Poolbeg Pharma Regulatory News (POLB)

Poolbeg Pharma plc

Grant of first POLB 001 cancer immunotherapy-induced CRS patent

Significant milestone for Poolbeg's global intellectual property portfolio

31 March 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 that it has received formal notification of the grant for its POLB 001 cancer immunotherapy-induced Cytokine Release Syndrome ("CRS") patent application from IP Australia, the Australian patent office.

This represents the first national grant within Poolbeg's cancer immunotherapy-induced CRS patent family, marking an important milestone for the Company. Poolbeg continues to actively build a comprehensive, worldwide IP portfolio, with patents covering use of p38 MAPK inhibitors for the prevention and treatment of cancer immunotherapy-induced CRS, as well as severe influenza.

This patent covers the use of any p38 MAPK inhibitor, including POLB 001, for the prevention of cancer immunotherapy-induced CRS, supported by proprietary data generated by the Company. Poolbeg initially filed its oncology patent applications in the UK in January 2023, and subsequently filed a Patent Cooperation Treaty application in January 2024. To accelerate examination, Poolbeg utilised the Patent Prosecution Highway, an international framework that enables expedited review following a favourable patent examination in another participating jurisdiction.

This grant further strengthens the Company's robust intellectual property portfolio, enhancing POLB 001's future value and appeal to potential partners. The Company looks forward to providing further updates to the market regarding the extension of coverage in other jurisdictions in due course.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: "The grant by IP Australia of our first patent for cancer immunotherapy-induced CRS represents an important step in strengthening our global intellectual property position for POLB 001. With the TOPICAL trial on track to deliver interim data in summer 2026, the timing of this first patent grant could not be better. Protection in this indication is a key component of our strategy, and securing this coverage in Australia provides valuable support for the continued advancement of POLB 001. We look forward to progressing corresponding applications in other jurisdictions, expedited by the use of the Patent Prosecution Highway international framework."

\* 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.