ORPH.L Regulatory News (ORPH)

28 September 2020

Open Orphan plc

("Open Orphan" or the "Company")

New £4.3m Challenge Study Contract Win with Global Top 10 Vaccine Company

Interim Results to be published Wednesday 30th September 2020

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 £4.3 million contract to conduct a human viral challenge study utilising one of our 8 traditional challenge study models for another of the global top 10 vaccine companies.

This trial will be conducted in the Company's dedicated human viral challenge quarantine unit in London with all volunteers recruited through hVIVO's volunteer recruitment website, www.flucamp.com. The hVIVO unit is Europe's only commercial 24-bedroom quarantine clinic with on-site virology laboratory.

Work on this major new contract has started already and the contract is expected to be delivered in Q1 2021 with the majority of revenues being generated in H1 2021. It is a further example of Open Orphan delivering on its pipeline and stated strategy of winning sizeable contracts.

The Company's Interim Results will be published on the morning of Wednesday the 30th of September 2020, analyst conference call scheduled for 10.30am on the 30th of September.

Cathal Friel, Executive Chairman, Open Orphan, said:

"Open Orphan continues to execute on its substantial pipeline that has been built up by the expertise and experience of our professional and hardworking teams in hVIVO and Venn Life Sciences. We are focused on continuing to deliver large and profitable contracts which demonstrate hVIVO's position as the world leader in the testing of vaccines and antivirals using human challenge clinical trials.

Our stated objectives when we acquired hVIVO in January of this year was to increase its 24-bedroom quarantine clinic annual utilisation from its traditional 20-25% utilisation up to maximum capacity and to build out a clear pipeline of signed contracts going forward. With this contract, we are close to having the hVIVO quarantine clinic block booked with our conventional challenge studies until December 2021. Within a month or two we are likely to have our quarantine clinic block booked out for the next 18 months to two years with conventional challenge study contracts.

I am hugely excited by the progress we are making as a Group since our IPO in 2019 and I look forward to continuing to update shareholders on the work we are doing over the coming months."

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. hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment. Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com.

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.

For further information please contact

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. hVIVO's challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. The hVIVO facility 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. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering. 

Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO  and  Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world's largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer's via wearables during clinical trials. Therefore, Open Orphan's data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.