REG - Poolbeg Pharma PLC - Results for the year ended 31 December 2024
20/05/2025 07:00
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RNS Number : 3026J Poolbeg Pharma PLC 20 May 2025
Poolbeg Pharma plc
Results for the year ended 31 December 2024
20 May 2025- Poolbeg Pharma (https://www.poolbegpharma.com/) (AIM: POLB,
'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company
focussed on the development of innovative medicines to address unmet medical
needs, announces its audited results for the year ended 31 December 2024.
2024 Highlights
• Cash balance of £7.8 million as at 31 December 2024, reflecting disciplined
capital allocation to drive pipeline advancements
• Cathal Friel appointed as Executive Chair to drive performance and seek to
replicate the success of other companies he co-founded, including hVIVO plc
and Amryt Pharma plc
• POLB 001's potential to improve patient access to cancer immunotherapies
validated by an independent committee of international key opinion leaders
• Independent research confirmed a potential market opportunity of more than
US$10 billion for POLB 001 as an oral preventative therapy for cancer
immunotherapy-induced Cytokine Release Syndrome ("CRS")
• Positive preclinical data demonstrated statistically significant cytokine
inhibition of POLB 001 and a dose dependent reduction in clinical CRS score -
facilitating the expansion of patent applications and supporting its
development in a Phase 2 clinical trial
• The preclinical data was also presented at the 66th American Society of
Hematology (ASH) Annual Meeting and Exposition and garnered interest from
industry leaders and potential partners
• The US Patent Office granted the Immunomodulator II patent application
covering a class of drugs, including POLB 001, to treat or prevent
hypercytokinemia (cytokine storm) induced in any disease indication
• Amid sustained global interest in glucagon-like peptide 1 receptor agonists,
the Company progressed towards commencement of a proof of concept trial for
its oral GLP-1 programme in the coming months
• Poolbeg's artificial intelligence ("AI") led drug discovery programmes have
successfully identified potential drug targets and treatments - discussions
with potential partners are ongoing
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg, commented: "2024
was marked by a growing understanding of the potential impact of POLB 001 as
an oral preventative therapy for cancer immunotherapy-induced Cytokine Release
Syndrome. Not only is there a potential market opportunity of more than US$10
billion, but we believe POLB 001 could greatly enhance the uptake of cancer
immunotherapy treatments by preventing CRS. We are pleased to have seen such
interest and engagement in our programmes from prospective partners in 2024
and into 2025.
"Our existing cash balance of £6.2 million as at the end of March 2025*,
alongside a proposed fundraising of approximately £4.1 million that will
shortly be announced, will support our anticipated POLB 001 Phase 2a trial and
the proof of concept trial for our oral GLP-1 programme, both of which
represent major potential value inflection points for the Company."
* Unaudited management accounts as at 31 March 2025
Enquiries
Poolbeg Pharma Plc +44 (0) 207 183 1499
Jeremy Skillington, CEO 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, Isobel Jones (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 is a clinical-stage biopharmaceutical company focussed on
the development of innovative medicines to address unmet medical needs. The
Company's clinical programmes target large addressable markets including,
cancer immunotherapy-induced Cytokine Release Syndrome ("CRS") and metabolic
conditions such as obesity with the development of an oral encapsulated
glucagon-like peptide GLP-1R agonist.
For more information, please go to www.poolbegpharma.com
(https://www.poolbegpharma.com/) or follow us on Twitter
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@PoolbegPharma.
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
Dear Shareholder,
I am pleased to present Poolbeg Pharma plc's ("Poolbeg") annual report and
financial statements for the year ended 31 December 2024.
During 2024, we made significant advancements across our pipeline of drug
candidates while maintaining our disciplined approach to capital allocation.
Our clinical programmes target large addressable markets, including cancer
immunotherapy-induced Cytokine Release Syndrome ("CRS") with our lead
programme POLB 001, and we remain focused on maximising their potential to
create value for our shareholders.
