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Results for the year ended 31 December 2025

28th Apr 2026 07:00

RNS Number : 1063C
Poolbeg Pharma PLC
28 April 2026
 

 

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

·

Cash balance of £7.7 million as at 31 December 2025, with the Company funded through to delivery of near-term clinical milestones into 2027

·

£4.865 million gross proceeds raised as part of an oversubscribed and upsized fundraise in June 2025

·

Poolbeg anticipates strong potential for partnering on positive data from its clinical trials and is progressing constructive partnering discussions with several companies, with increased engagement as it advances towards data

·

Significant progress made in the first-in-patient POLB 001 clinical trial, titled TOPICAL, with interim data expected this summer

Agreement signed with Accelerating Clinical Trials (ACT) to conduct the trial, led by Dr Emma Searle, Consultant Haematologist at The Christie NHS Foundation Trust, Manchester

Participation confirmed for additional cancer centres including The Royal Marsden, University College London Hospitals, and University Hospitals Birmingham NHS Foundation Trusts

Teclistamab, an approved bispecific antibody, secured for the trial from Johnson & Johnson at no cost to the Company

Protocol finalised

·

POLB 001 granted Orphan Drug Designation by the FDA as an oral preventative therapy for T-cell engager bispecific antibody-induced Cytokine Release Syndrome ("CRS")

·

Grant of European Immunomodulator II patent by the European Patent Office and the Republic of Korea, further strengthening Poolbeg's global intellectual property portfolio

·

Positive data from an in vivo animal study supports the use of POLB 001 to prevent cancer immunotherapy-induced CRS

·

TOPICAL trial to 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

·

Progress made towards commencement of oral GLP-1 proof of concept trial at University of Ulster, led by Prof Carel le Roux with up to 20 obese subjects, now expected to commence in H2 2026 due to revised manufacturing lead times

 

Post Period End

·

First national patent grant within Poolbeg's cancer immunotherapy-induced CRS patent family received from IP Australia, marking a significant milestone for POLB 001's global intellectual property portfolio

·

Peer-Reviewed LPS human challenge trial paper published in Frontiers in Immunology, validating the significant potential of POLB 001

·

Appointment of Dr Adrian Kilcoyne to Scientific Advisory Board, bringing a wealth of knowledge in haematological malignancies, T-cell therapies and CRS

·

NHS Lothian and Royal Stoke University Hospital added as sites for the TOPICAL trial, all regulatory clearances received, including MHRA authorisation, and site initiation visits scheduled with patient screening and dosing set to commence shortly

·

New independent US-focused pricing research indicates multi-billion-dollar peak sales potential for POLB 001 in the United States

·

Grant of Immunomodulator II patent in Hong Kong

 

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

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O'Connell, CFO

+44 (0) 207 183 1499

[email protected]

Cavendish Capital Markets Ltd (NOMAD & Joint Broker)

Geoff Nash, Trisyia Jamaludin (Corporate Finance)

Nigel Birks (Life Science Specialist Sales)

Harriet Ward (ECM)

+44 (0) 207 220 0500

Shore Capital Stockbrokers Ltd (Joint Broker)

David Coaten, Harry Davies-Ball (Corporate Advisory)Malachy McEntyre (Corporate Broking)

+44 (0) 207 408 4090

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

+353 (0) 1 679 6363

Optimum Strategic Communications

Nick Bastin, Vici Rabbetts, Elena Bates

+44 (0) 208 078 4357

[email protected]

 

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.

 

 

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 rates6,7. 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 5th line treatment (patients who have progressed following other therapies), was approved in the 2nd 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).

Consolidated Statement of Comprehensive Income

For the year ended 31 December 2025

 

 

 

2025

 

 

2024

Note

£'000

£'000

Revenue

 

-

-

Cost of sales

 

-

-

Gross profit

 

-

-

Administrative expenses

 

(4,893)

(5,258)

Other operating income

 

422

530

Research and development expenses

 

(1,525)

(1,383)

Impairment of intangible assets

4

(26)

-

Net losses on disposal of assets

 

(5)

(261)

Operating loss

 

(6,027)

(6,372)

Finance income

 

253

428

Loss before income tax

 

(5,774)

(5,944)

Taxation

 

79

154

Loss and total comprehensive loss for the year attributable to the equity holders of the Company

 

(5,695)

(5,790)

 

Loss per share:

 

 

Loss per share - basic and diluted, attributable to ordinary equity holders of the parent

 

3

 

(0.94)p

 

(1.16)p

 

 

Consolidated Statement of Financial Position

As at 31 December 2025

 

2025

2024

Note

£'000

£'000

Assets

 

