Poolbeg Pharma (POLB) , a clinical-stage biopharmaceutical company focused on infectious diseases, issued a trading update for the 6 months to June 30, 2025 (H1 2025).
Poolbeg closed H1 2025 with a strong cash balance of £10.0 m, including £4.87m raised from an oversubscribed placing during the period. This strengthened balance sheet extends Poolbeg's financial runway into 2027, supporting its clinical pipeline as it approaches several milestones over the next year.
A key upcoming milestone is the Phase 2a trial of Poolbeg's flagship anti-inflammatory oral candidate POLB 001, proven to reduce Cytokine Release Syndrome (CRS) associated with certain cancer immunotherapies. Poolbeg recently appointed Accelerating Clinical Trials (ACT), a specialist blood cancer organisation, to conduct the trial.
CRS is a toxicity that occurs frequently following cancer immunotherapies, such as T-cell engaging antibodies and CAR T cell therapies. Due to CRS risk, administration of such immunotherapies is currently restricted to specialist centres, which limits their uptake. As an oral therapy to prevent or treat CRS, POLB 001 has the potential to enable broader use of the immunotherapies in an outpatient setting.
POLB 001's Phase 2a trial is an advanced stage of preparation, and is scheduled to take place at the Christie NHS Foundation Trust and other leading UK specialist cancer centres, with interim data expected in summer 2026. Poolbeg also confirmed the supply of a bispecific antibody for the study at no cost to POLB.
Earlier in 2025, Poolbeg presented data related to POLB 001 from a pre-clinical in vivo study, which evaluated the effect of POLB 001 on CRS compared to Adalimumab, the gold standard CRS inhibitor. In short, POLB 001 effectively reduced CRS and demonstrated superior cytokine inhibition compared to Adalimumab. Delivering an effective oral drug for CRS will be a significant value inflection point for Poolbeg, with POLB 001 having a 3rd party-estimated market potential of US$10bn.
The demand for effective CRS prevention is driven by the rapid growth of CRS-inducing immunotherapies, with more than 70% of patients receiving such treatments affected. With the >US$10bn opportunity, there is strong potential for partnering on positive data from the Phase 2a trial. In May 2025, POLB 001 was granted an Orphan Drug Designation (ODD) by the FDA, further validating its value and increasing the appeal to prospective partners.
In addition to POLB 001, Poolbeg is progressing toward a concept trial for its GLP-1R candidate for metabolic disorders (eg obesity and diabetes) to be conducted at the University of Ulster, with topline data expected in H1 2026.
Jeremy Skillington, CEO of Poolbeg, commenting: "We have made excellent progress this year and have entered a catalyst-rich period for Poolbeg. Preparations for the POLB 001 Phase 2a trial are well advanced, with the approved bispecific antibody secured at no cost to the Company. The data from this study will further strengthen our extensive preclinical and clinical package, supported by the recent FDA Orphan Drug Designation, which underscores the strong scientific rationale behind POLB 001 and enhances its commercial appeal with prospective partners.
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. We look forward to providing further updates to the market in due course."
POLB shares jumped 6% on today's announcement.
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