VENN final year reports - Hybridian's view

Poolbeg Pharma PLC - Distribution in Specie update #POLB @PoolbegPharma https://www.voxmarkets.co.uk/rns/announcement/bf71526a-1523-43f5-bae2-782de5f08799

 

28 April 2022

Open Orphan plc

("Open Orphan" or the "Company")


Appointment of Nominated Adviser and Joint Broker


Open Orphan plc (AIM: ORPH), 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 further to the announcements by Arden Partners Plc on 11 and 14 April 2022 regarding the loss of its Nominated Adviser status upon the completion of its recommended takeover, the Company has appointed Liberum Capital Limited ("Liberum") as its Nominated Adviser and Joint Broker. Given the timing of the completion of the recommended takeover of Arden Partners Plc, the Exchange has agreed that subject to initial due diligence being undertaken, Liberum has until 5pm on 27 July 2022 to complete its full due diligence.

There can be no guarantee on the outcome of the full due diligence and its impact on Liberum's decision to continue to act as Nominated Adviser. Accordingly, in such circumstances there is a risk that if the Liberum does not continue to act as Nominated Adviser following completion of its full due diligence and the Company has not found an alternative Nominated Adviser, the Company's AIM securities may be suspended pursuant to AIM Rule 1. If within one month of that suspension, the Company has failed to appoint a replacement Nominated Adviser, the admission of its AIM securities will be cancelled.

Notwithstanding the extension of time provided in respect of completing full due diligence obligations at engagement, Liberum will continue to be subject to all the ongoing Nominated Adviser responsibilities under the AIM Rules for Nominated Advisers.

finnCap plc and Davy will continue to act as the Company's Joint Brokers.


Yamin 'Mo' Khan, Chief Executive Officer at Open Orphan, said: "As the market is aware, Arden Partners can no longer act as Nomad for listed companies from 29 April 2022 and as such, we thank them for their support over the past number of years. We are delighted to now be working with such a prestigious investment bank as Liberum."

 

04 May 2022


Open Orphan plc

("Open Orphan" or the "Company")


Comment re: speculation

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes market speculation regarding a potential delisting. The Company confirms that it has no plans to delist and is working with Liberum to complete their due diligence following their appointment as Nominated Adviser to the Company. It looks forward to confirming the completion of the required due diligence in due course.

The wording included in the announcement dated 28 April 2022 announcing the appointment of Liberum as Nominated Adviser was standard wording for all former clients of Arden Partners given the relatively short notice provided to the Company to appoint and complete take-on of a new Nominated Adviser following the recommended takeover of Arden Partners by The Ince Group plc.

 

04 May 2022

Open Orphan plc

("Open Orphan" or the "Company")


Challenge virus manufacturing contract for top 5 global pharmaceutical client


Open Orphan plc (AIM: ORPH), 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 hVIVO, a subsidiary of Open Orphan, has signed a substantial contract with an existing top 5 global pharmaceutical client to manufacture a virus for use in human challenge studies.

Virus manufacturing activities have commenced and are expected to be completed by end of Q3 2022. The Company is optimistic that a characterisation study and a substantial human challenge study would follow the completion of the GMP-compliant manufacturing process. The aim of a characterisation study is to establish the right dose of the virus that causes a safe and reliable infection in healthy volunteers. The revenue for the manufacturing process will be recognised in 2022.

The manufacture of new challenge viruses ensures that hVIVO has contemporary challenge agents available to meet the needs of the global pharmaceutical industry as they continue to fight the battle against infectious disease. Furthermore, this ensures the Company continues to enhance and expand its offering of human challenge studies, especially among infectious diseases where variants continually emerge and are often poorly understood.


Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said: "We are delighted to have secured this challenge virus manufacturing contract, from an existing Big Pharma client. This contract is testament to our world-class capabilities in the entire challenge trial process, beginning with virus manufacture, through to characterisation study and challenge study execution. This contract illustrates our ability to leverage this to build deep, long-lasting relationships with our clients over significant periods of time.

"This contract is also a further example of the Company's ability to secure repeat contracts from its existing base of Big Pharma clients, who have great confidence in our decades of world leading clinical trial experience. With this experience coupled with our expanded offering following the facilities expansion, I look forward to providing further clinical services support to the significantly enlarged and growing infectious and respiratory disease market."

