hVIVO PLC on Wednesday said it signed a deal with an unnamed existing client to test a respiratory syncytial virus antiviral drug candidate using its study model.
Shares in hVIVO were up 8.1% to 21.62 pence each in London on Wednesday morning in response.
hVIVO is a London-based specialist contract research organisation that tests for infectious and respiratory vaccines.
It said the £16.8 million deal with the ‘top five global pharmaceutical client’ includes the the expedited manufacturing of the RSV challenge agent, a confirmatory challenge cohort, and a multiple cohort challenge trial.
hVIVO said 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 the contract will be recognised across 2023, 2024 and 2025, hVIVO said, with the majority of the revenue being recognised in 2024.
hVIVO said it will begin good manufacturing practice compliant virus manufacturing activities immediately, which is expected to complete in the first half of 2024.
Upon completion of manufacturing, it 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 all this, and the receipt of relevant regulatory approvals, hVIVO expects to start the RSV human challenge trial in the second half of 2024. This will be a randomised, double-blinded, placebo-controlled phase 2a study.
hVIVO also said trading has continued to be strong across the group, expecting full-year revenue to be slightly ahead of previous market expectations.
hVIVO said it has continued to improve operational efficiencies which, coupled with the facilities funding that will benefit both 2023 and 2024, has resulted in earnings before interest, tax, depreciation and amortisation margins exceeding 20% for 2023.
As a result, it now expects 2023 Ebitda to be ahead of previous market expectations, and with the addition of Wednesday’s contract, it said it has ‘clear’ revenue visibility into 2024.
‘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,’ said Chief Executive Officer Yamin Khan.
‘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.’
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