hVIVO secures £11.5m RSV contract with global pharma client, reaffirms 2024 guidance
() , a contract research organisation specialising in human challenge trials, announced a new £11.5m contract with an existing 'top-tier global pharmaceutical client' to test its antiviral candidate using hVIVO's respiratory syncytial virus (RSV) human challenge study model.
hVIVO will evaluate the safety, pharmacokinetics and antiviral activity of the candidate in a Phase 2a randomised, double-blinded placebo-controlled human challenge trial. Recruitment will be handled by 's in-house recruitment arm FluCamp.
The study will commence in H2 2025 at 's new CL3 quarantine facility in Canary Wharf, with revenue expected to be recognised across FY25 in FY26.
RSV remains a leading cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and adults with chronic medical problems, such as COPD. Globally, RSV affects an estimated 33 million people annually, leading to approximately 4 million hospitalisations and 101,000 RSV-attributable deaths in children under 5 years.
Yamin 'Mo' Khan, CEO of hVIVO, commenting: "This contract further demonstrates the trust and confidence that leading pharmaceutical companies place in hVIVO's human challenge study models. We are proud to work with four of the top 10 global pharmaceutical companies to address unmet medical need in infectious and respiratory diseases. Our unique and established RSV model can provide valuable data on a candidate's safety, pharmacokinetics, and efficacy, reducing the risks associated with later-stage clinical development and accelerating the pathway to market."
View from Vox
hVIVO adds a large £11.5m repeat contract to its pipeline, bolstering revenue visibility across FY25 and FY26, and reaffirming the value of its human challenge trials to global pharmas. hVIVO's trials are in high demand as they offer time-efficient and cost-effective ways to generate early human efficacy data and inform later-stage trial design, accelerating the path to market for new drugs.
The RSV challenge study announced today will take place at hVIVO's new state-of-the-art C3L quarantine unit in Canary Wharf. The facility is now the world's largest commercial human challenge trial unit and is expected to significantly diversify 's pipeline with new pathogen models, as well as materially boost operational efficiency and margins in the medium term.
RSV remains a major cause of respiratory infections with 33 million affected annually. While a number of RSV vaccines have been approved in recent years, there remains significant unmet medical need for effective antivirals. is a pioneer in testing RSV candidates with over 30 RSV challenge trials run, which have expedited the development of RSV drugs and vaccines for its biopharma clients. Some of those have received FDA Fast Track or Breakthrough designations, and have been successfully acquired.
hVIVO maintained a strong orderbook of £71m at the end of H1 2024, with full visibility for the remainder of FY24 as well as excellent visibility for FY25, bolstered by today's announcement. Unsurprisingly, today reaffirmed its full-year revenue guidance of £62m, with management projecting full-year EBITDA margins to be at the upper end of market expectations.
hVIVO has a significant pipeline that is continuing to grow, including new challenge models and new revenue streams (eg clinical site studies, standalone lab services, and volunteer/patient recruitment). aims for £100m of revenues by FY28, which is highly achievable given its strong sales momentum and US$37m cash position.
shares rose 8% on today's announcement.
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