Poolbeg Pharma plc

Pre-IND Meeting with the FDA for POLB 001

FDA feedback supports Poolbeg's proposed development pathway for POLB 001, providing further clarity for ongoing partnering discussions

26 May 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 positive outcome of a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") for POLB 001, the Company's lead asset, a potential preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome ("CRS").

In a pre-IND meeting the FDA provides feedback on the clinical development strategy for drug candidates. This allows pharma companies to align their strategy with the FDA's requirements. The FDA feedback received by Poolbeg was broadly aligned with key aspects of the Company's envisioned development pathway for POLB 001. Poolbeg believes that there is an attractive route to market for POLB 001 and that this feedback re-affirms the appeal of the programme to potential partners.

The overall clinical development strategy was discussed and there was alignment on the proposed primary endpoint for a future Phase 3 clinical trial. Alignment with regulatory authorities on POLB 001's development pathway is an important milestone and provides potential partners with a higher degree of certainty of the route to market, thereby further de-risking the programme.

Bruno Speder, VP of Regulatory Affairs at Poolbeg Pharma, said: "We received constructive feedback from the FDA and achieved broad alignment on several important aspects of the development pathway for POLB 001. We believe that POLB 001 has the potential to address a critical unmet need in cancer immunotherapy-induced CRS, and this feedback provides greater clarity as we continue to advance the programme and supports our ongoing partnering discussions."

Nothing in this announcement is intended to imply FDA approval, nor does it represent FDA opinion on the efficacy, safety or approvability of the programme. The FDA meeting was intended only to obtain regulatory guidance on specific aspects of the proposed development and testing pathway.

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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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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.