REG - hVIVO PLC - £11.5m RSV contract and notice of trading update

hVIVOAnnouncement

10/12/2024 07:00

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RNS Number : 4023P  hVIVO PLC  10 December 2024

hVIVO plc

("hVIVO" or the "Company")

 

£11.5 million RSV contract signed with existing top-tier global
pharmaceutical client

 

Notice of trading update

 

hVIVO plc (AIM: 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 signed an £11.5
million contract with an existing top-tier global pharmaceutical client to
test its antiviral candidate using hVIVO's Respiratory Syncytial Virus ("RSV")
Human Challenge Study Model.

 

The Phase 2a randomised, double-blinded placebo-controlled human challenge
trial will evaluate the safety, pharmacokinetics and antiviral activity of the
drug candidate. hVIVO will leverage its in-house volunteer recruitment arm,
FluCamp (https://flucamp.com/) , to enrol healthy volunteers into the study.
The study is scheduled to commence in H2 2025 at hVIVO's state-of-the-art
quarantine facilities in Canary Wharf, with revenue expected to be recognised
across 2025 and 2026.

 

This repeat contract with an existing client highlights the value that global
pharma place on hVIVO's human challenge trials. hVIVO's trials offer a
time-efficient and cost-effective way to generate early human efficacy data
and inform later stage trial design, which can accelerate the path to market
for new therapies.

 

RSV remains a leading cause of childhood lower respiratory infections and is
responsible for a significant burden of disease in the elderly and in adults
with chronic medical problems, such as COPD. Globally RSV affects an estimated
33 million people annually, leading to approximately 4 million
hospitalisations and approximately 101,000 RSV attributable deaths in children
under five years.(1) Even with a number of RSV vaccines approved in recent
years, there remains a considerable unmet need for effective antivirals that
address acute disease which continues to have a major impact on vulnerable
populations globally.

 

To date, hVIVO has inoculated c.2,000 healthy volunteers across 30 RSV
challenge trials which has successfully expedited the development of several
RSV drug and vaccine candidates for a number of biopharmaceutical companies.
Use of hVIVO's RSV challenge model has provided compelling, pivotal, proof of
concept data that has directly led to product acquisitions as well as some
products receiving FDA Fast Track and / or Breakthrough Designations. The
model has also been used for an RSV product that has now been launched to
market. hVIVO's challenge trials continue to be a key drug development tool
helping companies to develop products to combat RSV as well as other
infectious and respiratory diseases.

 

Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "This contract
further demonstrates the trust and confidence that leading pharmaceutical
companies place in hVIVO's human challenge study models. We are proud to work
with four of the top 10 global pharmaceutical companies to address unmet
medical need in infectious and respiratory diseases. Our unique and
established RSV model can provide valuable data on a candidate's safety,
pharmacokinetics, and efficacy, reducing the risks associated with later-stage
clinical development and accelerating the pathway to market."

 

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "While the
recent approvals of the world's first RSV vaccines represent a major step
forward, the virus continues to pose a substantial risk to public health,
especially among vulnerable populations. The need for effective antiviral
treatments that can counteract severe illness remains urgent, and human
challenge trials can play a pivotal role in the development of these
therapeutics."

 

Confirmation of FY 2024 guidance and notice of trading update

 

The Company reaffirms its FY 2024 revenue guidance of £62 million, with full
year EBITDA margins anticipated to be at the upper end of market
expectations.*

 

Consistent with the Company's usual timetable for providing forward guidance
the Company expects to announce a trading update for the year ended 31
December 2024 before the end of February 2025, which will include the outlook
for 2025.

 

*Consensus market expectations for FY24 EBITDA margins are 22.7%, within a
range of 22-24%.

 

(1) Li Y et al. Global, regional, and national disease burden estimates of
acute lower respiratory infections due to respiratory syncytial virus in
children younger than 5 years in 2019: a systematic analysis. Lancet. 2022 May
28;399(10340):2047-2064. doi: 10.1016/S0140-6736(22)00478-0. Epub 2022 May 19.
PMID: 35598608; PMCID: PMC7613574.

 

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.

 

For further information please contact:

 

 hVIVO plc                                       +44 (0) 20 7756 1300
 Yamin 'Mo' Khan, Chief Executive Officer

 Stephen Pinkerton, Chief Financial Officer

 Cavendish Capital Markets Limited (Nominated Adviser and Joint Broker)                  +44 (0) 20 7220 0500
 Geoff Nash, Camilla Hume, Harriet Ward
 Nigel Birks - Life Science Specialist Sales

 Louise Talbot - Sales

 Peel Hunt LLP (Joint Broker)                                        +44 (0)20 7418 8900
 James Steel, Dr Christopher Golden

 Davy (Joint Broker)                                                 +353 (0) 1 679 6363
 Anthony Farrell, Niall Gilchrist

 Walbrook PR (Financial PR & IR)                 +44 (0) 20 7933 8780 or hvivo@walbrookpr.com

 Paul McManus, Phillip Marriage,                 +44 (0)7980 541 893 / +44 (0) 7867 984 082 /

Louis Ashe-Jepson
+44 (0) 7747 515 393

 

 

Notes to Editors

 

About hVIVO

 

hVIVO plc (http://www.hvivo.com) (ticker: HVO) 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 (https://hlabservices.com/) brand,
which includes virology, immunology biomarker and molecular testing. The Group
also 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 (http://www.flucamp.com/) volunteer screening facilities
in London and Manchester.

 

 

 

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