hVIVO plc

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

Interim Results

Contracted orderbook more than doubles in H1 2026

CRS Berlin acquisition expands hVIVO’s clinical platform and addressable market

London, UK – 15 September 2026, hVIVO plc (AIM: HVO), a purpose-built, full-service international clinical development partner and the world leader in human challenge trials, announces its unaudited interim results for the six months ended 30 June 2026.

Financial highlights

*Adjusted EBITDA is stated before one off exceptional items related to acquisitions & re-organisation costs. Prior-period comparatives have been restated as set out in note 4

Operational highlights

*As previously communicated, the orderbook now includes only signed Clinical Trial Agreements (CTAs), providing a higher degree of confidence in our orderbook converting into revenue.

Post period highlights

Outlook

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "The first half of 2026 saw a clear improvement in commercial momentum. With proposal volumes ramping up and our contracted orderbook more than doubling since the start of the year, the growing demand across our integrated early clinical development platform is very evident.

“We expect to see a near doubling in revenue from H1 2026 to H2 2026, with FY 2026 Group revenue now expected to be approximately £47 million. The deferrals and phasing of revenue recognition across certain contracted client programmes are expected to boost FY 2027 and 2028 revenues, along with a material contribution from CRS Berlin. Our record orderbook now provides us with good revenue visibility and positions the Group for significant revenue growth in 2027.”

Investor presentation

Yamin 'Mo' Khan, Chief Executive Officer, and Stephen Pinkerton, Chief Financial Officer, will provide a live presentation relating to the Interim Results via the Investor Meet Company platform today at 5.30pm BST.

The presentation is open to all existing and potential shareholders. Questions can be submitted at any time during the live presentation. 

Investors can sign up to Investor Meet Company for free and add to meet hVIVO here. Investors who already follow hVIVO on the Investor Meet Company platform will automatically be invited.

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.

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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.

CEO Statement

September 2026

Increasing commercial momentum across the Group

The first half of 2026 saw a significant improvement in the focus and performance of our commercial operation, with one of our strongest periods of new contract sales more than doubling our contracted orderbook. Our priority for the remainder of the year is to build on this momentum through disciplined execution and position the Group for sustainable growth, profitability and cash generation over the medium term.

Revenue for the half was £16.3 million (H1 2025: £24.2 million), reflecting the anticipated second-half weighting of revenue following the previously signalled weaker order intake during 2025, together with the timing of revenue recognition on certain contracted client programmes.  Adjusted EBITDA was a £4.5 million loss, principally reflecting the lower H1 revenue base. Cash stood at £13.0 million at 30 June 2026 (31 December 2025: £14.3 million), supported by positive working capital inflows from contract wins during the period, in line with our business model. 

Our contracted orderbook more than doubled by 30 June 2026 to £65 million from £30 million at the start of the year, with proposal volumes up approximately 45% year-on-year. Including CRS Berlin’s €10 million (£8.6 million) orderbook, as disclosed at acquisition, the enlarged Group orderbook is now £72 million, providing strong revenue visibility for the remainder of the year, 2027 and extending into 2028. As previously communicated, the orderbook now includes only signed Clinical Trial Agreements (CTAs), providing a higher degree of confidence in our orderbook converting into revenue.

While the timing of individual programmes can shift between reporting periods, with certain programmes now expected to commence in 2027, underlying demand has strengthened materially, reflected in our contracted orderbook and a c.45% year-on-year increase in proposal volumes. Together, these provide increased confidence and visibility in the outlook for 2027 and 2028.

We have made an encouraging start to the second half of the year, with participant recruitment and enrolment activities underway for key contracts, alongside growing activity across our state-of-the-art Canary Wharf quarantine facility and specialist laboratories.

A broader customer base and more diverse revenue mix

The commercial benefits of unifying the Group under one hVIVO brand across four service lines of Consulting, Clinical Trials, Human Challenge Trials and Laboratory Services are increasingly visible. Revenue concentration among our top ten customers has reduced from 92% in 2024 to 75% at the half-year, while repeat customers now account for approximately three-quarters of Group revenue. Together these trends demonstrate a broader customer base, longer customer engagement, customer confidence in our performance, and a more resilient revenue model.

