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#POLB Poolbeg Pharma Plc- Capital Markets Day

17 November 2022 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces that it will be holding a Capital Markets Day for analysts and institutional investors on Wednesday 30 November between 10am – 12:45pm.

 

The event, which will be chaired by Jeremy Skillington, Chief Executive Officer, will provide insights into a number of the Company’s growing pipeline of infectious disease vaccines and treatments and one of its innovative artificial intelligence programmes which is unlocking the power of human challenge trial data. In addition, attendees will gain a greater understanding of how Poolbeg’s unique model and business development strategy can drive growth from the infectious disease market. A networking lunch will follow at the end of the session.

 

There will be an opportunity for attendees to take part in a Q&A with Poolbeg’s management team including Ian O’Connell, Chief Financial Officer and David English, VP of Business Development as well as a number of guest speakers:

 

Dr Tal Almog of CytoReason, one of Poolbeg’s artificial intelligence partners; a world leader in AI which to date has worked with five of the world’s top ten pharma companies

Derek Gilroy, Head of the Centre for Clinical Pharmacology and Professor of Immunology at University College London and has pioneered research examining the molecular and biochemical pathways that regulates the resolution of acute immune reactions

Professor Brendan Buckley, co-founder of Minerva Medical, acquired by IQVIA and Firecrest Clinical, acquired by ICON plc where he held the position of Chief Medical Officer. Brendan has over thirty years of experience in clinical research and has published over 150 scientific papers

Further speakers will be announced in advance of the event

 

Analysts, institutional investors and media are welcome to attend the event in the City of London. Due to restrictions on numbers, it will not be possible for all interested parties to attend in-person. However, a live webcast will be available for retail investors and others to view the presentations here.

 

To register your interest to attend the in-person event, please RSVP to poolbeg@instinctif.com.

 

A recording of the presentation will be made available on the Company’s website after the event here.

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, Charlie Beeson 
Nigel Birks, Harriet Ward (ECM)

 

+44 (0) 207 220 0500

Singer Capital Markets (Joint Broker)

Phil Davies, Sam Butcher

 

+44 (0) 207 496 3000

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

About Poolbeg Pharma

 

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for Big Pharma seeking mid-stage products to license or acquire.

 

The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.

 

With its initial assets from hVIVO plc (formerly named Open Orphan plc), an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has commenced its LPS human challenge trial with initial results expected by year end 2022; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) programmes to accelerate the power of its human challenge model data and biobank, with outputs from the first programme expected by year end 2022.

#POLB Poolbeg Pharma PLC – Upcoming Events

21 October 2022 – Poolbeg Pharma (AIM: POLB, OTCQB: POLBF), a clinical stage infectious disease pharmaceutical company with a capital light clinical model, announces that its management and business development team will be attending and presenting at a number upcoming partnering and investor events from October 2022 to January 2023.

 

Partnering events

BIO-Europe from 24-26 October 2022 at Leipzig Messe, Leipzig, Germany 04356

Jefferies London Healthcare Conference from 15-17 November 2022 in London

JP Morgan 41st Annual Healthcare Conference from 9-12 January 2023 at the Westin St. Francis Hotel, San Francisco, CA

 

Investor events

London South East Webinar (virtual) on 8 November 2022. Register here

LSX Inv€$tival ShowcaseTM on 14 November 2022 at Old Billingsgate, London EC3R 6DX. Poolbeg CEO, Jeremy Skillington, will present at 14:15 on Stage 4: Biotech Late Growth. Register here

 

Event details may be subject to change – further information and updates are available on the Poolbeg Pharma website here.

– Ends –

Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 +44 (0) 20 7183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson

Nigel Birks, Harriet Ward (ECM)

 

+44 (0) 20 7220 0500

Singer Capital Markets (Joint Broker)

Phil Davies, Sam Butcher

 

+44 (0) 20 7496 3000

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a unique capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for pharma and biotech seeking mid-stage products to license or acquire.

 

The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.

