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Interim results for the six months to 30 June 2024

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RNS Number : 5871E  Poolbeg Pharma PLC  18 September 2024

 

Poolbeg Pharma plc - Interim results for the six months to 30 June 2024

 

Lead development candidate (POLB 001) on track with positive data
demonstrating efficacy

Independent research endorses potential US$10bn market opportunity for POLB
001 in cancer immunotherapy-induced CRS

Patent portfolio significantly strengthened & expanded

Continued focus on high value programmes & partnerships to develop &
commercialise assets

Strong Balance Sheet - cash balance of £10.1m

Experienced leadership team with track record of delivering significant value

 

18 September 2024- Poolbeg Pharma (https://www.poolbegpharma.com/)  (AIM:
POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company
focussed on the development and commercialisation of innovative medicines
targeting diseases with a high unmet medical need, announces its unaudited
interim results for the six months to 30 June 2024 ("H1 24").

 

Highlights, Business Update & Outlook

 ●    Cash balance of £10.1 million as at 30 June 2024, demonstrating continued
      prudent financial management
 ●    Independent research has confirmed a potential market opportunity of c.US$10
      billion for POLB 001 as an orally delivered preventative therapy for cancer
      immunotherapy-induced Cytokine Release Syndrome (CRS)(1)
 ●    Robust data package in place for POLB 001 - efficacy demonstrated in reducing
      cancer immunotherapy-induced CRS in an in vivo animal model, strengthening
      and facilitating the expansion of patent applications
 ●    US Patent Office granted the Company's Immunomodulator II patent application
      covering a class of drugs, including POLB 001, to treat or prevent
      hypercytokinemia (cytokine storm) induced in any disease indication
 ●    Engagement continues with potential partners in relation to POLB 001
 ●    Exclusive 12-month option agreement signed for tPTX, a novel, topical,
      muco-adherent treatment for oral ulcers in patients suffering from Behçet's
      Disease, with FDA Fast Track Designation, Orphan Drug Designation and
      potential 505(b)(2) approval pathway in the US
 ●    Continued progress made in preparation for the upcoming orally-delivered,
      glucagon-like peptide 1 receptor agonist's (GLP-1R) clinical trial, expected
      to commence in late 2024
 ●    Engaged with partners relating to drug targets and treatments identified in
      the Company's Artificial Intelligence (AI) led infectious-disease programmes
 ●    Successful onboarding of a number of former Amryt Pharma senior executives.
      Amryt Pharma was a global, commercial-stage biopharmaceutical company
      dedicated to acquiring, developing and commercialising novel treatments for
      rare diseases. Previously listed on NASDAQ and AIM, it was acquired by Chiesi
      Farmaceutica for US$1.48 billion in 2023
 ●    The strengthened Poolbeg team has a significant and successful track record of
      acquiring, integrating, partnering, developing and commercialising therapies
      for conditions with a high unmet medical need
 ●    The Company strategy remains to partner in-house programmes to realise
      near-term value, while also targeting revenue generation and profitability
      from commercial-stage rare and orphan drugs

 

 

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg, commented: "The
value and attractiveness of POLB 001 to Pharma partners has been greatly
enhanced following the independent confirmation of a potential market
opportunity of c.US$10 billion as an oral preventative therapy for cancer
immunotherapy-induced CRS. During the period, we also strengthened our patent
and overall intellectual property portfolio with positive in vivo data. As
Pharma companies seek to enhance the safety and market reach of their cancer
immunotherapies, we believe that POLB 001 is well placed to generate value for
shareholders while addressing a critical unmet medical need for patients.

 

"Our increasing focus on rare and orphan diseases is exemplified by the
exclusive option agreement we signed to acquire tPTX, which comes with robust
clinical data, FDA Fast Track Designation, Orphan Drug Designation and the
potential for a 505(b)(2) approval pathway in the US. tPTX has the potential
to reach patients rapidly and offers a transformative solution for those
suffering from Behçet's Disease.

