GCIhVIVO lands £13.1m contract to develop an influenza B virus challenge model
() , a specialist contract research organisation, announced a £13.1m contract with an existing client to develop an Influenza B human challenge model.
The contract involves manufacturing an influenza B challenge virus, conducting a characterisation study, and paying a supplementary fee for faster processing. Successful manufacture of the challenge virus is a prerequisite for receiving characterisation trial revenue, expected to start in Q4 2023 after GMP completion.
The characterisation study will aim to identify a dose of influenza B that elicits a safe and reproducible infection in volunteers recruited through hVIVO's FluCamp platform. Assuming the study is successful and regulatory approvals are obtained, the company expects to conduct an influenza B human challenge trial in H1 2024. Revenue from this human challenge model contract will be recognised in 2023 and 2024.
This large contract with an existing top 5 global pharma client marks hVIVO's second bespoke human challenge model contract announced within the last 2 months. hVIVO is the exclusive CRO offering this bespoke human challenge model, and was chosen for its expertise in the field going back to the UK Common Cold Unit. The new influenza B model will be used by the client to test its vaccine candidate, further strengthening hVIVO's range of human challenge models and diversifying its revenue pipeline while providing good revenue visibility into 2024.
hVIVO's Flu B challenge model will enable the client's vaccine to gain quick efficacy data against a type of influenza which is near impossible to obtain through conventional field trails. The data is highly valuable as it can open up new markets and strengthen existing product label claims.
This is yet another example of the benefits of human challenge studies. Such studies provide great value for biopharma companies as they offer access to fast and cost-effective data that enables easy decisions ahead of larger Phase 2 trials. This gives companies the best possible chance of quickly advancing their candidates through the development pathway.
hVIVO's pipeline is growing rapidly. The company delivered 7 challenge trials last year, supported by recently expanded facilities. Its orderbook grew 65% to a record £76m, providing excellent visibility on future revenues into H1 2024, further strengthened by today's announcement. hVIVO remains well-capitalised and debt free with £28.4m in the bank at the end of FY22, up 81% from the year before.
The company entered FY23 with strong momentum and revenue guidance of £55m for the year, targeting 2023 EBITDA margin in the mid-to-high teens. As of April 2023, hVIVO had at least 95% of its FY23 revenue target contracted.
shares jumped 4.2% on the news. Shares are up 36% so far this year.
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