 

With its initial assets from Open Orphan plc, an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001) which has commenced its LPS human challenge trial with initial results expected by year end 2022; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) programmes to accelerate the power of its human challenge model data and biobank, with results from the first programme expected by year end 2022. 

#ORPH Open Orphan Plc – Capital Markets Day

Open Orphan plc (AIM: ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces it will be holding a Capital Markets Day for analysts, institutional investors and media on Wednesday 2 November 2022 at 9.30 am – 12.00 pm (GMT).

 

The event, which will be chaired by CEO Yamin ‘Mo’ Khan, will provide a deeper insight into the Company’s end-to-end early clinical development services business, the human challenge trial market, and the benefits of human challenge to the Company’s clients. There will also be an opportunity for attendees to take part in a Q&A with the Company’s management team including its new CFO, Stephen Pinkerton, and guest speakers which include Peter Openshaw, Professor of Experimental Medicine at Imperial College London.

 

Analysts, institutional investors and media are welcome to attend the event in the City of London. Due to restrictions on numbers, it will not be possible for all interested parties to attend in-person, however, a live webcast will be available on the Company’s website for retail investors and others to view the presentations here.

 

To register your interest for the webcast, please contact Walbrook PR on +44 20 7933 8780 or email
openorphan@walbrookpr.com.

 

A recording of the presentation will be made available on the Company’s website after the event.

 

 

For further information please contact:

 

Open Orphan plc

+44 (0) 20 7756 1300

Yamin ‘Mo’ Khan, Chief Executive 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 / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Stephanie Cuthbert / Phillip Marriage /
Louis Ashe-Jepson

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

+44 (0) 7796 794 663 / +44 (0) 7867 984 082 /
+44 (0) 7747 515 393

#ORPH Open Orphan – £10.4m contract with existing Big Pharma client

hVIVO to develop new influenza challenge strain to test oral antiviral candidate

 

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 thathVIVO, a subsidiary of Open Orphan, has signed a £10.4m contract with an existing top 5 global pharmaceutical client to manufacture a new batch of H1N1 influenza challenge virus, leveraging off an existing in-house generated challenge model, and to conduct a human challenge trial to test the client’s antiviral product.

 

hVIVO has world-leading expertise in challenge agent manufacture, with the ability to manufacture specific subtypes of viruses, as well as unrivalled experience in conducting challenge studies. Since the COVID-19 pandemic, the Company has seen an increase in the number of clients looking to test their vaccines and antivirals against specific subtypes of viruses that are circulating in the population or that have the potential to be widely spread. As a result, there is a greater interest in end-to-end human challenge contracts such as this, that include a novel challenge agent manufacture and a challenge study.

 

The study will evaluate the efficacy profile of the antiviral against the specific influenza subtype, generating data quickly and efficiently. This is the third human challenge contract signed with this client, highlighting the Company’s world leading expertise and the clear benefits of human challenge trials to Big Pharma’s drug development process. 

 

Good Manufacturing Practice (“GMP”) compliant virus manufacturing activities will commence immediately and are expected to complete by Q2 2023. Once completed, hVIVO will conduct a Phase 2a double-blinded placebo-controlled human challenge study which is expected to be completed by Q4 2023. hVIVO will recruit healthy volunteers via the Company’s dedicated volunteer recruitment arm, FluCamp.The majority of revenue from the contract is expected to be recognised during 2023.

 

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said : “We’re delighted to be working again with this top 5 global pharmaceutical company to test its antiviral, using a new influenza strain developed by our highly experienced team. This contract is the third challenge study with this client, and our second end-to-end full-service contract overall. Our one-stop shop service offerings from manufacturing bespoke challenge agents to conducting full challenge studies is unique in the market. I am confident, that with our highly qualified teams and their clinical development expertise, we are well placed to address the growing infectious disease and respiratory research markets.

