Letter to Shareholders – 2025 a year of great progress, with momentum maintained into 2026 when multiple value inflection points are expected
18 December 2025 – Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field, publishes an end of year letter from the Company’s Executive Chair, Cathal Friel, providing an overview of the significant progress made by the Company in 2025 and outlook for 2026.
Dear Shareholders,
As 2025 draws to a close, we wanted to reflect on the substantial progress made by Poolbeg this year, as we move POLB 001 into the clinic and anticipate data readouts from multiple clinical trials in 2026.
Our oversubscribed and upsized fundraise in June 2025 raised gross proceeds of £4.865 million, extending our cash runway into 2027. The Company’s cash balance of £10.0 million (as at 30 June 2025) will support the delivery of multiple key clinical milestones. To align resourcing with these near-term clinical priorities, the Company implemented a series of operational efficiency measures, including selective headcount reductions during the year.
POLB 001 – Upcoming TOPICAL trial
Preparations for the forthcoming POLB 001 TOPICAL trial have advanced at pace, with multiple key milestones achieved in rapid succession:
|
· |
Secured the approved bispecific antibody, teclistamab, for the study from Johnson & Johnson, a top-five global pharmaceutical company, at no cost to the Company |
|
· |
Signed an agreement for Accelerating Clinical Trials (ACT) to conduct the trial, led by Dr Emma Searle, Consultant Haematologist at The Christie NHS Foundation Trust |
|
· |
Confirmed participation from a number of additional cancer centres, including the NHS Foundation Trusts at The Royal Marsden, University College London Hospitals, and University Hospitals Birmingham |
|
· |
Finalised the protocol and preparing POLB 001 shipment to trial sites |
|
· |
Single-arm, open-label design enables early insights and safety assessment; interim data expected in summer 2026 |
In December 2025, we announced that the TOPICAL trial will play a key role in the RISE programme, led by University of Manchester and The Christie, which is investigating cancer immunotherapy-induced CRS and the safer delivery of these treatments to patients. Poolbeg is the lead business partner alongside Johnson & Johnson and others. Greatly improved response and survival rates are turning the focus to how these truly lifesaving cancer immunotherapies can be made more widely available, with CRS being one of the largest bottlenecks. The continued growth and dominance of these CRS inducing cancer immunotherapies further enhances the value proposition of POLB 001.
Partnering focused
We are continuing to progress partnering discussions with several major and mid-sized pharmaceutical companies regarding POLB 001 which, the directors believe, addresses a potential market opportunity of >US$10 billion1. We secured Orphan Drug Designation from the FDA earlier this year and also strengthened our intellectual property position with the granting of multiple new patents.
Oral GLP-1 programme
Topline data from the proof-of-concept clinical trial for our oral GLP-1 programme in up to 20 obese subjects is expected in H1 2026. The trial is due to take place at the University of Ulster, led by a team that includes Professor Carel le Roux, a notable figure in the field of metabolic medicine.
Whilst we are currently prioritising the upcoming clinical trials for POLB 001 and our oral GLP-1 programme, we are seeking to progress potential collaborations in our AI-led programmes. AI-driven drug discovery is seeing continued global interest due to its potential in accelerating target identification, reducing costs, de-risking development, and improving success rates.
Outlook
2025 has been a remarkable year of significant achievement, positioning Poolbeg strongly to deliver on a series of exciting clinical milestones in 2026. We are well-funded through a catalyst-rich period, with a cash runway into 2027.
We would like to thank our shareholders for their continued support, and we look forward to reporting on our progress in 2026.
Cathal Friel,
Executive Chair
Enquiries
|
Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
|
+44 (0) 207 183 1499 |
