Announcement • 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. Announcement • 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 Announcement • 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. 