“Influenza poses a serious global health threat, causing an estimated 290,000 – 650,000 deaths per year with significant pandemic potential, and as such, the development of new vaccines and antivirals to fight flu remains vitally important.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said“This contract is a strong example of where human challenge studies can provide significant value. These studies can quickly and cost-effectively generate efficacy data for our clients in specific viral subtypes. As illustrated with this contract, our world-class manufacturing capabilities can produce a challenge agent for subtypes that pose a particular global health risk or are already circulating in the population. The resulting data can then indicate whether the candidate is viable for Phase II/III studies, providing substantial time and financial savings compared to traditional field-based studies.”

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

 

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.

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin Khan, Chief Executive 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 / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Stephanie Cuthbert / Phillip Marriage /
Louis Ashe-Jepson

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

+44 (0) 7796 794 663 / +44 (0) 7867 984 082 /
+44 (0) 7747 515 393

Alan Green discusses #WTB Whitbread, #POLB Poolbeg Pharma & #FCM First Class Metals on the Vox Market Podcast

Alan Green discusses #WTB Whitbread, #POLB Poolbeg Pharma & #FCM First Class Metals on the Vox Market Podcast

Listen here

#ORPH Open Orphan – Omicron human challenge model

  Vaxart becomes the first client of the programme to test its oral COVID-19 vaccine candidate

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, is developing the world’s first Omicron human challenge model. hVIVO has signed an agreement with Vaxart Inc. (“Vaxart”), (NASDAQ: VXRT) to develop the model with the intent to conduct a subsequent Omicron human challenge study in 2023 to test the efficacy of Vaxart’s oral vaccine candidate, VXA-CoV2-1.

 

To develop the model, hVIVO will manufacture a new SARS-CoV-2 (COVID-19) challenge agent based on the Omicron variant. The Good Manufacturing Practice (“GMP”) compliant virus manufacturing activities will commence immediately and are expected to complete by Q4 2022. Following manufacture of the challenge agent, the Company intends to conduct a characterisation study. Subject to the successful completion of the characterisation study and receipt of relevant regulatory approvals, hVIVO expects to conduct Omicron human challenge studies in 2023.

The characterisation study will establish a dose of the Omicron challenge agent that will cause a safe and reliable infection in healthy volunteers. The study will enrol healthy male and female volunteers who have previously been vaccinated against or infected with SARS-CoV-2, with no known risk factors for severe COVID-19 and low levels of serum neutralising antibodies (and therefore still likely to become infected following inoculation).

hVIVO has two decades of experience and expertise in challenge agent manufacture and clinical characterisation across a range of respiratory viruses including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (hRV – common cold virus), as well as the initial circulating SARS-CoV-2 virus and variants which have since emerged. hVIVO leads the Challenge Agent Manufacture Consortium, which has developed international standards that pertain to challenge agent manufacture and storage, to ensure safety, quality and consistency.

Yamin Khan, Chief Executive Officer of Open Orphan, said: “With our leading end-to-end human challenge expertise, we are delighted to be developing the world’s first Omicron human challenge model and to welcome Vaxart as the first client of this programme.

“hVIVO’s fight against the pandemic continues with the development of this new challenge agent. The benefits to Vaxart are immense, and we have already been contacted by a number of biopharma companies looking to test the efficacy of their products using this challenge virus. I have no doubt that the successful completion of the world’s first COVID-19 characterisation, which was published in Nature Medicine earlier this year, has given our customers the confidence to move forward with the less severe yet more infective Omicron challenge model.”

Dr. James Cummings, Chief Medical Officer of Vaxart, said: “A human challenge study of our oral tablet COVID-19 vaccine candidate against the Omicron variant of SARS-CoV-2 is the most rapid and direct way to assess the efficacy of this candidate against a highly prevalent viral strain.

