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Poolbeg Pharma (POLB) investor relations material

Poolbeg Pharma Study Update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Study Update summary29 Sep, 2025

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.

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Frequently asked questions

Poolbeg Pharma PLC is a biotechnology company focused on the development of infectious disease treatments and immune-related therapies. The company specializes in repurposing and developing new pharmaceutical candidates using data-driven drug discovery. Poolbeg Pharma targets conditions such as severe influenza and other viral infections. The company is headquartered in London, United Kingdom, and its shares are listed on the AIM.

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