Aankondiging • May 11
Poolbeg Pharma Receives Patent Grant For POLB 001 Cancer Immunotherapy-Induced CRS In Canada Poolbeg Pharma had received formal notification of the grant for its POLB 001 cancer immunotherapy-induced Cytokine Release Syndrome patent application from the Canadian patent office. This represents the second national grant within Poolbeg's cancer immunotherapy-induced CRS patent family, following the grant by IP Australia announced in March 2026, and marks a further important milestone for the Company. This patent covers the use of any p38 MAPK inhibitor, including POLB 001, for the prevention of cancer immunotherapy-induced CRS, and is underpinned by proprietary data generated by Poolbeg. Poolbeg filed its initial oncology patent applications in the UK in January 2023 before entering the international Patent Cooperation Treaty system in January 2024. This new patent grant was accelerated through the Patent Prosecution Highway, which enables expedited examination in participating countries where a favourable ruling has already been secured in another participating jurisdiction. The Company's IP portfolio now spans both cancer immunotherapy-induced CRS and severe influenza across multiple jurisdictions, and Poolbeg continues to pursue protection in further territories. This grant further strengthens the Company's robust intellectual property portfolio, enhancing POLB 001's future value and appeal to potential partners. Aankondiging • May 07
Poolbeg Pharma PLC, Annual General Meeting, Jun 09, 2026 Poolbeg Pharma PLC, Annual General Meeting, Jun 09, 2026. Location: the offices of gravita at aldgate tower, 2 leman street, e1 8fa, london United Kingdom Aankondiging • Apr 17
Poolbeg Pharma plc Receives Clinical Trial Authorisation for Polb 001 Topical Trial Poolbeg Pharma announced that the UK Medicines and Healthcare products Regulatory Agency ("MHRA") has granted Clinical Trial Authorisation ("CTA") for the POLB 001 TOPICAL trial. With all required regulatory clearances now in place and site initiation visits scheduled, the trial remains on track to deliver interim data this summer. The Company also announces positive findings from new independent US focused payer research conducted by Acumetis Global indicates multi-billion-dollar peak sales potential in the United States. POLB 001 is being developed as a potential first approved preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome ("CRS"). The TOPICAL trial will investigate POLB 001 in approximately 30 relapsed/refractory multiple myeloma patients receiving the approved bispecific antibody teclistamab, which has been supplied by Johnson & Johnson at no cost to Poolbeg. The study now spans six sites across the UK, with NHS Lothian in Edinburgh and the Royal Stoke University Hospital joining existing sites at the NHS Trusts at The Christie, The Royal Marsden, University College London Hospitals, and University Hospitals Birmingham. Site initiation visits are scheduled with patient screening set to commence shortly. Unlike many oncology studies, given that CRS is an acute condition which occurs within days or weeks of initiation of a bispecific antibody, the design of the TOPICAL trial will allow rapid read out. The research, which engaged current payers covering approximately 75 million lives across a mix of commercial insurance providers, Medicare and Medicaid, confirms the strong, clearly defined value proposition for POLB 001. In particular, findings underscore POLB 001's potential to play an important role in the management of CRS by reducing the significant hospital costs associated with the condition and enabling a meaningful shift in care away from specialist centres of excellence toward outpatient and community settings. The report also noted that CRS occurs in the majority of CAR T and bispecific antibody treatments, with no established diagnostic method currently available to predict either the likelihood or severity of CRS in individual patients. Dosing of bispecific antibodies must be withheld until CRS resolves, often delaying patients from achieving therapeutically effective dosing levels and prolonging hospitalisation, while those who experience high-grade CRS must permanently discontinue treatment, meaning that these patients can no longer receive the potentially life-saving treatment. The research reconfirmed the significant cost burden associated with managing CRS and that an effective preventative treatment would represent a compelling value proposition for healthcare systems. The findings highlight pricing levels that demonstrate POLB 001's multi-billion-dollar peak sales potential, providing increased confidence in the Company's anticipated market opportunity and further supports POLB 001's future value and appeal to potential partners. Aankondiging • Nov 22
Poolbeg Pharma plc Receives European Immunomodulator II Patent Application Covering POLB 001 for the Treatment of Severe Influenza Poolbeg Pharma announced that the European Patent Office has granted Poolbeg's European Immunomodulator II patent application covering POLB 001 for the treatment of severe influenza. POLB 001 is a potent and selective p38 MAP kinase inhibitor with strong potential across multiple disease areas, including the prevention and treatment of cancer immunotherapy-induced Cytokine Release Syndrome ("CRS"), a potential market opportunity of over USD 10 billion, and the treatment of severe influenza. POLB 001 holds the potential to address significant unmet needs affecting patients and healthcare systems globally. Poolbeg is actively building a comprehensive, worldwide IP portfolio, with patents covering use of p38 MAPK inhibitors in patients with severe influenza and for the prevention and treatment of cancer Immunotherapy-induced CRS. This patent grant further strengthens the Company's robust intellectual property portfolio, enhancing POLB 001's value and appeal to potential partners. Aankondiging • May 27
Poolbeg Pharma PLC, Annual General Meeting, Jun 23, 2025 Poolbeg Pharma PLC, Annual General Meeting, Jun 23, 2025. Location: the offices of dac beachcroft llp, 25 walbrook, ec4n 8af, london United Kingdom Aankondiging • May 23
Poolbeg Pharma PLC has completed a Follow-on Equity Offering in the amount of £0.15 million. Poolbeg Pharma PLC has completed a Follow-on Equity Offering in the amount of £0.15 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,000,000
Price\Range: £0.025 Aankondiging • Mar 20
Poolbeg Pharma plc Receives Korean Intellectual Property Office Grant in Korea Poolbeg Pharma announced that the Korean Intellectual Property Office has notified the Company of its official decision to grant Poolbeg's Republic of Korea Immunomodulator II patent application providing protection to POLB 001 for the treatment of severe influenza to December 2038. POLB 001 is a potent and selective p38 MAP kinase inhibitor with strong potential across multiple disease areas, including the prevention and treatment of cancer immunotherapy-induced Cytokine Release Syndrome and severe influenza. POLB 001 holds the potential to address significant unmet needs affecting patients and healthcare systems globally. This patent grant further strengthens Poolbeg's IP portfolio. Poolbeg has a robust portfolio of patents in place covering p38 MAP kinase inhibitors for the treatment of severe influenza; and for POLB 001 for the prevention or treatment of hypercytokinemia. Additional patent applications have been filed to strengthen and complement Poolbeg's POLB 001 patent portfolio, particularly for cytokine release syndrome caused by cancer immunotherapies. Developing a strong intellectual property portfolio remains a key priority for Poolbeg, enhancing POLB 001's value and appeal to potential partners. Aankondiging • Jan 03
Poolbeg Expects to Become A Private Subsidiary of HOOKIPA and Apply for Cancellation of the Admission of Its Shares to Trading on AIM The boards of directors (each a “Board”) of HOOKIPA Pharma Inc. (“HOOKIPA”) and Poolbeg Pharma plc (“Poolbeg”) are pleased to announce that they have entered into non-binding discussions for an all-share acquisition by HOOKIPA of Poolbeg (the “Potential Combination”) to create a strong clinical-stage biopharmaceutical company focused on developing and commercialising innovative medicines for critical unmet medical needs, with a special focus on next-generation immunotherapies for the treatment of cancer and other serious diseases (the “Combined Group”). HOOKIPA intends to remain as the listed entity for the Combined Group on the Nasdaq Capital Market and Poolbeg is expected to become a private subsidiary of HOOKIPA and apply for cancellation of the admission of its shares to trading on AIM. Aankondiging • Jan 02
Poolbeg Pharma PLC (AIM:POLB) entered into non-binding discussions to acquire HOOKIPA Pharma Inc. (NasdaqCM:HOOK) for $1.3 million in a reverse merger transaction. Poolbeg Pharma PLC (AIM:POLB) entered into non-binding discussions to acquire HOOKIPA Pharma Inc. (NasdaqCM:HOOK) for $1.3 million in a reverse merger transaction on January 2, 2025. The Boards believe that the Potential Combination would create a Nasdaq-listed Combined Group operated by a combined management team. Poolbeg shareholders will receive 0.03 HOOKIPA shares for each Poolbeg share held (the “ Exchange Ratio ”); based on the Exchange Ratio, the Potential Combination would have the effect (on the basis of the assumptions set out below and prior to the dilution resulting from the Fundraise (as defined below)) that Poolbeg shareholders prior to the completion of the Potential Combination are expected to receive, on a fully diluted basis, approximately 55% of the equity in the Combined Group (the “ Poolbeg Ownership Percentage ”) and HOOKIPA shareholders are expected to hold approximately 45% of the equity in the Combined Group (the “ HOOKIPA Ownership Percentage ”); HOOKIPA is expected to undertake a 100% primary private placement fundraise of up to approximately $30 million (the “ Fundraise ”) which will be funded into HOOKIPA immediately following the completion of the Potential Combination; a percentage of the potential value from certain of HOOKIPA’s programmes will be retained by holders of HOOKIPA shares as at a date to be determined ahead of completion of the Potential Combination (“ HOOKIPA Shareholders ”) via a contingent value right instrument (“ CVR ”); HOOKIPA intends to remain as the listed entity for the Combined Group on the Nasdaq Capital Market and Poolbeg is expected to become a private subsidiary of HOOKIPA and apply for cancellation of the admission of its shares to trading on AIM; and The Combined Group is expected to have operations in the European Union, the United Kingdom and the United States of America, and anticipates benefiting from a strong international leadership team comprised of the following individuals: Malte Peters: Chief Executive Officer, Cathal Friel: Poolbeg Co-Founder, Ian O’Connell: Chief Financial Officer, Poolbeg Co-Founder, Mark Winderlich: Chief Development Officer, David Allmond: Chief Business Officer and John McEvoy: Chief Legal Officer.
Combination is subject to the satisfaction or waiver of a number of customary pre-conditions, including, amongst other things, the satisfactory completion of customary due diligence, finalisation of the terms of the transaction, Board approvals of binding terms and sufficient prior expressions of interest from participants in respect to the Fundraise. The Potential Combination would be subject to the approval of both HOOKIPA and Poolbeg shareholders and other conditions.