I transitioned to the Executive Chair role at Poolbeg in 2024 as we looked to
replicate the success of prior companies I co-founded, including the AIM
listed hVIVO plc ("hVIVO") and Amryt Pharma plc ("Amryt"). I look forward to
working alongside our CEO Jeremy Skillington and the team to realise the
significant potential of Poolbeg and its high value programmes.
Pipeline progress and market potential
In 2024, we continued to progress our pipeline of high value programmes,
particularly POLB 001. During the year, Poolbeg commissioned independent
research that confirmed a potential market opportunity exceeding US$10
billion(1) for POLB 001 as an oral preventative therapy for cancer
immunotherapy-induced CRS. We were encouraged by the size and attractiveness
of this market, as the field of cancer immunotherapies including CAR T and
bispecific antibody ("BsAb") treatments, is rapidly expanding and is expected
to grow to US$120 billion by 2030(2)(,)(3)(,)(4). CRS occurs in the majority
of patients receiving CAR T and BsAb treatments, impacting >70%(5) of
patients, and it is not possible to predict who will experience it. The
independent market research focused only on the opportunity for POLB 001
within multiple myeloma and diffuse large B-cell lymphoma, indications in
which cancer immunotherapies have a dominant position for the treatment of
late-stage disease, but the market opportunity has the potential to expand
further as the use of cancer immunotherapies broadens to other haematological
malignancies and solid tumours.
During the year, significant progress was made on the design of a Phase 2a
clinical trial for POLB 001, aimed at generating efficacy data for the
prevention of CRS in relapsed refractory multiple myeloma patients receiving a
BsAb. Leading myeloma clinicians are enthusiastic to participate in the
proposed trial. We have also received strong indications that Big Pharma are
willing to provide an approved BsAb for this trial free of charge, which is a
strong endorsement of the potential of POLB 001 to address cancer
immunotherapy-induced CRS. The anticipated Phase 2a trial commencement is
targeted for H2 2025, with topline data expected to be available in H2 2026
(interim data H1 2026).
We continued to progress our oral encapsulated glucagon-like peptide ("GLP-1")
programme towards a proof of concept trial that is expected to deliver topline
data in H1 2026. With obesity affecting 42% of the US population(6), and the
prescription weight-loss market projected to reach US$150 billion by 2031(7),
this programme represents a major commercial opportunity.
Additionally, we progressed discussions with a number of potential partners
for our artificial intelligence programmes, following the successful
identification of potential drug targets for influenza and treatment
candidates for respiratory syncytial virus ("RSV"). Effective therapeutics for
RSV and influenza remain a key focus of the industry, with their markets
projected to reach US$3.6 billion(8) and US$1.79 billion(9) respectively by
2032.
Financial
Poolbeg ended the year with a cash balance of £7.8 million (2023: £12.2
million). The loss for the year amounted to £5.8 million (2023: £3.9
million) and comprises R&D expenses £1.4 million (2023: £1.7 million),
administrative expenses £5.3 million (2023: £3.4 million), and tax rebates
and other income & charges of £0.9 million (2023: £1.1 million).
Outlook
Poolbeg is well-positioned for success, leveraging our proven leadership
team's track record and expertise in the pharmaceutical industry. Our focus
remains on executing our strategy to generate shareholder value while
addressing critical unmet medical needs for patients and we believe we are
well positioned to do so with our high value pipeline.
I am pleased with our progress in 2024, particularly with POLB 001, and I look
forward to the commencement and results from our oral GLP-1 proof of concept
trial and look forward to providing updates on our anticipated POLB 001 Phase
2a trial, both of which represent major potential value inflection points for
the Company.
Cathal Friel
Executive Chair
19 May 2025
CEO's Operations Review
We continue to make strong progress across our pipeline. With strong industry
interest, scientific validation and a focus on execution, we are
well-positioned to drive innovation and deliver value for our shareholders.
