ORPH.L Regulatory News (ORPH)

9 July 2021

Open Orphan plc

("Open Orphan" or the "Company")

Significant HRV & Influenza human challenge study contract win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services 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 significant contract with AIM ImmunoTech Inc ("AIM IT") to test its antiviral candidate, Ampligen, using both the human Rhinovirus HRV (common cold virus) and Influenza human challenge study models as part of a single study.

This antiviral study will be conducted by hVIVO. AIM IT will be the study sponsor of the Phase 2 human challenge trial, which is expected to commence in Q4 2021. The Company expects the majority of revenue from the contract to be recognised in the current financial year. The AIM IT contract demonstrates the breadth of Open Orphan's service offering and its ability to test multiple pathogens at once in its state-of-the-art zoned unit, reinforcing its status as the world leader in its field. The Company expects to sign more contracts in this area due to the increased international focus on respiratory and infectious diseases following the outbreak of COVID-19 and as attention turns to potential future outbreaks of other viral diseases.

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). In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan, said: "We are delighted to commence work with AIM ImmunoTech, a leading immuno-pharma company, to test their product against both HRV and Influenza human challenge study models as part of a single study. Being able to test our client's product against multiple pathogens in a single study demonstrates our capability of our state-of-the-art London unit, our industry leading experience, and our position as the go to provider of human challenge studies for biotech and pharmaceutical companies globally. Fortunately, with our access to three challenge study clinics in London, we were able to find a small gap in our schedule later this year to slot this particular study in at short notice.

"Likewise, as previously confirmed to the market, our London facilities are comprehensively prebooked throughout this year and into next year. As such, I am also delighted to confirm that we were solidly EBITDA profitable in H1 2021 and we remain on target for a profitable and successful 2021."

Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech Inc., said: "It is our belief that Ampligen's mechanism of action regarding the human innate immune system gives Ampligen broad-spectrum capabilities as an antiviral prophylaxis and therapeutic. The ability to do a human challenge trial using HRV and Influenza allows us to test in humans Ampligen's potential role as a powerful prophylaxis and therapeutic for a wide range of respiratory viruses. It is our belief that if it works in these two viruses, then it will have the potential to have a similar impact in other respiratory viruses."

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 pharmaceutical service/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, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world's first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

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. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

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.

AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.