hVIVO Plc (HVO) is a specialist contract research organisation (CRO) and a world leader in conducting human challenge trials for infectious and respiratory disease vaccines and therapeutics.
The London-based company has over three decades of experience and operates state-of-the-art quarantine facilities, safely running controlled infection studies across diseases ranging from influenza and RSV to malaria and asthma. This human challenge model expertise allows hVIVO to accelerate vaccine and antiviral development by deliberately exposing healthy volunteers to targeted pathogens in a controlled setting. In addition to challenge trials, hVIVO provides end-to-end early clinical development services, including study design, volunteer recruitment (via its FluCamp unit), laboratory analytics (hLAB), and regulatory consulting, enabling pharmaceutical clients to efficiently obtain proof-of-concept efficacy data for their novel therapeutics.
In 2025, hVIVO has continued to secure significant new contracts and partnerships. In January, the company signed a Letter of Intent with ILiAD Biotechnologies to conduct the world’s first Phase 3 human challenge trial for a whooping cough (pertussis) vaccine (ILiAD’s BPZE1), a landmark study expected to be hVIVO’s largest to date and scheduled to commence in H2 2025. This was followed in February by a £2.0 million contract with a new biopharmaceutical client to complete the final stage of an hMPV (human metapneumovirus) challenge agent characterization study, after a successful pilot trial demonstrated the model’s safety and viability. hVIVO also expanded its client base with a new RSV trial agreement: it will test Inhalon Biopharma’s inhaled antiviral candidate in a Phase 2a RSV challenge study, with the trial slated to begin in H2 2026 and the majority of revenue to be recognized that year. These 2025 wins underscore the growing demand for hVIVO’s challenge trial services and broaden the company’s pipeline of studies.
Financially, hVIVO delivered record results for FY2024, reflecting robust growth and operational progress. Revenue for the year rose 11.9% to £62.7 million (FY2023: £56.0m) while EBITDA jumped 25.9% to £16.4 million, representing a healthy 26.2% EBITDA margin. The company remained debt-free and ended 2024 with a strong cash balance of £44.2 million, after paying a £1.4m dividend to shareholders. Operationally, hVIVO broadened its capabilities through both organic growth and acquisition. In January 2025, it completed the €10.0 million acquisition of two clinical research sites in Germany (adding 120 inpatient beds) to expand into Phase I and Phase II trials across a wider range of therapeutic areas. The company also launched new service offerings, such as standalone lab services under the hLAB brand and an in-house field trial recruitment service, which quickly translated into multiple contract wins. Notably, hVIVO delivered its largest-ever field study in 2024, recruiting 817 participants in just 43 days for a client’s trial, highlighting the efficiency of its expanded clinical site services.
hVIVO enters 2025 with a robust order book and a positive growth trajectory. The Group has guided to £73 million in revenue for 2025, with approximately 70% of this already contracted (excluding the pending ILiAD Phase 3 trial). Management is also reiterating a medium-term goal of reaching £100 million in annual revenues by 2028, underpinned by a strong pipeline of new challenge studies (including upcoming hMPV trials) and contributions from its recent acquisitions. The integration of the German clinical sites is underway and expected to be earnings-accretive by 2026, supporting improved operating margins over the next two years. With a debt-free, cash-generative balance sheet and deep expertise in a niche field, hVIVO is well positioned to deliver sustained profitable growth. The proven ability of human challenge trials to rapidly generate efficacy data in a cost-effective manner, thus de-risking later-stage development, continues to attract leading pharma clients to hVIVO’s services, providing confidence in the company’s future prospects.
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Notes to Editors
hVIVO plc (Ticker: HVO) is a full-service 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.