We are increasingly seeing this integrated model play out in individual client relationships. Cidara, now part of MSD following its $9.2 billion acquisition last year, provides a strong example of how our integrated platform can support accelerated drug development and contribute to high-value clinical outcomes. Having supported Cidara’s lead respiratory antiviral programme, with a HCT in 2024 through to laboratory and site support for its Phase II and III studies, the Group continues to support the programme during 2026 and 2027. Post-period end, the Group has also been engaged to provide additional site and recruitment support. This multi-service relationship is an example of the longer customer engagement achievable under the new end-to-end drug development platform.

Clinical Trials also delivered a strong period of contract awards and study execution including a Phase III study for a leading vaccine developer which exceeded its enrolment target of 200, delivering more than 350 participants. The expanded UK and German footprint continues to generate cross-selling opportunities, with several multi-site proposals now active across both geographies. Early activity in expanded therapeutic areas is also encouraging, with a number of active proposals across cardiometabolic and respiratory diseases.

Our Consulting business plays an important role in engaging clients earlier in the development pathway, helping shape translational, development, and regulatory strategies while creating opportunities for follow-on work across the broader hVIVO platform. The consultancy contract with Decoy Therapeutics, announced in June 2026, is a strong example of this approach. Through this partnership, we are supporting the development of Decoy’s respiratory antiviral portfolio, with the potential to expand into regulatory, clinical, and other development support services as the programme advances. By partnering with clients at an earlier strategic stage of the drug development process, the business is building a pipeline of opportunities that can progress into Investigational New Drug (IND)-enabling activities, First-in-Human (FIH) trials, HCTs, later-stage clinical trials, and laboratory services over time.

Laboratory Services performed strongly during the period, with its orderbook increasing approximately 18%, supported by new standalone development work, including virology and molecular biology projects for a US biotechnology company and testing of an existing product's virus-neutralising effectiveness for a European pharmaceutical client. We continued to build on this momentum by expanding our capabilities, qualifying droplet digital polymerase chain reaction (PCR) for routine use and growing our next-generation sequencing (NGS) work, alongside new automation to increase throughput and reduce the sample volumes required per test. We have added dedicated business development capacity to initially focus on, and accelerate lead generation across molecular biology applications, (incorporating NGS, PCR), biomarker coverage and storage services. This progress supports our strategy to scale Laboratories as a distinct growth area alongside its important role supporting HCT and broader clinical trial activity.

Alongside this, we continue to invest in our three targeted growth initiatives: expanding our cardiometabolic offering under the leadership of Chief Medical Officer Professor Thomas Forst; broadening our respiratory capabilities beyond infectious disease into asthma and COPD; and, as outlined above, further scaling Laboratory Services as a distinct growth area.

Expanding clinical development platform into dermatology and women's health

Post-period end, we announced the acquisition of CRS Berlin, extending our wholly owned German network and expanding hVIVO’s expertise into dermatology and women's health. CRS Berlin is a Phase I/II clinical research unit with an established revenue base and a proven track record, having completed more than 350 studies to date, and holds long-standing relationships with two of the world's leading pharmaceutical companies.

The acquisition adds specialist clinical capability in two complementary therapeutic areas, broadening the Group’s clinical development platform and increasing its addressable market opportunity. It also supports the Group’s therapeutic diversification strategy, reducing reliance on any single indication while creating additional cross-selling opportunities across the wider platform.

Recruitment, back-office, and operational processes are already aligned with our existing Mannheim and Kiel sites, supporting an efficient, low-risk integration. The transaction has been structured on disciplined terms, with a nominal upfront consideration and a revenue-based earnout, and is expected to be immediately earnings accretive. The acquisition reflects the capital allocation priorities we set out at our Capital Markets Day in June: complementary scientific capability, geographic reach and genuine cross-selling potential.

HCTs remain the core of the platform

hVIVO is the world leader in the design and delivery of HCTs and this service capability remains the core competitive differentiator and foundational element of our platform.  The recent contract wins demonstrate renewed sponsor demand in HCTs, which we see – and the external speakers at our recent Capital Markets Day validated – as an area of clinical research which has the potential to create the framework to drive critical advances in medicine. In addition to being a driver of revenue and profit growth, the HCT business also has a financial role in generating positive working capital for the Group, with a significant upfront payment on contract. hVIVO’s human challenge models can enable sponsors to generate proof-of-concept data up to 3.5 times faster than natural infection studies, with top line data typically delivered within 12 months from CTA signature. We are seeing consistently strong interest across antiviral and other non-vaccine prophylactic programmes, broadening the potential of HCTs beyond vaccine development.