POLB 001 - Potential to make immunotherapies safer and more accessible
Having identified POLB 001 as a potential preventative therapy for cancer
immunotherapy-induced CRS in 2023, we are pleased to have brought this from
novel concept to Phase 2 ready in just 24-months. 2024 was a transformative
year for POLB 001, reinforcing our confidence in its potential as a potent and
selective Phase 2 ready p38 MAPK inhibitor with broad therapeutic
applications. This significant progress has not only unlocked substantial
value but also strengthened our belief in POLB 001's ability to address
critical challenges in cancer immunotherapy treatment. With strong interest
from scientific, clinical, and commercial partners, we are excited about the
potential of POLB 001 to make a meaningful impact on patients' lives while
simultaneously unlocking its full commercial potential.
Addressing a multi-billion dollar unmet need
Early in 2024, independent research conducted on behalf of Poolbeg confirmed a
market opportunity exceeding US$10 billion for POLB 001 as an oral
preventative therapy for cancer immunotherapy-induced CRS; a severe,
potentially life-threatening side effect impacting over 70% of cancer patients
receiving certain CAR T and bispecific antibody ("BsAb") therapies. CRS poses
a major barrier to widespread adoption of these life-saving treatments as, due
to the high incidence and severity of CRS, patients must be treated
exclusively in specialist cancer centres with staff trained and equipped to
manage severe reactions, this significantly limits access and increases costs.
In addition, the requirement for prolonged hospitalisation due to CRS further
strains healthcare resources, creating a bottleneck in patient care and
treatment accessibility.
With the cancer immunotherapy market expected to reach US$120 billion by 2030,
the need for effective CRS management is critical. There are currently no
approved preventative therapies for CRS management. A safe, effective primary
preventative therapy for CRS, like POLB 001, could revolutionise cancer
immunotherapy delivery by making it safer, enabling outpatient administration,
reducing hospitalisation requirements, and ultimately expanding patient access
to these breakthrough treatments.
The >US$10 billion market opportunity for POLB 001 only accounts for
multiple myeloma and diffuse large B-cell lymphoma patients, indications in
which cancer immunotherapies have a dominant position for the treatment of
late stage disease. However, we believe this is a conservative estimate, as
the demand for CRS management may increase as immunotherapies are developed
for a wider range of cancers.
Expert validation
The potential of POLB 001 to improve patient access to cancer immunotherapies
has been validated by international key opinion leaders, healthcare payers and
clinical trial experts. Professor Gareth Morgan, director of multiple myeloma
research at the Perlmutter Cancer Center and a Professor of Medicine at NYU
Grossman School of Medicine, said, "Bispecific antibodies will only be
delivered in specialist cancer centres until there is a way to make them
safer. POLB 001 could make treatment safe enough to extend them to a much
wider patient population."
Compelling data
In clinical trials completed to date, POLB 001 has demonstrated a favourable
safety and tolerability profile, with potent inhibition of key inflammatory
markers, including TNF-α and IL-6, two cytokines central to CRS. Further
supporting its potential, new preclinical data presented at the 66th American
Society of Hematology ("ASH") Annual Meeting and Exposition in December 2024
demonstrated statistically significant cytokine inhibition and a dose
dependent reduction in clinical CRS compared to Adalimumab (the gold standard
inhibitor of CRS in humanised tumour-bearing mouse models). These positive
results garnered industry interest, facilitated the expansion of patent
applications and support the development of POLB 001 in a Phase 2 clinical
trial as a preventative for cancer immunotherapy-induced CRS.
Following the endorsement of the potential of POLB 001 by key opinion leaders,
our anticipated Phase 2a trial has been designed. The trial design aims to
investigate efficacy, including the incidence of all grades of CRS, along with
evaluating the safety and pharmacokinetics of the drug in relapsed refractory
multiple myeloma patients receiving an approved BsAb. Leading myeloma
clinicians are enthusiastic to participate in the trial. In recent months we
have seen significant interest in the potential of POLB 001 from industry,
pharma, and international specialist biotech investors which further increases
our excitement about the potential of this drug. We have also received strong
indications that Big Pharma companies are willing to provide, free of charge,
an approved BsAb for a future POLB 001 Phase 2a trial which is a strong
endorsement of the potential of POLB 001 to address cancer
immunotherapy-induced CRS. We look forward to providing an update to the
market on this anticipated trial in due course.
