hVIVO Regulatory News (HVO)

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation ("MAR") EU no.596/2014. Upon the publication of this announcement via Regulatory Information Service ("RIS"), this inside information is now considered to be in the public domain.

hVIVO plc

("hVIVO" or the "Company")

£16.8m full-service RSV contract with top five global pharma client

Trading ahead of guidance

Highlights

· Pharma client is funding expedited manufacture of additional supply of RSV challenge agent

· Confirmatory challenge cohort to verify infectivity of the new RSV challenge virus batch

· Multiple cohort challenge trial to test efficacy of client's RSV antiviral candidate

· Trading ahead of previous market expectations driven by margin expansion

hVIVO plc (AIM & Euronext: HVO), the world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that it has signed a £16.8m full-service contract with an existing top five global pharmaceutical client to test its respiratory syncytial virus ("RSV") antiviral drug candidate using the hVIVO RSV Human Challenge Study Model.

The contract includes the expedited manufacturing of the RSV challenge agent, a confirmatory challenge cohort and a multiple cohort challenge trial. The purpose of the trial is to evaluate the efficacy of the antiviral candidate against RSV infection in healthy adults and identify the most effective dosing ahead of later stage clinical trials. Revenue from this contract will be recognised across 2023, 2024 and 2025 with the majority of the revenues being recognised in 2024.

hVIVO will commence Good Manufacturing Practice (GMP) compliant virus manufacturing activities immediately, which is expected to complete in H1 2024. Upon completion of manufacturing, the Company expects to confirm infectivity of the new RSV challenge virus batch in small number of healthy volunteers recruited via FluCamp.

Subject to the successful completion of the above, and the receipt of relevant regulatory approvals, the Company expects to start the RSV human challenge trial in H2 2024. This will be a randomised, double-blinded, placebo-controlled Phase 2a study. It will consist of multiple cohorts to evaluate the efficacy of the client's RSV antiviral candidate via different dosing regimens. The multiple cohort study highlights the expanding utility of human challenge trials, demonstrating their ability to not just provide quick efficacy data, but also refine dosing strategies ahead of critical later stage clinical trials. The challenge study is planned to take place at the Company's new state-of-the-art quarantine facilities in Canary Wharf, which is on track to be operational in H1 2024.

The Company is pleased to report that trading has continued to be strong across the Group, with revenue slightly ahead of previous market expectations. The Group has continued to improve operational efficiencies which, coupled with the facilities funding that will benefit both FY23 and FY24, has resulted in EBITDA margins exceeding 20% for the year ending 31 December 2023. Consequently, the Group now expects EBITDA to be ahead of previous market expectations. With the addition of today's contract, the Company has clear revenue visibility into 2024. Further details will be shared as part of the Company's FY23 Trading Update in late January 2024.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "Our RSV (Memphis strain) challenge agent has played a significant role in the development of RSV vaccines and we are delighted that it is continuing to be used as the go-to model for our clients. We have built a world-leading portfolio of challenge agents and are working hard with our clients to add new models all the time. This contract is another example of the end-to-end full service offering that hVIVO has already successfully provided to several clients. We are also delighted with the Company's strong operational performance in 2023 and now expect to exceed the previous market guidance and look forward to updating the market further in the new year."

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "As clinical assets approach critical and high-cost late-stage trials, biopharma companies want to minimise the risk of failure, and know that their asset has the best chance of reaching the market. By using multiple cohorts and testing different dosing regimens, our clients are able to use a human challenge trial to optimise the dosing strategy as well as gain vital quick efficacy data, further de-risking future clinical development. With the expanded capacity and enhanced capabilities of our new facility, we are well-equipped to deliver on the increasing demand for multiple cohort studies of this kind."

Interested in becoming a volunteer?

hVIVO recruits 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.

For further information please contact:

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 11 human challenge models, with a number of new models under development, to test a broad range of infectious and respiratory disease products. The Company has 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 capability 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 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.

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).