Poolbeg Pharma (POLB) Study Update summary

Clinical program highlights

• POLB 001, a P38 MAP kinase inhibitor, is advancing as a preventative for cancer immunotherapy-induced CRS, with phase 2A trial preparation at an advanced stage and interim data expected in summer 2026.

• The phase 2A open-label, single-arm trial will enroll about 30 relapsed/refractory multiple myeloma patients at leading UK cancer centers, using an approved bispecific antibody supplied at no cost.

• The trial will be conducted by Accelerating Clinical Trials Ltd (ACT), with Dr Emma Searle as Chief Investigator.

• POLB 001 has demonstrated favorable safety, broad cytokine inhibition, and preserved immune function in preclinical and phase 1 studies.

• No further preclinical studies are required before the phase 2A trial; the trial is designed to deliver rapid, actionable results.

Market need and differentiation

• CRS affects up to 70% of patients receiving CAR-T or bispecific therapies, creating a bottleneck in access and straining healthcare resources.

• Current treatments for CRS are reactive, with no approved preventative options; POLB 001 aims to fill this gap as an oral, non-immunosuppressive therapy.

• POLB 001's mechanism targets a broad range of cytokines, potentially offering superior efficacy over existing agents like tocilizumab.

• The addressable market is estimated at over $10 billion, with significant interest from pharma partners.

• POLB 001 could enable wider, community-based administration of immunotherapies, reducing hospital stays and improving patient quality of life.

Strategic and financial outlook

• The company is well-capitalized with a cash runway into 2027, supporting near-term clinical milestones.

• Partnering is a core focus, with ongoing outreach to major pharma companies and flexible monetization options including licensing or program sale.

• Additional pipeline includes an oral GLP-1 obesity program, with proof-of-concept data expected in the first half of next year.

• The team has a strong track record in clinical development and transactions, aiming to generate compelling human data to drive value.

• Focus remains on high-value programs addressing critical unmet medical needs and large markets.