TIDMHVO
RNS Number : 5442W
hVIVO PLC
13 December 2023
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.
hVIVO plc
("hVIVO" or the "Company")
GBP16.8m full-service RSV contract with top five global pharma
client
Trading ahead of guidance
Highlights
-- Pharma client is funding expedited manufacture of additional supply of RSV challenge agent
-- Confirmatory challenge cohort to verify infectivity of the new RSV challenge virus batch
-- Multiple cohort challenge trial to test efficacy of client's RSV antiviral candidate
-- Trading ahead of previous market expectations driven by margin expansion
hVIVO plc (AIM & Euronext: HVO) , the world leader in
testing infectious and respiratory disease products using human
challenge clinical trials, announces that it has signed a GBP16.8m
full-service contract with an existing top five global
pharmaceutical client to test its respiratory syncytial virus
("RSV") antiviral drug candidate using the hVIVO RSV Human
Challenge Study Model.
The contract includes the expedited manufacturing of the RSV
challenge agent, a confirmatory challenge cohort and a multiple
cohort challenge trial. The purpose of the trial is to evaluate the
efficacy of the antiviral candidate against RSV infection in
healthy adults and identify the most effective dosing ahead of
later stage clinical trials. Revenue from this contract will be
recognised across 2023, 2024 and 2025 with the majority of the
revenues being recognised in 2024.
hVIVO will commence Good Manufacturing Practice (GMP) compliant
virus manufacturing activities immediately, which is expected to
complete in H1 2024. Upon completion of manufacturing, the Company
expects to confirm infectivity of the new RSV challenge virus batch
in small number of healthy volunteers recruited via FluCamp .
Subject to the successful completion of the above, and the
receipt of relevant regulatory approvals, the Company expects to
start the RSV human challenge trial in H2 2024. This will be a
randomised, double-blinded, placebo-controlled Phase 2a study. It
will consist of multiple cohorts to evaluate the efficacy of the
client's RSV antiviral candidate via different dosing regimens. The
multiple cohort study highlights the expanding utility of human
challenge trials, demonstrating their ability to not just provide
quick efficacy data, but also refine dosing strategies ahead of
critical later stage clinical trials. The challenge study is
planned to take place at the Company's new state-of-the-art
quarantine facilities in Canary Wharf, which is on track to be
operational in H1 2024.
The Company is pleased to report that trading has continued to
be strong across the Group, with revenue slightly ahead of previous
market expectations. The Group has continued to improve operational
efficiencies which, coupled with the facilities funding that will
benefit both FY23 and FY24, has resulted in EBITDA margins
exceeding 20% for the year ending 31 December 2023. Consequently,
the Group now expects EBITDA to be ahead of previous market
expectations. With the addition of today's contract, the Company
has clear revenue visibility into 2024. Further details will be
shared as part of the Company's FY23 Trading Update in late January
2024.
Yamin 'Mo' Khan, Chief Executive Officer of hVIVO, said: "Our
RSV (Memphis strain) challenge agent has played a significant role
in the development of RSV vaccines and we are delighted that it is
continuing to be used as the go-to model for our clients. We have
built a world-leading portfolio of challenge agents and are working
hard with our clients to add new models all the time. This contract
is another example of the end-to-end full service offering that
hVIVO has already successfully provided to several clients. We are
also delighted with the Company's strong operational performance in
2023 and now expect to exceed the previous market guidance and look
forward to updating the market further in the new year."
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said:
"As clinical assets approach critical and high-cost late-stage
trials, biopharma companies want to minimise the risk of failure,
and know that their asset has the best chance of reaching the
market. By using multiple cohorts and testing different dosing
regimens, our clients are able to use a human challenge trial to
optimise the dosing strategy as well as gain vital quick efficacy
data, further de-risking future clinical development. With the
expanded capacity and enhanced capabilities of our new facility, we
are well-equipped to deliver on the increasing demand for multiple
cohort studies of this kind."
Interested in becoming a volunteer?
hVIVO recruits its volunteers for its challenge study clinical
trials through its dedicated volunteer recruitment website,
www.flucamp.com . By volunteering to take part in one of our
studies in a safe, controlled, clinical environment under expertly
supervised conditions you are playing your part to further medical
research and help increase the understanding of respiratory
illnesses.
For further information please contact:
hVIVO plc +44 (0) 20 7756 1300
Yamin 'Mo' Khan, Chief Executive
Officer
Stephen Pinkerton, Chief Financial
Officer
Liberum Capital (Nominated Adviser and
Joint Broker) +44 (0) 20 3100 2000
Ben Cryer, Edward Mansfield, Phil Walker,
Will King
Cavendish Capital Markets Limited (Joint
Broker) +44 (0) 20 7220 0500
Geoff Nash, Charlie Beeson, Nigel Birks,
Harriet Ward
Davy (Euronext Growth Adviser and 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
Stephanie Cuthbert / Phillip +44 (0) 7796 794 663 / +44 (0) 7867 984
Marriage / 082 /
Louis Ashe-Jepson +44 (0) 7747 515 393
Notes to Editors
About hVIVO
hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly
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 Company has world class challenge
agent manufacturing, specialist drug development and clinical
consultancy services via its Venn Life Sciences brand, and a lab
offering via its hLAB brand, which includes virology, immunology
biomarker and molecular testing. The Group offers additional
clinical field trial services such as patient recruitment and
clinical trial site services.
hVIVO runs challenge studies in London from its Whitechapel
quarantine clinic, its state-of-the-art QMB clinic with its highly
specialised on-site virology and immunology laboratory, and its
clinic in Plumbers Row. To recruit volunteers / patients for its
studies, the Company leverages its unique clinical trial
recruitment capability via its FluCamp volunteer screening
facilities in London and Manchester.
About RSV
RSV is the main 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 it affects an estimated 50 million people annually,
leading to four million hospitalisations and approximately 60,000
in-hospital deaths in children younger than five years.(1) hVIVO
has inoculated over 1,600 healthy volunteers across 28 RSV
challenge trials to date and the challenge trial data has already
expedited the development of several RSV vaccines for a number of
pharmaceutical companies.
(1) Shi, T. et al. Global, regional, and national disease burden
estimates of acute lower respiratory infections due to respiratory
syncytial virus in young children in 2015: a systematic review and
modelling study. The Lancet 390, 946-958 (2017).
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