In April, we signed a contract with ILiAD Biotechnologies to conduct the world's first pivotal Phase III HCT, to evaluate its whooping cough vaccine candidate BPZE1, representing our largest HCT to date and a landmark programme for both hVIVO and the wider HCT model. Revenue recognition began in H1 2026, with this multi-year contract expected to make a strong contribution to near- and medium-term revenues. The programme represents an important precedent for the potential use of HCT data within pivotal development programmes and, over time could support wider adoption of the model in seasonal indications where conventional field trials can be difficult, time sensitive or unfeasible. A further two influenza HCT contracts were signed during the period: one with Traws Pharma in April and a second £6 million contract in May.

The recent HCT wins reinforce our confidence in the long-term opportunity for the human challenge model. At the same time, our broader Clinical Trials, Consulting and Laboratory capabilities give us access to a significantly larger early clinical development market and provide multiple additional routes to growth. As sponsors increasingly prioritise speed, capital efficiency and earlier generation of high-quality decision-enabling data, we believe hVIVO's specialist integrated model positions us well to capture this opportunity.

Leadership

Stephen Pinkerton has informed the Board of his intention to retire as CFO on 30 September 2026 after ten years with the Company. Richard Cotton, currently a NED of the Company and an experienced CFO and financial leader, will serve as Interim CFO while the Board completes the appointment of a permanent successor. On behalf of the Board, I would like to thank Stephen for his commitment and contribution to hVIVO over the past decade and the role he has played in supporting the Company’s evolution into an integrated early clinical development partner.

Outlook

We see a significant opportunity to grow our share of the broader early-phase CRO market. Independent estimates value the outsourced Phase I-II market at around $9.5 billion in 2025 and forecast it to reach almost $15 billion by 2030.1   Rising biopharma M&A activity, resilient financing markets and the approaching patent cliff for large pharma provide further supportive industry dynamics, increasing demand for de-risked, data-rich, later-stage assets, underpinning the need for specialist development partners capable of accelerating programmes and supporting earlier development decisions.

Whilst H2 2026 revenue is expected to nearly double that reported in H1, reflecting the expected second-half weighting of contracted programme delivery, the phasing and deferral of certain contracted client programmes are now expected to shift a proportion of revenue previously expected in FY 2026 into 2027 and 2028. Including an expected c.£3.0 million contribution from CRS Berlin, net of existing revenue overlap for services supplied by hVIVO, the Group expects to report FY 2026 revenue of approximately £47 million. The Group expects positive adjusted EBITDA in H2 2026 and a low single-digit adjusted EBITDA loss for FY 2026, including an expected c.£0.5 million contribution from CRS Berlin.

Trading since 30 June 2026 has continued to improve, with particularly strong momentum in our sales pipeline and proposal volumes. This follows a 26% increase in the aggregate value of customer proposals submitted in H1 2026 vs. H1 2025. The significant strengthening of our contracted orderbook, together with the phasing of certain client programmes into 2027 and 2028, also provides increased visibility and positions the Group to return to significant growth in 2027.

1 The Business Research Company, Early Phase Clinical Trial Outsourcing Market Report 2026.

Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2026

Consolidated Statement of Financial Position

As at 30 June 2026

Consolidated Statement of Changes in Shareholders’ Equity

Consolidated Statement of Cash Flows

For the 6 months ended 30 June 2026

NOTES FORMING PART OF THE INTERIM FINANCIAL STATEMENTS

1. General information

hVIVO plc is a company incorporated in England and Wales. The Company is a public limited company, limited by shares, listed on the AIM market of the London Stock Exchange.

The address of the registered office is 40 Bank Street, Floor 24, London, E14 5NR.

The hVIVO Group operates as a full-service Contract Research Organisation (CRO) and the global leader in human challenge trials. The Group has a presence in the UK, Germany, the Netherlands and France.

The financial statements are presented in thousands of GBP (“£’000”), except where otherwise indicated. The Group comprises hVIVO plc and its subsidiary companies.

The registered number of the Company is 07514939.

2. Basis of preparation and accounting policies

The consolidated financial information of hVIVO plc has been prepared in accordance with UK adopted international accounting standards (IFRSs), IFRIC interpretations and the Companies Act 2006 applicable to companies reporting under IFRS.

