hVIVO plc

("hVIVO" or the "Company")

£6.8m RSV human challenge contract signed

Second contract with an APAC client in 2023

hVIVO plc (AIM & Euronext: HVO), (formerly Open Orphan plc) a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that it has signed a £6.8m contract with a leading pharmaceutical company based in Asia Pacific ("APAC"), to test its respiratory syncytial virus ("RSV") antiviral drug candidate, using the hVIVO RSV Human Challenge Study Model.

The Phase 2a double-blinded placebo-controlled human challenge trial will take place at the Company's specialist quarantine facilities in Whitechapel and will evaluate the efficacy profile of the antiviral against RSV infection in healthy volunteers. The study is expected to commence in H1 2024, with revenue mostly recognised in 2024. As part of the study, hVIVO will recruit healthy volunteers via the Company's dedicated volunteer recruitment arm, FluCamp.

RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50 million people annually, leading to four million hospitalisations and approximately 60,000 in-hospital deaths in children younger than five years.¹ hVIVO has inoculated over 1,600 healthy volunteers across 28 RSV challenge trials to date and the challenge trial data has already expedited the development of several RSV vaccines for a number of pharmaceutical companies.

This is the second human challenge trial contract that hVIVO has signed with an Asia-Pacific client in 2023 following the identification of this region as a key growth area for the Company. The strength of data generated from hVIVO's human challenge trials is resulting in a growing demand from global biopharmaceutical companies, as they seek to de-risk their development programmes ahead of later stage field studies.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We are delighted to be working with this client on their important RSV programme. RSV has been a particular blight on humanity with no effective vaccine against this virus in over 60 years of R&D. Our RSV challenge trial model is a tried and tested model that has been used to expedite the development of several RSV vaccine candidates, and we expect that at least one of the vaccines we have worked on will reach patients this year. This new client will benefit from our experience and expertise to impact their drug development plans.

"For hVIVO, it is highly encouraging to see our global client list continue to grow and our orderbook further diversify with our second significant contract with an APAC client. One of our goals for 2023 is to attract more customers from the APAC region, and we have already seen this come to fruition with two contracts. It is a great start to the year and builds our pipeline for 2024. We expect to continue this strong momentum in the APAC region, and the rest of the world, as the growing number of biopharma companies recognise the strong value of human challenge models."

¹ Shi, T. et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. The Lancet 390, 946-958 (2017).

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Notes to Editors

About hVIVO

hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.

The Group's fast-growing services business includes a unique portfolio of 10+ human challenge models to test a broad range of infectious and respiratory disease products, world class challenge agent manufacturing, specialist drug development and clinical consultancy services via its Venn Life Sciences brand, and a lab offering via its hLAB brand, which includes virology, immunology biomarker and molecular testing. The Group offers additional clinical field trial services such as patient recruitment and clinical trial site services.

hVIVO runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester.