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#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  

#ORPH Open Orphan – Appointment of Nominated Adviser and Joint Broker

Open Orphan

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that further to the announcements by Arden Partners Plc on 11 and 14 April 2022 regarding the loss of its Nominated Adviser status upon the completion of its recommended takeover, the Company has appointed Liberum Capital Limited (“Liberum”) as its Nominated Adviser and Joint Broker. Given the timing of the completion of the recommended takeover of Arden Partners Plc, the Exchange has agreed that subject to initial due diligence being undertaken, Liberum has until 5pm on 27 July 2022 to complete its full due diligence.

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

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

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

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

 

 

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

#POLB Poolbeg Pharma – Proposal to Purchase Shares from Distribution in Specie Shareholders

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 a number of new investors (“New Investors”) have expressed interest in acquiring up to £1.6m of Poolbeg Pharma plc shares which are currently locked-up and held in trust by Croft Nominees Limited (“Croft”) as a result of the distribution in specie from Open Orphan plc (“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. There is strong demand from these New Investors in acquiring shares in the Company, with the largest individual investor being an experienced life science investor. 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 the Company’s prospects as it enters an extremely exciting phase of its development with its first 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. Poolbeg ended 2021 well capitalised with a strong cash balance of £20.9m so it is important to note that the Company is not raising any new funds as part of this process and, as such, there will be no dilution of existing shareholders.

 

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, and the Company recognises that many distribution in specie shareholders are committed to holding their shares long term. 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. A copy of the letter to distribution in specie shareholders can be found on the Company’s website here and an FAQ is available here.

 

The Directors are delighted by the clear vote of confidence being given by these New Investors in the Company and are confident that many of the existing distribution in specie shareholders will remain invested in the Company going forward based on the multiple value inflection points expected in 2022 and beyond combined with the positive developments and significant progress on its strategy since its IPO in July 2021 including:

 

  • Progressing the clinical development of its POLB 001 programme for severe influenza which is due to commence in June 2022 with first data from its forthcoming LPS human challenge clinical trial expected before the end of 2022 at which point the Company aims to rapidly monetise by partnering or out licensing the asset to pharma / biotech for further development;
  • Delivering on its plans to leverage its proprietary databank of human challenge study derived disease progression data to identify new pharmaceutical assets using artificial intelligence (AI), by signing deals with two leading AI firms. Preliminary outputs from the RSV Artificial Intelligence Discovery Programme are expected in H2 2022;
  • Obtained licensed access to use micro- and nanoencapsulation technology to develop oral vaccines for multiple disease indications;
  • In-licenced a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002) to its portfolio;
  • Signed an option to licence a vaccine against the tropical and subtropical disease Melioidosis (POLB 003), while also evaluating a further 5 bacterial vaccine candidates; and
  • Successfully commenced trading on the OTCQB market in the US in March 2022, a first step towards its ambition and strategy to dual-list on a national securities exchange in the US, such as Nasdaq, subject to meeting their listing requirements.

 

Cathal Friel, Chairman at Poolbeg Pharma said: We are delighted to see this significant interest from new investors in committing to purchase up to £1.6m of the distribution in specie shares at the market price the day before this announcement, Friday 8 April 2022, which was 5.9 pence. Coming mainly from high-net-worth family offices, our new investors have shown great interest in the Poolbeg story, our significant progress since IPO, and our capabilities in developing novel infectious disease products utilising our unique cost-effective model. The Company is well capitalised with c. £20.9m at year end 2021, and given its capital light business model is therefore well funded with a long cash runway.”

 

“This arrangement has followed significant efforts from the Poolbeg team to help widen our investor base, increase future liquidity, and maximise shareholder value over the long-term. Due to the nature of the lock-up period, which was designed to allow for an orderly market following our 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.”

 

“As outlined previously, we have started to put in place a number of strategic initiatives so as to widen our investor base, help drive future liquidity and build shareholder value for the long term. These include todays proposal to locked-up distribution in specie shareholders following strong demand from new investors, our recent commencement to trading on OTCQB market in the US. We also received permission at the annual general meeting on 4 April 2022 for potential future buybacks using the Company’s funds should it be in the best interest of all shareholders.”

 

“We have made excellent progress post IPO and I am confident that the Company has a very bright future.”

 

 

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.

 

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.

 

– 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) 20 7220 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

#ORPH Open Orphan – £5m RSV human challenge study contract win

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £5m respiratory syncytial virus (“RSV”) human challenge study contract with a European biotechnology company (“European biotech”) to test its intravenous antiviral candidate, using the hVIVO RSV Human Challenge Study Model.