Geoff Nash, Henrik Persson, Hamish Waller and Trisyia Jamaludin of Cavendish Capital Markets Ltd?acted as financial advisors to Poolbeg Pharma. Eugene Rozelman, David Coatenand and Harry Davies-Ball
of Canaccord Genuity acted as financial advisors to Poolbeg Pharma. Chris Raff and Simon Chaudhuri from London office and Ashish Contractor from New York office of Moelis & Company acted as financial advisors to HOOKIPA. Aankondiging • Nov 20
Poolbeg Pharma plc Announces U.S. Patent Office Grants U.S. Immunomodulator I Patent Poolbeg Pharma announced that the U.S. Patent Office has notified the Company of its official decision to grant Poolbeg's US Immunomodulator I patent application. The claims cover POLB 001, and other p38 MAP kinase inhibitors, for the treatment of patients at risk of severe influenza after an immune response has been triggered, and for the treatment of hypercytokinemia (cytokine storm) characteristic of severe influenza. POLB 001 is a potent and selective Phase II-ready p38 MAP kinase inhibitor with strong potential across multiple disease areas. This patent grant further strengthens Poolbeg's robust Intellectual Property (IP) portfolio. The Company has patents in place covering p38 MAP kinase inhibitors for the treatment of severe influenza; and covering POLB 001 for the treatment of hypercyTokinemia. Further patent applications have been filed and have complementary coverage as the Company continues to expand its patent portfolio covering POLB 001 and the wider class of p38 MAP kinase inhibitors., particularly in respect of cytokine release syndrome induced by cancer immunotherapies. Building a robust IP portfolio is a key focus for Poolbeg to further enhance POLB 001's value and attractiveness to potential partners. Aankondiging • Jul 26
Poolbeg Pharma Announces Voluntary Delist from OTCQB Market Poolbeg Pharma PLC announced that it is voluntarily delisting its ordinary shares (‘Ordinary Shares’) from trading on the OTCQB Market due to low trading volume and the associated administrative requirements. The company's last day of trading on the OTCQB Market will be 29 July 2024. Poolbeg will retain its listing on the London Stock Exchange's AIM Market under its existing ticker ‘POLB’. The delisting from the OTCQB market will have no impact on Poolbeg's Ordinary Shares, which will continue to trade on the AIM Market. Poolbeg reaffirms its ambitions to be dual listed on a national securities exchange in the US, such as Nasdaq, subject to meeting their listing requirements at the appropriate time. Aankondiging • May 11
Poolbeg Pharma PLC, Annual General Meeting, Jun 13, 2024 Poolbeg Pharma PLC, Annual General Meeting, Jun 13, 2024. Location: the offices of dac beachcroft llp, 25 walbrook, ec4n 8af, london United Kingdom Aankondiging • May 03
Poolbeg Pharma PLC Receives the Fully Granted Patent from the U.S. Patent Office for Its Immunomodulator II Patent Application Poolbeg Pharma PLC announced that further to its announcement on 20 March 2024, the Company has received the fully granted patent from the U.S Patent Office for its Immunomodulator II patent application. The claims cover a class of drugs (including POLB 001) for treating hypercytokinaemia (cytokine storm) and for preventing hypercytokinaemia in a patient after an immune response has been triggered. This encompasses cytokine storm that is induced in any disease indication. This further strengthens the Company's robust intellectual property portfolio for POLB 001, thereby enhancing the value and attractiveness of POLB 001 to potential Pharma partners. Poolbeg is actively building a comprehensive and worldwide IP portfolio, with patents in place covering p38 MAP kinase inhibitors for the treatment of severe influenza; and covering POLB 001 for the treatment of hypercytokinaemia. Further patent applications have been filed and have complementary coverage as the Company continues to expand its patent portfolio covering POLB 001 and the wider class of p38 MAP kinase inhibitors, particularly in respect of the treatment of cytokine release syndrome following cancer immunotherapy. New Risk • Mar 31
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£5.8m net loss next year). Share price has been volatile over the past 3 months (8.2% average weekly change). Market cap is less than US$100m (€57.6m market cap, or US$62.1m). Recent Insider Transactions • Feb 22
Executive Chairman of The Board recently bought €113k worth of stock On the 19th of February, Cathal Friel bought around 830k shares on-market at roughly €0.14 per share. This transaction amounted to 2.3% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Cathal's only on-market trade for the last 12 months. Aankondiging • Feb 15
Poolbeg Pharma plc Appoints Cathal Friel as Executive Chairman Poolbeg Pharma plc announced a change of Board role. Cathal Friel, Co-Founder, substantial shareholder, and currently Non-Executive Chairman of the company is assuming the role of Executive Chairman at the company effective immediately. Cathal brings valuable experience from his longstanding track record of value creation in a number of public companies, including as Co-Founder of Amryt Pharma plc. He was also the Executive Chairman and Co-Founder of hVIVO plc. Since then, Cathal and his team have transformed hVIVO into a fast growing, profitable company with revenues of over £56 million, a share price of c. 28 pence and a market capitalisation of c. £200 million. Cathal will continue to work closely with the Company's Chief Executive Officer, Jeremy Skillington and the now expanded leadership team, several of whom have recently joined from Amryt Pharma. Cathal will focus on it's strategic initiatives, leveraging his strong track record of value creation, including the company's growing focus upon rare and orphan diseases, whilst Jeremy will continue his successful leadership of the company's clinical programmes and business development efforts alongside David Allmond. Aankondiging • Feb 12
