hVIVO Regulatory News (HVO)

hVIVO plc

("hVIVO" or the "Company")

£6.3m HRV contract signed with biotechnology client

Highlights

· Study to enter hVIVO's state-of-the-art Canary Wharf quarantine facilities in H2 2024

· Potential to enhance value of the client's antiviral by generating efficacy data in HRV

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 £6.3m contract with a biotechnology client to test its antiviral candidate using the hVIVO Human Rhinovirus (HRV - common cold virus) Human Challenge Study Model.

The Phase 2a randomised, double-blinded placebo-controlled human challenge trial is planned to take place at the Company's new specialist state-of-the-art quarantine facilities in Canary Wharf. It will evaluate the effect of the antiviral candidate on viral load, safety, tolerability, and prophylactic antiviral activity against HRV infection in multiple cohorts of healthy volunteers.

The study is expected to commence in H2 2024, with revenue recognised in 2024 and 2025. As part of the study, hVIVO will recruit healthy volunteers via the Company's dedicated volunteer recruitment arm, FluCamp. This biotechnology client recognises the benefit of human challenge in quickly generating early human efficacy data, which has the potential of significantly enhancing the value of their clinical asset.

Human rhinoviruses (HRV) are a group of pathogens that cause 'the common cold', with over 150 distinct types of HRV currently known. Although one third of HRV infections are asymptomatic, it can be potentially serious in the elderly, immunocompromised and those with existing respiratory diseases, and there is strong evidence of a relationship between HRV infection and more severe symptoms of asthma and COPD.1 To date, no antiviral has been approved in the prevention or treatment of HRV infection.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We are delighted to be partnering with this biotech client to investigate the use of their antiviral candidate against HRV. Our human challenge trials can provide quick efficacy data, that has the potential to significantly enhance the value of our clients' assets, something which is critical in the current tight biotech investment landscape. There is renewed focus and capital available to biopharma companies with assets targeting respiratory disease indications. Our HRV Human Challenge Model offers our clients the opportunity to open up these markets, given HRV's association to exacerbation of asthma and COPD."

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "With our new state-of-the-art facility, we are able to conduct significantly more multi-cohort challenge trials concurrently, providing quick efficacy data to accelerate drug development. There remains no approved antiviral to treat HRV infections, despite their dangerous impact on large and vulnerable population groups. I look forward to following the progress of this antiviral candidate when it enters the clinic later this year."

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3787546/#

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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 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.