Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF), the clinical-stage biopharmaceutical company, is advancing partnering discussions with multiple pharmaceutical companies as it moves towards a series of near-term clinical data readouts that management believes could catalyse a deal.
Its lead programme, POLB 001, is being developed as a preventative therapy for Cytokine Release Syndrome (CRS), a potentially life-threatening immune overreaction triggered by certain cancer immunotherapies, particularly bispecific antibodies, which work by simultaneously binding to cancer cells and immune cells to direct an attack on tumours.
Interim data from the TOPICAL trial, the first-in-patient study of POLB 001, is expected this summer, with the trial now enrolling patients across a network of leading UK cancer centres, including The Christie in Manchester, The Royal Marsden, University College London Hospitals, University Hospitals Birmingham, NHS Lothian, and Royal Stoke University Hospital.
Poolbeg said engagement from potential partners has increased as it advances towards data, with independent US pricing research pointing to multi-billion-dollar peak sales potential for POLB 001 in the United States.
The company estimates the addressable market at more than $10 billion in relapsed or refractory multiple myeloma and diffuse large B-cell lymphoma alone, two blood cancers commonly treated with CRS-inducing therapies.
POLB 001 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA), a status granted to treatments targeting rare or serious conditions that can accelerate the regulatory review process and confer commercial exclusivity.
Poolbeg is also progressing a second programme, an oral encapsulated GLP-1 (glucagon-like peptide-1) therapy for obesity, a drug format designed to replicate the effects of injectable weight-loss drugs in pill form, with a proof-of-concept trial expected to begin in the second half of 2026.
Chief executive Jeremy Skillington said 2025 had been transformative and described 2026 as potentially exceptional for the company.
Poolbeg ended 2025 with a cash balance of £7.7 million, broadly flat against the prior year's £7.8 million, following a £4.87 million fundraise completed in June that the company said was oversubscribed.
The full-year loss was £5.7 million, compared with £5.8 million in 2024, which reflects heavy investment in its drug R&D.