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Open Orphan #ORPH – Exercise of Warrants & TVR

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials , has received notice of exercise of warrants by investors, who participated in the Venn loan note financing in December 2018, over 404,806 ordinary shares of  0.1 pence each in the capital of the Company (“Ordinary Shares”) at a price of 0.1 pence per share for 143,312 Ordinary Shares and at a price of 2.2 pence per share for 261,494 Ordinary Shares. The gross proceeds of this exercise received by the Company amount to £5,896.18.

Following this exercise, the warrants issued to investors in connection with the 2018 Venn loan note have been substantially exercised with only the Chairman’s 657,285 warrants outstanding.

The total outstanding warrants over Ordinary Shares are as follows:

Number of Ordinary Shares

Exercise Price per share

Date awarded

Expiry Date

Beneficiary

232,696

0.1 pence

11 December 2018

10 December 2023

Venn loan note investor

424,589

2.2 pence

11 December 2018

10 December 2023

Venn loan note investor

1,607,142

5.6 pence

28 June 2019

27 June 2024

An advisor


The Company has made application for 404,806 new Ordinary Shares, to be issued and allotted as a result of the warrant exercise set out above, to be admitted to trading on AIM and Euronext Growth. Admission is expected to occur at 8.00 a.m. on 16 June 2021.

Total Voting Rights

Following the admission of the 404,806 new Ordinary Shares, the Company’s total issued ordinary share capital will consist of 670,855,002 Ordinary Shares. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website,  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.

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at  www.UKCovidChallenge.com .

For further information, please contact: 

Open Orphan plc

www.openorphan.com

Cathal Friel, Executive Chairman

+353 (0) 1 644 0007 

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Richard Johnson / Oscair McGrath

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Paul McManus / Sam Allen /

Lianne Cawthorne

+44 (0)7980 541 893 / +44 (0)7748 651 727 /

+44 (0)7584 391 303

 

Notes to Editors

Open Orphan plc  (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations. 

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the  Human Challenge Programme  and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies. 

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial  contracts .

Open Orphan #ORPH – New contract win with Oxford BioTherapeutics

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its subsidiary Venn Life Sciences (“Venn”) has been awarded a contract for a study with Oxford BioTherapeutics, a clinical stage oncology company with a pipeline of immune-oncology and antibody-drug conjugate-based therapies.

This is a phase I, open-label, dose finding study which will be used to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of OBT076, a CD205-directed antibody-drug conjugate, in recurrent and/or metastatic CD205-positive solid tumours and in women with CD205-positive HER2-negative metastatic breast cancer.

For this study, the Venn Paris team will deliver high-quality data management and statistics services. Venn’s team in Paris are highly regarded in the field as one of the leading providers in this area which is a perfect complement to the Company’s London offering. The study is due to start immediately.

Cathal Friel, Executive Chairman, Open Orphan, commented: “We are delighted to be in a position to announce another contract win for the Paris team. This deal further demonstrates Open Orphan’s ability to execute on its significant pipeline of contracts with important pharmaceutical businesses. 

“Oxford BioTherapeutics is a clinical stage oncology company with a pipeline of first-in-class therapies aiming to fulfil major unmet patient needs by targeting difficult-to-treat cancers. The Venn team are looking forward to assisting with the study and providing the preliminary data required to advance this breast cancer trial.”

Dr Rahim Fandi, MD, PhD Oxford BioTherapeutics CMO commented: “We are delighted to work with Venn and are sure that Oxford BioTherapeutics will benefit from their expertise.”

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893  

 

Notes to Editors

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases. 

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

Open Orphan #ORPH – Exercise of Investor Warrants by Investors, Issue of Shares and TVR

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organization (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials , has received notice of exercise of warrants by investors who participated in the Venn loan note financing in December 2018 over 1,349,349 ordinary shares of  0.1 pence each in the capital of the Company (“Ordinary Shares”) at a price of 0.1 pence per share for 477,703 Ordinary Shares and at a price of 2.2 pence per share for 871,646 Ordinary Shares. The gross proceeds of this exercise received by the Company amounts to £19,653.91.

Following this exercise the warrants issued in connection with the 2018 Venn loan note have been substantially exercised with 1,062,111 warrants outstanding. In addition, the 2018 Venn loan note has now been fully repaid, and as such, the current outstanding debt and loans owed by the Company is £319,000.

The total outstanding warrants over Ordinary Shares are as follows:

Number of Ordinary Shares

Exercise Price per share

Date awarded

Expiry Date

Beneficiary

166,666

30 pence

7 June 2011

6 June 2021

An advisor

376,008

0.1 pence

11 December 2018

10 December 2023

Venn loan note investors

686,083

2.2 pence

11 December 2018

10 December 2023

Venn loan note investors

1,607,142

5.6 pence

28 June 2019

27 June 2024

An advisor


The Company has made application for 1,349,349 new Ordinary Shares, to be issued and allotted as a result of the warrant exercise set out above, to be admitted to trading on AIM and Euronext Growth. Admission is expected to occur at 8.00 a.m. on 8 February 2021.

Total Voting Rights

Following the admission of 1,349,349 new Ordinary Shares, the Company’s total issued ordinary share capital will consist of 669,401,610 Ordinary Shares. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website,  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.

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at  www.UKCovidChallenge.com .

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or  openorphan@walbrookpr.com

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

About Open Orphan  ( www.openorphan.com )

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.  hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at  www.FluCamp.com 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.  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.  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.  

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteers via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 is an integrated drug development consultancy firm which 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.

Open Orphan #ORPH – Contract extension with Carna Biosciences

Open Orphan (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a further contract renewal with Carna Biosciences, Inc. (“Carna”), extending its integrated drug development consultancy services with Venn Life Sciences (“Venn”), part of Open Orphan plc.

Carna Biosciences is a clinical-stage biopharmaceutical company which focuses on the discovery and development of innovative therapies to treat serious unmet medical needs, focusing on small molecule drugs. The renewal of this contract is expected to deliver significant revenue for Venn over the next twelve months.

The Venn team in the Breda office in the Netherlands, will provide Chemistry, Manufacturing & Control (CMC), Non-Clinical, Clinical and Regulatory consultancy services to this client for two of the client’s leading development programmes. This successful collaboration has been extended until the end of December 2021.

Cathal Friel, Executive Chairman of Open Orphan, said: “The extension of this contract further demonstrates our ability to collaborate successfully with our clients and provide a service that results in repeat business. Venn and Carna have built up a good working relationship over a period of several years where both parties closely collaborated on drug development planning and its execution through consultancy services contracts. We look forward to delivering this contract for Carna in the year ahead.”

Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences, said:“The partnership with Venn Life Sciences complements our clinical development team and underlines our commitment to become a clinical stage company. By continuing the collaboration with the Venn team, we will accelerate our drug development.”

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

   +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893  

Notes to Editors 

About Carna Biosciences, Inc. (www.carnabio.com/english)

Carna Biosciences is a clinical-stage biopharmaceutical company founded in April 2003 in Kobe, Japan to discover and develop innovative therapies to treat serious unmet medical needs, focusing on small molecule drugs, mainly targeting kinases. We also offer a broad range of high-quality products and innovative drug discovery services to scientists worldwide to help efficiently identify new kinase inhibitors.

About Open Orphan plc (www.openorphan.com)

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. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.comThe hVIVO facility 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. 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. 

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteers via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 is an integrated drug development consultancy firm which 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.

Open Orphan PLC #ORPH – Venn Life Sciences contract wins

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 its subsidiary Venn Life Sciences (“Venn”) has been awarded two new contracts.

The first contract, which will commence immediately, is a COVID-19 study for a European pharmaceutical company which involves 200 patients in 50 sites across 5 countries around the world. Venn’s Paris team will manage the randomisation and supply management for this randomised, double-blind, placebo-controlled Phase 2 Clinical Trial to evaluate the safety and efficacy of a combination treatment of two drugs, and the best supportive care for patients with moderate and severe COVID-19 in a hospitalised setting.

Venn’s team based in the Breda office, in the Netherlands has also signed a contract with a European pharmaceutical company. The contract will see Venn assist with project management, design and implementation of new processes related to clinical development and use its expertise to deliver process improvement. The contract, which starts immediately, will run until December 2021 delivering significant revenues for Venn.

This contract builds on Venn’s existing relationship with this European pharmaceutical company whom Venn currently provides a variety of services to including IMPD writing, regulatory briefing book writing, preclinical and clinical consultancy.

Cathal Friel, Executive Chairman, Open Orphan, said:

“As we come towards the end of 2020, it’s wonderful to see all the elements of the Open Orphan business are delivering substantial revenues and both new contract wins and renewal of existing long-term customer contracts. The merger and integration of Open Orphan, Venn and hVIVO is very much now complete, and having become profitable in Q4 2020, we now have a very valuable, fast growing and secure business on our hands. Both Venn and hVIVO are converting their substantial pipeline of work whilst providing a high-quality service to their customers. The Paris team’s contract is a further demonstration of our work in the fight against COVID-19 and the contract win by our Dutch Breda team shows how we continue to generate repeat business through our expertise.

