Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF) pointed out that it has a cash runway out into 2027 as it begins a "catalyst-rich period" of clinical activity as data emerges from key trials.
The biopharmaceutical company reported a cash balance of £10 million at the end of June 2025, including £4.9 million raised from an oversubscribed and upsized fundraise.
The first half of the year saw lead drug candidate POLB 001 granted Orphan Drug Designation by the US Food & Drug Administration for use as an oral preventative treatment for cytokine release syndrome (CRS) caused by T-cell engager bispecific antibodies. Positive in vivo animal data earlier in the year supported its use for CRS prevention.
Preparations are underway to begin a Phase 2a trial of POLB 001, with Accelerating Clinical Trials LTd now appointed to run the study, with an approved bispecific antibody drug secured at no cost to Poolbeg.
The trial will take place at The Christie NHS Foundation Trust and other UK specialist cancer centres, with interim data expected in summer 2026.
Poolbeg is also preparing to start a proof-of-concept trial of its oral GLP-1 candidate at the University of Ulster, involving up to 20 obese participants. Top-line data are expected in the first half of 2026.
Chief executive officer Jeremy Skillington said: "We have made excellent progress this year and have entered a catalyst-rich period for Poolbeg."
He said preparations for the POLB 001 Phase 2a trial are "well advanced", with data from the study and the recent FDA Orphan Drug designation, "which underscores the strong scientific rationale behind POLB 001 and enhances its commercial appeal with prospective partners".
He added: "Looking ahead, we anticipate a series of potential value-creating milestones as data emerges from our POLB 001 and Oral GLP-1 trials in 2026. This, combined with a robust cash runway and a team with proven expertise in clinical trial execution and deal-making, means that we believe we are well positioned to deliver value for shareholders."