 

Non-current assets

 

 

Intangible assets

4

1,674

1,684

Total non-current assets

 

1,674

1,684

 

 

Current assets

 

 

Trade and other receivables

5

555

739

Cash and cash equivalents

 

7,713

7,824

Total current assets

 

8,268

8,563

 

 

 

Total assets

 

9,942

10,247

 

 

Equity and liabilities

 

 

Equity attributable to owners of the parent

 

 

Share capital

 

139

100

Share premium

 

27,538

23,100

Other reserves

 

3,362

2,816

Accumulated deficit

 

(22,438)

(16,743)

Total equity

 

8,601

9,273

 

 

Current liabilities

 

 

Trade and other payables

6

1,341

974

Total current liabilities

 

1,341

974

Total liabilities

 

1,341

974

 

 

 

Total equity and liabilities

 

9,942

10,247

 

Consolidated Statement of Changes in Equity

For the year ended 31 December 2025

 

 

 

 

 

Share

capital

 

 

Share premium

 

Share based payment reserve

 

 

Merger reserve

 

 

Accumulated deficit

 

 

 

Total

 

Note

£'000

£'000

£'000

£'000

£'000

£'000

Balance at 31 December 2023

 

100

23,100

740

1,455

(10,953)

14,442

Loss and total comprehensive loss for the year

 

-

-

-

-

(5,790)

(5,790)

Share based payments

7

-

-

621

-

-

621

Balance at 31 December 2024

 

100

23,100

1,361

1,455

(16,743)

9,273

Loss and total comprehensive loss for the year

 

-

-

-

-

(5,695)

(5,695)

Issue of fee shares

 

-

65

-

-

-

65

Issue of shares for cash

 

39

4,826

-

-

-

4,865

Costs charged against share premium

 

-

(453)

-

-

-

(453)

Share based payments

7

-

-

546

-

-

546

Balance at 31 December 2025

 

139

27,538

1,907

1,455

(22,438)

8,601

 

Consolidated Statement of Cash Flows

For the year ended 31 December 2025

 

 

 

2025

 

 

2024

Note

£'000

£'000

Cash flows from operating activities

 

 

Loss on ordinary activities before taxation

 

(5,774)

(5,944)

Amortisation

4

59

114

Impairment of intangible assets

4

26

-

Disposal of intangible assets

4

5

261

Share based payment expense

7

546

621

Finance income

 

(253)

(428)

R&D tax credits

 

74

595

Movements in working capital and other adjustments:

 

 

Change in trade and other receivables

5

189

147

Change in trade and other payables

6

367

(12)

Net cash flow used in operating activities

 

(4,761)

(4,646)

 

 

Cash flow from investing activities

 

 

Payments for intangible assets

4

(80)

(129)

Interest received from bank

 

253

428

Net cash flow from investing activities

 

173

299

 

 

 

Cash flow from financing activities

 

 

Net proceeds from issue of equity instruments

 

4,477

-

Net cash flow from financing activities

 

4,477

-

 

 

 

Net change in cash and cash equivalents

 

(111)

(4,347)

Cash and cash equivalents at beginning of year

 

7,824

12,171

Cash and cash equivalents at end of year

 

7,713

7,824

 

 

1 General information

Poolbeg Pharma plc ("Poolbeg" or the "Company") is a public company limited by shares incorporated in England and Wales with company number 13279507. The Company is listed on the AIM market of the London Stock Exchange (ticker: POLB.L, ISIN: GB00BKPG7Z60).

 

Poolbeg is a clinical-stage biopharmaceutical company with a core focus on transforming the cancer immunotherapy field.

 

2 Basis of preparation and significant judgements

The Results Announcement does not constitute the Company's statutory accounts for the years ended 31 December 2025 and 31 December 2024, within the meaning of Section 435 of the Companies Act 2006 but is derived from those statutory accounts. The Company's statutory accounts for the year ended 31 December 2024 have been filed with the Registrar of Companies, and those for 31 December 2025 will be delivered to the Registrar of Companies in due course. Auditors have reported on the statutory accounts for 31 December 2025 and 31 December 2024; their reports were unqualified, did not draw attention to any matters by way of emphasis and did not contain statements under section 498(2) or section 498(3) of the Companies Act 2006.

 

Compliance with applicable law and IFRS

The consolidated Financial Statements comprise those of the Company and its subsidiaries (together the "Group"). The consolidated Financial Statements of the Group and the individual Financial Statements of the Company have been prepared on the going concern basis and under the historical cost convention in accordance with United Kingdom adopted international accounting standards ("IFRS") and their interpretations issued by the International Accounting Standards Board ("IASB") that are effective or issued and adopted as at the time of preparing these Financial Statements, and in accordance with those parts of the Companies Act 2006 applicable to companies reporting under IFRS.

