ORPH.L Regulatory News (ORPH)

10 December 2021

Open Orphan plc

("Open Orphan" or the "Company")

$13.4m Influenza human challenge study contract win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed a $13.4m contract with a US-based biotechnology company to test its novel antiviral candidate using the hVIVO Influenza Human Challenge Study Model.

The study is expected to commence in H2 2022 and will be conducted at hVIVO's state-of-the-art quarantine facilities in London. The Company expect the majority of revenues to be recognised in 2022.

The Company expects to sign an increasing number of contracts in this area as the global pandemic has highlighted the increased investment needed from governments and Big Pharma to develop effective, novel treatments for a range of infectious diseases that have potential to cause the next pandemic. Influenza is one such disease, with emergences of flu pandemics impossible to predict. Symptoms of influenza may be mild or cause severe disease, or in certain cases, death. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 - 650,000 deaths per year.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (HRV - common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan, said: "We are delighted to announce this significant challenge study contract valued at over £10m, with a US-based biotechnology client testing its highly promising influenza antiviral candidate. This contract demonstrates the Company's continued ability to convert its leading portfolio of challenge study models into substantial contracts, with signed contracts across a number of our challenge study models including RSV, asthma, hRV, and flu in the clinic next year. This underlines our market position as the world leader in the testing of vaccines, antivirals and respiratory products using human challenge trials.

"The recent emergence of the Omicron variant has illustrated the threat of pandemic infectious diseases, and as a result, pharma companies globally are looking to address the next cohort of infectious diseases which have potential to reach pandemic level, and are developing new therapeutics to help tackle them. Influenza is high on this list, and we expect to sign more contracts of this type as the infectious disease market grows exponentially in the coming years to be worth $250 billion by 2025."

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 (as implemented into English law) ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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.

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

For further information please contact:

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 an explosion in the 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.