The consolidated financial information has been prepared under the historical cost convention.

The accounting policies applied by the Group in this financial information are the same as those applied by the Group in its financial statements for the year ended 31 December 2025 and which will form the basis of the 2026 financial statements.

The financial information presented herein does not constitute full statutory accounts under Section 434 of the Companies Act 2006 and was not subject to a formal review by the Group’s auditor. The financial information in respect of the year ended 31 December 2025 has been extracted from the statutory accounts which have been delivered to the Registrar of Companies. The Group's Independent Auditor's report on those accounts was unqualified, did not include references to any matters to which the auditor drew attention by way of emphasis without qualifying their report and did not contain a statement under section 498(2) or 498(3) of the Companies Act 2006. The financial information for the half years ended 30 June 2026 and 30 June 2025 is unaudited and the twelve months to 31 December 2025 is audited.

The Interim Financial Statements were approved by the Board of Directors on 14 September 2026.

3.  Presentational changes

Consolidated income statement

In order to give further clarity to users of the financial statements, from 30 June 2026, the Group is presenting cost of sales in the Consolidated Income Statement as a separate line item.  Cost of sales was previously included within “Direct project and administrative costs” which has been renamed to “Selling and administrative costs”.  The 31 December 2025 and 30 June 2025 Consolidated Income Statements have been updated to reflect this change of presentation.

Consolidated statement of cashflows

For the periods ended 30 June 2026 and 31 December 2025, the impact of Other operating income (mainly R&D tax credits) on the Consolidated Statement of Cash Flows is shown in (Increase)/decrease in trade and other receivables.  In previously published financial statements, R&D tax credit cash received was shown in a separate line on the Statement of Cash Flows.  The 30 June 2025 Consolidated Statement of Cash Flows has been updated to reflect this change of presentation.

4.  Finalisation of prior year acquisition accounting

The acquisition accounting for CRS Clinical Research Services Mannheim GmbH and CRS Clinical Research Services Kiel GmbH was provisional in the financial information previously reported for the six months ended 30 June 2025 and was subsequently finalised by 31 December 2025. Accordingly, the comparative financial information for the six months ended 30 June 2025 has been restated to reflect the final acquisition-date fair values. The restatement resulted in an increase to Intangibles assets of £1,975,000, a reduction to Goodwill of £674,000, an increase to Foreign currency reserves of £19,000, a decrease to Retained earnings of £126,000 and an increase to Deferred tax liability of £674,000 as at 30 June 2025.

5. Loss per share

Basic earnings per share has been calculated by dividing the profit attributable to shareholders by the weighted average number of shares in issue during the period.

Where there is a profit for the period, diluted earnings per share has been calculated after adjusting the weighted average number of shares used in the basic calculation to assume the conversion of all potentially dilutive shares. A potentially dilutive share is a warrant or option where its exercise price is below the average market price of hVIVO shares during the period and any performance conditions attaching to the scheme have been met at the balance sheet date.

Where there is a loss for the period, potentially dilutive shares are not dilutive, and therefore diluted earnings per share has been calculated by dividing the loss attributable to shareholders by the weighted average number of shares in issue during the period.

The adjusted profit is used in the calculation of adjusted earnings per share as reconciled below:

*Items denoted with an asterisk form part of Exceptional items as disclosed on the Consolidated Income Statement.

The numbers of shares used in calculating basic and diluted earnings per share are reconciled below.

6. Trade and other receivables

7. Trade and other payables

8. Share based payments

There was a share-based payment charge in the period of £284,000 (H1 2025: £404,000).

9. Dividend

No dividend was paid in the period ended 30 June 2026 (30 June 2025: a final dividend of 0.20 pence per share relating to the year ended 31 December 2024 was paid to shareholders on 11 June 2025; the total amount paid by the Company was £1,372,000).

10. Post balance sheet events

In August 2026, the Group acquired 100% of the share capital of CRS Clinical Services Berlin GmbH (‘CRS Berlin’).  The Group 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), provided a minimum revenue threshold is met in each period.   No amounts relating to the acquisition have been recognised in these interim financial statements. The Group is in the process of completing the acquisition accounting and assessing the fair values of the assets acquired and liabilities assumed.

11. Press

A copy of this announcement is available from the Company’s website, being www.hvivo.com.  If you would like to receive a hard copy of the interim report, please contact the hVIVO plc offices at [email protected] to request a copy.