hVIVO plc: Diversification in Action as 2026 Growth Beckons

After a turbulent year for the clinical research sector, hVIVO plc (AIM: HVO) has found itself back in penny-stock territory. Its share price, which stood at 29.8 GBX in November 2024, now trades around 7.16 GBX (October 2025), a steep fall that reflects a mix of investor frustration, delayed contracts, and the wider pullback across biotech funding markets. It’s been a difficult environment, with many small-cap healthcare firms caught in the same downdraft.

But what often gets overlooked in moments like this is the difference between a company in decline and one in transition. hVIVO is firmly in the latter camp. Beneath the share price, there’s a business reshaping itself with purpose, streamlining operations, integrating new acquisitions, and broadening its reach beyond its traditional human challenge trial base. The management team has been quietly building the foundations for the next phase of growth, confident that the diversification now taking shape will start to show real results in 2026.

This is where the story gets interesting. For all the noise surrounding short-term performance, hVIVO today is more diversified, more international, and strategically better positioned than it was a year ago. The coming year will test that progress, but the direction of travel is clear, this is a business moving towards long-term stability and renewed growth.

The Diversification Drive – CRS and Cryostore Join the Stage

At the heart of hVIVO’s renewal are two complementary acquisitions completed over the past year, CRS Mannheim & Kiel, a leading German clinical research organisation specialising in Phase I and II trials, acquired in late January for €10 million, and Cryostore, a biobank and temperature-controlled storage provider acquired in February 2025 for up to £3.2 million. Together, they have broadened hVIVO’s revenue base beyond its traditional human challenge trial (HCT) model and created a wider mix of laboratory and clinical income, as well as broadening the Group’s client base and therapeutic expertise beyond infectious disease alone.

CRS adds 120 beds across Mannheim and Kiel and brings deep expertise in cardiometabolic and obesity trials. Under Key Opinion Leader, Professor Thomas Forst, its Chief Medical Officer, the division is already a leading provider of  obesity-related studies, part of a market projected to exceed $64 billion globally by 2034. Cryostore, meanwhile, contributes strong profit margins and a highly stable stream of recurring income and strengthens hVIVO’s hLAB division through integrated biobanking and regulated long-term storage for biological samples.

Combined, these two acquisitions generated £5.5 million in H1 2025 revenue (from acquisition dates in late January for CRS and late February for Cryostore), accelerating diversification and reducing reliance on the vaccine-trial market. Cryostore is already earnings-accretive, while CRS remains on track to become profitable in 2026.

Integration in Motion – Building One Cohesive Platform

hVIVO’s integration strategy has been built around three clear pillars: People, Processes, and Systems. This framework underpins its ambition to operate as one unified early-phase Contract Research Organisation across the UK, Germany, the Netherlands, and France. The focus has been on creating consistency, standardising how studies are managed, how teams communicate, and how data flows between clinical and laboratory sites.

Integration is now nearing completion, with harmonised roles, aligned oversight, and shared operational standards across the group. The process has already unlocked over £1 million in annualised cost savings through pricing optimisation and staff synergies, while also strengthening KPI monitoring, IT security, and automation. These changes will support hVIVO’s efficient delivery of client projects across multiple geographies.

Both CRS and Cryostore are now fully embedded within hVIVO’s four new service lines: Human Challenge Trials, Clinical Services, Laboratory Services (including hLAB and Cryostore), and Consultancy through Venn Life Sciences. This new structure improves coordination between divisions and strengthens cross-functional delivery, ensuring clients can access the company’s full range of expertise through a single point of engagement.

The systems integration phase is expected to complete by the end of 2025, creating a unified operational platform across Europe. Early signs of commercial benefit are already visible, with £2.1 million in new cross-selling opportunities identified between CRS and Venn Life Sciences and the first joint contracts already signed. As CEO Yamin ‘Mo’ Khan summarised at their recent interim results, this integration is about more than efficiency, it’s about building the base for sustainable, diversified growth as hVIVO enters 2026.

Expanding Capabilities Across Four Divisions

Following its recent acquisitions, hVIVO now operates as a full-service early phase Contract Research Organisation spanning four divisions: Human Challenge Trials, Clinical Services, Laboratory Services, and Consulting. The aim is simple, to create a joined-up business that can move seamlessly from preclinical advice to early human studies, offering clients a single, reliable development partner. By aligning its operations in this way, hVIVO has strengthened coordination between trial delivery, laboratory testing, and data reporting while improving transparency and speed across the whole workflow.

Within Laboratory Services, hLAB delivered a standout performance in the first half of 2025, securing a £3.2 million standalone contract for a Phase II field trial. The order book continues to build, supported by a further £5 million pipeline of awards in the second half, including a large Phase III global field trial. The acquisition of Cryostore has enhanced this momentum, providing steady recurring revenue from long-term biobanking and sample storage contracts. Together, hLAB and Cryostore support hVIVO’s challenge trials, field trials, and external client studies.

