ORPH.L Regulatory News (ORPH)

Open Orphan plc

("Open Orphan" or the "Company")

£5.7m Influenza human challenge study contract win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist clinical 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 £5.7m contract with a specialist biotechnology company developing therapeutics for respiratory viral infections, to test its antiviral product using the hVIVO Influenza human challenge study model.

The human challenge study is expected to commence in Q1 2022 and will be conducted at hVIVO's state-of-the-art facilities in London. The Company expects the revenue from the contract to be recognised across 2021 and 2022.

The client's influenza antiviral product has demonstrated effectiveness in animal preclinical models of respiratory viruses and has several clinical and commercial advantages with respect to convenience, resistance, durability and compatibility when compared to similar products.

The Company expects to sign more contracts in this area as attention switches to potential future Influenza outbreaks. Influenza is expected to be a major global issue due to low level population immunity caused by reduced infection rates over the last 18 months, which is the result of COVID-19 mitigation measures such as social distancing and mask wearing. After a solidly EBITDA profitable H1, this contract will help ensure the Company enters a period of sustained growth and profitability across a whole range of challenge studies.

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) and human Rhinovirus HRV (common cold virus), malaria, 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 be working with this biotechnology company to test their exciting antiviral product against our Influenza human challenge study model. As a result of social distancing, hand washing and other COVID-19 mitigation measures, there has been extremely low levels of population immunity to Influenza. As such, there is an increasing concern that in the year ahead Influenza outbreaks could spike considerably and therefore this type of therapeutic could form part of an effective defence against future outbreaks of Influenza due to its compelling array of clinical and commercial advantages.

"This contract is also a further demonstration of our expertise and capabilities testing therapeutics across the infectious disease and respiratory market, which is due to grow exponentially to over $250 billion by 2025, as pharmaceutical companies around the world look to restock the medicine cabinets with novel vaccines and antivirals. With this in mind, we expect that moving into 2022, our work will continue to come from a broad range of infectious and respiratory diseases, as we see rapid growth in those spaces."

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.

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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 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.