hVIVO Regulatory News (HVO)

hVIVO plc

("hVIVO", the "Company" or the "Group")

hMPV challenge model update

Highlights

· hVIVO successfully completes pilot hMPV characterisation study

· Study exhibited strong infectivity rate and induced symptomatic disease in healthy volunteers

· Now marketing for hMPV challenge trials to support the development of hMPV vaccines and antivirals

· Dr Andrew Catchpole to present data from the study at the 13th International RSV Symposium in Brazil

hVIVO plc (AIM: HVO), a fast-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 successfully completed a pilot characterisation study for its human metapneumovirus (hMPV) strain A2 challenge agent, demonstrating proof-of-concept for a future hVIVO hMPV challenge model to test new vaccines and antivirals.

The pilot study, which took place at the Company's state-of-the-art quarantine facility in Canary Wharf, produced a safe, measurable and reproducible disease in healthy volunteers with strong rates of infection and symptomatic disease. This study confirms that the Company has a viable hMPV human challenge model which can be used in future human challenge trials to support the development of hMPV vaccines and antivirals to meet this unmet medical need. The Company is now marketing its hMPV challenge model and will look to complete the remainder of the characterisation study with a partner in advance of completing future human challenge trials.

Dr Andrew Catchpole, Chief Scientific Officer at hVIVO, will present data from the pilot study at a presentation titled 'Disease characteristics and immunological profiles obtained from pilot study in a newly developed hMPV human challenge model' at the 13th International RSV Symposium on 12-15 March 2025 in Iguazu, Brazil.

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO plc, said: "The pilot hMPV characterisation study in healthy volunteers was designed to test the feasibility of this new model and has been very successful, producing good infectivity rates and clear disease symptoms. Like the hVIVO RSV models, I am confident our hMPV model can play a crucial role in speeding up the development of a first vaccine or antiviral for this global pathogen, which is currently causing particular concern in China1 where a surge in cases has been recorded."

1 https://www.ecdc.europa.eu/en/news-events/increase-respiratory-infections-china

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Notes to Editors

hVIVO plc (ticker: HVO) is a fast-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 Group has world class challenge agent manufacturing capabilities, 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 also offers additional clinical field trial services such as patient recruitment and clinical trial site services.

hVIVO runs challenge trials in London - its new state-of-the-art facilities in Canary Wharf opened in 2024 and is the world's largest commercial human challenge trial unit, with highly specialised on-site virology and immunology laboratories, and an outpatient unit. To recruit volunteers / patients for its studies, the Group leverages its unique clinical trial recruitment capability via its FluCamp volunteer screening facilities in London and Manchester.

About hMPV

hMPV is a common virus that causes an upper respiratory infection, similar to the common cold. Symptoms include cough, fever, nasal congestion, and shortness of breath. Most people have mild cases of hMPV, but severe cases can result in bronchiolitis, bronchitis and pneumonia. hMPV is associated with approximately 20% of respiratory tract infections in children worldwide2. Up to 16% of the children infected with hMPV develop more severe symptoms3, with over 16,000 deaths worldwide in children under the age of five each year.4 Despite its prevalence and potential severity, there are currently no vaccines or antivirals approved to treat hMPV.5

2 https://www.sciencedirect.com/topics/immunology-and-microbiology/human-metapneumovirus

3 Howard LM, et al. 2021

4 Wang X, et al. 2021

5 CDC