hVIVO PLC (AIM:HVO) has reported the cancellation of one trial and the postponement of another, but said its pipeline of new business has reached record levels, with several large contracts in late-stage negotiations.
The London-listed clinical research group, which specialises in human challenge trials (HCTs), said the changes were driven by wider uncertainty in the pharmaceutical sector and weak biotech funding, particularly in the United States.
Despite the disruption, hVIVO said demand for its services remained strong, with upcoming opportunities that could begin in late 2025 and contribute materially to 2026 revenues.
The company has already secured £47 million in revenue for 2025, including fees from cancelled and postponed studies. If no additional work is secured, it expects a mid-single-digit operating loss before exceptional items.
With all but one of next year’s trials already underway, the risk of further cancellations is considered low.
hVIVO added that integration of its recent acquisitions, German trial operators CRS Mannheim and Kiel, and Cryostore, was progressing well, with early commercial benefits starting to come through. A half-year trading update is due in July.
CEO Mo Khan said: "Whilst we are disappointed to have received notification from these clients due to matters beyond our control, we still remain confident in the continued growth of human challenge trials and the overall prospects for hVIVO as we also continue to diversify our revenue streams and build our offering as a full-service CRO.
"We currently have our largest ever sales pipeline, including projects under discussion that would represent some of our largest ever value contracts for human challenge trials, such as the world's first ever phase III HCT.
"We have also successfully targeted a more diversified revenue base and we remain very excited about the growth prospects of our hLAB services as well as our new revenue streams from CRS's early-phase clinical trial services and participant recruitment."