POLB 001 TOPICAL trial recruitment update

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Poolbeg Pharma plc

POLB 001 TOPICAL trial recruitment update

28 September 2026 - Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, reaffirms that participant recruitment for the POLB 001 TOPICAL trial is progressing well. Following the previously announced six-patient safety cohort, a total of eight participants have now been dosed out of c.30, since the first patient dosed in July 2026.

Recruitment activity remains encouraging, with strong engagement from investigators, participating centres and patients. In addition, further clinical sites have expressed interest in joining the trial, supporting ongoing recruitment and potential site expansion in the coming months.

The TOPICAL trial is evaluating POLB 001 as a potential preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome ("CRS") in relapsed/refractory multiple myeloma patients receiving the approved bispecific antibody teclistamab.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: “With eight participants dosed since mid-July and continued patient & investigator interest in the study, the trial continues to advance positively. We thank the TOPICAL trial team for their collaboration and excellent execution to date."

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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.