Poolbeg Pharma FY24: advancing POLB 001 to $10bn market opportunity, supported by strong balance sheet
() , a clinical-stage biopharma company focused on infectious diseases, issued a trading and operational update, and its financial results for the year ended December 31, 2024 (FY24).
Poolbeg significantly advanced its flagship anti-inflammatory candidate POLB 001 during the year. The asset is a Phase 2-ready oral drug, proved effective in reducing Cytokine Release Syndrome (CRS) associated with certain cancer immunotherapies. POLB 001's effectiveness was validated by an independent committee of international key opinion leaders, healthcare payers, and clinical trial experts.
During the period, positive preclinical data demonstrated statistically significant cytokine inhibition of POLB 001, with a dose-dependent reduction in clinical CRS score. Simultaneously, 3rd party research confirmed a potential market opportunity of more than US$10bn for POLB 001 as an oral preventative therapy for cancer immunotherapy-induced CRS.
The preclinical data was presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. was also granted an Immunomodulator II patent application by the US Patent Office, covering POLB 001 to treat or prevent hypercytokinemia induced in any disease indication.
also reported good progress on its GLP-1R candidate for metabolic disorders (eg obesity and diabetes) as well as its AI-led drug discovery programmes. GLP-1R advanced toward a proof-of-concept trial expected in the coming months, bolstered by growing global interest in glucagon-like peptide 1 receptor agonists. The AI programmes, in partnership with CytoReason and OneThree Biotech, successfully identified several targets, with discussions currently underway with potential partners.
In terms of balance sheet, ended the year with a comfortable £7.8m in cash, giving it ample runway to drive further pipeline advancements.
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Poolbeg delivered a successful FY24, marked by strong operational progress, solid financials, and significant advancement of its flagship anti-inflammatory candidate POLB 001. The Phase 2-ready asset has shown significant promise in treating CRS - a toxicity that occurs frequently following certain cancer immunotherapies. 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.
Poolbeg recently presented excellent 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. Next, investors can look forward to Phase 2a clinical studies. 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.
In terms of balance sheet, the company had a comfortable £6.2m in cash at the end of March 2025. This will be significantly bolstered by a proposed £4.1m fundraising to support the POLB 001 Phase 2a trial, and the proof-of-concept trial for 's oral GLP-1 programme. The increased cash balance will give ample runway to develop its pipeline and ongoing negotiations with prospective partners into FY26 and beyond.
For POLB 001's Phase 2a trial, expects the first patient to be dosed in H2 2025 and Phase 2a topline data to be available in H2 2026, including interim analysis in H1 2026. For the oral GLP-1 proof-of-concept trial, expects the study to begin in the coming months, with topline proof-of-concept to be available in H1 2026.
Poolbeg also continues to advance its AI-led programmes in partnership with CytoReason and OneThree Biotech. The two programmes have identified drug targets with significant commercial appeal within drastically reduced timelines compared to traditional methods. Both projects - for influenza and RSV - are supported by extensive, high-quality datasets ideal for AI analysis. Both are in the preclinical stage with significant near-term upside and offtake discussions in progress.
In terms of management, Cathal Friel was appointed as Executive Chair in February 2024 to drive performance and seek to replicate the success of other companies he co-founded, including hVIVO and Amryt Pharma. Friel brought to substantial experience in M&A and investment banking, and a longstanding record of value creation. Amryt went on to be acquired by Chiesi Farmaceutici for US$1.48bn in 2023 with a number of its key former staff later joining Poolbeg. And hVIVO's share price rose from 5.6p at IPO in 2019 to 28p under Friel's supervision.
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