Clinical Progress — TOPICAL (POLB 001) Ready to Start
MHRA approval obtained, protocol finalized, 6 UK sites secured (The Christie, UCH, Royal Marsden, Birmingham, NHS North Midlands/Royal Stoke, Edinburgh), ACT appointed as CRO, J&J supplying teclistamab at no cost, patient recruitment and dosing imminent for ~30 relapsed/refractory multiple myeloma patients.
Strong Efficacy Signal from LPS Human Challenge
Placebo-controlled LPS challenge in healthy volunteers showed dose-dependent suppression of key cytokines (IL-6, IL-8). The two upper POLB 001 doses achieved approximately 85%–95% inhibition of cytokine induction, demonstrating potent target engagement without immunosuppression.
Regulatory and IP Achievements
U.S. FDA Orphan Drug designation received for POLB 001 related indication; multiple patents granted (including Australia) and broad patent family projected to give coverage to at least 2044.
Financial Position and Fundraising
Cash balance of GBP 7.7 million at year-end with financial runway into 2027. Successfully raised GBP 4.865 million in 2025 despite challenging market conditions.
Significant Market Opportunity Identified
Independent analysis estimates >USD 10 billion peak market opportunity for CRS prevention in bispecifics and CAR T in the U.S. and EU5. Analysis based on ~500,000 eligible patients (2023–2030) and a pricing comparator in the ~USD 18–20k per treatment range.
Partnership and Payer Interest
Active partnering discussions with multiple large and midsize pharma; virtual data room open. Feedback from three U.S. payers covering ~75 million lives indicates willingness to pay for a CRS preventative that reduces hospitalization and overall costs.
Academic and Grant Support
GBP 3.4 million RISE grant awarded to University of Manchester and The Christie (Poolbeg is lead business partner) to fund broader CRS research, combining industry (J&J), academic and clinical resources.
Additional Program — Oral GLP-1 Development
Oral GLP-1 program progressing with clinical trial design ready; partnered with AnaBio for encapsulation technology; planned Phase I study of ~20 volunteers to assess safety, tolerability and PK in H2 2026 (start delayed due to manufacturing lead times).