Independent Research Confirms >$10 Billion Market Opportunity for POLB 001 as A Preventative Therapy for Cancer Immunotherapy-Induced Cytokine Release Syndrome (CRS) Poolbeg Pharma PLC announced that independent research conducted on behalf of Poolbeg confirms a >$10 billion market opportunity for POLB 001 in Cancer Immunotherapy-Induced CRS as an orally delivered preventative therapy. Cancer immunotherapies have been approved in rare and orphan blood cancers and so the Company can see potential for POLB 001 in one or more of these cancer types. POLB 001 in cancer immunotherapy-induced CRS will be developed alongside Poolbeg's existing portfolio of assets including its influenza programme; its AI drug discovery programmes; and oral delivery of GLP-1 for obesity and other metabolic diseases. Rare and orphan diseases represent a significant value creation opportunity for the Company and its shareholders as they are underserved and there remains a substantial opportunity for innovative medicines to treat these severe and often chronic conditions. It is anticipated that acquiring and commercialising rare and orphan drugs could potentially lead to attractive revenue generation opportunities. Poolbeg will draw on the expertise of the wider team, including the individuals of the former Amryt team, who have a proven track record of successfully building and commercialising orphan drugs. Regulatory authorities offer incentives to companies developing orphan drugs, such as reduced filing fees, tax breaks and market exclusivity post approval and the Company Directors believe that Poolbeg is well positioned to benefit from these opportunities. The Company also announced further detail on the significant market opportunity for POLB 001 CRS induced by CAR-T and bispecific antibody treatments (BsAb), where CRS can affect the majority of patients and can lead to extended hospital stays, discontinuation of treatment and mortality risk. There are currently few approved therapies for the management of acute CRS and no preventative therapies indicated for CRS. The size and attractiveness of this market has encouraged the Company, as the field of cancer immunotherapies, including CAR-T and BsAb, is burgeoning and is expected to grow to USD 100 billion - USD 140 billion by 2030. CRS occurs in the majority of CAR-T and BsAb treatments frequently impacting >70% [iv] of patients and cannot be predicted. All grades of CRS can lead to extended hospital stays, causing an estimated USD 5.5 billion of hospitalisation costs to healthcare systems, and further indirect costs through patient treatment and follow up. An effective oral preventative therapy for cancer immunotherapy-induced CRS has the potential to significantly reduce direct costs in the healthcare system and improve patient access to these therapeutics, potentially including access to these therapies outside of specialist centres, while further augmenting wider market uptake. Poolbeg recently announced promising in vivo results for POLB 001 in addressing cancer immunotherapy-induced CRS, where CRS clinical symptoms were significantly improved by administration of POLB 001. Dose dependent reductions were seen in all serum proinflammatory cytokines measured. Aankondiging • Jan 17
Poolbeg Pharma plc Further Data Confirms Polb 001'S Potential in Cancer Immunotherapy-Induced Cytokine Release Syndrome Poolbeg Pharma announced promising in vivo results for POLB 001 in addressing cancer immunotherapy-induced CRS. Positive study results POLB 001 demonstrated efficacy in reducing cancer immunotherapy-induced C RS in an in vivo animal model with CRS symptoms significantly improved following administration of POLB 001. Red reductions were seen in all serum proinflammatory cytokines tested. The results, together with the data from the recent LPS human challenge tria l, further support the Company's strategic expansion of the Phase II ready POLB 001 to treat and prevent cancer immunotherapy-induced CS. In the U.S., the American Cancer Society estimates that there will be 24.6 million cases of cancer by 2030. Cancer immunotherapies, such as bispecific antibodies and CAR T cell therapy, are rapidly moving into earlier lines of treatment in many tumour types, with these markets anticipated to grow to USD 100 billion+ (35% CAGR) by 2030. Board Change • Dec 31
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 1 experienced director. No highly experienced directors. Chairman of The Board Cathal Friel is the most experienced director on the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Dec 20
Poolbeg Pharma plc Announces Positive Outputs from Lab-Based Analysis of RSV Drug Candidates Identified Using AI RSV Drug Candidates with the High Probability of Successful Successful Successfully Poolbeg Pharma announced the positive outputs from the lab-based analysis and successful prioritisation of the Respiratory Syncytial Virus ('RSV') drug targets and treatments identified as part of its artificial intelligence ('AI') led programme. Poolbeg's team of scientific experts have reviewed the comprehensive data package obtained from this lab-based analysis and has strategically prioritised a select number of the RSV drug candidates that were analysed. The Company is actively exploring the most effective way to progress the prioritised drug candidates in order to generate value. Poolbeg believes the data obtained reflects the high potential of this AI-led programme and supports its partnering efforts. The global interest in AI-led drug discovery continues to grow, with major pharmaceutical players making substantial investments in the field. Poolbeg's RSV AI programme identified these drug treatment candidates in just 10 months. AI-led drug discovery can accelerate the timeline achievable which reduces costs while also decreasing risks and providing a higher likelihood of success in bringing therapies to patients. Aankondiging • Dec 11
Poolbeg Pharma plc Announces Key Insights from Its Poster Presentation at ASH POLB 001 Poolbeg Pharma announced key insights from its poster presentation at the 65th American Society of Hematology ('ASH') Annual Meeting and Exposition, San Diego. The poster, which details POLB 001 as a potential therapy for Cytokine Release Syndrome ('CRS') associated with cancer immunotherapies, was presented by Dr. Emma Searle from The Christie Hospital, Manchester, UK on Saturday 9 December. CRS is a well-recognised toxicity that occurs frequently following certain cancer treatments such as T-cell engaging antibodies and CAR T cell therapies. In addition to patient mortality and morbidity risk, the high frequency of CRS associated with these treatments represents a barrier to outpatient delivery. The need for in-patient management of CRS adds to the overall healthcare costs of delivering these treatments and contributes to restricting their availability. Meanwhile, the POLB 001 LPS human challenge trial conducted by Poolbeg demonstrated good safety and tolerability, a clear dose-response relationship, inhibition of p38 MAPK activation, and a reduction in all measured pro-inflammatory cytokines. The effects observed were a negation of immune over-reaction rather than an ablation of core immune function. Phase II trial enabling activities are underway with strong interest from potential pharma partners. Aankondiging • Nov 30
Poolbeg Pharma plc Announces Directorate Changes Poolbeg Pharma PLC announces a change to its Board of Directors. Patrick Ashe, Independent Non-Executive Director, will step down from the Board at the end of November. Patrick played a significant role in guiding the Company through its initial phase of development. Eddie Gibson, Non-Executive Director will replace Patrick as Chair of the Audit & Risk Committee and Prof Brendan Buckley, Non-Executive Director will become Chair of the Remuneration Committee. Aankondiging • Nov 09
Poolbeg Pharma plc Announces Executive Appointments Poolbeg Pharma announced the appointment of key former executives of Amryt Pharma plc to its leadership team. David Allmond will join Poolbeg Pharma as Chief Business Officer from 1 December 2023. David was previously Chief Business Officer at Amryt and was instrumental in putting in place the global commercial infrastructure at Amryt which supported its revenue growth from c. USD 1.5 million when he joined in 2016, to approaching USD 250 million some six years later, when Amryt was sold to Chiesi Farmaceutici S.P.A. David played a pivotal role in Amryt, acquiring the Lojuxta distribution rights for Europe and the Middle East in 2016 and joined Amyrt thereafter. Lojuxta became Amryt's first approved, revenue generating product. David also played a very significant role in Amryt's acquisition of Aegerion in 2019 and Chiasma Pharmaceuticals in 2021. Previously, he played a key role leading the EMEA team at Aegerion Pharmaceuticals and was the Corporate Vice President of Global Marketing at Celgene during a period of very rapid growth for the company having previously established Celgene's UK operating company and led their marketing and market access team for EMEA. John McEvoy will become SVP, Chief Legal Officer, at Poolbeg from 1 January 2024. John was Global General Counsel at Amryt from 2017 and continued in his role at Amryt following its sale to Chiesi Farmaceutici S.P.A. earlier this year. John played an instrumental role in Amryt's rapid growth, leading the acquisition of Aegerion Pharmaceuticals in 2019 and Chiasma Pharmaceuticals in 2021. He also led the company's dual-listing on Nasdaq in 2020 and its subsequent sale to Chiesi. John is a qualified lawyer in the US (New York), England & Wales, and Ireland. Aankondiging • Oct 27
Poolbeg Pharma plc Announces Scientific Advisory Board Endorses Influenza Drug Targets Identified in Ai Drug Discovery Programme Poolbeg Pharma announced that its Scientific Advisory Board ('SAB') has endorsed the influenza drug targets identified in its AI-led drug discovery programme. The SAB was presented with comprehensive data and information regarding the large number of novel drug targets identified as part of the CytoReason collaboration in June 2023, along with a proposed list of prioritised candidates. Prioritisation was based on several key criteria and an evaluation by both Poolbeg and CytoReason's teams of expert biologists and data scientists to identify the top-ranking genes potentially suitable for the treatment of influenza. The members of the SAB considered the data and were impressed with the outputs of the programme, a consensus was reached on the prioritised list of novel drug targets to bring forward for lab-based validation, which is expected to complete in 2024. They also provided valuable insight into how to most effectively validate the targets in line with Poolbeg's model. Aankondiging • Sep 29
Poolbeg Pharma PLC Announces Favourable Conclusion of Patent Opposition Poolbeg Pharma PLC announced that further to its announcement on 19 September 2023, the oral opposition hearing scheduled by the European Patent Office ('EPO') relating to the challenge to the Company's European patent (Immunomodulator I), has been cancelled. This favourably concludes this matter with the patent maintained as granted. The Immunomodulator I European patent was opposed by a third party in September 2021 and the opposition was subsequently withdrawn in September 2023. Following the opposition withdrawal, the EPO has now concluded that there is no need to proceed with the scheduled hearing, concluding this matter. Aankondiging • Sep 21
