hVIVO Regulatory News (HVO)

hVIVO plc

("hVIVO" or the "Company")

€3.2m contract for Venn Life Sciences with global pharmaceutical client

For provision of pharmacokinetic and programming services

hVIVO plc (AIM & Euronext: HVO) (formerly Open Orphan plc), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces its consultancy services division, Venn Life Sciences ("Venn"), has signed a contract with a major global pharmaceutical client worth €3.2m over two years.

The contract commences in January 2023, with the Venn team in Breda providing dedicated complex clinical pharmacokinetics ("PK") consultancy and programming services to this global pharmaceutical client on a number of drug development programmes across multiple therapeutic areas, to study the absorption, distribution and excretion of drugs within the body.

Venn has nearly 30 experts dedicated to providing PK and programming services to clients and has been a trusted partner to the pharma industry for over 25 years. These services cover a diverse range of trials and therapeutic areas ranging from traditional phase I trials to more complex and challenging trials, such as oncology and ATMP (Advanced Therapy Medicinal Product) trials. Venn is a leader in providing fully integrated drug development services from early drug discovery to clinical trials. Its offering includes drug development consultancy, clinical trial design and execution services with expertise and capabilities in CMC (Chemistry, Manufacturing and Controls), Non-Clinical, Clinical Pharmacology and Development, Statistics, Study Design and Methodology, Data Management, Medical Writing and Regulatory Affairs. These combined services enable Venn to provide its clients with a complete end-to-end service on all stages of their drug development programmes, from the early planning phase to final execution. Venn has offices in Breda (Netherlands) and Paris (France).

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "The consultancy work included in this two-year contract highlights the continued expansion of our pharmacokinetic and programming services as part of Venn's integrated drug development services provision. Venn's outstanding expertise and reputation in the industry over the past 25 years makes them a go-to partner. In addition, for infectious disease products, hVIVO and Venn have also been able to conduct projects from discovery to Phase II Challenge Studies, something no one else can offer."

Dr Katsuhiro Mihara, Head of Clinical Development of Venn Life Sciences, commented: "This contract is a great example of Venn's ability to deliver on long term PK and programming projects. We have worked closely with hVIVO to identify ways to leverage this strong client base, to drive both upselling and cross-selling opportunities, and find even greater synergies between the two integrated clinical services businesses."

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Notes to Editors

hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.

The Group's fast-growing services business includes a unique portfolio of 10+ human challenge models to test a broad range of infectious and respiratory disease products, world class challenge agent manufacturing, specialist drug development and clinical consultancy services via its Venn Life Sciences brand, and a lab offering via its hLAB brand, which includes virology, immunology biomarker and molecular testing. The Group offers additional clinical field trial services such as patient recruitment and clinical trial site services.

hVIVO runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester.