REG - Poolbeg Pharma PLC - Results for the year ended 31 December 2025
Today 07:00
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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
(https://protect.checkpoint.com/v2/r02/___https:/www.poolbegpharma.com/___.YXAxZTpzaG9yZWNhcDpjOm86MmI2OWFmYmU2ZGVmOGFmMjRjZjIwYTZhMWI0YzUzOTI6Nzo2M2Q2OjY1YTk2ZTY1YWRmZjg0ODYzZmE1YmExZmY4OTc5NjgwNzMxMTZlYjlhZmI1YzRhMzdhZjYyODA5YWE1NDFkNTU6cDpGOk4)
(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
o 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
o Participation confirmed for additional cancer centres including The Royal
Marsden, University College London Hospitals, and University Hospitals
Birmingham NHS Foundation Trusts
o Teclistamab, an approved bispecific antibody, secured for the trial from
Johnson & Johnson at no cost to the Company
o 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
(https://www.investormeetcompany.com/companies/poolbeg-pharma-plc) .
Enquiries
Poolbeg Pharma Plc +44 (0) 207 183 1499
Jeremy Skillington, CEO ir@poolbegpharma.com (mailto:ir@poolbegpharma.com)
Ian O'Connell, CFO
Cavendish Capital Markets Ltd (NOMAD & Joint Broker) +44 (0) 207 220 0500
Geoff Nash, Trisyia Jamaludin (Corporate Finance)
Nigel Birks (Life Science Specialist Sales)
Harriet Ward (ECM)
Shore Capital Stockbrokers Ltd (Joint Broker) +44 (0) 207 408 4090
David Coaten, Harry Davies-Ball (Corporate Advisory)
Malachy McEntyre (Corporate Broking)
J&E Davy (Joint Broker) +353 (0) 1 679 6363
Anthony Farrell, Niall Gilchrist
Optimum Strategic Communications +44 (0) 208 078 4357
Nick Bastin, Vici Rabbetts, Elena Bates poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)
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
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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 billion(1) 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 billion(9).
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 (5,695) (5,790)
holders of the Company
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 based payment reserve
Share Share premium Merger reserve Accumulated deficit
capital 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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