hVIVO plc

hVIVO acquires CRS Berlin, expanding expertise into dermatology and women's health markets

London, UK – 27 August 2026, hVIVO plc (AIM: HVO), a purpose-built, full-service international clinical development partner and the world leader in human challenge trials, announces the acquisition of CRS Clinical Research Services Berlin GmbH ("CRS Berlin").

Highlights

• Acquisition of a specialist Phase I/II clinical research unit with an established revenue base, multiple pharma relationships, a strong orderbook and proven track record with 350 studies completed to date
• Expected to be immediately earnings accretive and contribute positively to both revenue and EBITDA in FY26, with CRS Berlin’s contracted orderbook of €10 million providing excellent visibility
• Favourable acquisition terms agreed with three-year revenue-based earnout and nominal upfront consideration payable preserving the Group’s balance sheet strength
• Expected gross earnout of approximately €6 million in cash, representing a modest revenue multiple on CRS Berlin’s forecast revenue. Expected aggregate payments to CRS Berlin vendors of approximately €4 million after deductions for an acquired pension liability
• Acquisition is a natural extension of the Group’s Clinical Trials service line, with shared patient recruitment, back-office and operational processes already established
• Further broadens hVIVO’s addressable market through exposure to attractive specialist therapeutic areas

The acquisition marks a further step in hVIVO's strategy to build a wholly owned international clinical network in primary care indications, adding specialist capabilities in dermatology and women's health. CRS Berlin is a natural fit with hVIVO’s existing German operations, with established alignment across participant recruitment, back-office support and operational processes. Upfront consideration payable is only €0.025 million and all earnout payments are dependent on CRS Berlin's future revenue performance. The acquisition is expected to be immediately accretive to earnings while preserving the Company’s cash resources.

Information on CRS Berlin

CRS Berlin serves a broad base of pharmaceutical and biotechnology clients, including long-standing relationships with leading global pharma customers. Its work is focused on Phase I/II clinical studies, particularly in dermatology and women’s health, where sponsors require access to specialist patient populations, strong recruitment capability, intensive monitoring infrastructure and deep clinical expertise. The acquisition further strengthens the Group’s capacity to support larger and more complex clinical trials across its network.

CRS Berlin has 32 beds, including 18 intensive monitoring beds, and is a centre of excellence in dermatology and women's health trials. The facility has operated in close partnership with hVIVO since the Group's acquisition of CRS Mannheim and CRS Kiel in January 2025, with participant recruitment, quality assurance, sales and marketing, and IT infrastructure already aligned across the CRS network.

In 2025, CRS Berlin achieved unaudited EBITDA of €0.3 million on revenues of €10 million and had net assets of €0.1 million at 31 December 2025.   CRS Berlin’s trading in 2026 has started strongly with an orderbook of approximately €10 million as at 30 June 2026, providing a very high level of revenue visibility over its forecast 2026 revenue and including orders scheduled for delivery in 2027.

Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, said: “Dermatology and women’s health are large and strategically attractive areas of drug development, and CRS Berlin brings us specialist capabilities in both. These specialisms meaningfully broaden hVIVO's addressable market and complement our existing expertise. The transaction terms reflect our disciplined approach to capital allocation, with the acquisition expected to be self-funding, supported by the business’s contracted orderbook and expected revenues. With earnout payments dependent on CRS Berlin’s revenue performance, we are acquiring a profitable, well-regarded business with long-term relationships with pharma and biotech partners on attractive terms.

“CRS Berlin strengthens the platform we are building for the next phase of hVIVO’s growth, adding specialist clinical trial expertise, broader participant recruitment reach and an established operational fit with our existing German network. This enhances our ability to deliver larger clinical trials across a wider range of therapeutic areas, while creating further cross-selling and commercial opportunities across our integrated service lines.”

Dr Sybille Baumann, Medical Director of CRS Berlin, said: “CRS Berlin has a long and successful track record in conducting complex clinical pharmacology studies in healthy volunteers, especially in dermatology and women’s health. These are areas where sponsors increasingly require deep clinical expertise, strong patient recruitment capability and high-quality early-phase execution. Together, these capabilities support a more seamless development pathway, enabling sponsors to move from first-in-human and early-phase studies into patient populations.

“We see a significant opportunity to scale this expertise as part of hVIVO’s international platform, while continuing to support clients with the specialist site capabilities which they value. Having worked closely with hVIVO’s existing CRS network for some time, and with alignment already in place across quality, project management, participant recruitment and operational processes, this is a logical next step for CRS Berlin, our clients and our team.”

Terms of acquisition and strategic rationale

hVIVO has acquired the entire issued share capital of CRS Berlin.

Under the terms of the acquisition, the Company has paid initial consideration of €0.025 million and has agreed to pay, in cash, 18% of CRS Berlin’s annual revenue for each of the next three years (ending 31 December 2026, 2027 and 2028, the “Earnout Period”), provided a minimum revenue threshold is met in each period. On the basis of management’s estimates, the Company expects to pay approximately €6 million in cash in aggregate over the Earnout Period, representing a modest multiple on CRS Berlin’s forecast revenue over the Earnout Period. The Company will deduct an existing pension liability of approximately €2 million from the earnout payments over the Earnout Period. The expected aggregate payments, net of the pension liability deductions, are therefore approximately €4 million.   Based on CRS Berlin's current financial performance and its contracted orderbook, the acquisition is expected to be immediately earnings accretive for the Group whilst also contributing positively to both FY26 revenue and EBITDA.