 

Open Orphan PLC - Vaccine field study contract #ORPH @OpenOrphan https://www.voxmarkets.co.uk/rns/announcement/67a7fecf-bede-4087-85f5-ad7ee1b4765d

 

12 May 2022

Open Orphan plc

("Open Orphan" or the "Company")


Key considerations document for developing and manufacturing challenge agents published


Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes a key considerations document for developing and manufacturing challenge agents published in the Wellcome Open Research Journal co-authored by Alex Mann, Senior Director of Clinical Research of hVIVO and the project lead, a subsidiary of Open Orphan plc, titled 'Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models'.

The project was funded by the Wellcome Trust and HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines, based at Imperial College London. The considerations document was prepared by an hVIVO led consortium, involving engagement with global experts in the human challenge field and manufacturing. It outlines the key aspects of the development, characterisation and manufacture of infectious challenge agents. The aim of the document is to promote volunteer safety whilst maximising access to challenge agents and challenge models in low-income or middle-income countries (LMICs) and academic institutions globally.

It is hoped that these considerations will be used across high-, middle- and low-income countries for the safe production of challenge agents by trained personnel with appropriate facilities, quality control measures and other best practices.

The increase in human challenge studies being established in LMICs and the need for challenge agents to reflect naturally occurring and epidemiologically relevant pathogen strains means there is an increased likelihood that they will be manufactured in conditions where full Good Manufacturing Practice ("GMP") is not possible. This document fills the previous gap of clear guidance on the minimum requirements for high-quality and safe manufacture outside of GMP facilities.

Challenge agents are the viruses, parasites, bacteria used in human challenge trials that volunteers are purposely challenged with. Depending on the design of the trial, the volunteers may or may not be administered a trial drug candidate before or after being exposed to the challenge agent to provide early proof of concept, allowing the candidate to progress more quickly to phase II or phase III trials.

Wellcome Open Research provides all Wellcome researchers with a place to rapidly publish any results they think are worth sharing. All articles benefit from rapid publication, transparent peer review and editorial guidance on making all source data openly available.


Yamin Khan, Chief Executive Officer of Open Orphan, said: "As the world leader in conducting human challenge studies I am delighted that Open Orphan continues to play a key role in democratising access to human challenge trials. This latest document provides clear considerations for challenge agent manufacturing, where previously a gap existed regarding the minimum requirements for high-quality safe manufacture outside of GMP facilities. Human challenge trials have clear advantages over traditional clinical field trials, and their global adoption will be vital to progressing the development of vaccines and anti-infectives around the world."

Alex Mann, Project leader and Senior Director, Clinical Science at hVIVO, said: "I was pleased to co-author the considerations document and the associated summary publication in collaboration with the Wellcome Trust and HIC-Vac, that recommends key aspects for researchers to consider for challenge agent development and manufacturing. In recent years, there has been an increase in human challenge studies in low- or middle-income countries where GMP facilities are not readily available. This document will support the development, characterisation and manufacture of challenge agents in these settings, while also maximising volunteer safety and access to challenge agents and challenge models."

Shobana Balasingam, Research Lead in Infectious Disease Prevention at Wellcome, said: "The guidance to manufacture safe and effective challenge agents under GMP conditions differs globally and is not always feasible, which can slow down vital research, particularly in low- and middle-income countries where this research is often most-needed. However, guidelines for manufacturing outside of GMP facilities are not currently available.

"As funders of global infectious disease research, Wellcome are please to support this clear and practical document for developing challenge agents where GMP is not possible. This guidance can ensure the full potential of human infection studies around the world, which provide crucial insight into infectious diseases, helping to rapidly accelerate the development of vaccines."


An editorial will be published alongside the report: 'Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents For Use In Human Infection Models' by Shobana Balasingam, Sarah Meillon, Cecilia Chui, Alex Mann, Carine La, Charlie Weller, Debbie King and Emma Smith. Available in Wellcome Open Research. DOI: https://doi.org/10.12688/wellcomeopenres.17869.1

 

Poolbeg Pharma PLC - GMP manufacturing contract signed #POLB @PoolbegPharma https://www.voxmarkets.co.uk/rns/announcement/7e358e7c-815a-4a45-b5e8-b9d2a9c816c7

 

18 May 2022

Open Orphan plc

("Open Orphan" or the "Company")


£7.3m Influenza human challenge study contract win


Open Orphan plc (AIM: ORPH), 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 hVIVO, a subsidiary of Open Orphan, has signed a £7.3m influenza human challenge study ("Study") contract with a leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model.

