HVO Hvivo Plc

hVIVO plc

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

£2m hMPV characterisation study contract

hVIVO plc (AIM: HVO), a fast-growing early-stage Contract Research Organisation (CRO) and the world leader in human challenge clinical trials, announces that, following the success of its pilot human metapneumovirus ("hMPV") characterisation trial announced in January 2025, it has signed a £2 million contract with a new biopharmaceutical client to complete the final stage of the characterisation study ahead of future hMPV human challenge trials ("HCTs").

The pilot characterisation trial produced a safe, measurable and reproducible disease in healthy volunteers, demonstrating strong infection and symptomatic response rates. It also confirmed the optimal dose of the challenge agent, validating the viability of hVIVO's hMPV human challenge model. This next phase aims to expand the dataset by enrolling additional healthy volunteers, further strengthening the model and ensuring robust powering for future hMPV HCTs. The final phase of the study is expected to commence in H125, with the revenue being recognised in 2025.

The Company has active interest in this challenge model from prospective clients and should be in a position to commence hMPV HCTs from H225, subject to the successful completion of this study and receipt of the necessary regulatory approvals. With over three decades of expertise in challenge agent manufacturing and human challenge model development and world leading facilities, the Company continues to lead in safely conducting HCTs for a broad range of infectious and respiratory diseases.

Given the rising global focus on hMPV due to recent outbreaks and increasing case numbers, the Company anticipates growing demand for hMPV drug development services. hVIVO is proud to support global biopharmaceutical companies by generating fast, cost-effective efficacy data to accelerate the development of critical vaccines and antivirals. These efforts can facilitate regulatory designations, drive product acquisitions, expedite market approval and ultimately address critical unmet medical need.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "We are pleased to have secured this £2 million contract with a new biopharmaceutical client so soon after the successful pilot hMPV characterisation study. This underscores the significant value HCTs can bring in providing rapid, high-quality efficacy data to support vaccine and therapeutic development. hMPV currently has no approved vaccine or therapeutic on the market, and hVIVO is proud to lead the charge in helping our client bring medicines to the patients."

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Notes to Editors

hVIVO plc (Ticker: HVO) is a rapidly growing early-stage Contract Research Organisation (CRO) and the global leader in human challenge trials. The company delivers end-to-end clinical development services to a diverse and expanding client base, including seven of the world's ten largest biopharma companies.

hVIVO specialises in conducting human challenge trials across multiple infectious and respiratory indications, leveraging its state-of-the-art quarantine facility in London-the largest of its kind worldwide. The company also offers comprehensive virology and immunology laboratory services under the hLAB brand.

Through its German subsidiary, CRS, hVIVO operates a 120-bed capacity across Mannheim and Kiel, providing early-phase clinical trial services, including first-in-human and proof-of-concept studies. Its second subsidiary, Venn Life Sciences, offers Early Drug Development Consulting and Biometry services to the biopharma sector.

The Group provides fully integrated drug development solutions from preclinical stages through Phase II trials, alongside patient recruitment via FluCamp. Additionally, its five clinical sites support outpatient Phase II and III trials, ensuring a seamless and efficient pathway from discovery to late-stage development.

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 worldwide¹. Up to 16% of the children infected with hMPV develop more severe symptoms², with over 16,000 deaths worldwide in children under the age of five each year.³ Despite its prevalence and potential severity, there are currently no vaccines or antivirals approved to treat hMPV.⁴

1.Science Direct. 2. Howard LM, et al. 2021. 3 Wang X, et al. 2021. 4. CDC