 

Presentation of Balances

The Financial Statements are presented in pounds sterling ("£") which is the functional and presentation currency of the Company. Balances in the Financial Statements are rounded to the nearest thousand (£'000) except where otherwise indicated.

 

Summary of significant accounting policies

Research and development expenses

The costs relating to the development of products are accounted for in accordance with IAS 38 "Intangible Assets", where they meet the criteria for capitalisation.

 

Development costs are capitalised as an intangible asset if all of the following criteria are met:

1. The technical feasibility of completing the asset so that it will be available for use or sale;

2. The intention to complete the asset and use or sell it;

3. The ability to use or sell the asset;

4. The asset will generate probable future economic benefits and demonstrate the existence of a market or the usefulness of the asset if it is to be used internally;

5. The availability of adequate technical, financial and other resources to complete the development and to use or sell it; and

6. The ability to measure reliably the expenditure attributable to the intangible asset.

 

Research costs are expensed when they are incurred.

The assessment whether development costs can be capitalised requires management to make significant judgements. Management has reviewed the facts and circumstances of each project in relation to the above criteria and in management's opinion, the criteria prescribed under IAS 38.57 "Intangible Assets" for capitalising development costs as assets have not yet been met by the Company in relation to its current product candidates which are all pre Phase 3. Accordingly, all of the Company's costs related to research and development projects are recognised as expenses in the income statement in the period in which they are incurred with £1,525,000 (2024: £1,383,000) expensed in the current year. Management expects that the above criteria will be met on filing of a submission to the regulatory authority for final drug approval or potentially in advance of that on the receipt of information that strongly indicates that the development will be successful.

Share based payments

The Company has issued share options as an incentive to certain senior management. The fair value of options granted is recognised as an expense with a corresponding credit to the share-based payment reserve. The fair value is measured at grant date and spread over the period during which the awards vest.

 

For equity-settled share-based payment transactions, the goods or services received and the corresponding increase in equity are measured directly at the fair value of the goods or services received, unless that fair value cannot be estimated reliably. If it is not possible to estimate reliably the fair value of the goods or services received, the fair value of the equity instruments granted as calculated using a suitable valuation model as a proxy.

 

When a valuation model is used, they take into account conditions attached to the vesting and exercise of the equity instruments. The expected life used in the model is adjusted; based on management's best estimate, for the effects of non-transferability, exercise restrictions and behavioural considerations. The share price volatility percentage factor used in the calculation is based on historical share price performance of a group of peer companies if historical share price performance is not available for the Company on the date of grant. For the measurement of the fair value of share options issued under the Employee Performance Incentive Plan ("EIP") in February 2024, a Monte-Carlo simulation model was used.

 

3 Loss per share - basic and diluted

The Group presents basic and diluted loss per share ("LPS") data for its ordinary shares. Basic LPS is calculated by dividing the loss attributable to ordinary shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. Diluted LPS is determined by adjusting the loss attributable to ordinary shareholders and the weighted average number of ordinary shares outstanding for the effects of all dilutive potential ordinary shares, which comprise warrants and share options granted by the Company.

 

Weighted average number of shares in issue

Share Issue Details

Number of shares

Weighted average shares

31 December 2024

500,000,000

500,000,000

25 June 2025 - share placing & fee shares

197,200,000

 

31 December 2025

697,200,000

602,652,055

 

On 25 June 2025, 194,600,000 ordinary shares of 0.02p were issued at 2.5p per share as part of a £4,865,000 (before expenses) fund raising. In addition, as part of the fundraising arrangements, the Company issued 2,600,000 ordinary shares at the issue price to advisors in lieu of advisory fees.

 

The calculation of loss per share is based on the following:

2025

2024

Loss after tax attributable to equity holders of the Company (£'000)

(5,695)

(5,790)

Weighted average number of ordinary shares in issue

602,652,055

500,000,000

Fully diluted average number of ordinary shares in issue

602,652,055

500,000,000

Basic and diluted loss per share (pence)

(0.94)

(1.16)

 

Under IAS 33.43 "Earnings per Share", the calculation of loss per share does not assume conversion, exercise, or other issue of potential shares that would have an antidilutive effect on LPS. For the current year, the effect of options would be to reduce the loss per share and as such the basic and diluted LPS are the same. The share options and warrants outstanding as at 31 December 2025 totalled 61,124,709 (2024: 65,076,600) and are potentially dilutive.

