Highlights
· Pharma client is funding expedited manufacture of additional supply of RSV challenge agent
· Confirmatory challenge cohort to verify infectivity of the new RSV challenge virus batch
· Multiple cohort challenge trial to test efficacy of client’s RSV antiviral candidate
· Trading ahead of previous market expectations driven by margin expansion
hVIVO plc (Euronext / LON:HVO), the world leader in testing infectious and respiratory disease products using human challenge clinical trials, has announced that it has signed a £16.8m full-service contract with an existing top five global pharmaceutical client to test its respiratory syncytial virus (“RSV”) antiviral drug candidate using the hVIVO RSV Human Challenge Study Model.
The contract includes the expedited manufacturing of the RSV challenge agent, a confirmatory challenge cohort and a multiple cohort challenge trial. The purpose of the trial is to evaluate the efficacy of the antiviral candidate against RSV infection in healthy adults and identify the most effective dosing ahead of later stage clinical trials. Revenue from this contract will be recognised across 2023, 2024 and 2025 with the majority of the revenues being recognised in 2024.
hVIVO plc will commence Good Manufacturing Practice (GMP) compliant virus manufacturing activities immediately, which is expected to complete in H1 2024. Upon completion of manufacturing, the Company expects to confirm infectivity of the new RSV challenge virus batch in small number of healthy volunteers recruited via FluCamp.
Subject to the successful completion of the above, and the receipt of relevant regulatory approvals, the Company expects to start the RSV human challenge trial in H2 2024. This will be a randomised, double-blinded, placebo-controlled Phase 2a study. It will consist of multiple cohorts to evaluate the efficacy of the client’s RSV antiviral candidate via different dosing regimens. The multiple cohort study highlights the expanding utility of human challenge trials, demonstrating their ability to not just provide quick efficacy data, but also refine dosing strategies ahead of critical later stage clinical trials. The challenge study is planned to take place at the Company’s new state-of-the-art quarantine facilities in Canary Wharf, which is on track to be operational in H1 2024.
The Company is pleased to report that trading has continued to be strong across the Group, with revenue slightly ahead of previous market expectations. The Group has continued to improve operational efficiencies which, coupled with the facilities funding that will benefit both FY23 and FY24, has resulted in EBITDA margins exceeding 20% for the year ending 31 December 2023. Consequently, the Group now expects EBITDA to be ahead of previous market expectations. With the addition of today’s contract, the Company has clear revenue visibility into 2024. Further details will be shared as part of the Company’s FY23 Trading Update in late January 2024.
Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO plc, said: “Our RSV (Memphis strain) challenge agent has played a significant role in the development of RSV vaccines and we are delighted that it is continuing to be used as the go-to model for our clients. We have built a world-leading portfolio of challenge agents and are working hard with our clients to add new models all the time. This contract is another example of the end-to-end full service offering that hVIVO has already successfully provided to several clients. We are also delighted with the Company’s strong operational performance in 2023 and now expect to exceed the previous market guidance and look forward to updating the market further in the new year.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “As clinical assets approach critical and high-cost late-stage trials, biopharma companies want to minimise the risk of failure, and know that their asset has the best chance of reaching the market. By using multiple cohorts and testing different dosing regimens, our clients are able to use a human challenge trial to optimise the dosing strategy as well as gain vital quick efficacy data, further de-risking future clinical development. With the expanded capacity and enhanced capabilities of our new facility, we are well-equipped to deliver on the increasing demand for multiple cohort studies of this kind.”