Expanding intellectual property portfolio
In May 2024, the US Patent and Trademark Office ("USPTO") granted a patent for
Immunomodulator II, covering a class of drugs, including POLB 001, for
treating hypercytokinemia (cytokine storm) and for preventing hypercytokinemia
in a patient after an immune response has been triggered. This encompasses
cytokine storm that is induced in any disease indication. In November 2024,
the USPTO granted an additional patent for Immunomodulator I, covering POLB
001 and other p38 MAPK inhibitors for the treatment of patients at risk of
severe influenza after an immune response has been triggered, and for the
treatment of hypercytokinemia (cytokine storm) characteristic of severe
influenza. Further patent applications have been filed and have complementary
coverage to the existing patent portfolio covering POLB 001.
Oral encapsulated GLP-1 programme - potential to improve access for patients
The World Health Organisation ("WHO") has categorised obesity as a global
healthcare issue of epidemic proportions with the US Centres for Disease
Control and Prevention ("CDC") estimating that c.42% of the US population is
affected. Obesity is estimated to have caused US$347.5 billion in economic
costs to US businesses and employees in 2023(10). Such factors have catalysed
the growth of prescription weight loss drugs, including glucagon-like peptide
1 receptor agonists ("GLP-1R"). The global GLP-1R market is projected to reach
US$150 billion by 2031 in obesity and diabetes alone.
Oral GLP-1R options remain limited yet highly sought after within the clinical
community owing to their non-invasiveness, ease of access and greater patient
compliance, particularly those with chronic conditions who require long-term
treatment. There is currently only one oral GLP-1R agonist on the market with
a bioavailability of just c.1%(11).
Our oral encapsulated GLP-1 programme leverages an advanced delivery system
that encapsulates active pharmaceutical ingredients ("API's") using Generally
Regarded as Safe ("GRAS") components. This approach targets delivery to
specific areas of the gut and into systemic circulation for the treatment of
metabolic disorders, such as diabetes and obesity. The effectiveness of the
technology has already been validated via the commercialisation of
encapsulated oral probiotics and nutraceuticals by our collaborative partner,
AnaBio Technologies. We are progressing towards the initiation of a proof of
concept trial designed to demonstrate the successful delivery of an oral
GLP-1R agonist in humans, expected to start within the coming months and with
topline data expected in H1 2026.
Artificial Intelligence led drug discovery programmes
In 2024, we saw interest from prospective partners in the outputs from our
Artificial Intelligence led drug discovery programmes, following the
successful prioritisation of candidates in late 2023, discussions in respect
to potential collaborations are ongoing. 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.
As part of our AI led programmes, we successfully identified valuable novel
drug targets and new potential drug candidates represent potential new classes
of therapy for the treatment of Influenza and Respiratory Syncytial Virus.
There are currently no approved treatments for RSV, an infection responsible
for over 100,000 deaths annually, predominantly in infants and elderly
populations, and influenza, in addition to its risk as a source of future
pandemics, is responsible for c. 500,000 deaths per annum(12,13,14). The
potential targets and clinical stage repurposing candidates were identified by
our disease progression datasets from human challenge trials; a unique and
highly controlled approach that tracks healthy individuals through infection
and recovery, collecting matched baseline and follow-up samples before and
after infection. Unlike traditional datasets, this provides clean longitudinal
virology, health, biomarker, and symptom data. This depth and precision has
revolutionised AI-driven insights, identifying host-response-based targets
that could halt or slow disease progression, with reduced risk of viral
resistance which is a critical challenge in the development of treatments for
respiratory viral diseases.
Exclusive option to acquire tPTX for Behçet's Disease
In April 2024 we signed an exclusive 12-month option agreement with Silk Road
Therapeutics Inc to acquire a novel topical muco-adherent formulation of
pentoxifylline ("tPTX") for the treatment of oral ulcers in Behçet's Disease.
Poolbeg has decided not to proceed with exercising the option to acquire tPTX
as we focus on the forthcoming trials for POLB 001 and our oral GLP-1
programme.
