioenterprises Centre ("QMB") clinic will both be exclusively dedicated to conducting human challenge studies going forward. The space at QMB currently providing volunteer screening will be converted into further quarantine bedrooms. As such, the Company's QMB facility will expand to 31 beds, adding to the Whitechapel Clinic's 19 beds and the Plumbers Row Facility's 12; in total the Company's bed count will reach 62. These new facilities offer an opportunity to the Company to expand the scope of the business to offer Phase I and Phase II vaccine field trials, PK (pharmacokinetics) studies, bridging studies, and patient trials (as opposed to healthy volunteer human challenge trials) as part of large international multi-centre studies which do not require a quarantine setting.

The increase in volunteer recruitment capacity will enable the Company to recruit larger cohorts more quickly than before and cement Open Orphan's world leading position and reputation in volunteer recruitment. Particularly in Manchester, the secondary facility extends the Company's reach for more volunteers and facilitates the increasing demand for human challenge studies. During volunteer screening there are large numbers of volunteers that are ineligible to take part in challenge studies for a variety of reasons, such as previous infection by the virus under investigation. By broadening the business offering to include Phase I and Phase II field trials, a large proportion of the volunteers already in the FluCamp facility could be eligible to take part in these studies.

The Plumbers Row Facility, London, plus the volunteer recruitment facility in Manchester, will have additional laboratory capacity, meaning samples collected during volunteer screening visits can be processed and stabilised on site. As a result, the primary laboratory at QMB has the capacity to expand its virology lab services business and increases its biomarker and molecular testing capabilities.

In addition, the Company's corporate office will move from Alie Street to an upper floor in Plumbers Row. Both London and Manchester facilities offered attractive terms; the new Plumbers Row space is c. 9,000 sq ft and is a third of the cost of the current space of 4,000 sq ft; the new Manchester facility comes at the same cost as the old facility, but with four times the floor space at c. 2,000 sq ft.

Cathal Friel, Executive Chairman of Open Orphan, said: "Despite difficult market conditions during the year, which have continued into 2022, I am pleased with the performance of the Open Orphan team and during 2021 we signed an impressive number of human challenge study contracts with Big Pharma and biotechnology clients.

"We have continued our strong work at the start of this year, and our new facilities in both London and Manchester will not only enable the Company to screen a greater number of potential volunteers, it will also increase our total bed count to 62. Considering the greater size and functionality of the new facilities, as well as their cost, the Company has executed the expansion in a highly cost-efficient manner."

Yamin Khan, Chief Executive Officer of Open Orphan, said: "I am delighted to be opening a new primary FluCamp volunteer recruitment and screening facility within walking distance from our other Whitechapel facilities as well as a new, larger Manchester volunteer recruitment facility. These facilities double our volunteer screening capacity and importantly, expand on our already world leading clinical trial and laboratory services offering.

"As a result of the changes, we have the potential to expand the scope of our business as we head into a crucial period of substantial growth across the infectious disease market. I believe we are now very well positioned with an enhanced clinical trial offering and unique volunteer and patient recruitment capacity, which will enable us to serve an increasing pool of Big Pharma and biotechnology clients seeking to test novel therapeutics against different infectious and respiratory diseases."

Robin Rogiers, Director of Clinical Delivery & Innovation of hVIVO, said: "The opening of the new primary and secondary FluCamp volunteer facilities means we now boast a truly world class clinical trial offering. With quarantine capacity significantly increased and volunteer recruitment capacity doubled, we will be able to expand the scope of our clinical trial business to include vaccine field trials, PK studies, bridging studies and patient trials as part of large international multi-centre studies. The increased scope also includes an enhanced virology lab services offering at QMB, which will now be able to increase its biomarker and molecular testing capabilities."

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

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Notes to Editors

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company's Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma, and biotech companies.

Open Orphan's Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company's Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing, and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.