Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF) said 2025 had been a year of “significant achievement”, with preparations now in place for a series of clinical milestones in 2026.
The company is preparing to commence its POLB 001 TOPICAL trial, a study focused on cancer immunotherapy-induced cytokine release syndrome (CRS), with interim data expected in summer 2026.
Poolbeg secured teclistamab for the trial from Johnson & Johnson at no cost and appointed ACT to conduct the study under the leadership of Dr Emma Searle at The Christie NHS Foundation Trust.
Additional sites participating include The Royal Marsden, University College London Hospitals, and University Hospitals Birmingham.
The trial forms part of the RISE programme, led by the University of Manchester and The Christie, where Poolbeg is the lead industry partner.
POLB 001 has also received Orphan Drug Designation from the FDA, and partnering discussions are ongoing with pharmaceutical companies targeting a market of over US$10 billion.
An oral GLP-1 programme is also advancing, with top-line data from a proof-of-concept trial in up to 20 obese subjects expected in the first half of 2026.
"2025 has been a remarkable year of significant achievement, positioning Poolbeg strongly to deliver on a series of exciting clinical milestones in 2026," said executive chair Cathal Friel.
"We are well-funded through a catalyst-rich period, with a cash runway into 2027."
The company raised £4.9 million in an oversubscribed placing in June and held a cash balance of £10 million at the end of that month.