The randomised, double-blinded, placebo-controlled study will test and assess the antiviral prophylactic and post-inoculation treatment activity of the antiviral in healthy adult volunteers enrolled through the Company's specialist, tech-enabled volunteer recruitment arm, FluCamp. The Study will be conducted by hVIVO's team of medics at its state-of-the-art quarantine facilities in London andis expected to commence next year. Revenue from the contract is expected to be recognised across FY23 and FY24.

The Company's specialised virology laboratories, hLAB, will determine the viral load of the influenza challenge agent used to inoculate volunteers, hLAB will also provide serology services and virology services (viral infectivity assay) for the study.

Influenza is a contagious respiratory illness caused by influenza viruses that affect the nose, throat and the lungs. It can cause mild to severe illness, and occasionally lead to death. According to Financial Times1 analysis of official data in England, since the development of effective vaccines and the emergence of the less severe Omicron variant, influenza is now more lethal than COVID-19. For every 100,000 Omicron infections, 35 will result in death, while the equivalent number of flu infections will lead to around 40 fatalities.


Yamin 'Mo' Khan, Chief Executive Officer of Open Orphan, said: "I am pleased to sign a contract with this leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. hVIVO has seen a steady increase in flu studies, a reflection of the shift in market sentiment following recent scrutiny of infectious disease data that has outlined the significant threat of flu and the potential of human challenge studies to the advancement of drug development candidates."

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: "We are excited to test the antiviral prophylactic and post inoculation treatment activity against flu infection using the hVIVO Influenza Human Challenge Study Model. hVIVO has pioneered influenza human challenge studies for decades, with our history dating back to the Salisbury Common Cold Clinic.

"Since the advent of effective vaccines and treatments for COVID-19, there has been renewed focus on influenza and official data shows flu is now a more lethal threat. After completing the study, we hope to provide positive data and early proof of concept for our client's product, in order to accelerate its development into a Phase II programme."


1'Vaccines and Omicron mean Covid now less deadly than flu in England', The Financial Times, by Burn-Murdoch, John, and Barnes, Oliver. Link: https://www.ft.com/content/e26c93a0-90e7-4dec-a796-3e25e94bc59b

 

New £7.3m flu study contract for 2023 - 2024 ......

 

24 May 2022

Open Orphan plc

("Open Orphan" or the "Company")


Notice of results


Open Orphan plc (AIM: ORPH), 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 it will release its full year results for the year ended 31 December 2021 on Tuesday 7 June 2022.


Investor Presentation

Yamin 'Mo' Khan, Chief Executive Officer, and Leo Toole, Chief Financial Officer, will be hosting a live online presentation relating to the final results via the Investor Meet Company platform at 6pm on Tuesday 7 June 2022. The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and register for the presentation here.

Investors who already follow Open Orphan on the Investor Meet Company platform will automatically be invited.

Questions can be submitted pre-event via your IMC dashboard or in real time during the presentation, via the "Ask a Question" function. Whilst the Company may not be in a position to answer every question it receives, it will address the most prominent within the confines of information already disclosed to the market through regulatory notifications. A recording of the presentation and a PDF of the slides used will be available on the Investor Meet Company platform and the Company's website afterwards.

 

Poolbeg Pharma PLC - US patents granted for POLB 001 and POLB 002 #POLB @PoolbegPharma https://www.voxmarkets.co.uk/rns/announcement/1739aa33-4692-4dcf-88a4-ec96e9f3d133

 

01/06/22

Open Orphan PLC - GBP14.7m influenza contract signed #ORPH @OpenOrphan https://www.voxmarkets.co.uk/rns/announcement/920e4f7b-1a38-48c1-ab34-d76ff9f6f32b

 

07/06/2022
Open Orphan PLC - Final results #ORPH @OpenOrphan https://www.voxmarkets.co.uk/rns/announcement/08be204e-b2bf-43ed-99c1-8ff5d115fbf2

 

14/06/22
Open Orphan PLC - £7.2m RSV human challenge study contract #ORPH @OpenOrphan https://www.voxmarkets.co.uk/rns/announcement/3c94184b-6571-4337-b823-08f9683c3f71