The Clinical Services division has also expanded meaningfully through CRS, which bring new therapeutic expertise in dermatology, immunology/inflammation, renal/hepatic impairment, and cardiometabolic including obesity, some of the fastest-growing therapeutic markets worldwide. With 120 beds across Germany, CRS brings added capacity and expertise in first-in-human and proof-of-concept studies. This complements hVIVO’s London-based operations and extends the group’s reach into new therapeutic areas.

The successful launch of the Human Metapneumovirus (hMPV) challenge model, the first of its kind globally, adds another proprietary study platform to its growing portfolio.

At the Canary Wharf facility, operational performance remains strong, with the site supporting both human challenge trials, field trials, recruitment, and standalone lab contracts. The completion of an 817-participant Phase II influenza trial in just 43 days late last year remains a benchmark of what the company’s model can deliver, speed, control, and quality. With these systems and capabilities now in place, hVIVO enters 2026 as a more resilient, better-diversified, and fully scalable business, ready to convert its integrated structure into renewed growth.

Strengthening Client Base and Recurring Revenue Streams

The benefits of diversification are already visible in hVIVO’s 2025 interim results. Around one-third of first-half revenue (£7.9 million) now comes from laboratory and clinical services rather than challenge trials, reflecting the early success of the company’s broader strategy. Recurring income from long-term consultancy and biobanking contracts, particularly through Cryostore, is also providing greater stability and visibility in cash flow. Historically, hVIVO was reliant on large HCT contracts whereas today, the growing mix of services and revenue streams is creating a broader base of smaller, repeatable contracts, which supports the company’s broader goal of enhancing revenue resilience, reduce volatility over time, and ultimately lead to a higher quality earnings stream.

hVIVO now works with a wider client mix, including seven of the world’s ten largest pharmaceutical companies, and maintains operations across the UK, Germany, France, and the Netherlands. This European footprint gives the company access to more cross-border outsourcing opportunities at a time when global drug developers are prioritising faster and more cost-efficient early-phase studies. CRS has also strengthened the company’s relationships in continental Europe. hVIVO noted in its interim results that since acquiring CRS, it has re-established long-standing relationships with several German partners. Venn Life Sciences continues to secure repeat contracts through its integrated consultancy work while also supporting hVIVO trials and now providing key services for CRS that would previously have been outsourced – increasing retained earnings.

While the human challenge trial pipeline has faced delays in contract conversion, the company’s growing mix of smaller, repeatable laboratory and clinical engagements has cushioned overall volatility. As these segments scale through 2026, hVIVO is set to emerge with a steadier revenue base and stronger long-term client retention.

Financial Position and Outlook for 2026

For the six months to June 2025, hVIVO reported revenue of £24.2 million, EBITDA (pre-exceptionals) of £3.0 million, and a cash position of £23.3 million, with no debt on the balance sheet. The company has reaffirmed full-year revenue guidance of £47 million and anticipates a low-single-digit EBITDA loss, reflecting a temporary slowdown in human challenge trial activity. Its £40 million contracted order book and strong sales pipeline highlights solid demand across newly diversified service lines, including laboratory and clinical research. It’s worth noting that the orderbook figure does not include the potential contract with ILiAD for the world’s first pivotal Phase III HCT. Importantly the aggregate value of customer proposals submitted in H1 2025 surpassed FY24 which bodes well for the medium-term growth of the group, as does the increased conversion rate of proposals to contracts by CRS year-to-date versus 2024.

Looking ahead, management expects to return to growth in 2026, targeting high-single-digit revenue expansion as CRS becomes earnings-accretive and Cryostore continues to deliver steady recurring income. Group profitability is forecast to return in 2027, supported by growing cross-border clinical work and a stronger mix of long-term contracts.

The recent appointment of Shaun Chilton as independent Chair brings additional sector experience, following his tenure at Clinigen Group where he oversaw a period of significant international growth. Despite a lower cash balance due to recent acquisitions, hVIVO remains financially robust and fully funded for its operational and integration plans without the need for external borrowing.

Investor Reflection – Patience for Re-Emerging Value

hVIVO’s transformation is now visible in both structure and strategy. The integration of CRS and Cryostore has reshaped the company into a more balanced and resilient business, one that can generate steady revenue from laboratory and clinical work while retaining its global leadership in human challenge trials. What was once a single-stream model is now a multi-service platform built for scale.

2025 has been a year of adjustment rather than acceleration, but the company’s progress beneath the surface has been meaningful. The foundations for 2026 are stronger, a unified operating platform, a more diverse client base, and a clear roadmap back to profitability. As contract flow improves and new divisions mature, hVIVO’s ability to generate consistent growth across multiple markets should become clearer.

For investors, the message is simple: this is a transition worth watching. The short-term challenges are visible, but so is the strategy to overcome them. With integration largely complete, a solid cash position, and credible leadership in place, hVIVO looks well set to convert its diversification into sustainable, long-term value as 2026 unfolds.

Disclaimer: The information presented in this article represents the opinions and research of the author and is provided for informational purposes only. It is not intended to be, nor should it be interpreted as, financial, investment, or legal advice. Investors are encouraged to perform their own due diligence and consult with qualified financial advisors before making any investment decisions. Investing in small-cap stocks involves significant risks, and past performance is not indicative of future results. The author and publisher are not liable for any financial losses or actions taken based on the content of this article.


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