REG - hVIVO PLC - Trading update

hVIVOAnnouncement

30/05/2025 07:00

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RNS Number : 6937K  hVIVO PLC  30 May 2025

hVIVO plc

("hVIVO", the "Company" or the "Group")

 

Trading update

 

hVIVO plc (AIM: HVO), a full-service Contract Research Organisation (CRO)
and the world leader in human challenge clinical trials, announces that it has
received notification of a significant human challenge trial ("HCT") contract
cancellation alongside a postponement and a smaller study cancellation. These
client decisions are believed to be related to the current uncertainties in
the pharmaceutical industry and the continued depressed biotech financing
market. The current volatility in the pharmaceutical industry, particularly in
the US, is impacting the whole CRO industry and has led to an increase in
cancellation rates, postponement of clinical trials, and delays in approvals
for new projects.

 

The Board remains confident that the underlying concept of HCTs and their
place in the drug development process is stronger than ever. The Company's
sales pipeline is at a record level and includes some large, high probability
opportunities in advanced discussions which could commence in late 2025 and
provide significant revenues in FY26. Furthermore, the integration of CRS
Mannheim and Kiel ("CRS"), as well as Cryostore, is progressing well with
revenue synergies across CRS and Venn beginning to materialise.

 

As a result, the Company currently has £47 million of revenue contracted for
FY25 which is inclusive of cancellation and postponement fees. The Company
expects to achieve further contract wins during the course of FY25.However,
should these not materialise, revenues of £47 million would result in a mid
single digit operating loss (pre exceptional items) for the full year.  All
but one of the contracts for FY25 have already commenced and, as such, the
Board believes there is a low risk of any further cancellations. The Company
will provide further clarity around FY25 outlook later in the year and will
update the market as new contracts are signed.

 

The Company retains a strong cash position and is well funded to execute on
its strategy of building a sustainable and diversified business. As in prior
years, the Company will provide a H1 trading update in late July.

 

Dr Yamin 'Mo' Khan, Chief Executive Officer of hVIVO plc, 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 3 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."

 

 

For further information please contact:

 

 hVIVO plc                                       +44 (0)20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial Officer

 Cavendish Capital Markets Limited (Nominated Adviser and Joint Broker)                  +44 (0)20 7220 0500
 Geoff Nash, Callum Davidson,

Trisyia Jamaludin, Harriet Ward

 Nigel Birks - Life Science Specialist Sales

 Louise Talbot - Sales

 Peel Hunt LLP (Joint Broker)                                        +44 (0)20 7418 8900
 James Steel, Dr Christopher Golden

 Davy (Joint Broker)                                                 +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Walbrook PR (Financial PR & IR)                 +44 (0)20 7933 8780 or hvivo@walbrookpr.com

 Paul McManus / Alice Woodings /                 +44 (0)7980 541 893 / +44 (0)7407 804 654/

+44 (0)7584 391 303
 Lianne Applegarth

 

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulation
("MAR") EU no.596/2014. Upon the publication of this announcement via
Regulatory Information Service ("RIS"), this inside information is now
considered to be in the public domain.

 

 

Notes to Editors

 

hVIVO plc (https://hvivo.com/)  (Ticker: HVO) is full-service Contract
Research Organisation (CRO) and the global leader in human challenge trials.
The company delivers end-to-end clinical development services to a diverse and
expanding client base, including seven of the world's ten largest biopharma
companies.

 

hVIVO specialises in conducting human challenge trials across multiple
infectious and respiratory indications, leveraging its state-of-the-art
quarantine facility in London-the largest of its kind worldwide. The company
also offers comprehensive virology and immunology laboratory services under
the hLAB (https://hlabservices.com/)  brand.

 

Through its German subsidiary, CRS (https://crs-earlyphase.com/) , hVIVO
operates a 120-bed capacity across Mannheim and Kiel, providing early-phase
clinical trial services, including first-in-human and proof-of-concept
studies. Its second subsidiary, Venn Life Sciences
(https://www.vennlifesciences.com/) , offers Early Drug Development
Consulting and Biometry services to the biopharma sector.

 

The Group provides fully integrated drug development solutions from
preclinical stages through Phase II trials, alongside patient recruitment
via FluCamp (https://flucamp.com/) . Additionally, its five clinical sites
support outpatient Phase II and III trials, ensuring a seamless and
efficient pathway from discovery to late-stage development.

 

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