TIDMHVO

RNS Number : 1389T

hVIVO PLC

16 March 2023

hVIVO plc

("hVIVO" or the "Company")

Omicron human challenge model update

hVIVO plc (AIM & Euronext: HVO) , (formerly Open Orphan plc) a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that its Omicron human challenge agent has been successfully manufactured.

Subject to the successful completion of the characterisation study and receipt of relevant regulatory approvals, this has expanded the Company's unique portfolio to 11 human challenge models to test a broad range of infectious and respiratory disease products. hVIVO actively offers Omicron human challenge trials as part of its service offering and is currently in discussions with a number of existing and potential customers.

As announced on 30 June 2022, the model was developed with Vaxart Inc. ("Vaxart"), (NASDAQ: VXRT) with the intent to conduct a subsequent Omicron human challenge study to test the efficacy of Vaxart's oral vaccine candidate. The Company notes the announcement from Vaxart and its decision to postpone further clinical trials in its COVID-19 programme, including the challenge study, as they focus upon the development of an oral pan-betacoronavirus vaccine, which may provide improved protection against SARS-CoV-2 as the virus continues to mutate and protection against other types of betacoronaviruses.

The Vaxart challenge study was not included in the Company's order book and its postponement will have no impact on hVIVO's 2023 financial guidance. As at 31 December 2022 the Company's orderbook was GBP76m, with over 95% of forecasted revenue for 2023 contracted.

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 
 
 finnCap plc (Joint Broker)                                          +44 (0) 20 7220 0500 
 Geoff Nash, Charlie Beeson, Nigel Birks, 
  Harriet Ward (ECM) 
 
 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 capacity via its FluCamp volunteer screening facilities in London and Manchester.

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March 16, 2023 03:00 ET (07:00 GMT)

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