Outlook
Looking ahead, we remain focused on building momentum across our portfolio in
2025. With our proof of concept clinical trial for the oral encapsulated GLP-1
programme on track to commence, POLB 001 ready for Phase 2, and our AI led
programmes generating interest, we are entering a period of significant
potential value creation. We will continue to explore partnerships, drive our
pipeline forward, and execute on our strategic objectives to deliver
meaningful clinical impact while generating value for our shareholders.
Jeremy Skillington, PhD
CEO
19 May
2025
References
1. Independent research by Decisive Consulting Limited.
https://teamdecisive.com/meet-the-tea (https://teamdecisive.com/meet-the-tea)
2. Grand View Research. CAR T-Cell Therapy Market Analysis 2023-2030
3. Grand View Research. Bispecific Antibodies Market Size, Share &
Trends Analysis Report
4. Datamonitor Healthcare. Forecast: Diffuse Large B-Cell Lymphoma and
Multiple Myeloma, 2023
5. FDA label CRS occurrence rates for Yescarta, Tecartus, Abecma,
Kymriah, Tecvayli and Talvey
6. Stierman B, Afful J, Carroll MD, et al. National Health and
Nutrition Examination Survey 2017-March 2020 prepandemic data files
development of files and prevalence estimates for selected health outcomes.
Natl Health Stat Report. 2021;158
7. The Economist, March 2023
8. Credence Research, Human Respiratory Syncytial Virus (RSV)
Treatment Market By Treatment, Dec 2024
9. Straits Research, influenza treatment market size, Dec 2024
10. Global Data, Assessing the Economic Impact of Obesity and Overweight on
Employers, Feb 2024
11. EMA Product information 2020
12. Li et al. Lancet. 2022 May 19;399(10340):2047-2064
13. Neumann and Kawaoka. 2019 Apr 8;219(Suppl 1):S14-S20
14. www.who.int Influenza (Seasonal) Factsheet
Consolidated Statement of Comprehensive Income
For the year ended 31 December 2024
2024 2023
Note £'000 £'000
Revenue - -
Cost of sales - -
Gross profit - -
Administrative expenses (5,258) (3,376)
Other operating income 530 367
Research and development expenses 2 (1,383) (1,677)
Impairment of intangible assets 4 - (353)
Net losses on disposal of assets 4 (261) -
Operating loss (6,372) (5,039)
Finance income 428 534
Loss before income tax (5,944) (4,505)
Taxation 2 154 574
Loss and total comprehensive loss for the year attributable to the equity (5,790) (3,931)
holders of the Company
Loss per share:
Loss per share - basic and diluted, attributable to ordinary equity holders of
the parent
3 (1.16)p (0.79)p
Consolidated Statement of Financial Position
As at 31 December 2024
2024 2023
Note £'000 £'000
Assets
Non-current assets
Intangible assets 4 1,684 1,930
Total non-current assets 1,684 1,930
Current assets
Trade and other receivables 5 739 1,327
Cash and cash equivalents 7,824 12,171
Total current assets 8,563 13,498
Total assets 10,247 15,428
Equity and liabilities
Equity attributable to owners of the parent
Share capital 100 100
Share premium 23,100 23,100
Other reserves 2,816 2,195
Accumulated deficit (16,743) (10,953)
Total equity 9,273 14,442
Current liabilities
Trade and other payables 974 986
Total current liabilities 974 986
Total liabilities 974 986
Total equity and liabilities 10,247 15,428
Consolidated Statement of Changes in Equity
For the year ended 31 December 2024
Share based payment reserve
Share Share premium Merger reserve Accumulated deficit
capital Total
Note £'000 £'000 £'000 £'000 £'000 £'000
Balance at 31 December 2022 100 23,100 690 1,455 (7,022) 18,323
Loss and total comprehensive loss for the year - - - - (3,931) (3,931)
Share based payments 6 - - 50 - - 50
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 6 - - 621 - - 621
Balance at 31 December 2024 100 23,100 1,361 1,455 (16,743) 9,273
Consolidated Statement of Cash Flows
For the year ended 31 December 2024
2024 2023
Note £'000 £'000
Cash flows from operating activities
Loss on ordinary activities before taxation (5,944) (4,505)
Amortisation 4 114 26
Impairment of intangible assets 4 - 353
Disposal of intangible assets 4 261 -
Share based payment expense 6 621 50
Finance income (428) (534)
R&D tax credits 595 -
Movements in working capital and other adjustments:
Change in trade and other receivables 5 147 209
Change in trade and other payables (12) 20
Net cash flow used in operating activities (4,646) (4,381)
Cash flow from investing activities
Payments for intangible assets 4 (129) (175)
Interest received from bank 428 534
Net cash flow from investing activities 299 359
Net cash flow from financing activities - -
Net change in cash and cash equivalents (4,347) (4,022)
Cash and cash equivalents at beginning of year 12,171 16,193
Cash and cash equivalents at end of year 7,824 12,171
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 focussed on acquiring,
developing and commercialising innovative medicines that will help improve the
lives of patients with serious diseases and where there is a high unmet
medical need.
2 Basis of preparation
The Results Announcement does not constitute the Company's statutory accounts
for the years ended 31 December 2024 and 31 December 2023, 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 2023 have been filed with the Registrar of Companies, and those
for 31 December 2024 will be delivered following the Company's Annual
General Meeting. Auditors have reported on the statutory accounts for 31
December 2024 and 31 December 2023.
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 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.
Consolidation
The consolidated Financial Statements comprise the Financial Statements of the
Company and its subsidiaries as at and for the year to 31 December 2024.
Subsidiaries are entities controlled by the Group. Where the Group has control
over an investee, it is classified as a subsidiary. The Group controls an
investee if all three of the following elements are present: power over an
investee, exposure to variable returns from the investee, and the ability of
the investor to use its power to affect those variable returns. Control is
reassessed whenever facts and circumstances indicate that there may be a
change in any of these elements of control. Subsidiaries are fully
consolidated from the date that control commences until the date that control
ceases. Accounting policies of subsidiaries have been changed where necessary
to ensure consistency with the policies adopted by the Group. Intergroup
balances and any unrealised gains or losses or income or expenses arising from
intergroup transactions are eliminated in preparing the consolidated Financial
Statements.
Presentation of Balances
The Financial Statements are presented in £ 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 2. 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 £1,383,000 (2023: £1,677,000)
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.
Acquired intangible assets
Acquired intangible assets are stated at the lower of cost less provision for
amortisation and impairment or the recoverable amount. Acquired intangibles
assets are amortised over their expected useful economic life on a straight
line basis and are tested for impairment annually. In determining the useful
economic life each acquisition is reviewed separately and consideration given
to the period over which the Group expects to derive economic benefit. It is
the Company's policy not to amortise assets in development that are not ready
for use.
Patents and trademarks are measured initially at purchase cost and are
amortised on a straight-line basis over their life from the date that they are
available for use.
Amortisation for the year has been charged to administrative expenses in the
Statement of Comprehensive Income. The expected useful economic life for
intangible assets subject to amortisation during the year is as follows:
· Acquired data - 10 years
· Acquired licences - once in use, over the term of the licence
· Patents - 20 years
· Trademarks - 10-20 years
Taxes
Tax comprises current and deferred tax. Current tax is the expected tax
payable on the taxable income for the period, using tax rates enacted or
substantially enacted at the reporting date. Deferred tax assets or
liabilities are recognised where the carrying value of an asset or liability
in the Statement of Financial Position differs to its tax base, and is
accounted for using the statement of financial position liability method.
Recognition of deferred tax assets is restricted to those instances where it
is probable that taxable profit will be available against which the difference
can be utilised.
Where eligible the Group applies for R&D tax credits in the jurisdictions
in which it operates. Where the Group has built up a track record of R&D
tax credit receipts, an estimation of the potential R&D tax credit
receivable for the current year has been recognised in the Income Statement.
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.