Poolbeg Pharma Receives Notice of Allowance from the Japanese Patent Office in Relation to its Immunomodulator I Patent Application Poolbeg Pharma announced that it has received a notice of allowance from the Japanese Patent Office in relation to its Immunomodulator I patent application. The claims deemed allowable cover a p38 MAPK (mitogen-activated protein kinase) inhibitor for use in the treatment of severe influenza in human patients and strengthens the Company's robust intellectual property in the territory. Grant of the application as a patent is expected upon completion of formalities. Poolbeg has a worldwide licence for POLB 001 for all uses in humans and is developing a strong IP portfolio with patents in place, including Immunomodulator I and Immunomodulator II, covering the use of the class of p38 MAP kinase (mitogen-activated protein Kinase) inhibitors for the treatment of severe influenza and hypercytokinaemia. The Company has also filed patent applications to expand its IP around POLB 001 and the use of p38 MAP kinase inhibitors in new disease areas, such as oncology. This enhances the value and attractiveness of POLB 001 to potential pharma partners. Aankondiging • Sep 19
Poolbeg Pharma plc Announces Immunomodulator I Patent Opposition Withdrawal Poolbeg Pharma announced that the opposition to one of its European patents (Immunomodulator I) that was previously filed by a third party is to be withdrawn. In the pharmaceutical industry it is not unusual for patents to be challenged. The Immunomodulator I European patent was opposed by a third party in September 2021. Further to engaging with the opposing party, Poolbeg has reached an amicable conclusion in relation to the patent dispute without any financial compensation between the parties. The Company will be communicating with the European Patent Office ('EPO') regarding the necessity of continuing with the scheduled hearing in November. Based on specialist advice received, and the fact that the patent went through an extensive examination process prior to being granted by the EPO, Poolbeg continues to have full confidence in the validity and strength of the patent and will defend its intellectual property to the extent required. Poolbeg has a worldwide licence for POLB 001 for all uses in humans and is developing a strong IP portfolio with patents in place, including Immunomodulator I and Immunomodulator II, covering the use of the class of p38 MAP kinase (mitogen-activated protein kinase) inhibitors for the treatment of severe influenza and hypercytokinaemia. The Company has also filed patent applications to expand its IP around POLB 001 and the use of p38 MAP kinase inhibitors in new disease areas, such as oncology. This enhances the value and attractiveness of POLB 001 to potential pharma partners. Aankondiging • Jun 30
Poolbeg Pharma plc Announces Significant Breakthrough in Its World First Influenza Artificial Intelligence Programme with Cytoreason Poolbeg Pharma announced a significant breakthrough in its world first influenza Artificial Intelligence ('AI') Programme with CytoReason. Poolbeg has been working with CytoReason since March 2022. Poolbeg's unique disease progression data from influenza human challenge trials combined with CytoReason's broad repositories of curated disease data were analysed using CytoReason's AI-led platform. The analysis has led to the discovery of multiple novel drug targets for the treatment of influenza. Identification of drug targets from this unique data-set has previously been successful as p38 MAP Kinase, inhibited by POLB 001, was identified as a driver of severe influenza but this required manual analysis that took several years. However, through the utilisation of CytoReason's cutting-edge AI technology, Poolbeg has now identified multiple novel drug targets in just 15 months. Moreover, CytoReason's analysis independently confirmed the significance of the p38 MAP kinase pathway in influenza, providing further validation for Poolbeg's POLB 001 programme. The Company is actively exploring the most effective way to further develop the novel drug targets in order to generate value and looks forward to updating shareholders about the progress of this programme in due course. Poolbeg Pharma has access to a unique repository of clinical samples and associated data from human challenge trials. Data from human challenge trials are unique in that they track a healthy subject through disease to recovery in carefully controlled and monitored isolation units, collecting samples throughout the course of disease, and vitally collecting matched baseline and follow-up samples before and after infection. This data is unique in the depth of longitudinal virology, health, biomarker and symptom data collected during the course of disease. Board Change • Jun 02
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Patrick Ashe was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • May 24
Poolbeg Pharma PLC Announces Board Changes Poolbeg Pharma announced the appointment of Brendan Buckley as an Independent Non-Executive Director of the Company with immediate effect. Brendan will also replace Cathal Friel as a member of the Remuneration Committee. Professor Buckley is the former Chief Medical Officer of ICON plc, a medical graduate of University College Cork and a doctoral graduate in Biochemistry in the Faculty of Medicine at Oxford University. Prof Buckley has advised Poolbeg since inception and has deep experience in metabolic diseases including over 40 years' experience in clinical practice as a Consultant Physician in endocrinology, diabetes and in academic clinical pharmacology. Brendan was a member of the Board of Directors of the Irish Medicines Board (now the Health Products Regulatory Authority), chairing its statutory Advisory Committee for Human Medicines. He was also a member of the European Medicines Agency Committee for Orphan Medicinal Products (COMP) and of the European Medicines Agency Scientific Advisory Committee on diabetes and metabolism. Brendan has published over 150 scientific papers, mainly on metabolic disease, as well as the recent key opinion-leading book 'Re-Engineering Clinical Trials'. Mr. Brendan Mary Buckley, aged 73, has held the following directorships and/or partnerships in the past five years: Current directorships: hVIVO plc, FIGHTING BLINDNESS, DS BIOPHARMA LIMITED, Afimmune Limited, Open Orphan DAC, Imutex Ltd. Past directorships: BREAKTHROUGH CANCER RESEARCH and Alliance for Clinical Research Excellence and Safety Inc. Aankondiging • Jan 16