 

"We continue to pursue our efforts to maximise the value of our development
pipeline and are seeing significant interest from potential partners. Our
experienced team, bolstered by the addition of a number of the former Amryt
leadership team, is well-positioned to execute on our strategy of acquiring,
developing, partnering, and commercialising innovative medicines that will
help improve the lives of patients with rare and orphan diseases, and where
there is a high unmet medical need."

 

References

1. Independent research commissioned by Poolbeg

 

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, Camilla Hume, 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
acquiring, developing and commercialising innovative medicines that will help
improve the lives of patients with rare and orphan diseases and where there is
a high unmet medical need. Poolbeg comprises a strong and growing portfolio of
development assets. For more information, please go to www.poolbegpharma.com
(https://www.poolbegpharma.com/)  or follow us on Twitter
(https://twitter.com/PoolbegPharma)  and LinkedIn
(https://www.linkedin.com/company/poolbeg-pharma/)  @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.

CEO Statement

 

I am delighted to present the unaudited Interim Financial Statements
of Poolbeg Pharma plc for the six months to 30 June 2024.

 

A Growing Focus on Rare and Orphan Diseases

We are actively increasing our focus on rare and orphan diseases, leveraging
both the expertise of the key former Amryt Pharma plc executives that joined
Poolbeg in early 2024, and the potential of POLB 001 to address cancer
immunotherapy-induced Cytokine Release Syndrome (CRS). We believe that there
is potential for POLB 001 to be a rare and orphan therapy, as the patients
receiving T cell engaging bispecific antibodies and CAR T-cell therapy are
often suffering from rare or orphan blood cancers. Rare diseases affect a
small percentage of the population, and due to the high unmet medical need,
regulatory authorities offer significant incentives for developing orphan
drugs. The orphan drug market is expected to grow to US$368 billion by
2030(2), with orphan drug sales due to account for 20% of global prescription
drug sales by 2026(3). With our Leadership Team's extensive expertise and
proven track record in rare and orphan diseases, we believe Poolbeg is
well-positioned to capitalise on these opportunities.

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
patients. This disease, which has no cure, causes severe inflammation leading
to debilitating symptoms, the most common being painful oral ulcers which
significantly impact essential functions like eating, drinking and speaking.
tPTX has shown promising results in a Phase 2 trial, as presented at the
American College of Rheumatology meeting in 2019, demonstrating faster healing
and pain reduction compared to standard of care treatments. tPTX has secured
FDA Fast Track and Orphan Drug Designation, providing seven years of market
exclusivity upon marketing authorisation, and is potentially positioned for
the expedited route to approval and commercialisation available via the
505(b)(2) pathway in the U.S.

 

Strong Progress Across our Pipeline of Assets

POLB 001 - A breakthrough preventative therapy for cancer
immunotherapy-induced CRS, as well as a promising treatment for severe
influenza. CRS affects over 70% of patients receiving T cell-engaging
bispecific antibodies or CAR T-cell therapy.(4) With the cancer immunotherapy
market expected to grow to US$120 billion by 2030(5, 6, 7), the need for
effective CRS management is critical, as the condition currently leads to
significant healthcare costs and restricts access to treatment at specialist
cancer centres. Earlier this year, independent research commissioned by
Poolbeg confirmed a market potential for POLB 001 of c.US$10 billion in
Multiple Myeloma and Diffuse Large B-Cell Lymphoma alone due to the
significant advances in bispecific antibody and CAR T-cell therapies for these
indications.(8) Cancer immunotherapies are being widely developed across a
broader range of haematological malignancies (including many rare or orphan
cancers) and solid tumours, which we believe will expand the opportunity for
POLB 001 far beyond the estimate of US$10 billion.

