Poolbeg Pharma Reports Full Year 2025 Results and Key Progress on POLB 001 Clinical Trial

Poolbeg Pharma full year 2025 results – a clinical progress story more than a profit story

Poolbeg Pharma’s 2025 results are exactly what you would expect from a clinical-stage biotech: no revenue yet, another annual loss, and a lot riding on trial milestones. The difference here is that the operational update is doing the heavy lifting. For retail investors, this RNS is really about whether POLB 001 is getting closer to meaningful data and potential partnering interest.

On that front, the update is encouraging. Poolbeg says it ended 2025 with £7.7 million of cash and is funded through to delivery of near-term clinical milestones into 2027, while the lead POLB 001 TOPICAL trial is now set up with regulatory clearances, multiple UK cancer sites, and interim data expected this summer.

Key number	2025	2024
Cash balance at year end	£7.713 million	£7.824 million
Loss for the year	£5.695 million	£5.790 million
R&D expenses	£1.525 million	£1.383 million
Administrative expenses	£4.893 million	£5.258 million
Operating cash outflow	£4.761 million	£4.646 million
Basic and diluted loss per share	0.94p	1.16p

POLB 001 TOPICAL trial progress is the big value driver for Poolbeg Pharma

The main reason this update matters is POLB 001. This is Poolbeg’s lead asset, being developed as an oral preventative treatment for Cytokine Release Syndrome, or CRS – a severe inflammatory side effect linked to some cancer immunotherapies such as bispecific antibodies and CAR T therapies.

Poolbeg’s first-in-patient study, called TOPICAL, is designed to test POLB 001 in approximately 30 relapsed/refractory multiple myeloma patients receiving teclistamab, an approved bispecific antibody. The company says interim data are expected this summer, with full data to follow later.

This matters because the trial design looks built for speed. Poolbeg says CRS tends to occur early in treatment, so the company does not need to wait years for readouts in the way a traditional oncology trial often does. It is also a single-arm, open-label study, meaning there is no placebo arm and both doctors and patients know what is being given.

Operationally, there has been decent progress. Poolbeg secured teclistamab from Johnson & Johnson at no cost, signed up Accelerating Clinical Trials to run the study, and expanded the site list to six UK centres including The Christie, The Royal Marsden, University College London Hospitals, University Hospitals Birmingham, NHS Lothian and Royal Stoke University Hospital.

Post period end, the company also received MHRA Clinical Trial Authorisation, which is a proper regulatory milestone rather than just a planning update. For me, that is one of the most useful bits of the RNS because it moves the story from promise to execution.

Why POLB 001 could matter commercially if the summer data are positive

Poolbeg is pitching POLB 001 as a way to make cancer immunotherapy safer and easier to deliver outside major specialist centres. That is a serious commercial angle. If CRS risk can be reduced, these therapies may become easier to use in community hospitals and outpatient settings, which could expand access and reduce the burden on healthcare systems.

The company repeats an estimated market opportunity of more than US$10 billion in relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma alone. It also points to new US-focused pricing research indicating multi-billion-dollar peak sales potential in the United States. That sounds exciting, but investors should keep their feet on the ground – this is third-party research cited by the company, not actual sales guidance, and clinical proof still needs to arrive.

Even so, the partnering angle is credible. Poolbeg says it is in constructive discussions with several companies and that engagement has increased as it advances towards data. No names, deal terms or timelines are disclosed, but if the trial reads out well, that is the obvious next step management wants the market to focus on.

Poolbeg Pharma cash runway and June 2025 fundraise – solid enough, but dilution is part of the picture

Biotech investors always need to check the cash. Poolbeg raised £4.865 million gross in June 2025 at 2.5p per share in an oversubscribed and upsized fundraise. According to the accounts, 194,600,000 new ordinary shares were issued for cash, plus 2,600,000 fee shares to advisers.

That fundraise clearly helped stabilise the balance sheet. Despite spending heavily on development, cash only edged down from £7.824 million to £7.713 million over the year because of the fresh equity raised.

The positive spin is straightforward: the company says it is funded into 2027 and can now get through near-term milestones without immediately coming back to shareholders. The less cheerful side is dilution. The weighted average share count rose to 602,652,055, and after period end a further 7,903,778 shares were issued following option exercises, taking total shares in issue to 705,103,778.

That is not unusual for an AIM biotech, but it matters. If you own the shares, you want future value creation from data or partnerships to outweigh the impact of all that paper being issued.

FDA Orphan Drug Designation and patent wins add weight to the POLB 001 story

Poolbeg also strengthened the non-clinical side of the investment case. POLB 001 received FDA Orphan Drug Designation as an oral preventative therapy for T-cell engager bispecific antibody-induced CRS. In simple terms, orphan designation is intended to support development in rare conditions and can add regulatory and commercial benefits, although the RNS does not quantify those benefits here.

On intellectual property, the company reported patent progress in Europe, the Republic of Korea, Hong Kong and, post period end, Australia. That first national grant within the cancer immunotherapy-induced CRS patent family in Australia is a useful milestone because partners tend to care a lot about exclusivity and future defensibility.

It does not guarantee a deal, but it makes the asset easier to sell.

Oral GLP-1 programme still has upside, but the start date slipped

There is a second programme here too: an oral GLP-1 obesity treatment being developed with AnaBio. The proof-of-concept trial at the University of Ulster, involving up to 20 obese subjects, is now expected to start in H2 2026 due to revised manufacturing lead times.

That is the main negative operational update in the RNS. It is not a cancellation, but it is a delay, and early-stage biotech delays tend to test patience. The company says it has received interest from potential partners ahead of the study, but again, no further detail is disclosed.

Poolbeg Pharma profit and loss – losses are still there, but cost control has improved a bit

Financially, the headline is simple: Poolbeg is still loss-making and pre-revenue. Revenue was not disclosed because there was none in the accounts, and total loss for the year was £5.695 million.

There are a few signs of discipline. Administrative expenses fell to £4.893 million from £5.258 million, while the company said it made selective headcount reductions to streamline the cost base. R&D spend increased to £1.525 million from £1.383 million, which is what you would want to see if the pipeline is genuinely moving forward.

The audit opinion was unqualified, which is reassuring in a basic but important way. There was also only a small £26,000 impairment charge tied to de-prioritised R&D programmes.

What this Poolbeg Pharma RNS means for retail investors

My take is that this is a positive update overall, but it is positive because of execution and upcoming catalysts, not because the financials are suddenly attractive. The summer interim data from TOPICAL are now the centre of gravity for the whole story.

• The positives: cash runway into 2027, trial clearances in place, six UK sites, free supply of teclistamab, orphan designation, patent progress, and clearer partnering intent.
• The negatives: still no revenue, continued annual losses, shareholder dilution from the fundraise and option exercises, and a delay to the oral GLP-1 study.
• The key watchpoint: whether interim POLB 001 data this summer are strong enough to move partnering discussions from polite interest to something concrete.

In short, Poolbeg has bought itself time and got its lead programme closer to a proper clinical test. For shareholders, that is good news. But this remains a data-driven biotech share, so the next readout matters far more than the rear-view mirror numbers in the accounts.