Issued share capital - ordinary shares of 0.02p each
Share Issue Details Number of shares Weighted average shares
31 December 2023 500,000,000 500,000,000
31 December 2024 500,000,000 500,000,000
The calculation of loss per share is based on the following:
2024 2023
Loss after tax attributable to equity holders of the Company (£'000) (5,790) (3,931)
Weighted average number of ordinary shares in issue 500,000,000 500,000,000
Fully diluted average number of ordinary shares in issue 500,000,000 500,000,000
Basic and diluted loss per share (pence) (1.16) (0.79)
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 2024 totalled 65,076,600 (2023: 36,829,181) and are potentially
dilutive.
4 Intangible Assets
Acquired Licences & Data Patents & Trademarks
Total
Group £'000 £'000 £'000
Cost
At 1 January 2023 1,935 243 2,178
Additions 29 146 175
At 31 December 2023 1,964 389 2,353
Additions - 129 129
Disposals (443) (171) (614)
At 31 December 2024 1,521 347 1,868
Amortisation and impairment
At 1 January 2023 43 1 44
Amortisation charge 25 1 26
Impairment 250 103 353
At 31 December 2023 318 105 423
Amortisation charge 25 89 114
Disposals (250) (103) (353)
At 31 December 2024 93 91 184
Net book value
Net book value at 31 December 2024 1,428 256 1,684
Net book value at 31 December 2023 1,646 284 1,930
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. In
the prior year an impairment charge of £353,000 was made to the Consolidated
Income Statement in relation to de-prioritised R&D programmes. This is as
a result of the Directors reviewing ongoing programmes and concluding that the
Group should concentrate the use of its resources on certain core programmes.
The current year disposals of £614,000 relates to (i) the intangible assets
of £353,000 that were fully impaired in the prior year and (ii) £261,000 for
the termination of the POLB 002 licence and removal of the cost and net book
value in relation to it which resulted in a charge of £261,000 being made to
the Consolidated Income Statement.
5 Trade and other receivables
2024 2023
£'000 £'000
Accounts receivable 20 -
Prepayments and accrued income 465 669
Amounts due from group company - -
Grant receivable 34 31
VAT recoverable 87 53
R&D tax credit 133 574
Trade and other receivables 739 1,327
6 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
objective with those of shareholders and to encourage retention. All warrants
granted were granted under individual agreements.
Each share option and warrant converts 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 2023 & 31 December 2023 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
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 fair value of the share options granted during the year, was estimated at
the date of grant using a Monte-Carlo simulation model, taking into account
the terms and conditions attached to the grant. The following are the inputs
to the model for the equity instruments granted during the period:
2024 EIP Options Inputs
Expected volatility 60%
Risk-free interest rate 4.0%
Share price at grant 9.7p
Fair value per award 5.0p
The value of share options and warrants charged to administrative expenses in
the Statement of Comprehensive Income is as follows:
2024 2023
£'000 £'000
Share options 621 50
Total 621 50
The share options outstanding as at 31 December 2024 have a weighted remaining
contractual life of 6.3 years with exercise prices ranging from 0.02p to
13.3p.
The warrants outstanding as at 31 December 2024 have a weighted remaining
contractual life of 1.5 years with an exercise price of 10p.
7 Events after the reporting period
On 2 January 2025, the Company announced under rule 2.4 of the city code on
takeovers and mergers ("the Code") that Poolbeg had entered into non-binging
discussions for an all-share acquisition by Hookipa Pharma Inc. ("Hookipa").
In accordance with Rule 2.4(c) of the Code, Hookipa was required, pursuant to
Rule 2.6(a) of the Code, by no later than 5.00 p.m. on 30 January 2025,
later extended to 5.00pm on 27 February 2025, to either announce a firm
intention to make an offer for the Company, under Rule 2.7 of the Code, or
announce that it does not intend to make an offer for the Company. Pursuant to
Rule 2.8 of the Code on 20 February 2025 Hookipa announced that it does not
intend to make an offer for Poolbeg under Rule 2.7 of the Code.
8 Annual Report and Annual General Meeting
The Company's Annual Report and Accounts for the year ended 31 December
2024 will be distributed to shareholders in due course together with the
notice of the 2024 Annual General Meeting, and will be available on the
Company's website, www.poolbegpharma.com/investors/documents/
(https://www.poolbegpharma.com/investors/documents/)
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