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#POLB Poolbeg Pharma PLC – Poolbeg identifies novel RSV drug candidates

Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a leading infectious disease focused biopharmaceutical company, announces that it has successfully identified potential new drug candidates from its Respiratory Syncytial Virus (‘RSV’) artificial intelligence (‘AI’) Programme with OneThree Biotech, Inc.

 

Since initiating the collaboration in February 2022, Poolbeg’s scientific team has worked closely with OneThree to build a tailored AI approach that leverages Poolbeg’s unique RSV human challenge trial data in order to identify disease-relevant biological pathways and potential drug targets. Based on those newly discovered drug targets, the collaboration has now identified a number of promising drug candidates to rapidly bring forward to lab-based validation to determine the full potential of these assets.

 

The Company has prioritised compounds with existing Phase I clinical data and which could, if successfully validated, be repositioned as novel treatments for RSV infection. Candidates with solid safety and pharmacodynamic data in humans are well positioned to rapidly enter a clinical trial to generate early human efficacy data for RSV. This is in line with Poolbeg’s efficient, capital light clinical development strategy that is at the core of its ambitious growth model.  

 

RSV, which inflames the smallest airways of the lungs, usually sends an average of 58,000-80,000 children under the age of 5 to hospital each year in the US alone, according to the US Centers for Disease Control and Prevention (CDC). RSV can also be dangerous for adults over the age of 65, resulting in around 177,000 hospitalisations per year in the United States alone. The current cold and flu season commenced about two months earlier than anticipated and already rivals some of the worst seasons on record with RSV hospitalising young children in the United States and Europe at an alarming rate. Public health officials have been warning for weeks that a “tripledemic” of SARS-CoV-2, influenza and RSV would strain an already weary healthcare system. RSV has made so many young children ill this fall that weekly paediatric hospitalisations in the US are the highest recorded.

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “In the past few months, RSV has been sending children to hospital at alarming rates in the United States and Europe. As paediatric units fill beyond capacity, and our healthcare systems contend with a ‘tripledemic’ of RSV, influenza and SARS-CoV-2, the need for better treatments has never been so urgent.

 

We’re impressed with the quality of work executed so far with OneThree leveraging their AI expertise to present new drug potential candidates from our unique human challenge trial data which Poolbeg will now optimise for further development in RSV, the only one of the three main respiratory illnesses for which there are not yet any approved vaccines and where treatment options are limited.”

Neel S. Madhukar, PhD, co-founder and CEO of OneThree Biotech, said: We are very pleased to be working with Poolbeg and to have the opportunity to deploy the ATLANTIS platform to complete the first ever AI-driven analysis of RSV disease progression data. I am delighted that Poolbeg’s unique dataset combined with OneThree’s externally validated platform have now delivered new actionable insights surrounding disease biology and drug discovery that can bring much needed treatment options for both the young and the elderly; the most vulnerable to RSV infection.”

 

-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, 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

Optimum Strategic Communications

Mary Clark, Nick Bastin, Manel Mateus, Vici Rabbetts 

 

+44 (0) 208 078 4357

poolbeg@optimumcomms.com

 

About Poolbeg Pharma

 

Poolbeg Pharma specialises in the development of innovative medicines to address the unmet need in prevalent and emerging infectious diseases. Poolbeg has a disciplined portfolio approach to mitigate risk, accelerate drug development and enhance investor returns. The Company simultaneously advances multiple programmes in cost-effective clinical trials, rapidly generating early human safety and efficacy data to enable early partnering / out-licensing, with the funds generated reinvested in the pipeline. Poolbeg also uses AI to interrogate human challenge trial data sets to quickly identify new targets and drugs, and in-license near or in the clinic medicines, leading to faster development and greater commercial appeal.

 

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 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 completed its LPS human challenge trial with full data read-out expected in Q2 2023; 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 two Oral Delivery Programmes and is progressing two Artificial Intelligence (AI) Programmes to add promising new assets to its pipeline.

 

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

 

About OneThree Biotech

 

OneThree Biotech is a private, clinically validated, biology-driven artificial intelligence (AI) company focused on using its proprietary ATLANTIS AI platform in combination with systems biology to understand the mechanisms that drive drug-target-disease relationships. This approach has been used not only to generate a pipeline of first-in-class programs, but also in partnerships with other biopharmaceutical companies. OneThree Biotech’s proven technology platform integrates chemical, biological, and clinical data with cutting-edge computational tools to answer complex questions surrounding disease biology and drug discovery. The company’s AI platform has shown success in identifying new targets for the treatment of various cancers and optimizing early-stage drug discovery and development by quickly and accurately generating new, testable insights and hypotheses. The OneThree platform has been validated across early-stage drug discovery through multiple partnerships, clinical trials, and more than 20 peer-reviewed publications. OneThree Biotech is based in New York City.