 

The study is expected to commence this year and will test and assess the efficacy of the client’s antiviral candidate in a cohort of healthy young adult volunteers. This contract builds on Open Orphan’s existing relationship with this European biotech, following previous early clinical work completed by the Venn Breda team, highlighting the Company’s ability to maintain relationships with its clients over time and to cross sell services between brands. The Company expects the revenues from the contract to be recognised across 2022 and 2023.

 

The study will be conducted by hVIVO’s highly trained team of medics at its state-of-the-art quarantine facilities in London which was recently expanded in a cost-efficient manner from 43 to 62 beds, an increase of c. 45%. The Company’s specialised virology laboratories, hLAB, will provide qPCR (quantitative polymerase chain reaction), infectivity and serology data for the study.

 

Healthy volunteers for the study will be recruited through the Company’s volunteer recruitment arm, FluCamp. The FluCamp volunteer recruitment capacity was also recently expanded across its screening facilities in London and Manchester to enable larger cohorts to be recruited more quickly than before. The new screening facilities opened in Manchester expands the Company’s reach to facilitate the increasing demand for human challenge studies and allows the Company to recruit volunteers beyond the greater London area.

 

RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50-million people annually, leading to 4 million hospitalisations and up to 75,000 in-hospital deaths in children under the age of 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.

 

hVIVO has a long history of challenge studies with its roots dating back to 1947 with the establishment of the UK Common Cold Clinic in Salisbury, which conducted some of the first influenza human challenge studies. Since its establishment, the Company has been conducting human challenge studies for a range of industry, governmental and academic clients, and has the most frequently used commercial challenge models on the market. hVIVO has expertise in conducting challenge studies in its highly controlled clinical environment, across a range of infectious and respiratory diseases, including influenza, RSV, human rhinovirus (HRV – common cold virus), malaria, SARS-CoV-2, asthma, COPD, and cough, and is continuing to expand its offering.

 

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to announce this £5m contract to test our client’s antiviral candidate using the hVIVO RSV Human Challenge Study Model. RSV is a significant threat to public health, and we are delighted to support this European biotech in the development of its antiviral candidate.

 

“Following the recent expansion of our FluCamp facilities, which boosts our volunteer and patient recruitment capabilities as well as increasing our bed capacity by c.45%, we are now even better equipped to identify volunteers and to complete our growing pipeline of studies in a time efficient manner.

 

“Leveraging my extensive CRO experience, I look forward to continuing to drive further contract wins across our portfolio of infectious and respiratory disease challenge models.”

 

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a further demonstration of the significant value of human challenge studies. Efficacy data provided by the Company following the completion of the study can lead to entry into Phase II as well as optimisation of a Phase III programme. For Big Pharma as well as smaller biotechs, the substantial time and financial savings compared to typical field-based studies is increasingly making human challenge the trial design of choice for achieving early proof of concept data.”

 

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  
   
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

#ORPH Open Orphan – Open Orphan plc distribution in specie of Poolbeg Pharma plc shares – FAQ

Open Orphan

When will I receive my share certificate?

The Poolbeg Pharma shares received are subject to a lock-up period that ends on 19 April 2022. Within 14 days of that date, shareholders will be sent a certificate for their distribution in specie shares. Shareholders will then have the option to dematerialise the shares and hold via CREST.

If your Open Orphan plc 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 your broker who can add these to your account.

There has been some confusion among some investors enquiring whether these locked-up distribution in specie shares can currently be traded. Please note that these shares cannot yet be traded because they have not yet been transferred from the nominee (Croft Nominees Ltd) where they are being held in trust during the lock-up period. After the end of the lock-up period when the shares have been transferred, they will then be fully tradeable like any other public company share.

Why aren’t the shares in my online trading account?

As explained above, during the lock-up period the legal title to the shares are held by Croft Nominees Limited. The underlying shareholders retain the beneficial ownership of the shares. Shareholders with online trading accounts should see their future entitlement on their online platform but they cannot be traded and will show no value until after the end of the lock-up period when the shares will be transferred.

Therefore, as per above, you cannot trade shares that you are not yet in receipt of, but after the end of the lock-up period when the shares have been transferred, they will be fully tradeable like any other public company share.

Who are Croft Nominees Limited?

Croft Nominees Limited, is an entity controlled by the lawyers to Open Orphan and Poolbeg Pharma, DAC Beachcroft. DAC Beachcroft were appointed by Open Orphan and Poolbeg Pharma to act as custodian for the nine-month post IPO lock-up of Poolbeg Pharma shares. This appointment is to help facilitate the practical enforcement of the lock-up restrictions.

Within 14 days post the end of the lock-up, Croft Nominees will no longer hold any of these shares, as their sole function was to act as a holding nominee which is standard practice in these types of transactions.