 

In January 2024, we announced positive in vivo results which demonstrated POLB
001's efficacy in reducing cancer immunotherapy-induced CRS symptoms in an
animal model. The data strengthened and facilitated the expansion of patent
applications for POLB 001 in cancer immunotherapy-induced CRS. We also
convened an Independent Advisory Board with international Key Opinion Leaders,
healthcare payers and clinical trial experts, which endorsed the
attractiveness of POLB 001's Target Product Profile (TPP) and its potential as
an oral therapy to address the significant unmet medical need of cancer
immunotherapy-induced CRS.

 

In May 2024, we received the fully granted patent from the US Patent Office
for our Immunomodulator II patent application, 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. Further patent applications have been filed and have complementary
coverage as we continue to expand our existing patent portfolio covering POLB
001.

 

As an oral therapy to prevent or treat CRS, POLB 001 has the potential to
enable broader use of cancer immunotherapies in an outpatient setting to make
these life-saving therapeutics more accessible to patients. With robust data
and intellectual property, and interest from scientific, clinical, and
commercial partners to advance its development, we are excited by the
potential of POLB 001 to have a meaningful impact on patients' lives while
generating value for our shareholders.

 

Oral GLP-1R Agonist - With approximately 42% of the US population affected by
obesity(9), the economic impact of the condition on US businesses and
employees reached an estimated US$347.5 billion in 2023.(10) This has driven
the growth of prescription weight loss drugs, particularly glucagon-like
peptide 1 receptor agonists (GLP-1R), a market projected to reach US$150
billion by 2031.(11) Despite the demand, oral GLP-1R options are limited, with
only one available drug offering just 1% bioavailability.(12) Our Oral GLP-1R
agonist programme aims to address this unmet need using a delivery system that
utilises Generally Regarded as Safe (GRAS) components to encapsulate API's
(active pharmaceutical ingredients), such as GLP-1R agonist, for oral delivery
to specific areas of the gut and into systemic circulation with the aim of
enhancing bioavailability and improving convenience. We are progressing
towards the initiation of a proof-of-technology clinical trial in late 2024 to
demonstrate the successful delivery of an oral GLP-1R agonist in humans.

 

Artificial Intelligence - As part of our AI-led programmes, we have
successfully identified valuable novel drug targets for influenza and new
potential drug candidates for the treatment of Respiratory Syncytial Virus
(RSV). Using our data-first approach, these novel targets are based on the
host response to stop or slow disease progression. This strategy is less
likely to be impacted by viral resistance versus traditional vaccines and
antivirals, which target the virus itself. AI-led solutions typically enable
faster target identification, at lower cost, reduced risk, and potentially
increased likelihood of success. Having successfully prioritised candidates
from both programmes late last year, and with continued global interest in
AI-led drug discovery, we are continuing to actively discuss the exciting
outputs from our AI-led drug discovery programmes with prospective partners.

 

Financial

Poolbeg had a cash balance of £10.1 million as at 30 June 2024. The loss for
the period amounted to £2.3 million (H1 23: £1.8 million) comprised of
R&D expenses of £0.7 million (H1 23: £0.9 million), administrative
expenses £2.1 million (H1 23: £1.4 million), and tax rebates and other
income & charges of £0.6 million (H1 23: £0.5 million).

 

Outlook

As we build on the momentum from H1 24, our focus remains on strategically
partnering our in-house programmes to unlock near-term value, while also
targeting future revenue generation and profitability from commercial-stage
rare and orphan drugs. We are excited by the results of in vivo data
demonstrating POLB 001's efficacy in reducing cancer immunotherapy-induced
CRS and the potential for this market opportunity to generate value for
shareholders while addressing a critical unmet medical need.

 

The option agreement signed with Silk Road Therapeutics underscores our
commitment to strategic cash management by providing us the opportunity to
evaluate the potential of the asset whilst preserving capital. This approach
aligns with our disciplined financial strategy, ensuring that we continue to
manage our resources effectively as we explore opportunities that could
enhance our pipeline and deliver value to our shareholders. The addition of
former Amryt Pharma team members, with proven experience in scaling a rare
disease company and establishing commercial infrastructure in the US and
globally, further strengthens our Leadership Team and our ability to execute
on this growth strategy.

