First patient dosed in POLB 001 TOPICAL trial

Poolbeg Pharma plc

First Patient Dosed in the POLB 001 TOPICAL Clinical Trial

Interim data remains on track for summer 2026 and partnering discussions continue to advance with multiple companies

Highlights

·    First patient dosed in the POLB 001 TOPICAL clinical trial

·    Second site, University College London Hospital, activated with patient recruitment underway

·    Additional clinical sites expected to open imminently, supporting continued patient recruitment

13 July 2026 - Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, today announces that the first patient has been dosed in the POLB 001 TOPICAL clinical trial.

The dosing of the first patient in the TOPICAL clinical trial marks the start of an active period of clinical execution for the POLB 001 programme. The trial is investigating POLB 001 as a potential preventative therapy for Cytokine Release Syndrome ("CRS") in patients with relapsed/refractory multiple myeloma receiving the approved bispecific antibody, teclistamab, which is being supplied by Johnson & Johnson at no cost to the Company.

University College London Hospital (UCLH) has now also been activated as a clinical trial site. Activation of additional trial sites is expected imminently, supporting continued patient recruitment.

The TOPICAL clinical trial has generated strong interest from the haematology community, including unsolicited enquiries from investigators interested in participating in the study, reflecting the enthusiasm for POLB 001 as a preventative therapy for CRS. Interim data remains on track for late summer 2026 and represents a significant value inflection point for the programme. In parallel, Poolbeg continues to advance partnering discussions with multiple companies, with engagement expected to accelerate as additional clinical data becomes available.

The recent successful FDA pre-IND meeting has helped clarify the US regulatory pathway and independent US payer research validates the significant commercial opportunity for POLB 001, supporting premium pricing assumptions and reinforcing the programme's multi-billion-dollar peak sales potential. These findings further strengthen POLB 001's attractiveness to potential commercial partners.

The Company expects a steady flow of operational and clinical milestones over the coming months as recruitment progresses, additional sites become active and interim data is generated. Poolbeg will update shareholders as these milestones are achieved and as partnering discussions continue to advance.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: "The dosing of the first patient is an important milestone as we evaluate POLB 001 as a potential therapy to prevent CRS associated with cancer immunotherapies. Bispecific antibodies, such as teclistamab, are rapidly improving cancer patient outcomes and are increasingly being used earlier in disease treatment, making effective CRS management a priority for patients, clinicians and healthcare systems.

"As recruitment progresses and additional clinical sites become active, we anticipate a steady stream of operational updates ahead of interim data later this summer. We also continue to make encouraging advances in discussions with potential partners and believe the combination of clinical execution, regulatory progress and upcoming data creates a compelling period of value creation for Poolbeg."

Dr Paul Sherrington, CEO of Accelerating Clinical Trials Ltd said:  "In recent times, many novel therapies have been approved for blood cancer patients, and it is now vitally important that we make these more broadly available to the patients who need them. The outcome of this important trial may have a very significant impact for patients."

Enquiries  

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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Forward-Looking Statements

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.