“hVIVO has pioneered COVID-19 characterization and the Omicron human challenge model, and the use of this model in our planned Phase II human challenge trial will rapidly generate robust, controlled data on the ability of our COVID-19 vaccine candidate to prevent infection and the development of symptomatic disease, as well as its effect on viral shedding, which plays a critical role in the spread of infection from one person to another. The results of this study will inform the next steps in the development of our COVID-19 vaccine candidate, which has the potential to transform personal and public health approaches to controlling the global pandemic.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “The team and I at hVIVO are excited to begin work to manufacture an Omicron challenge agent, the follow-on characterisation, and future human challenge trials. We have unparalleled expertise in SARS-CoV-2 challenge agent manufacturing, having completed work on both the original Wuhan strain and the subsequent Delta variant, in addition to our prior experience in successfully conducting the world’s first COVID-19 characterisation study, and our decades of experience in conducting human challenge trials. We are delighted to be working with Vaxart on this programme and look forward to the opportunity to subsequently test the efficacy of their exciting novel vaccine.”

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.

 

For further information please contact:

 

Open Orphan plc

+44 (0) 20 7756 1300

Yamin Khan, Chief Executive 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 / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /

+44 (0)7747 515393

#ORPH Open Orphan – Board appointment

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 the appointment of Martin Gouldstone as an Independent Non-Executive Director of the Company with effect from 8 June 2022.Martin will also Chair the Audit & Risk Committee and will be a member of the Nominations Committee and the Remuneration Committee.

Martin brings 30 years of corporate development experience in the CRO, healthcare and pharmaceutical sectors, holding a number of senior roles at healthcare AI businesses. Martin has expertise in executing multi-billion dollar deals across Europe and the US, architecting end-to-end portfolio out-sourcing deals, and negotiating multi-year research partnerships.

Martin is currently Global SVP, Business Development at Owkin, a French-American start-up using artificial intelligence to discover and develop better treatments for unmet medical needs. Previously, Martin has held the roles of Chief Business Officer at both BenevolentAI and Sensyne Health and was a Partner at Results Healthcare, an international M&A advisory firm, where he co-led the company’s healthcare practice. Prior to this, Martin was Head of Life Sciences for BDO UK LLP, Senior Director responsible for M&A and joint venture opportunities in Europe for Quintiles (now IQVIA), and Business Development and Licensing Lead at Confirmant Ltd, Pharmacopeia Inc, Sareum Ltd.

Martin holds a BSc in Genetics and has completed a range of post graduate management courses.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to welcome Martin to the Board of Open Orphan. Martin has extensive corporate development experience in the CRO, healthcare and pharmaceutical sectors and held a number of senior roles in healthcare AI businesses. I look forward to working closely with Martin as we drive further growth across the business.”

Martin Gouldstone, Non-Executive Director, said: “I am delighted to join the Board of Open Orphan at what is an exciting time for the Company and the infectious disease market as it continues to grow significantly post pandemic. I am delighted to bring my previous three decades of experience in the CRO, healthcare and pharmaceutical industry to the Company as it continues to build and expand on partnerships with leading global biopharma companies.”

Regulatory Disclosures

Save for the information set out above and below, there are no further disclosures to be made in accordance with Rule 17, Schedule Two (g) of the AIM Rules for Companies in respect of the appointment of Mr Martin John Gouldstone, aged 55, Martin does not hold an interest in the Company’s share capital.

Current Directorships

Past Directorships

Novara Therapeutics Limited

n.a.

Orthopaedic Research UK

Sempiternum Ltd

For further information please contact:

 

Open Orphan plc

+44 20 7756 1300

Yamin ‘Mo’ Khan, Chief Executive 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 / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

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

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393 

#ORPH Open Orphan – Challenge virus manufacturing contract

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.”

 

The Company also 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.

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.

 

Individuals interested in taking part in  COVID-19 human challenge study  research can learn more at   www.UKCovidChallenge.com .

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive 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 / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393  

#POLB Poolbeg Pharma – Key POLB 002 European Patent Granted

Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, provides an update on the strengthening of its intellectual property (IP) for its asset POLB 002, a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections.

 

In January this year, Poolbeg secured an exclusive licence for the dual antiviral prophylactic and therapeutic candidate, which is being developed as POLB 002. Data suggests it could provide pan-viral protection from respiratory virus infections including influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others. As a nasally administered and rapidly effective prophylactic antiviral candidate, it could potentially provide an effective solution for protecting at risk patient populations (e.g. the elderly, COPD patients, and asthmatics).

