hVIVO Regulatory News (HVO)

hVIVO plc

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

Phase 2b Influenza Field Study Contract

Highlights

· hVIVO to enrol up to 1,000 healthy volunteers as part of a multicenter field study testing an influenza drug candidate, with hVIVO selected as the sole UK clinical site

· Largest field study contract supporting a new income stream

· Expected to improve staff utilisation and leverage in-house volunteer recruitment platform

· Expansion of Plumbers Row outpatient unit to support future Phase II and Phase III field studies

hVIVO plc (AIM & Euronext: HVO), a fast growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that it has been engaged for a Phase 2b field study assessing an influenza candidate. This contract is with a US company ('the client') and will commence later this year with hVIVO enrolling up to 1,000 healthy volunteers as part of a multicenter study with hVIVO being selected as the sole UK clinical site.

As part of the randomised, double-blind, placebo-controlled, multicenter dose selection study, hVIVO will enroll healthy volunteers via the Company's dedicated volunteer recruitment arm, FluCamp. Participants will be administered with either the influenza drug candidate or a placebo at hVIVO's Plumbers Row site. Participants will then be free to leave the facilities, where they will then be monitored over the following months, with regular clinical check-ups, to assess the efficacy and safety of the candidate. The study is expected to begin in Q4 2024, with the majority of the revenue from the contract expected to be recognised in FY 2025.

As part of hVIVO's move to Canary Wharf, the Company initiated plans to convert its former corporate office at Plumbers Row into an expanded outpatient unit, increasing the existing outpatient capacity at Plumbers Row. This expansion will support future Phase II and Phase III field study contracts, aligning with the Company's strategic focus on diversifying its revenue streams. hVIVO anticipates its new complementary services, such as Phase II and Phase III field studies, will positively impact its growth and margins by improving staff utilisation and leveraging its in-house volunteer recruitment platform, FluCamp.

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "I am delighted to sign this field study contract to assess the efficacy and safety of our client's influenza drug candidate. This is our largest field study contract to date, further evidencing the recognition we have earned for our highly effective recruitment capabilities and also opens up a new growth opportunity for the Group. This project comes at a time when we are in the process of expanding our screening site in London to accommodate these types of studies. Our achievements in recruiting large numbers of volunteers and patients into clinical studies was a key reason for this award. This is an important facet of our growth strategy that will diversify our revenue base whilst using our existing resources and infrastructure."

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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

About hVIVO

hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a fast 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 11 human challenge models, with a number of new models under development, to test a broad range of infectious and respiratory disease products. The Group has world class challenge agent manufacturing capabilities, 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 trials in London - its new state-of-the-art facilities in Canary Wharf opened in 2024 and is the world's largest commercial human challenge trial unit, with highly specialised on-site virology and immunology laboratories, and an outpatient unit. To recruit volunteers / patients for its studies, the Group leverages its unique clinical trial recruitment capability via its FluCamp volunteer screening facilities in London and Manchester.