 

For more information, please go to https://onethree.bio/

Twitter: @onethreebiotech

#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

#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.

Open Orphan #ORPH – £5.1m RSV Human Challenge Study Contract Win

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan, has signed a £5.1m contract with a biopharmaceutical company to test its Investigational Medicinal Product (IMP) using hVIVO’s respiratory syncytial virus (RSV) Human Challenge Study Model.

The study is due to commence in H2 2022, with the revenue from the contract being recognised across 2021 and 2022. hVIVO will conduct this study on behalf of this biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection.  

RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan said: “We are pleased to have signed this contract to test our client’s product using our RSV Human Challenge Study Model. It is testament to our position as the world leading provider of Phase IIa human challenge study clinical trials that innovative biopharmaceutical companies, as well as Big Pharma, are actively and regularly engaging us to test their novel vaccine and antiviral candidates.

“RSV is one of several infectious and respiratory disease areas of unmet need that we are seeing rapidly growing interest in from drug developers. We look forward to working with more companies across the world to test their antivirals and vaccines, as Phase IIa human challenge studies increasingly become part of mainstream clinical trial design.”

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.

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

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)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

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

 

Notes to Editors

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

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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

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

Open Orphan #ORPH – New hVIVO contract signed with a European Biotech Company to provide RSV human challenge study

6 March 2020: Open Orphan plc (ORPH) the rapidly growing CRO specialist pharmaceutical services Group which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services, is pleased to announce the signing of a new contract with a European Biotech Company for the provision of a RSV human challenge study. The study is projected to deliver £3.2m in revenue all of which is expected to be recognised in 2020.  If the study is successful, it is anticipated that an additional follow-on larger pivotal challenge study will commence end Q4 2020, delivering significant further revenue and expected to be a minimum of £7m.

This contract demonstrates hVIVO, part of Open Orphan, successfully converting its pipeline and reinforces its position as world leader in the provision of viral challenge studies, vaccine and viral laboratory services, supporting product development for customers developing antivirals, vaccines and respiratory therapeutics. These services are particularly relevant and topical in the environment of heightened awareness of virology following Covid-19. London-based hVIVO is unique as it has Europe’s only commercial 24-bed quarantine clinic and on-site virology laboratory and is the only company globally with the capability to run an RSV human challenge study.

This breakthrough study reinforces hVIVO’s position as the leader in the provision of virology services.

Trevor Phillips, CEO of Open Orphan, said: “This agreement continues to endorse the importance being placed on the use of viral challenge models supporting product development for companies developing antivirals, vaccines and respiratory therapeutics. This agreement is the first agreement utilising what is now, a broader and complementary in-house service offering. All aspects of the study will be conducted within Open Orphan, leading to the elimination of sub-contractor costs and retain more contracted revenue. We look forward to delivering the work for a European Biotech Company and further developing our relationship.”

Cathal Friel, Executive Chairman of Open Orphan, said: “This agreement demonstrates one of the benefits of the merger with hVIVO and the opportunity the broadened service offering provides in delivering a catalyst for significant revenue growth and margin expansion within the business. In the short term, the combination of Open Orphan and hVIVO is expected to result in substantial cost savings through the elimination of subcontractor costs where they can be replaced by new capabilities within the Company.

 

For further information please contact

Open Orphan plc 

Cathal Friel, Executive Chairman    +353 (0)1 644 0007

Trevor Phillips, Chief Executive Officer    +44 (0)20 7347 5350

Arden Partners plc (Nominated Adviser and Joint Broker)    +44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer

Davy (Euronext Growth Adviser and Joint Broker)  +353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)  +44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

Notes to Editors:

Open Orphan  is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services  and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in London. hVIVO  supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of the Coronavirus in 2020. The company also has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models.   No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.  

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019,   Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in   a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (c hemistry, manufacturing and controls) , preclinical, phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.

About RSV

RSV is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. It is the number one cause of childhood hospitalisation both in the United States and around the world. Nearly all children are infected with the virus at least once by the age of 2-3 years. The disease is particularly dangerous for premature babies, children with other health conditions and the elderly. Many children develop pulmonary disease and/or asthma from RSV that persists throughout adult life making them susceptible to re-infection. Currently, there are no approved vaccines for RSV.

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