ORPH.L Regulatory News (ORPH)

7 July 2020

Open Orphan plc

("Open Orphan" or the "Company")

Additional Laboratory Services Contracts Signed

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials is pleased to announce that as part of opening up its hVIVO laboratory services to third parties that it has signed 3 new contracts with third parties; NoBACZ Ltd who are a spin-out company of the University of Cambridge, a new second contract with Nearmedic International Ltd and a contract to run in-vitro testing from its laboratory for a Cambridge, Massachusetts biotech.

NoBACZ Ltd is developing an environmentally friendly antimicrobial, antiviral coating that prevents common-touch surfaces from being a major source of infection transmission during and beyond the COVID-19 outbreak. The innovative, customisable antimicrobial coating has a multitude of applications across public spaces and industries. Applied as a liquid, the NoBACZ product is adhesive and water repellent and sets into a solid but flexible barrier that is robust enough to form a semi-permanent coating on a wide variety of surfaces. The product's composition can be fine-tuned to produce a thin or thick coating to suit different surfaces and materials, with the ability to adapt the product's life-span before it naturally degrades such that there is no need to manually remove it.

NoBACZ Ltd is working with hVIVO, at its state-of-the-art laboratory in East London, to test its products against a range of viruses, including coronaviruses and ultimately, against SARS-CoV-2, the virus strain that causes COVID-19 disease. If successful, the long-lasting coating can be applied to high-touch surfaces in public transport, office buildings, hospitals, gyms, care-homes, and supermarkets.

hVIVO has also recently signed a contract to run in vitro testing from its laboratory for a Cambridge, Massachusetts based biotech company. In addition, hVIVO had also signed another contract with Nearmedic International Ltd, the Company's second in recent times, to support the development of a RegG3 drug as a treatment for COVID-19 followed by the expansion of this product into several disease areas such as Cystic Fibrosis.

As announced at Open Orphan's recent fundraise, the group is expanding its virology and laboratory testing services to third parties. This provision of third-party laboratory services is a growth area for the Group as numerous biotechnology companies and small cap pharmaceutical companies around the world do not have their own virology laboratory. hVIVO has a unique state-of-the-art virology laboratory which it needs to run its own clinical trials, however, quite often in the past it was no more than 15% to 20% utilised. Therefore, going forward it makes great business sense to build up the laboratory services to use this underutilised capacity, i.e. our existing staff resources and facilities, to build a more profitable and sustainable business going forward. These contracts are further evidence of the Open Orphan Group executing on its strategy of building out additional and sustainable revenue lines from each of its Group companies going forward and is in line with the strategy of becoming a leading pharma services provider to the viral, and respiratory diseases sector of the pharmaceutical industry.

Cathal Friel, Executive Chairman of Open Orphan, said:

"We are now continuing to sign additional new virology services contracts with third party customers and, as such, this is delivering upon one of our key commitments from when we acquired hVIVO earlier this year that, as part of our growth strategy, we were going to expand the range of our service offerings to third party pharmaceutical and biotech companies. I am excited by this area of growth for Open Orphan as we seek to maximise the value out of our fantastic facilities in East London."

Jonathan Powell, CEO of NoBACZ said:

"We are delighted to be working with hVIVO, a world-leading virology laboratory and pioneer of viral challenge studies, in our efforts to evaluate NoBACZ's ground-breaking coating technology and its effectiveness at contact-killing respiratory viruses. hVIVO has the requisite experience and professional commercial focus to execute our pivotal studies rapidly and efficiently, allowing us to move forward in our ambitions to provide a quick-to-market solution for protecting the public against a resurgence of COVID-19 or similar outbreaks." 

Rupert Holms, Chairman of Nearmedic said:

"hVIVO and Open Orphan have the unique combination of skills which shall help Nearmedic to get its novel ezrin peptide technology to the global pharmaceutical markets and help in the fight against the COVID-19 pandemic"

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Notes to Editors - Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. Which offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.  In June 2020 hVIVO COVID Clear Test was launched, the most accurate antibody test available to UK employers, helping them to get their people back to work.

Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences, and is developing an early stage orphan drug genomics data platform business. Open Orphan comprises of two commercial specialist CRO services businesses (hVIVO and Venn) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company's customer base and with complementary specialist CRO services, widened the range of the Company's service offerings.