Poolbeg Pharma plc Announces Strategic Expansion of Polb 001 into Oncology Poolbeg Pharma announces the strategic expansion of POLB 001 into oncology. While investigating the role of cytokine release syndrome ("CRS") in severe influenza, Poolbeg discovered data specific to the overt immune response in CAR T cell patients that suggest POLB 001 as a potential treatment option for this severe complication. The Company has submitted a patent application for the use of POLB 001 in addressing the impact of CRS in CAR T cell patients.CAR T cell therapies are a form of immunotherapy for cancer that have produced remarkable results across a range of haematological malignancies, including cases of complete and durable responses in patients with advanced leukaemia and lymphoma who failed on previous therapies. A significant number of patients suffer treatment related side effects, including CRS which in severe form can be life threatening. Cell therapies may induce these effects in up to 95% of patients1. Poolbeg has identified POLB 001 as a potentially valuable companion therapy to be used in conjunction with existing CAR T cell therapies to address this significant unmet need. POLB 001's mode of action, reducing hyperinflammation which is associated with CRS, has the potential to significantly reduce the serious adverse effects experienced by many CAR T cell patients. The filed patent application is expected to provide class protection for use of p38 inhibitors in CAR T cell treatment and opens up a significant new market opportunity for POLB 001 in addition to severe influenza. A long-term strategic objective for Poolbeg has been and continues to be to evaluate POLB 001's potential in additional indications to fully unlock the potential value of the molecule and strengthen Poolbeg's position with a view to potential partnering and out-licensing. The Company is performing oncology clinical trial enabling activities to progress towards trial initiation in CAR T cell patients in 2024. Further oncology-related data, regulatory feedback and non-clinical development updates are expected in 2023. Aankondiging • Jan 09
Poolbeg Pharma PLC Announces Positive Initial Data Analysis in POLB 001 Trial Poolbeg Pharma PLC announced positive initial data analysis for POLB 001, a viral strain agnostic, small molecule immunomodulator being developed to address the significant unmet medical need for severe influenza. As announced in December, full data read-out is expected in Second Quarter 2023. However, upon initial review, the data indicates that administration of POLB 001 resulted in a marked reduction in both systemic and localised inflammatory response in subjects challenged with bacterial lipopolysaccharide ("LPS") compared to those who received placebo. A clear dose-response relationship was also apparent. This LPS challenge trial was designed to evaluate the effect of POLB 001 on inflammatory responses in 36 healthy volunteers between 18 and 55 years of age following both an intradermal and an intravenous LPS challenge. LPS acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases. POLB 001 was well tolerated across all doses and no serious adverse events or volunteer withdrawals were reported. Aankondiging • Dec 22
Poolbeg Pharma Identifies Novel RSV Drug Candidates Poolbeg Pharma announced 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 thosenewly 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. Aankondiging • Dec 12
Poolbeg Pharma plc Announces POLB 001 LPS Human Challenge Clinical Trial Successfully Completed Poolbeg Pharma plc announced that, further to its announcement in July 2022,it has now received the initial results having completed the Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a viral strain agnostic, small molecule immunomodulator being developed to address the unmet medical need for severe influenza. This LPS challenge trial was designed to evaluate the effect of POLB 001 on inflammatory responses in 36 healthy volunteers between 18 and 55 years of age following an intradermal and an intravenous LPS challenge.LPS acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases. POLB 001 is a unique potential treatment for viruses such as severe influenza as it is strain agnostic, unlike other flu treatments and prophylactics. This means that it can be effective regardless of which strain of influenza is dominant in any particular season or geography. As a shelf-stable, oral drug it could also be ideal as a stockpiling candidate for both seasonal outbreaks and pandemic preparedness. Aankondiging • Nov 29
Poolbeg Pharma Announces Completion of Influenza AI Model Build Poolbeg Pharma announced that, further to its announcement in March 2022,the construction of the computational artificial intelligence (AI) influenza disease model has been completed by CytoReason Limited ('CytoReason'), indicating that it is on track to deliver outputs in Second Quarter 2023. The model aims to unlock clinically meaningful insights into influenza infection and recovery through the analysis of Poolbeg's unique human challenge trial data.CytoReason has now built a tailored AI model using Poolbeg's data which willallow the team to identify novel influenza drug targets for Poolbeg. CytoReason's technologies are externally validated through its commercial partnerships with five of the world's top ten global pharma companies accessing its world-leading AI models,including Pfizer, Roche, and Sanofi. CytoReason's application of Poolbeg's unique human challenge trial data to build and train its first AI model in infectious diseases further testifies to the value of this data. CytoReason's world leading algorithms and experts will enable the Poolbeg team to identify the most promising drug targets to treat disease. The Company plans to source drugs with existing Phase I safety data that, in line with the Poolbeg business model, can immediately continue clinical development to rapidly generate early human proof of concept data for influenza, with the ultimate aim ofmonetising the asset through partnerships and licensing deals with pharma and biotech. Aankondiging • Aug 31
