hVIVO Regulatory News (HVO)

hVIVO plc

("hVIVO" or the "Company")

£5.2m RSV human challenge study contract with global biotechnology company in Asia Pacific

and Notice of Trading Update

A new client from a new regional market

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 £5.2m contract with a global biotechnology company headquartered in Asia Pacific to test their respiratory syncytial virus ("RSV") vaccine candidate, using hVIVO's established RSV Human Challenge Study Model. The Company also announces that it will provide a trading update for the year ended 31 December 2022 on 25 January 2023.

The Phase 2a double-blinded placebo-controlled human challenge trial will take place at the Company's specialist quarantine facilities in London and will evaluate the safety, immunogenicity and efficacy of the client's vaccine candidate against RSV infection. The study is expected to commence in H2 2023, with the revenue being recognised across 2023 and 2024. As part of the study, hVIVO will recruit healthy volunteers via the Company's dedicated volunteer recruitment arm, FluCamp.

This is the first human challenge trial contract that hVIVO has signed with a client in the Asia-Pacific ("APAC") region in over a decade, and is a growth area for the Company as it seeks to further diversify its client base and orderbook. The contract also further highlights the growing demand for challenge trials from global biopharmaceutical companies as they seek to gain cost-effective efficacy data to de-risk their development programmes and enhance their candidate's value before commencing later-stage field studies.

hVIVO has three 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), and asthma, as well as malaria.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "I am delighted to have signed this contract with a biotechnology company headquartered in Asia Pacific to test its RSV vaccine candidate, which is our first contract signed in the region in over a decade. APAC has been identified as a key growth region for the Company, and this contract is an encouraging indicator that our strategy there is bearing fruit. I am optimistic that more biopharma companies in the APAC region will increasingly recognise both the value of human challenge trials, and hVIVO's reputation as the 'go-to' partner in the market.

"This award further strengthens our revenue visibility into 2024 and gives weight to the fact that we have a strong and sustainable growth model. The team has worked hard to achieve record numbers in 2022, and this award is the perfect start to 2023."

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO said: "Although RSV has a low chance of causing serious illness in healthy adults, it can be highly virulent for children and the elderly. The disease has caused particular strain on paediatric health this winter in the US and Europe, with reports suggesting newborns are being hospitalised in the US at seven times the rate observed in 2018, the last non-COVID-19 winter season1. This has reinforced the global need for innovative vaccines and antivirals; the hVIVO RSV Human Challenge Model can play a critical role in bringing these treatments to market more quickly."

1. CNBC News, 18 November 2022: Children's hospitals call on Biden to declare emergency in response to 'unprecedented' RSV surge

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Notes to Editors

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.

About RSV

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 4 million hospitalisations and approximately 60,000 in-hospital deaths in children younger than 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.