 

The European Patent Office has granted this important patent in the POLB 002 patent family, which protects the use of a defective interfering (DI) influenza virus against infection by influenza. POLB 002 works by triggering nasal cells into an antiviral state using DI influenza that resembles the infectious influenza virus but doesn’t have the ability to replicate and therefore can provoke an appropriate immune response but does not cause an infection. The Company will continue working with its patent advisors to broaden and expand this patent family, including the method by which defective interfering antiviral agents can be identified. Discussions with patent authorities in other jurisdictions, including the US, are continuing with further positive announcements expected following a recent ‘Notice of Allowance’ communication from the US patent authorities.

 

The development of POLB 002 and these patent updates come at a critical time with a global focus on respiratory virus infections and when such viruses are considered a top five global killer, resulting in more than three million annual deaths worldwide. The pandemic potential of influenza continues to be monitored closely by the global health authorities, while the World Health Organization (WHO) and infectious hazard experts have guided that there is statistical certainty that a future influenza pandemic can be expected. The CDC has advised that early action and effective preparedness are absolutely essential to mitigating risk, hence highlighting the importance of developing vaccines, prophylactics and antiviral treatments against viruses; with pan-viral products offering an important solution.

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “The granting of this patent marks an important step in our development and protection of this important respiratory virus disease treatment. Data for POLB 002 shows it is able to both prevent viral infections and rapidly reduce viral loads where infection has occurred, improving disease symptoms and aiding recovery. This makes it an attractive candidate in a market where a significant unmet need for the treatment of most respiratory virus infections still exists.

 

“Our patent portfolio in Europe, US and elsewhere for POLB 002 are growing as part of our overall strategy to enhance the protection of Poolbeg’s assets and we look forward to updating shareholders on future patent grants.”

 

– Ends –

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499
finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson
Richard Chambers, Sunila de Silva (ECM)

 

+44 (0) 207 220 0500
Arden Partners PLC (Joint Broker)

John Llewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900
J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363
Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

Open Orphan #ORPH – Proposal to purchase Poolbeg Pharma shares from distribution in specie shareholders

Open Orphan (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 the announcement dated 11 April 2022 from Poolbeg Pharma plc (“Poolbeg”), regarding a number of new investors (“New Investors”) having expressed interest in acquiring up to £1.6m of Poolbeg which are currently locked-up and held in trust by Croft Nominees Limited as a result of the distribution in specie from Open Orphan on 18 June 2021.

As part of these proposals, the New Investors have committed to purchase up to £1.6m of the distribution in specie shares on or around 26 April 2022 at a price of 5.9 pence per share, the closing market price on Friday 8 April 2022. The New Investors have shown great interest in the Poolbeg story, its significant progress since IPO in July 2021, and its capabilities in developing novel products utilising its unique cost-effective model in the fast-growing infectious disease market which is expected to be worth in excess of $250bn by 2025. This is a clear vote of confidence in Poolbeg’s prospects as it enters an extremely exciting phase of its development with its first LPS human challenge clinical trial due to commence in June 2022 with multiple value inflection points expected in 2022 and beyond.

This process will allow the locked-up distribution in specie shareholders in Poolbeg the opportunity to sell part or all of their shareholding, should they wish to do so, prior to receiving the shares once the lock-up period ends on 20 April 2022. The distribution in specie shareholders will receive a letter setting out the New Investors’ proposal and a Form of Election informing them how to participate should they wish to sell some or all of their shares prior to the lock-up ending on 20 April 2022. These proposals are open to all distribution in specie shareholders but participation is at each distribution in specie shareholder’s discretion. For those shareholders who do not participate, the title to their distribution in specie shares will be transferred to them on or around 26 April 2022. If more than £1.6m is offered by way of valid Forms of Election, then the distribution in specie shareholders will be scaled back on a pro-rata basis.