I am very excited by the momentum in the business and look forward to providing further updates in the weeks and months ahead of what is going to be a very exciting 2021″.

 

ENDS

Interested in becoming a volunteer?

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at  www.UKCovidChallenge.com .

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.

 Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com.

For further information please contact

Open Orphan plc

+353 (0)1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

 

LinkedIn/Facebook:

#ORPH @OpenOrphanplc subsidiary @VennLifeSciences contract wins

~ The first contract is a #COVID19 Phase 2 Clinical trial involving 200 patients in 50 sites across 5 countries.

~ The second contract will see #Venn assist a project related to clinical development, delivering significant revenues and running until Dec 2021.

~ Cathal Friel “I am very excited by the momentum in the business and look forward to providing further updates”

#pharma #testing #placebo

Open Orphan PLC #ORPH – Venn Life Sciences contract wins (branduk.net)

Twitter:

#ORPH @OpenOrphan @VennLifeScience contract wins:
 
~ #COVID19 Phase 2 #Clinicaltrial involving 200 patients
 
~ #Venn to assist clinical development project, delivering significant revenue
 
#lifesciences
 
Open Orphan PLC #ORPH – Venn Life Sciences contract wins (branduk.net)
Vox:
#ORPH Open Orphan plc subsidiary Venn Life Science contract wins:
~ COVID19 Phase 2 Clinical trial involving 200 patients
~ Venn to assist clinical development project, delivering significant revenue

Open Orphan #ORPH – Contract renewal with top-3 global pharmaceutical client

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a further contract renewal with a major top-3 global pharmaceutical client extending its consultancy services to end of December 2021. This follows on from the announcement made on 22 December 2020 regarding the same client and demonstrates the repeat business that Venn Life Sciences continues to win from its long-term clients.

The Venn team in the Breda office in the Netherlands, will provide Chemistry, Manufacturing & Control (“CMC”) consultancy services to this leading global pharmaceutical client for one of the client’s vaccine development programmes and follows the recently announced contract renewal for work on two of the client’s vaccine development programmes. This successful collaboration has been extended until end of December 2021.

Cathal Friel, Executive Chairman of Open Orphan, said:  “We are delighted to enter 2021 with another contract signed by the Venn team in Breda with this top-3 global pharmaceutical client. Venn have been providing CMC support to this top tier company since 2012 and are pleased to be continuing to work with this client in their vaccine development programme.

“This contract demonstrates the depth of vaccine development knowledge across the Company and, in addition to being the world leader in vaccine and antiviral testing using human challenge clinical trials, reinforces our position as the go-to clinical research organisation for many other services required by both large pharma and vaccine developers at all stages of development.”

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893   

About Open Orphan ( www.openorphan.com )

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.  hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at  www.FluCamp.com 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.  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.  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.  

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 is an integrated drug development consultancy firm which 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.

Open Orphan #ORPH – Successful completion of PrEP Biopharm Toxicology study for respiratory ‘viral mimic’

Phase IIb study to validate efficacy of PrEP-001 against circulating respiratory viruses such as COVID-19, flu and the common cold

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials, announces that drug development 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.

The animal model study provides safety data needed to move PrEP-001 into longer duration dosing in clinical studies. PrEP Biopharm intends to move forward with a real-world, field trial intended to validate the efficacy of its PrEP-001 against all circulating respiratory viruses, including COVID-19, influenza and the common cold.

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. 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. Previous studies in animals 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.

When Open Orphan acquired hVIVO in January 2020, in addition to acquiring the world leader in the testing of vaccines and antivirals using human challenge studies, hVIVO also came with a number of non-core assets including a 62.6% stake in PrEP Biopharm. The previous hVIVO Board had used shareholders’ funds to invest in these non-core assets. The Open Orphan Board and management team are primarily focussed upon cementing its position as a unique CRO and is committed to directing all resources to further improving the quality of earnings in both Venn Life Sciences and hVIVO and with shareholder funds only being used to support the profitable CRO services business. In recent months, Open Orphan has made it clear that it intends to monetise these non-core assets, however, as part of monetising these non-core assets, Open Orphan does not intend to invest any of the Open Orphan shareholders’ funds but will continue to work with the PrEP Biopharm management team to secure other sources of funding outside of the Open Orphan group while maximising the potential of these non-core assets.

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.”   

