Interim data from POLB 001 TOPICAL clinical trial

Poolbeg Pharma PLC

24 September 2026

 

Poolbeg Pharma plc

Interim data from POLB 001 TOPICAL clinical trial

Positive interim review marks key milestone for POLB 001 clinical development

24 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, announces that the ongoing TOPICAL clinical trial will proceed as planned following a positive review of data from the interim safety cohort. The completion of this review represents an important milestone for the TOPICAL trial.

The review recommended that the trial continue as planned, with no changes required to the study protocol. Patient recruitment is continuing across leading UK clinical sites, with further patients expected to be enrolled and additional sites activated.

The Company looks forward to generating further data and sharing more detail with prospective partners. Bispecific antibodies are becoming increasingly important in the treatment of cancer, and an effective CRS preventative therapy could represent an important advance for patients, clinicians and healthcare systems.

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: “The data from the interim cohort represent a significant milestone for the TOPICAL trial. The positive recommendation to continue the study as planned provides further confidence as we advance the POLB 001 programme.

“We are building momentum across the study, with recruitment continuing at leading UK clinical sites, further patients expected to be enrolled and additional sites activated. We look forward to generating further clinical data and sharing more detail with prospective partners as we continue discussions around the POLB 001 opportunity.”

Investor presentation

Poolbeg Pharma will provide a live presentation via the Investor Meet Company platform today, 24 September 2026 at 2:00pm.

The presentation is open to analysts and investors, those who already follow Poolbeg on the Investor Meet Company platform will automatically be invited. Investors can sign up to Investor Meet for free and add Poolbeg Pharma plc to their company dashboard here.

 The TOPICAL trial is evaluating POLB 001 as a preventative therapy for Cytokine Release Syndrome (“CRS”) in patients with relapsed/refractory multiple myeloma receiving the approved bispecific antibody teclistamab.

Enquiries  

Poolbeg Pharma Plc   Jeremy Skillington, CEO   Ian O'Connell, CFO	[phone]  [e-mail]
Cavendish Capital Markets Ltd (NOMAD & Joint Broker)   Geoff Nash, Trisyia Jamaludin (Corporate Finance)  Nigel Birks (Life Science Specialist Sales)  Harriet Ward (ECM)	[phone]
Oak Securities (Joint Broker)  Jerry Keen, Henry Poole	[phone]
Shore Capital Stockbrokers Ltd (Joint Broker)  David Coaten, Harry Davies-Ball (Corporate Advisory)  Malachy McEntyre (Corporate Broking)	[phone]
J&E Davy (Joint Broker)   Anthony Farrell, Niall Gilchrist	[phone]
Optimum Strategic Communications   Nick Bastin, Katie Flint, Henry Williams	[phone]   [e-mail]

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.

 

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