Why is there a lock-up period?

The lock-up period is intended to contribute to the creation of an orderly market for a period after Poolbeg Pharma’s admission to trading on AIM. Poolbeg Pharma’s admission to AIM took place on 19 July 2021. Such lock-up periods can vary from 3, 6, 9, or 12 months in length and the Company took the decision to lock-up shareholders for a 9-month period.

Will there be tax on the distribution in specie shares?

The following comments are intended only as a general guide, shareholders are encouraged and recommended to seek their own financial tax advice.

A. UK resident shareholders:  The distribution in specie shares issued to shareholders as part of the demerger from Open Orphan are treated as a distribution for UK tax purposes, which could be taxable as dividend income. However, as advance clearance for a statutory demerger was obtained from HMRC, the distribution is exempt for UK income tax purposes, and hence there should be no UK income tax liabilities for UK resident shareholders upon receipt of these distribution in specie shares.

Disposal of the distribution in specie shares by UK resident shareholders will be subject to capital gains tax if a chargeable gain is made. The capital gains tax base cost is close to nil (0), therefore nearly the full consideration will be subject to capital gains tax.

There has been some confusion around the base cost and some shareholders thought that the base cost for these shares might be 6p, however, we can clarify that the base cost for capital gains purposes is close to nil because no consideration was paid for the receipt of these shares.

B. UK resident shareholders with shares held in an ISA:

Open Orphan plc and Poolbeg Pharma plc ordinary shares are ISA qualifying investments.

The Company can confirm based on advice received that if a shareholder held Open Orphan plc shares in an ISA account on the ex-dividend date (17 June 2021), the resulting Poolbeg Pharma distribution in specie shares should be directed to and held in your ISA account after 19 April 2022 when they are released from lock-up. This dividend income received into your ISA is treated the same way as any other exempt income that was generated from your ISA qualifying investment.

As with all ISA held shares, should you sell your dividend in specie Poolbeg shares, there will be no tax payable if the proceeds remain within your ISA account.

In addition, if these distribution in specie Poolbeg shares remain within the ISA, they do not form part of the £20k annual ISA allowance as they result from a distribution from an existing ISA shareholding.

We fully understand that there had been some confusion among some of our investors and also potentially among some of the ISA online account managers, but we can confirm that shareholders should have no issue retaining Poolbeg Pharma dividend in specie shares within a qualifying ISA account.

C. Ireland resident shareholders: Advice has been obtained from professional advisors in Ireland who have confirmed that there should be no Irish income tax liabilities as a result of the issue of the distribution in specie shares as part of the demerger. The receipt of dividends could be subject to Irish income tax, and independent advice should be sought.

Disposal of the distribution in specie shares by Irish resident shareholders will be subject to capital gains tax if a chargeable gain is made. The capital gains tax base cost is close to nil, therefore nearly the full consideration will be subject to capital gains tax. There has been some confusion around the base cost and some shareholders thought that the base cost for these shares might be 6p, however, we can clarify that the base cost for capital gains purposes is close to nil because no consideration was paid for the receipt of these shares.

D. Non-UK and Non-Irish resident shareholders: May be subject to tax on dividend income under any law to which they are subject to outside the UK. In addition, they may be subject to tax on a future disposal of shares under any law to which they are subject to outside the UK. Such shareholders should consult their own tax advisers concerning their tax liabilities.

What is the base cost for tax purposes if distribution in speice Poolbeg Pharma shares which are not held in an ISA?

If a UK resident shareholder sells their Poolbeg Pharma distribution in specie shares there will be capital gains tax payable, however as stated above, there will be no income tax due on receipt on these shares. The base cost for capital gains calculation purposes will close to nil (0), therefore nearly the full consideration will be subject to capital gains tax.

There has been some confusion around the base cost and some shareholders thought that the base cost for these shares might be 6p, however, we can clarify that the base cost for capital gains purposes is close to nil because no consideration was paid for the receipt of these shares.
Please note, no capital gains or other tax will be due until the taxpayer sells the Poolbeg Pharma shares in the first instance.

How does general meeting voting work for distribution in speice shareholders?

Poolbeg Pharma and Croft Nominees Limited have organised for distribution in specie shareholders to vote in its upcoming AGM via Poolbeg Pharma’s share registrars, SLC Registrars Limited. Shareholders have been sent a Form of Direction to vote which should be returned to the registrars. This document and all other documents relating to the AGM can be found here: https://www.poolbegpharma.com/investors/documents/ 

How many shares are received for holdings in Open Orphan?

