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Results for the year ended 31 December 2024

20th May 2025 07:00

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 (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 

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, Isobel Jones (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 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 or follow us on Twitter and LinkedIn @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 billion1 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 20302,3,4. 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 population6, and the prescription weight-loss market projected to reach US$150 billion by 20317, 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 billion8 and US$1.79 billion9 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 202310. 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 annum12,13,14. 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, PhDCEO

19 May 2025

References

1. Independent research by Decisive Consulting Limited. 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 holders of the Company

 

(5,790)

(3,931)

 

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

capital

 

 

Share premium

 

Share based payment reserve

 

 

Merger reserve

 

 

Accumulated deficit

 

 

 

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/ 

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