ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

New hVIVO contract signed with a European Biotech Company

Initial study for the provision of a RSV human challenge study

· Respiratory Syncytial Virus ("RSV") human challenge study Projected to deliver £3.2m in revenue in 2020 with the pivotal challenge study expected to commence end Q4 2020, with the potential to deliver significant further revenue expected to be a minimum of £7m.

· First contract that utilises complementary in-house Clinical Research Organisation ("CRO") services of hVIVO and Venn Life Sciences ("Venn") following completion of merger with hVIVO

6 March 2020: Open Orphan plc (ORPH) the rapidly growing CRO specialist pharmaceutical services Group which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services, is pleased to announce the signing of a new contract with a European Biotech Company for the provision of a RSV human challenge study. The study is projected to deliver £3.2m in revenue all of which is expected to be recognised in 2020. If the study is successful, it is anticipated that an additional follow-on larger pivotal challenge study will commence end Q4 2020, delivering significant further revenue and expected to be a minimum of £7m.

This contract demonstrates hVIVO, part of Open Orphan, successfully converting its pipeline and reinforces its position as world leader in the provision of viral challenge studies, vaccine and viral laboratory services, supporting product development for customers developing antivirals, vaccines and respiratory therapeutics. These services are particularly relevant and topical in the environment of heightened awareness of virology following Covid-19. London-based hVIVO is unique as it has Europe's only commercial 24-bed quarantine clinic and on-site virology laboratory and is the only company globally with the capability to run an RSV human challenge study.

This breakthrough study reinforces hVIVO's position as the leader in the provision of virology services.

Trevor Phillips, CEO of Open Orphan, said:

"This agreement continues to endorse the importance being placed on the use of viral challenge models supporting product development for companies developing antivirals, vaccines and respiratory therapeutics. This agreement is the first agreement utilising what is now, a broader and complementary in-house service offering. All aspects of the study will be conducted within Open Orphan, leading to the elimination of sub-contractor costs and retain more contracted revenue. We look forward to delivering the work for a European Biotech Company and further developing our relationship."

Cathal Friel, Executive Chairman of Open Orphan, said:

"This agreement demonstrates one of the benefits of the merger with hVIVO and the opportunity the broadened service offering provides in delivering a catalyst for significant revenue growth and margin expansion within the business. In the short term, the combination of Open Orphan and hVIVO is expected to result in substantial cost savings through the elimination of subcontractor costs where they can be replaced by new capabilities within the Company."

For further information please contact

Open Orphan plc

Cathal Friel, Executive Chairman +353 (0)1 644 0007

Trevor Phillips, Chief Executive Officer +44 (0)20 7347 5350

Arden Partners plc (Nominated Adviser and Joint Broker) +44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer

Davy (Euronext Growth Adviser and Joint Broker) +353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR) +44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

Notes to Editors:

Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe's only 24-bedroom quarantine clinic with onsite virology lab in London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of the Coronavirus in 2020. The company also 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.  No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. 

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) 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.

About RSV

RSV is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. It is the number one cause of childhood hospitalisation both in the United States and around the world. Nearly all children are infected with the virus at least once by the age of 2-3 years. The disease is particularly dangerous for premature babies, children with other health conditions and the elderly. Many children develop pulmonary disease and/or asthma from RSV that persists throughout adult life making them susceptible to re-infection. Currently, there are no approved vaccines for RSV.