The distribution in specie shares are exempt from income tax for UK resident shareholders due to the advance clearance obtained by the Company from HMRC for a statutory demerger. As such, there should be no UK income tax liabilities for UK resident shareholders on receipt of these shares. The only time that UK resident shareholder will be subject to tax on these shares will be in the event that the shareholder sells them, and in that event there will be a capital gains tax payment due on any chargeable gain. The base cost for capital gains calculation purposes will be 1% of the original cost base of the Open Orphan shares which will be close to nil (0), therefore nearly the full consideration will be subject to capital gains tax. The above comments are intended only as a general guide, shareholders are encouraged and recommended to seek their own financial and tax advice.

Open Orphan plc and Poolbeg Pharma plc ordinary shares are ISA qualifying investments. Open Orphan understands that any distribution in specie shares held in an ISA should be treated in a similar way to any other income generated from ISA qualifying investments.

A copy of the letter to distribution in specie shareholders can be found on Poolbeg’s website here and an FAQ is available here.

Cathal Friel, Executive Chairman of Open Orphan, said: “We were delighted to see that despite the presently turbulent market that Poolbeg has successfully managed to bring in fresh investors to purchase up to £1.6m at 5.9p, the market price on Friday 8 April 2022. The new investors have shown great interest in the Poolbeg story and its significant progress since IPO, its capabilities in developing novel infectious disease products utilising its unique cost-effective model. Poolbeg is well capitalised, with c. £20.9m at year end 2021, so importantly it is not raising any new funds as part of this process and, as such, there will be no dilution of existing shareholders.

“This arrangement has followed significant efforts to help widen the Poolbeg investor base and increase future liquidity, in order to ensure that the dividend in specie remains as beneficial as possible to shareholders of both Open Orphan and Poolbeg in the long-term.

“Due to the nature of the lock-up period, which was designed to allow for an orderly market following Poolbeg’s admission to AIM, prospective investors looking to build more substantial stakes were unable to do so. These proposals ensure that any potential shares sold will be going to quality, long-term holders, whilst giving distribution in specie shareholders the option to sell shares prior to the end of the lock-up period, if they choose to do so. In addition, there will be substantially greater liquidity in our shares once the distribution in specie shares have been distributed after 26 April 2022 and we believe this will certainly help us to attract in even more new shareholders.”

Footnote

The distribution in specie shares were issued to all Open Orphan shareholders on the share register at close of business on 17 June 2021, following this, Poolbeg successfully listed on the London Stock Exchange AIM market on 19 July 2021. While the underlying shareholders retain the beneficial ownership of the shares, the distribution in specie shares are currently held in trust by Croft during a lock-up period of nine calendar months from Poolbeg’s admission to AIM, to contribute to the creation of an orderly market. This lock-up period will end on 20 April 2022 and on or around 26 April 2022, shareholders will be sent a share certificate for the distribution in specie shares. Shareholders will then have the option to dematerialise and hold the shares via CREST. If any Open Orphan shares that gave rise to the entitlement to the distribution in specie shares are held in a nominee account, the share certificate will be sent to the shareholders’ broker. 

The New Investors’ proposals are not open for participation by persons interested in shares who are residents or citizens of or who have an address in, or who otherwise appear to the Company or SLC Registrars to be connected to, the United States (or any of its territories or possessions), Canada, Australia, Japan, Belarus or Russia.

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Arden Partners plc (Nominated Adviser and Joint Broker)

 +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

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)

Paul McManus / Sam Allen / Louis Ashe-Jepson

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

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0)

7747 515393  

Notes to Editors

Open Orphan plc

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

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan 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 newly opened 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. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre 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.

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for Big Pharma seeking mid-stage products to license or acquire.

The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.

With its initial assets from  Open Orphan plc , an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001); a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) drug discovery programmes to accelerate the power of its human challenge model data and biobank. 

For more information, please go to  www.poolbegpharma.com  or follow us @PoolbegPharma

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