Poolbeg Pharma plc

Results for the year ended 31 December 2025

28 April 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 its audited results for the year ended 31 December 2025.

2025 Highlights

Post Period End

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg, commented: "2025 was a transformative year for Poolbeg. We saw strong interest in our fundraise, which has provided funding through multiple near-term clinical value inflection points. With two trials designed to generate rapid data, and strong interest from pharma partners, we believe 2026 will prove to be an exceptional year for Poolbeg."

Investor presentation

Poolbeg Pharma will provide a live presentation via the Investor Meet Company platform today, Tuesday 28 April 2026 at 5pm.

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.

Enquiries

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. 

Stay updated: Website | Sign up for RNS alerts | Presentation | X | LinkedIn

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.

Executive Chair's Statement

I am pleased to present the annual report and financial statements of Poolbeg Pharma plc ("Poolbeg") for the year ended 31 December 2025.

Poolbeg made significant operational progress in 2025. We saw strong investor support for our oversubscribed and upsized fundraise, which completed in June raising £4.865 million. This capital supports the delivery of major clinical milestones in oncology and obesity.

Pipeline progress in high-growth therapeutic areas

We made significant progress during the year in advancing both POLB 001 and our oral GLP-1 programme, including preparations for their respective clinical trials, with both programmes addressing areas of strong commercial and strategic interest within the pharmaceutical industry.

Cancer immunotherapies, and bispecific antibodies in particular, are revolutionising cancer care and represent an important and fast-growing area of oncology, with regulatory approvals expanding across multiple indications. However, Cytokine Release Syndrome remains a severe and potentially life-threatening side effect associated with certain cancer immunotherapies. POLB 001 is being developed as a potential preventative therapy for cancer immunotherapy-induced CRS. By addressing this significant issue, POLB 001 could increase the number of patients able to access these life-saving treatments, with an estimated market opportunity of >US$10B in relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma alone.

Post period end, independent research by Acumetis Global reconfirmed the significant cost burden associated with managing CRS and that an effective preventative therapy would represent a compelling value proposition for healthcare systems. The findings highlight pricing levels that demonstrate POLB 001's multi-billion-dollar peak sales potential. These insights provide increased confidence in the Company's anticipated market uptake in the US and further support POLB 001's future value and appeal to potential partners.

In the metabolic disease sector, 2025 marked a record year for obesity and diabetes deal-making, reaching US$20.2 billion¹ and underscoring sustained industry commitment to this space. Our oral encapsulated GLP-1 programme is designed to offer a differentiated, patient-friendly approach within one of the largest and fastest-growing global markets.

Focused on strategic partnering

We believe our upcoming clinical data could provide an important catalyst for partnering discussions across our portfolio. Since moving forward with the TOPICAL trial, we have seen increased engagement from potential partners regarding POLB 001, reflecting its significant commercial opportunity and its potential to support broader use of certain cancer immunotherapies by helping to address CRS. As increasing numbers of CRS-inducing cancer immunotherapies enter clinical development, we believe the need for and strategic interest in POLB 001 will continue to grow.

This commercial and strategic interest is further supported by the progress we made during 2025 in strengthening POLB 001's regulatory and intellectual property position. We were pleased to receive FDA Orphan Drug Designation for the prevention of T-cell engager bispecific antibody-induced CRS. We also strengthened our intellectual property position through additional patent grants during the year. Importantly, post-period end, we received the first national grant in our cancer immunotherapy-induced CRS patent family from IP Australia, further enhancing POLB 001's future value and appeal to potential partners. We look forward to continuing to engage with prospective partners as further clinical data become available during 2026. 

Financial

In 2025, we strengthened our financial position through a £4.865m (before expenses) fundraise, completed at 2.5p per share, extending the Company's financial runway significantly and supporting the delivery of key clinical milestones. To ensure resources remain aligned with our near-term development priorities, we implemented targeted operational efficiency measures during the year, including selective headcount reductions. These actions were designed to streamline the cost base and maintain strategic focus on delivering our clinical objectives into 2027.

Poolbeg ended the year with a cash balance of £7.7 million (2024: £7.8 million). The loss for the year amounted to £5.7 million (2024: £5.8 million) and comprises R&D expenses of £1.5 million (2024: £1.4 million), administrative expenses of £4.9 million (2024: £5.3 million), and tax rebates and other income & charges of £0.7 million (2024: £0.9 million).

Outlook

Looking ahead, we remain focused on delivering important milestones for the Company, namely interim data from the POLB 001 clinical trial in the summer, ahead of full data, and the commencement of the oral GLP-1 proof-of-concept trial, which is expected in H2 2026.

We are encouraged by, and excited about, the potential of POLB 001 to address an important unmet need for cancer patients. As potentially the first approved preventative therapy for cancer immunotherapy-induced CRS, POLB 001 has the opportunity to play an important role in the management of CRS, reducing healthcare system costs, improving patient quality of life and supporting broader access to certain cancer immunotherapies beyond specialist cancer centres and into outpatient and community settings.

