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 (Euronext / LON:HVO), a fast growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has announced 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.”
hVIVO plc also announcesd that the Company’s registered address has changed to Floor 24, 40 Bank Street, London, E14 5NR, United Kingdom.
The company went on to provide the following trading update for the financial year ending 31 July 2024 (‘FY24’).
Operational overview
· The Group continues to deliver all milestones in its two-year Joint Development Agreements (JDAs) for second generation sensing materials with ST Microelectronics and the Asian chemical company.
· The new Device Fab is now fully operational and sample devices have been shipped.
· Following customer dialogue, the Group no longer expects to receive a further production order for its validated first generation sensing products during FY24.
· The Group is working with its customer to understand the range of possible outcomes and any potential impact on Nanoco beyond the end of the financial year. The Group expects to issue a further update with the full year results in October.
· The Group continues with some small-scale commercial engagements for customers interested in display materials, although no new anchor customer has been signed at this time.
· The Group continues to commit retained funds to expand our business development activities as set out in our planned use of retained funds.
Financial overview
· As a result of the delayed receipt of the second production orders noted above, full year revenue is expected to be marginally below consensus forecasts.1
· The impact of the reduction in revenue alongside some small one-off increases in overheads means Adjusted EBITDA is likely to be towards the lower end of the range of market forecasts2, subject to the results of the year-end audit.
· The impact of the delayed demand noted above on the Group’s aim of becoming cash breakeven during CY25 will depend on the duration of that delay and subsequent speed of ramp up in demand for our technology.
· The Group still expects its cash reserves to be approximately £20.0m on 31 July 2024.
· The Group remains committed to completing the return of capital through its £3.0m broker managed share buy back programme with £1.3m having been returned to date.
1The consensus revenue forecast is £8.35m, being the average of forecasts from Cavendish and Edison.
2Adjusted EBITDA analyst forecasts range from £0.5m to £1.5m.The Group expects to announce its full year results on 22 October 2024.
Brian Tenner, Chief Executive Officer of Nanoco, said:
“We continue to work hard across a range of products, customers and market sectors to deliver the adoption of quantum dot technology. The number of potential applications continues to grow strongly. The majority of our income generating staff remain engaged in paid for development work on new products in sensing and display applications. By investing across a broad range of business development opportunities, we aim to further reduce any dependency on a single customer and to deliver increases in shareholder value in the medium term.”