Open Orphan shareholders who were on the register at close of business on 17 June 2021 were allocated shares using a ratio of 1 Poolbeg Pharma share for every 2.98 ordinary shares held in Open Orphan.

What is the ongoing relationship between Open Orphan and Poolbeg Pharma?

Open Orphan and Poolbeg Pharma are non associated companies that are run independently of each other, both are listed on the AIM market of the London Stock Exchange with independent boards and management teams. There is a number of cost synergies including shared office space and shared staff costs.

For further information, please read the following demerger update announced by Open Orphan on 17 June 2021:
https://www.investegate.co.uk/open-orphan-plc–orph-/rns/demerger-update/202106170700091713C/

Alan Green covers #POLB Poolbeg Pharma, #NTOG Nostra Terra O&G and #MNRG MetalNRG on the Vox Market Podcast

Alan Green covers #POLB Poolbeg Pharma, #NTOG Nostra Terra O&G and #MNRG MetalNRG on the Vox Market Podcast

Listen to the podcast here

#ANA Ananda Developments – Shareholder Update

ana

Ananda’s ambition is to be a leading UK grower and provider of high quality, consistent, carbon zero medical cannabis for the UK and international markets.

The Directors of Ananda provide the following update to shareholders.

 

Research programme

In early February 2022, 5 seeds of each of 13 strains of cannabis were planted at the DJT Plants Limited (“DJT”) medical cannabis research facility.  Since then, the DJT team has been undertaking the following activities:

  • The cannabis plants have been monitored daily, water requirements and nutrient requirements have been logged, and notes regarding the growth performance of each plant has been recorded.
  • Pruning has been undertaken to encourage the even growth of a larger number of branches of each plant.
  • Continued drafting of relevant Standard Operating Procedures (SOPs) to ensure best practice.

The seeds planted comprise a range of high THC / low CBD strains, low THC / high CBD strains and balanced strains.  The precise cannabinoid and terpene profile of each strain will be ascertained when the plants are sent for analysis to Israel and UK based labs.

The next step to achieve stable strains of cannabis for potential commercial growing will be for 9 cuttings to be taken from each plant.  These cuttings will be used for:

  • Planting in the multi chapelles to start to assess the performance of the strains in DJT’s specialised growing conditions.
  • Planting in the mother room so that there is a supply of mother plants which can then be compared with later generations of the same strain.
  • The self-crossing programme in which some of the plants are forced to become males and then to pollinate the female plant from the same seed.  This will increase the genetic stability of the next generation of plants.

There are a number of other parts to the research programme which are all designed to assist in the growing of stable strains of medical cannabis with cannabinoid and terpene profiles found to be beneficial in the treatment of a range of conditions.  A further update on these initiatives will be provided in due course.

 

Commercial growing

As the research programme progresses, the team is now focused on developing its commercial plans.  Commercial growing and selling is dependent on the successfully receipt of further licences from the Home Office and GMP (Good Manufacturing Practice) certification from the Medicines and Healthcare products Regulatory Agency (MHRA).

DJT Plants has retained a best-practice international GMP and pharmaceutical consulting firm with experience in designing GMP compliant medical cannabis facilities in jurisdictions with regulations similar to the UK. They will assist in the design of DJT’s cannabis manufacturing facility. As the UK is in the early years of its medical cannabis industry, it is the opinion of DJT’s management team that an internationally experienced consultancy is best placed to assist DJT. The conceptual manufacturing flowsheet has been created by DJT and activities will now proceed to the more rigorous planning and design processes to ensure optimum workflows, ease of access from the commercial growing areas and scalability.  The proposed facility will operate to GMP and will be fully compliant under the MHRA guidelines.

 

Corporate

There remains one outstanding item to complete the Circular to shareholders for the purchase of the 50% of DJT not owned by Ananda.  Once final sign off is obtained, the Circular will be posted to shareholders and the relevant General Meeting called.

-Ends-

 

The Directors of the Company accept responsibility for the contents of this announcement.

ANANDA DEVELOPMENTS PLC
Chief Executive Officer
Melissa Sturgess

Investor Relations
Jeremy Sturgess-Smith

+44 (0)7463 686 497
ir@anandadevelopments.com
PETERHOUSE CAPITAL LIMITED
Corporate Finance
Mark Anwyl

Corporate Broking
Lucy Williams
Duncan Vasey

+44 (0)20 7469 0930

#POLB Poolbeg Pharma – POLB sign AI discovery deal with OneThree Biotech for first human challenge trial

 

POLB’s CEO Jeremy Skillington & One Three Biotech‘s co-founder & COO Brad Pryde catch up with @proactive_UK to discuss the recent AI deal to identify new drugs & treatments for RSV.

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