We look forward to building on constructive engagement with prospective partners by sharing upcoming clinical data during 2026, which we believe could provide an important catalyst for advancing those discussions towards a potential transaction.

Cathal Friel

Executive Chair

27 April 2026

CEO's Operations Review

Significant progress has been made across our pipeline, with multiple clinical milestones achieved in 2025 and early 2026, and we are well-positioned to deliver a number of further important milestones in the months ahead.

Our lead programme, POLB 001, is an orally delivered p38 MAPK inhibitor being developed as a preventative therapy for cancer immunotherapy-induced CRS, with the potential to become the first approved therapy for this indication and with further life cycle expansion opportunities, including in severe influenza.

Changing the cancer treatment landscape & the role of bispecific antibodies

Over the past two decades, the multiple myeloma treatment landscape has shifted from conventional chemotherapy-based regimens to highly targeted immune-based therapies, which have significantly improved patient outcomes.

In the early 2000s, standard treatment for blood cancers such as multiple myeloma consisted of chemotherapy plus corticosteroids, VAD (Vincristine, Adriamycin, Dexamethasone) chemotherapy triplets, thalidomide, and stem cell transplant, with 5-year of survival of c.30-35%² and 10-year survival of c.20%³. Today, the treatment options have expanded significantly, and a key element of this is immunotherapy drugs such as CAR T therapies and bispecific antibodies that redirect the immune system to target and eradicate cancer cells. These treatments have transformed patient outcomes, with 5-year survival now estimated at over 80%⁴, and 10-year survival rates above an estimated 60%⁵ for certain patient groups.

Relapsed/refractory multiple myeloma patients treated with approved and late-stage bispecific antibodies have demonstrated overall response rates of c.60-75%, with 30-40% or greater complete response rates^6,7. Uptake of these therapies has been rapid with continued progress in their use in earlier lines of therapy demonstrating their profound clinical benefit and their potential to become a foundational treatment for blood cancers and beyond. Teclistamab, initially approved for use in patients as a 5^th line treatment (patients who have progressed following other therapies), was approved in the 2^nd line setting in March this year.

This expanding market has been driven by improved durability of response, combination strategies, earlier-line adoption, and expansion into new types of cancer.

Cytokine Release Syndrome - limiting uptake of breakthrough cancer immunotherapies

The rapid adoption of CAR T and bispecific antibodies has also brought renewed focus to CRS, a severe and potentially life-threatening inflammatory response associated with these treatments. CRS affects more than 70%⁸ of patients receiving CAR T and bispecific antibodies. Because onset of CRS can be rapid and unpredictable, patients require intensive monitoring, which often limits administration to specialist cancer centres and drives extended hospitalisation and significant healthcare resource utilisation.

As these therapies move into earlier lines of treatment and larger patient populations, the clinical burden associated with CRS is expected to increase. The Company's engagements with key opinion leaders have underscored the importance of strategies to make these breakthrough treatments available to a wider range of patients and to streamline their delivery.  We believe that POLB 001, as potentially the first approved preventative therapy for cancer immunotherapy-induced CRS, has the opportunity to materially expand patient access, reduce healthcare system costs, and address a market estimated to exceed US$10 billion⁹.

Democratising healthcare, community care, and improving patient quality of life

Several important themes emerged from leading global cancer conferences in 2025, including the American Society of Hematology Annual Meeting and the European Society for Medical Oncology Congress.

·    Democratisation of healthcare - Ensuring that innovative haematology treatments and technologies are accessible to all patients, not only those living near major specialist cancer centres.

·    Community Care - A shift from a purely centralised, specialist-driven model toward one that integrates local and regional care centres. This reflects a move toward scalability, practicality, and patient-centred treatment.

·   Focus on patient quality of life - Reducing treatment burden and addressing the severe side effects experienced by many cancer patients, with greater emphasis on tolerability alongside efficacy.

POLB 001 aligns closely with these themes. By making these cancer immunotherapies safer through the prevention of CRS, POLB 001 has the potential to support broader administration of these life-saving treatments beyond specialised cancer centres. Reducing the risk of CRS could allow treatment delivery in community hospitals and regional centres, expanding access for patients in remote or underserved areas, marking a significant step toward democratising cancer care. If successful, POLB 001 could also significantly enhance patient quality of life by reducing toxicity and treatment burden, supporting a more patient-centred standard of care.

POLB 001 TOPICAL trial 

Preparations for the POLB 001 clinical trial have advanced at pace, with multiple key milestones achieved in rapid succession. The trial, titled TOPICAL (Trial of Prevention of ImmunoCytokine Adverse events in Myeloma) is designed to generate rapid and compelling data for the effectiveness of POLB 001 to prevent CRS in approximately 30 relapsed / refractory multiple myeloma patients receiving an approved bispecific antibody.

