Open Orphan plc (ORPH) has announced its drug development subsidiary company PrEP Biopharm Limited (“PrEP Biopharm”), which is 62.6% owned by Open Orphan, has successfully completed a 12-week toxicology study for its novel pan-viral prophylactic asset, PrEP-001.
Planned Disposal
When Open Orphan acquired hVIVO in January 2020, hVIVO also came with a number of non-core assets including a 62.6% stake in PrEP Biopharm.
However, the new Open Orphan Board and management team are now primarily focussed upon cementing its position as a unique CRO and ‘world leader vaccine and antiviral testing using human challenge study models'. Management is therefore directing all resources to further improving the quality of earnings in both Venn Life Sciences and hVIVO to support the profitable CRO services business, while disposing of all non-core assets, without further use of ‘Open Orphan shareholder funds’.
It will however continue to work with the PrEP Biopharm management team to secure external sources of funding outside of the Open Orphan group while maximising the potential of these non-core assets.
The options for disposal of this unique asset are exciting, numerous and particularly timely given its mode of action.
These options could include a trade sale to a Big-Pharma for cash, reverse the asset into the resurgence of listed SPACs and Cash Shells, or even Spin the asset out into a newly listed entity, such as EKF Diagnostics (EKF) has done on numerous occasions, delivering investors dividends in specie of newly formed companies.
In any event, OPRH shareholders would do well to remain on the Shareholder register when this transaction takes place as, whilst the valuation of PrEP Biopharm is currently unknown, with little carrying value on the Open Orphan balance sheet, it should advance the share price accordingly.
About PrEP BioPHarm
PrEP-001 is neither a vaccine nor an antiviral. Rather, it is a synthetic RNA 'viral mimic' that stimulates the body's pan-viral innate immune response locally in the upper respiratory tract.
Administered via a once daily nasal spray it leverages the innate immune system to create an antiviral environment to stop invading respiratory viruses and does not require highly trained medical staff to administer.
As such, it is possible that PrEP-001 could be used as a stand-alone pan-viral prophylaxis or as an adjuvant for live and inactivated or peptide intranasal vaccines targeting specific respiratory viruses.
The positive Phase IIb pre-clinical study results announced today provides safety data needed to move PrEP-001 into longer duration dosing in human studies.
PrEP Biopharm will now move forward with a real-world, field trial intended to validate the efficacy of PrEP-001 against all circulating respiratory viruses, including COVID-19, influenza and the common cold.
Previous pre-clinical studies have demonstrated that intranasal administration of poly IC shortly after vaccination with live attenuated, inactivated and haemagglutinin antigen preparations of influenza virus enhanced respiratory dendritic cell function, CD8 T cell formation, and production of neutralising antibodies.
Cathal Friel, Executive Chairman of Open Orphan, said: "It is very encouraging to note PrEP Biopharm’s progress towards the ultimate goal of validating the effectiveness of their one dosage nasal spray for key respiratory viruses like COVID-19, flu and the common cold. This safety data allows them to move into Phase 2b field studies and we are very excited that PrEP-001 could play a meaningful role in the current COVID-19 pandemic and future potential pandemics caused by new respiratory viruses.”
Reasons to Follow Open Orphan
Open Orphan is a rapidly growing CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. All businesses are now working closely together to offer upselling and cross selling opportunities.
World Class Facilities
Open has Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and specialist laboratory facilities. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.
Largest Test Portfolio
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 2020, Open Orphan is also 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. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
Rapidly Expanding Market with Regular Positive Newsflow
The market for vaccine development and testing has grown rapidly over the past six months, largely due to the outbreak of Covid-19. However, Open Orphan now believes Governments and International pharmaceutical companies around the world will be making enormous ‘catch-up investments’ in all types of vaccine development to ensure the effects of any pandemic can be mitigated in the future, which should result in the hIVO facility being booked out for months, if not years, in advance going forward.
The Company is committed to providing regular Newsflow to ensure investors of all classes are fully briefed on the Investment opportunity for Open Orphan.
Planned Disposal
When Open Orphan acquired hVIVO in January 2020, hVIVO also came with a number of non-core assets including a 62.6% stake in PrEP Biopharm. However, the newThe Open Orphan Board and management team are primarily focussed upon cementing its position as a unique CRO and ‘world leader vaccine and antiviral testing using human challenge study models, and therefore earmarked all non-core assets for disposal.
The options for disposal of this unique asset are exciting, numerous and particularly timely given its mode of action. These options could include a trade sale to a Big-Pharma for cash, reverse the asset into the resurgence of listed SPACs and Cash Shells, or even Spin the asset out into a newly listed entity, such as EKF Diagnostics has done on numerous occasions, delivering investors dividends in specie of newly formed companies. In any event, OPRH shareholders would do well to remain on the Shareholder register when this transaction takes place as, whilst the valuation of PrEP Biopharm is currently unknown, with little carrying value on the Open Orphan balance sheet, it should advance the share price accordingly.