 

Jeremy Skillington,
PhD

CEO

17 September 2024

 

References

2. Fortune Business Insights, July 2023

3. European Pharmaceutical Review, May 2022

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

5. Grand View Research. CAR T-Cell Therapy Market Analysis 2023-2030

6. Grand View Research. Bispecific Antibodies Market Size, Share & Trends
Analysis Report

7. Datamonitor Healthcare. Forecast: Diffuse Large B-Cell Lymphoma and
Multiple Myeloma, 2023

8. Independent research commissioned by Poolbeg

9. 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
(https://url.avanan.click/v2/___https:/stacks.cdc.gov/view/cdc/106273___.YXAxZTpzaG9yZWNhcDphOm86YThlMDViNzJhYzlhNGIxNjA1YmNjOTdiY2EzODU3MWM6NjoyNGY5OjVlYzg5N2RkZDgwYThjMzNiNGZkODQ2ZGVmOWUxYzY3ZDUxNTdmYjdjNDIzZDU1MmFlMGRiMjdmM2UwYmJkNGY6cDpUOk4)
. Natl Health Stat Report. 2021;158.

10. Global Data, Assessing the Economic Impact of Obesity and Overweight on
Employers, Feb 2024

11. The Economist, March 2023

12. EMA Product information 2020

Consolidated Statement of Comprehensive Income

For the six months to 30 June 2024

 

                                                                                       Unaudited       Unaudited       Audited

                                                                                       Six months to   Six months to   Year ended

                                                                                       30 June 2024    30 June 2023    31 December 2023
                                                                                 Note  £'000           £'000           £'000
 Revenue                                                                               -               -               -
 Cost of sales                                                                         -               -               -
 Gross profit                                                                          -               -               -
 Administrative expenses                                                               (2,113)         (1,395)         (3,376)
 Other operating income                                                                285             177             367
 Research and development expenses                                                     (701)           (865)           (1,677)
 Impairment of intangible assets                                                       -               -               (353)
 Operating loss                                                                        (2,529)         (2,083)         (5,039)
 Finance income                                                                        246             272             534
 Loss before income tax                                                                (2,283)         (1,811)         (4,505)
 Taxation                                                                              25              -               574
 Loss and total comprehensive loss for the period attributable to the equity           (2,258)         (1,811)         (3,931)
 holders of the Company

 Loss per share:
 Loss per share - basic and diluted, attributable to ordinary equity holders of        (0.45)p         (0.36)p         (0.79)p
 the parent

                                                                                 3

 

 

Consolidated Statement of Financial Position

As at 30 June 2024

                                                    Unaudited     Unaudited     Audited
                                                    30 June 2024  30 June 2023  31 December 2023
                                              Note  £'000         £'000         £'000
 Assets
 Non-current assets
 Intangible assets                            5     2,011         2,183         1,930
 Total non-current assets                           2,011         2,183         1,930

 Current assets
 Trade and other receivables                  6     938           767           1,327
 Cash and cash equivalents                          10,061        14,120        12,171
 Total current assets                               10,999        14,887        13,498

 Total assets                                       13,010        17,070        15,428

 Equity and liabilities
 Equity attributable to owners of the parent
 Share capital                                      100           100           100
 Share premium                                      23,100        23,100        23,100
 Other reserves                                     2,460         2,192         2,195
 Accumulated deficit                                (13,211)      (8,833)       (10,953)
 Total equity                                       12,449        16,559        14,442

 Current liabilities
 Trade and other payables                           561           511           986
 Total current liabilities                          561           511           986
 Total liabilities                                  561           511           986

 Total equity and liabilities                       13,010        17,070        15,428

 

 

Consolidated Statement of Changes in Equity

For the six months to 30 June 2024

 

                                                                             Share based payment reserve

                                                   Share     Share premium                                 Merger reserve   Accumulated deficit