During the year, we secured the approved bispecific antibody, teclistamab, for the study from Johnson & Johnson, a top-five global pharmaceutical company, at no cost to Poolbeg. We also signed an agreement with specialist blood cancer trials organisation Accelerating Clinical Trials (ACT) to conduct the trial, led by Dr Emma Searle, Consultant Haematologist at The Christie NHS Foundation Trust in Manchester. The study now spans six sites across the UK, with NHS Lothian in Edinburgh and the Royal Stoke University Hospital joining existing sites at The Christie, The Royal Marsden, University College London Hospitals, and University Hospitals Birmingham NHS Trusts. We are delighted to have these leading UK cancer centres engaged in the study and supporting patient recruitment for the trial. With the protocol finalised, all regulatory clearances in place, site initiation visits scheduled, and patient screening and dosing set to commence shortly, the TOPICAL trial is on track to rapidly deliver interim data, expected this summer.

CRS typically develops during the early stages of bispecific antibody treatment. As such, unlike traditional oncology trials which may require many years to determine efficacy in each patient, the TOPICAL trial is designed to generate the required data from each patient within a few months. In addition, the single arm (no placebo) and open label (un-blinded) design further enables rapid data readout and early insights.

The RISE programme

In December 2025, we announced that the POLB 001 TOPICAL trial will play a key role in a groundbreaking cancer immunotherapy-induced CRS research programme titled RISE (Reducing Immune Stress from Excess cytokine release in advanced therapies). Poolbeg is acting as the lead business partner, alongside Johnson & Johnson and other partners, on the University of Manchester and The Christie research programme. RISE will facilitate wider research into cancer immunotherapy-induced CRS and the safer delivery of these treatments, reflecting the growing recognition of this major unmet medical need.

Oral GLP-1 programme

GLP-1 has become a key market for pharma in recent years and continues to grow, evidenced by the number of significant deals and the publication of the World Health Organization's (WHO) first global guideline recommending GLP-1 therapies for long-term treatment of obesity.

Poolbeg and our partner AnaBio are advancing an oral GLP-1 programme towards the proof-of-concept clinical study, which aims to demonstrate the ability to safely and efficiently deliver an oral encapsulated GLP-1 in up to 20 obese subjects. 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 metabolic disease medicine. Commencement is now targeted for H2 2026 reflecting revised manufacturing lead times. Leveraging this collaboration, the study has been designed to complete quickly following first subject dosing, providing a rapid path to readout once underway.

Our programme utilises a Generally Recognised as Safe (GRAS) oral encapsulation technology directing an approved GLP-1 receptor agonist to a specific area of the gut using a pH sensitive release mechanism, to deliver the drug to its intended site of action. We have received interest from potential partners ahead of the study due to this differentiated approach, reflecting strong market appetite for positive clinical data. As Poolbeg holds a licence to this proprietary oral encapsulation technology across all metabolic conditions, there are also further partnering opportunities beyond GLP-1 and the successful results from the trial may provide technology validation to support multiple opportunities for value creation. 

AI programmes

Whilst we are currently prioritising the clinical trials for POLB 001 and our oral GLP-1 programme, we are seeking to progress potential collaborations for our AI-led programmes. AI-driven drug discovery is seeing continued global interest as it has the potential to accelerate target identification, reduce costs, de-risk development, and improve success rates. 

Outlook

As we look ahead, we are approaching several significant milestones for the Company's pipeline during 2026. We expect to generate interim data from the POLB 001 TOPICAL trial this summer and to commence the oral GLP-1 proof-of-concept trial in H2 2026. We look forward to sharing these developments with prospective partners, the market and the wider scientific community. Poolbeg is led by a proven team with expertise in clinical execution and deal-making and we see strong potential to secure partnerships based on positive data from these trials.

Jeremy Skillington, PhD

CEO

27 April 2026

References

1.     J.P. Morgan Q4 2025 Biopharma Licensing and Venture Report, January 2026

2.     Michel Attal, M.D., et al. A Prospective, Randomized Trial of Autologous Bone Marrow Transplantation and Chemotherapy in Multiple Myeloma. N Engl J Med, 1996. DOI: 10.1056/NEJM199607113350204

3.     Recent major improvement in long-term survival of younger patients with multiple myeloma. Blood (2008) 111 (5): 2521-2526.

4.     MajesTEC-3: 'Unprecedented' Benefit in Previously Treated Multiple Myeloma. The ASCO Post. Feb 2026. 

5.     New long-term progression free survival data projections reinforce subcutaneous DARZALEX® (daratumumab) quadruplet therapy as a foundational standard of care for patients with newly diagnosed multiple myeloma. Johnson & Johnson Innovative Medicine. 25 April 2025.

6.     Teclistamab in Relapsed or Refractory Multiple Myeloma. P Moreau et al. N Engl J Med 2022;387:495-505

7.     Efficacy and safety of talquetamab + teclistamab in patients with Relapsed/Refractory multiple myeloma and extramedullary disease: Updated Phase 2 results from the redirectt-1 study with extended follow-up. Blood (2025) 146 (Supplement 1): 698.

8.     Average rate from Summary of Product Characteristics (SmPCs) for Yescarta, Tecartus, Abecma, Kymriah, Carvykti, Breyanzi, Elrexfio, Columvi, Epkinly, Tecvayli and Talvey;

9.     Independent research by Acumetis Global (formerly Decisive Consulting Limited).