REG - hVIVO PLC - £16.8m RSV contract & Trading ahead of guidance

hVIVOAnnouncement

13/12/2023 07:15

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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")

 

£16.8m 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 £16.8m 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 (http://www.flucamp.com) .

 

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
(http://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 Marriage /         +44 (0) 7796 794 663 / +44 (0) 7867 984 082 /

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
(https://eur05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.flucamp.com%2F&data=05%7C01%7CCarol.Dalton%40openorphan.com%7Cfb9f1a50aaa9492d81ed08da875cca71%7C131abc777e104bbd90170559abc5d601%7C1%7C0%7C637971129881295595%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=fQdtQTHu9Bo70yRgWcZW5liNTXPYiWl9YayUA01E%2FlA%3D&reserved=0)
 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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