Poolbeg Pharma PLC to Report First Half, 2022 Results on Sep 06, 2022 Poolbeg Pharma PLC announced that they will report first half, 2022 results on Sep 06, 2022 Aankondiging • Jul 20
Poolbeg Pharma plc Receives Ethics and Competent Authority Approval to Commence Its Lipopolysaccharide (Lps) Human Challenge Clinical Trial for Polb 00 Poolbeg Pharma PLC has received ethics and competent authority approval to commence its Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a strain agnostic, small molecule immunomodulator which aims to address the unmet medical need for a treatment for severe influenza. Key Highlights: Clinical trial activities will formally commence on 22 July 2022 . The trial will assess the efficacy of POLB 001 in dampening the robust immune response to LPS which acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases. Start of the trial demonstrates significant delivery on commitment at IPO. Initial results expected in Fourth Quarter 2022 at which point the Company intends to rapidly monetise by out-licensing /partnering with pharma and biotech companies for further development of POLB 001. Trial success would also pave the way for potential applications beyond severe influenza. Aankondiging • Jun 28
Poolbeg Pharma plc Provides Project Update for AI Model of RSV Data Poolbeg Pharma announced that, further to its announcement in February 2022, Artificial Intelligence ('AI') partnerOneThree Biotech Inc., has completed the build and optimisation of a tailored AI model of Poolbeg's Respiratory Syncytial Virus ('RSV') human challenge data and can now commence its analysis, with results expected in Fourth Quarter 2022. The tailored AI model is the platform from which OneThree Biotech and Poolbeg will mine truly unique insights from human challenge trial derived disease progression data, with the aim of identifying novel drug targets and therapies to treat RSV, a disease which is a significant public health threat. OneThree's clinically validated model has been optimised to harness the unique longitudinal clinical, molecular (e.g. gene and protein expression) and virological data collected during human challenge trials, and includes next generation sequencing data captured daily at all timepoints before, during and after a healthy volunteer has been infected with RSV. The controlled environment of the human challenge trial creates a uniquely clean and complete dataset which is ideally suited for AI disease modelling such as this. The research team have integrated OneThree Biotech's world class AI, with Poolbeg's dataset and publicly available datasets to optimise the power of the model and validate its results. The team will use the model to discover and identify the disease signatures that define RSV infection and then identify drugs that can effectively reverse those signatures with therapeutically meaningful benefits with a view to then adding such identified drugs to Poolbeg's pipeline. The research program will prioritise identifying drug candidates with existing Phase I safety and tolerability data generated during prior development for other disease indications. This approach significantly reduces spend and risk, with the resultant clinical development program rapidly progressing to a capital light clinical proof of concept trial. The approach is expected to generate multiple clinical stage candidates quickly and cost-effectively, in a manner consistent with Poolbeg's model. Aankondiging • May 13
Poolbeg Pharma PLC Provides Update on POLB 001 Clinical Development Poolbeg Pharma announced an update on its lead asset, POLB 001, a small molecule immunomodulator which aims to address a significant unmet need in severe influenza. The Company has signed a contract for GMP manufacturing, ensuring ample supply of GMP grade POLB 001 for use in its upcoming LPS human challenge clinical trial, due to commence in June 2022, and for use in investigating POLB 001 as a treatment for other disease indications. POLB 001 has potential therapeutic applications beyond severe influenza, due to its mode of action of reducing hyperinflammation which is linked with many diseases. This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage. POLB 001 can block this from happening. The Company holds the worldwide rights to POLB 001 for all uses in humans and as such, is in a position to expand its IP around this asset to cover new disease areas which greatly increases the value of the program for partnering purposes. Following receipt of the results from the upcoming bacterial lipopolysaccharide (LPS) human challenge trial, the Company aims to rapidly monetise POLB 001 by partnering or out licensing the product to pharma /biotech for further development and commercialization. The GMP manufacturing of the product began in late 2021 to ensure that sufficient grade and quantities of the product is available for use in the forthcoming human challenge trial which is due to commence in June 2022, with first results expected before the end of the year. The Company now has a validated manufacturing process for the development of the product for use in its clinical development for multiple disease areas. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Member of Scientific Advisory Board Daniel Hoft was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • Apr 14
Poolbeg Pharma plc Provides an Update on the Strengthening of Its Intellectual Property for Its Asset POLB 002 Poolbeg Pharma provided 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 patentin 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. Aankondiging • Feb 28
Poolbeg Pharma PLC to Report Q4, 2021 Results on Mar 03, 2022 Poolbeg Pharma PLC announced that they will report Q4, 2021 results on Mar 03, 2022 