For further information please contact

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Anna Dunphy / Paul McManus

+44 (0)7876 741 001 / +44 (0)7980 541 893 

 

About Open Orphan ( www.openorphan.com )

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.  hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at  www.FluCamp.com 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. 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.  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.   

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

Open Orphan #ORPH – Successful extension of contract with top-3 global pharmaceutical client underpins 2021 revenue growth expectations

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a contract renewal extending its consultancy services with a major top-3 global pharmaceutical client to December 2021.

Through the Venn Life Sciences team in the Breda office in the Netherlands, Open Orphan provides independent, up-to-date and hands-on Chemistry, Manufacturing & Control (“CMC”) consultancy services to a leading global pharmaceutical client and has done since 2012.   Venn’s CMC consultancy team provide essential support for two of this client’s vaccine development programmes and these successful collaborations have been extended until December 2021.

Venn’s CMC consultancy services focus on the strategic and technical aspects of pharmaceutical development and support the management of pharmaceutical development programmes covering small molecules and biologicals from chemical or cell line development up to submission of marketing authorisation application. 

Cathal Friel, Executive Chairman of Open Orphan, said: “This contract renewal underpins our confidence in delivering against ambitious growth targets for 2021 and securing strong revenue visibility moving forward. Open Orphan’s strengths lie in the established relationships we have with our pharmaceutical partners and we expect to continue to extend these relationships as well as focussing on converting the existing pipeline of new business opportunities we have before us.

“Market consensus forecast a significant increase in revenues in 2021. As we remain on target to be operationally profitable in the final quarter of this year, we also expect to see a significant impact on earnings next year from this revenue growth.”

For further information please contact

Open Orphan plc

+353 (0)1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Paul McManus / Anna Dunphy

+44 (0)7980 541 893 / +44 (0)7876 741 001

About Open Orphan ( www.openorphan.com )

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.  hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at  www.FluCamp.com 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.  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.  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.  

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

Pharma Tech Article – Open Orphan #ORPH – Accelerated Vaccine Development with Human Challenge Studies

Pharma Tech Article – Open Orphan #ORPH – Accelerated Vaccine Development with Human Challenge Studies

Pharmaceutical companies worldwide are joining global efforts to combat, diagnose, treat and prevent infections from COVID-19. As we have seen, the search for vaccines and possible treatment to curb the transmission and reduce the mortality and morbidity produced by the virus is in overdrive.

Link here to read the full article…

 

Open Orphan #ORPH subsidiary Venn Life Sciences wins two new contracts

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 its subsidiary Venn Life Sciences (“Venn”) has been awarded two new contracts.

The first contract, which will commence immediately, is a COVID-19 study for a European pharmaceutical company which involves 200 patients in 50 sites across 5 countries around the world. Venn’s Paris team will manage the randomisation and supply management for this randomised, double-blind, placebo-controlled Phase 2 Clinical Trial to evaluate the safety and efficacy of a combination treatment of two drugs, and the best supportive care for patients with moderate and severe COVID-19 in a hospitalised setting.

Venn’s team based in the Breda office, in the Netherlands has also signed a contract with a European pharmaceutical company. The contract will see Venn assist with project management, design and implementation of new processes related to clinical development and use its expertise to deliver process improvement. The contract, which starts immediately, will run until December 2021 delivering significant revenues for Venn.

This contract builds on Venn’s existing relationship with this European pharmaceutical company whom Venn currently provides a variety of services to including IMPD writing, regulatory briefing book writing, preclinical and clinical consultancy.

Cathal Friel, Executive Chairman, Open Orphan, said:

“As we come towards the end of 2020, it’s wonderful to see all the elements of the Open Orphan business are delivering substantial revenues and both new contract wins and renewal of existing long-term customer contracts. The merger and integration of Open Orphan, Venn and hVIVO is very much now complete, and having become profitable in Q4 2020, we now have a very valuable, fast growing and secure business on our hands. Both Venn and hVIVO are converting their substantial pipeline of work whilst providing a high-quality service to their customers. The Paris team’s contract is a further demonstration of our work in the fight against COVID-19 and the contract win by our Dutch Breda team shows how we continue to generate repeat business through our expertise.

I am very excited by the momentum in the business and look forward to providing further updates in the weeks and months ahead of what is going to be a very exciting 2021″.

ENDS

Interested in becoming a volunteer?

If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at  www.UKCovidChallenge.com.

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.

Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com.

For further information please contact

Open Orphan plc

+353 (0)1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Notes to Editors – Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is the 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 lab, providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. 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.  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. 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. 

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. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. 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 in January 2020. Venn is an integrated drug development consultancy firm which 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.

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