                                                   capital                                                                                        Total
                                                   £'000     £'000           £'000                         £'000            £'000                 £'000
 At 1 January 2023                                 100       23,100          690                           1,455            (7,022)               18,323
 Loss and total comprehensive loss for the period  -         -               -                             -                (1,811)               (1,811)
 Share based payments                              -         -               47                            -                -                     47
 Balance at 30 June 2023                           100       23,100          737                           1,455            (8,833)               16,559
 Loss and total comprehensive loss for the period  -         -               -                             -                (2,120)               (2,120)
 Share based payments                              -         -               3                             -                -                     3
 Balance at 31 December 2023                       100       23,100          740                           1,455            (10,953)              14,442
 Loss and total comprehensive loss for the period  -         -               -                             -                (2,258)               (2,258)
 Share based payments                              -         -               265                           -                -                     265
 Balance at 30 June 2024                           100       23,100          1,005                         1,455            (13,211)              12,449

Consolidated Statement of Cash Flows

For the six months to 30 June 2024

 

                                                            Unaudited       Unaudited       Audited

                                                            Six months to   Six months to   Year ended

                                                            30 June 2024    30 June 2023    31 December 2023
                                                      Note  £'000           £'000           £'000
 Cash flows from operating activities
 Loss on ordinary activities before taxation                (2,283)         (1,811)         (4,505)
 Amortisation                                         5     13              13              26
 Impairment of intangible assets                            -               -               353
 Share based payment expense                          4     265             47              50
 Finance income                                             (246)           (272)           (534)
 R&D tax credits                                            424             -               -
 Movements in working capital and other adjustments:
     Change in trade and other receivables            6     (10)            195             209
     Change in trade and other payables                     (425)           (455)           20
 Net cash flow used in operating activities                 (2,262)         (2,283)         (4,381)

 Cash flow from investing activities
 Payments for intangible assets                       5     (94)            (62)            (175)
 Interest received from bank                                246             272             534
 Net cash flow generated in investing activities            152             210             359

 Net cash flow from financing activities                    -               -               -

 Net change in cash and cash equivalents                    (2,110)         (2,073)         (4,022)
 Cash and cash equivalents at beginning of period           12,171          16,193          16,193
 Cash and cash equivalents at end of period                 10,061          14,120          12,171

 

 

Notes to the Interim Results

 

1. General information

Poolbeg Pharma plc ("Poolbeg" or the "Company") is a public limited company
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 rare and orphan diseases and where there is a high
unmet medical need.

 

2. Basis of preparation

The Interim Results of the Company for the six months to 30 June 2024 comprise
those of the Company and its subsidiaries (together the "Group"). The Interim
Results have been prepared on the going concern basis under the historical
cost convention in accordance with the recognition and measurement
requirements of United Kingdom adopted International Financial Reporting
Standards ("IFRS") and their interpretations issued by the International
Accounting Standards Board ("IASB"), and in accordance with those parts of the
Companies Act 2006 applicable to companies reporting under IFRS. As is
permitted by the AIM rules, the Directors have not adopted the requirements of
IAS 34 "Interim Financial Reporting" in preparing the financial statements.
Accordingly, the financial statements are not in full compliance with IFRS and
have neither been audited nor reviewed pursuant to guidance issued by the
Auditing Practices Board.

 

The financial information for the six months to 30 June 2024 and 30 June 2023
is unaudited. The information for the year ended 31 December 2023 has been
extracted from the Company's audited accounts on which the auditors issued an
unqualified audit opinion. The information presented for that period does not
constitute full accounts for that period. The 31 December 2023 audited
accounts have been delivered to the Companies House.

 

The financial information is presented in £ which is the functional and
presentational currency of the Company. Balances are rounded to the nearest
thousand (£'000) except where otherwise indicated.

 

The Interim Results were approved by the Board of Directors on 17 September
2024.

