Poolbeg Pharma plc

Poolbeg Pharma Announces Successful Site Activation for POLB 001 TOPICAL Clinical Trial

Major operational milestone achieved with interim data on track for summer 2026

11 June 2026- Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, announces the first site activation for the first-in-patient POLB 001 TOPICAL* clinical trial has occurred. This follows the successful completion of the site initiation visit, with patient recruitment underway and interim data expected in summer 2026.

The trial, being conducted by specialist blood cancer trials organisation Accelerating Clinical Trials Limited ("ACT"), is investigating POLB 001 as a potential preventative for Cytokine Release Syndrome ("CRS") in approximately 30 relapsed/refractory multiple myeloma patients that are receiving the approved bispecific antibody, teclistamab. This acute condition occurs within days to weeks of initiating bispecific antibody treatment, consequently, the TOPICAL trial is expected to generate a rapid read out of data.

The Company believes that the strong engagement and enthusiasm demonstrated by investigators and clinical teams reflects both the significant unmet medical need in cancer immunotherapy-induced Cytokine Release Syndrome and the potential of POLB 001 to prevent this condition.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: "The successful site activation marks a significant milestone for Poolbeg and our lead programme, POLB 001. We believe POLB 001 has the potential to transform the cancer immunotherapy field through the prevention of CRS. This could not only improve patient quality of life but also expand the number of patients that can receive these life-saving cancer immunotherapies. We look forward to receiving the first insights from the study and sharing these with prospective partners, the market, and the wider scientific community in due course."

Dr Paul Sherrington, CEO of Accelerating Clinical Trials Ltd said: "Site initiation and activation marks an important operational milestone for the study, as we now move forward to patient recruitment. We are pleased with the progress made to date and look forward to supporting efficient patient accrual recruitment and high-quality trial delivery as the study advances."

*TOPICAL: Trial of Prevention of ImmunoCytokine Adverse events in Myeloma. A single-arm, open-label trial investigating POLB 001 as a potential preventative for CRS in relapsed/refractory multiple myeloma patients receiving the approved bispecific antibody, teclistamab, provided by Johnson and Johnson at no cost to Poolbeg.

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About Poolbeg Pharma plc 

Poolbeg Pharma plc (AIM: POLB) is a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field. The Company's lead asset, POLB 001, has the potential to expand administration of cancer immunotherapies from centralised specialist cancer centres into community hospitals by making the treatments safer through the prevention of the life-threatening side effect, Cytokine Release Syndrome (CRS). As such, POLB 001 could increase the number of patients that can receive these life-saving treatments, thereby increasing the market opportunity. Poolbeg is also advancing the development of a patient-friendly therapy for obesity with an oral encapsulated GLP-1, offering a differentiated approach within one of the world's largest markets. With multiple near-term clinical value inflection points, and an experienced team with a proven track record, Poolbeg is focussed on partnering its high value programmes that are targeting large markets and addressing critical unmet medical needs. 

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This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Poolbeg's present and future business strategies and the environment in which Poolbeg expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Poolbeg's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Poolbeg's ability to obtain financing, changes in the political, social and regulatory framework in which Poolbeg operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information.