Poolbeg Pharma (POLB) has reported its audited results for the year ended 31 December 2025, highlighting continued progress across its clinical portfolio alongside a strengthened balance sheet.
The company ended the year with a cash balance of £7.7 million, which it expects will fund operations through to the delivery of near-term clinical milestones into 2027.
Operationally, the company made significant progress in its POLB 001 programme, with the first-in-patient TOPICAL clinical trial advancing and interim data expected this summer. The trial is being conducted in collaboration with Accelerating Clinical Trials (ACT), led by Dr Emma Searle at The Christie NHS Foundation Trust, with further participation from leading UK cancer centres including The Royal Marsden, University College London Hospitals and University Hospitals Birmingham.
Poolbeg also noted that the TOPICAL trial will play a role in the RISE programme led by the University of Manchester and The Christie, which is focused on improving the safety of cancer immunotherapy treatments.
The company’s POLB 001 was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) as a preventative therapy for cytokine release syndrome (CRS), a key side effect associated with cancer immunotherapy. Positive in vivo data also supported its potential use in preventing CRS.
On the intellectual property front, Poolbeg secured Immunomodulator II patent grants in Europe, the Republic of Korea, and post period end in Hong Kong and Australia, strengthening its global IP portfolio. Meanwhile, the company reported growing engagement with potential partners as it advances towards clinical data readouts.
Elsewhere, Poolbeg continues to progress its oral GLP-1 programme, with a proof-of-concept trial at the University of Ulster now expected to commence in the second half of 2026 following revised manufacturing timelines.
Post period end, additional developments included the publication of a peer-reviewed human challenge trial paper in Frontiers in Immunology, the appointment of Dr Adrian Kilcoyne to the Scientific Advisory Board, and the addition of new clinical sites including NHS Lothian and Royal Stoke University Hospital. Regulatory approvals, including authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA), have been secured, with patient screening and dosing expected to begin shortly.
Poolbeg also highlighted new independent US pricing research indicating multi-billion-dollar peak sales potential for POLB 001 in the United States.
Poolbeg’s Chief Executive Officer Jeremy Skillington said: “2025 was a transformative year for Poolbeg. We saw strong interest in our fundraise, which has provided funding through multiple near-term clinical value inflection points. With two trials designed to generate rapid data, and strong interest from pharma partners, we believe 2026 will prove to be an exceptional year for Poolbeg.”
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Poolbeg enters 2026 with funding visibility, multiple clinical catalysts and growing partner engagement. With interim data from POLB 001 approaching and broader validation building across its platform, the coming months look set to be pivotal in demonstrating both clinical and commercial potential.