The acquisition is consistent with hVIVO's strategy to build a diversified, full-service early-phase clinical development partner with a unique wholly owned multi-site capability across its four service lines of Clinical Trials, Consulting, Human Challenge Trials and Laboratories. CRS Berlin represents a natural extension of the Group's existing Clinical Trials platform in Germany, offering the following strategic benefits:

Expanding into attractive specialist therapeutic areas
CRS Berlin specialises in dermatology and women's health, areas of increasing pharmaceutical investment. The global dermatology CRO market was valued at approximately US$6.1 billion in 2026 and is forecast to grow at a compound annual growth rate (“CAGR”) of 6%, reaching up to US$9.7 billion by 2034.¹ Women's health represents a significant and under-served opportunity in early clinical development. The global women’s clinical trials and CROs market is valued at approximately US$9.9 billion in 2026 and is forecast to reach US$22.3 billion by 2036, at a CAGR of 8.5%.²

Women’s health has historically been overlooked in trial design but is now attracting substantial investment. Together with dermatology, these are specialist areas where sponsors increasingly value access to experienced sites, targeted recruitment capability and the infrastructure to deliver these studies effectively. CRS Berlin is one of a small number of European Phase I units with an established track record across both therapeutic areas. These specialisms are complementary to hVIVO's existing expertise in infectious disease, respiratory, cardiometabolic and immunology, further reducing the Group's reliance on any single therapeutic area.

Deep client relationships and proven commercial track record
CRS Berlin is a preferred clinical research site for two of the world's leading pharmaceutical companies and has established relationships across a broad range of global pharmaceutical and biotechnology companies. To date, CRS Berlin has completed over 350 studies led by Dr. Sybille Baumann, a board-certified anaesthesiologist and pharmacologist with extensive clinical research experience, including contributions as co-author to landmark COVID-19 vaccine publications in Nature and the New England Journal of Medicine.

Strengthening hVIVO's international footprint and multi-site capability
The acquisition provides hVIVO with an additional high-quality clinical research site in Germany, strengthening the Group’s wholly owned multi-site capability across the UK and Germany. Approximately 50% of CRS Berlin's request for proposals are currently submitted jointly with Mannheim, demonstrating the operational interdependencies that already exist between the two sites and the cross-selling opportunity available to hVIVO. Berlin's wider metropolitan catchment area of approximately 6.2 million³ people offers meaningfully enhanced recruitment capability for future studies. This established collaboration provides a practical platform to realise commercial and operational benefits by deepening customer relationships, supporting larger joint proposals and giving clients access to a broader range of specialist capabilities across hVIVO’s network.

¹Fortune Business Insights (2026) Dermatology CRO market size, share | analysis report [2034] (2026) Fortune Business Insights. Available at: https://www.fortunebusinessinsights.com/dermatology-cro-market-117000 and Mordor Intelligence (2026) Dermatology cro market size, report, Share & Growth trends 2030. Available at: https://www.mordorintelligence.com/industry-reports/dermatology-cro-market.
² Visiongain (2026) Women's Clinical Trials & CROs Market Report 2026-2036: 8.5% CAGR (2026) Visiongain. Available at: Women's Clinical Trials & CROs Market Report 2026-2036.
³Hauptstadtregion Berlin-Brandenburg (2026) Daten und Fakten (2026) Hauptstadtregion Berlin-Brandenburg. Available at: https://www.hauptstadtregion.de/.

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Notes to Editors

About hVIVO
hVIVO plc (AIM: HVO) is a purpose-built, full-service international clinical development partner and the global leader in human challenge trials, serving seven of the world's ten largest biopharma companies.

The Company has an end-to-end platform designed to bring important medicines to patients faster: spanning preclinical strategy, first-in-human studies, Phase II patient trials and specialist laboratory services, delivered through a large participant database, wholly owned sites and laboratories across the UK and Germany.

With a combined Group heritage of more than 100 years, hVIVO delivers an accelerated pathway to clinical proof-of-concept through four integrated service lines: Consulting, Clinical Trials, Human Challenge Trials, and Laboratories.

• Consulting provides expert-led preclinical and clinical strategy, encompassing non-clinical, clinical, CMC, pharmacokinetics, data management, biostatistics, and regulatory support to guide trial design, execution, and interpretation.
• Clinical Trials offers Phase I/II CRO services, Phase II/III site services across the UK and Germany, and specialist recruitment through FluCamp, Europe's largest recruitment database.
• Human Challenge Trials leverages hVIVO’s state-of-the-art quarantine facility in London – the largest of its kind worldwide – to deliver fast, controlled, high-quality efficacy data through guaranteed viral exposure.
• Laboratories provides cutting-edge virology and immunology laboratory services, including biobanking and sample storage, supporting both challenge trials and standalone client studies.