 

 

4 Intangible Assets

 

 

Acquired Licences & Data

 

Patents & Trademarks

 

 

Total

Group

£'000

£'000

£'000

Cost

 

At 1 January 2024

1,964

389

2,353

Additions

-

129

129

Disposal

(443)

(171)

(614)

At 31 December 2024

1,521

347

1,868

Additions

-

80

80

Disposals

-

(8)

(8)

At 31 December 2025

1,521

419

1,940

 

 

Amortisation and impairment

 

At 1 January 2024

318

105

423

Amortisation charge

25

89

114

Disposals

(250)

(103)

(353)

At 31 December 2024

93

91

184

Amortisation charge

25

34

59

Impairment charge

26

-

26

Disposals

-

(3)

(3)

At 31 December 2025

144

122

266

 

 

Net book value

 

Net book value at 31 December 2025

1,377

297

1,674

Net book value at 31 December 2024

1,428

256

1,684

 

The Group reviews the carrying amounts of its intangible assets to determine whether there are any indications that those assets have suffered an impairment loss. If any such indications exist, the recoverable amount of the asset is estimated in order to determine the extent of the impairment loss. Impairment indications include events causing significant changes in any of the underlying assumptions used in the income approach utilised in valuing in process R&D. These key assumptions are: the probability of success; the discount factor; the timing of future revenue flows; market penetration and peak sales assumptions; and expenditures required to complete development. For projected cashflows 2 years of projected expenditures are based on financial budgets/forecasts approved by management with a 2% growth rate of overheads for periods beyond that. The current year impairment charge of £26,000 was made in relation to de-prioritised R&D programmes.

 

5 Trade and other receivables

2025

2024

£'000

£'000

Accounts receivable

67

20

Prepayments and accrued income

265

465

Grant receivable

32

34

VAT recoverable

53

87

R&D tax credit

138

133

Trade and other receivables

555

739

 

 

6 Trade and other payables

2025

2024

£'000

£'000

Trade payables

151

165

Accrued expenses

1,144

723

Other payables

7

18

Social security costs and other taxes

39

68

Trade and other payables

1,341

974

 

7 Share-based payments

The Company has issued share options as an incentive to certain senior management. In addition, the Company has issued warrants to senior management and advisers in payment or part payment for services provided to the Group. All share options granted prior to 2024 were granted under individual agreements and are subject to market and service vesting conditions. On 14 February 2024, the Company adopted an Employee Performance Incentive Plan ("EIP") for a number of key senior management, to align medium and long term objectives with those of shareholders and to encourage retention. All warrants granted were granted under individual agreements.

 

Each share option and warrant convert into one ordinary share of Poolbeg Pharma plc on exercise and are accounted for as equity-settled share-based payments. The equity instruments granted carry neither rights to dividends nor voting rights.

 

Share options and warrants in issue:

Share Options

Warrants

Units

Weighted average exercise price

Units

Weighted average exercise price

1 January 2024

36,000,000

13.3p

829,181

10.0p

Issued during the period

28,247,419

0.02p

-

-

31 December 2024

64,247,419

7.5p

829,181

10.0p

Lapsed during the period

3,951,891

0.02p

-

-

31 December 2025

60,295,528

8.0p

829,181

10.0p

 

Further details on the vesting conditions attached to the share options granted are set out in the Group Directors' Report. The fair value was estimated at the date of grant using a valuation model, taking into account the terms and conditions attached to the grant.

 

The value of share options and warrants charged to administrative expenses in the Statement of Comprehensive Income is as follows:

2025

2024

£'000

£'000

Share options

546

621

Total

546

621

 

The share options outstanding as at 31 December 2025 have a weighted remaining contractual life of 5.4 years with exercise prices ranging from 0.02p to 15p.

 

The warrants outstanding as at 31 December 2025 have a weighted remaining contractual life of 0.5 years with an exercise price of 10p.

 

 

8 Events after the reporting period

On 3 February 2026, following the exercise of share options by former employees of the Company, 7,903,778 new ordinary shares of 0.02 pence each in the capital of the Company were admitted to trading on AIM. After admission, the total number of ordinary shares in issue is 705,103,778.

 

On 31 March 2026, Poolbeg announced that it 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.

 

On 15 April 2026, Poolbeg announced that the UK Medicines and Healthcare products Regulatory Agency ("MHRA") has granted Clinical Trial Authorisation ("CTA") for the POLB 001 TOPICAL trial.

 

9 Annual Report and Annual General Meeting

The Company's Annual Report and Accounts for the year ended 31 December 2025 will be distributed to shareholders in due course together with the notice of the Annual General Meeting and will be available on the Company's website: www.poolbegpharma.com/investors/documents.

 

 

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