 

The accounting policies used in the preparation of the Interim Results are
consistent with those used in the Company's audited financial statements for
the year to 31 December 2023. The application of the accounting policies can
involve significant estimation, uncertainty and critical judgement. The most
significant judgement made in relation to the Interim Results is:

 

Share based payments: in the current period, the Company 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. Estimating
fair value requires determination of the most appropriate valuation model,
which depends on the terms and conditions of the grant. For the measurement of
the fair value of share options issued under the Employee Performance
Incentive Plan ("EIP") 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.

 

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

                                                                        Unaudited          Unaudited          Audited

                                                                        Six months ended   Six months ended   Year ended

                                                                        30 June 2024       30 June 2023       31 December 2023
 Loss after tax attributable to equity holders of the Company (£'000)   (2,258)            (1,811)            (3,931)
 Weighted average number of ordinary shares in issue                    500,000,000        500,000,000        500,000,000
 Fully diluted average number of ordinary shares in issue               500,000,000        500,000,000        500,000,000
 Basic and diluted loss per share                                       (0.45)p            (0.36)p            (0.79)p

 

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 and comparative periods,
the effect of options would be to reduce the loss per share and as such the
basic and diluted LPS are the same. There were 65,076,600 share options and
warrants outstanding as at 30 June 2024 (30 June 2023 and 31 December 2023:
36,829,181) and these are potentially dilutive.

 

4. Share-based payments

On 15 February 2024, the Company announced the adoption of 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. The EIP was designed with the support of Aon, in their
role as advisors to the Remuneration Committee of the Company. Under the EIP,
these team members have been awarded a total of 28,247,419 nominal cost long
term incentive options ("EIP Options") over ordinary shares in the Company
with vesting conditional upon the weighted-average of the mid-market closing
price of the ordinary shares in the Company being 17.945 pence or above over
a period of fourteen calendar days (representing a c.85% premium to the share
price at close of market on 14 February 2024). The EIP Options are also
subject to acceleration in certain scenarios including a change of control of
the Company.

 

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          Units
 Balance at 31 December 2022, 30 June 2023 & 31 December 2023      36,000,000     829,181
 Granted during the period to 30 June 2024                         28,247,419     -
 Balance at 30 June 2024                                           64,247,419     829,181

 

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

                Unaudited       Unaudited       Audited

                Six months to   Six months to   Year ended

                30 June 2024    30 June 2023    31 December 2023
                £'000           £'000           £'000
 Share options  265             47              50
 Total          265             47              50

 

 

5. Intangible assets

                                     Acquired Licences & Data       Patents & Trademarks

                                                                                               Total
                                     £'000                          £'000                      £'000
 Cost
 At 31 December 2022                 1,935                          243                        2,178
 Additions                           29                             146                        175
 At 31 December 2023                 1,964                          389                        2,353
 Additions                           -                              94                         94
 At 30 June 2024                     1,964                          483                        2,447

 Amortisation and impairment
 At 31 December 2022                 43                             1                          44
 Amortisation charge                 25                             1                          26
 Impairment                          250                            103                        353
 At 31 December 2023                 318                            105                        423
 Amortisation charge                 12                             1                          13
 At 30 June 2024                     330                            106                        436

 Net book value
 Net book value at 30 June 2024      1,634                          377                        2,011
 Net book value at 31 December 2023  1,646                          284                        1,930

 

Additions in the period relate to patent applications. Patents 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.

 

6 Trade and other receivables

                                 Unaudited      Unaudited      Audited

                                 30 June 2024   30 June 2023   31 December 2023
                                 £'000          £'000          £'000
 Trade receivables               11             6              -
 Prepayments and accrued income  627            718            669
 Grant receivable                75             -              31
 VAT recoverable                 50             43             53
 R&D tax credit                  175            -              574
 Trade and other receivables     938            767            1,327

 

7. Events after the reporting period

None to report.

 

8. Copy of the interim results

A copy of the Company's Interim Results for the six months to 30 June 2024 is
available on the Company's
website,  www.poolbegpharma.com/investors/documents/
(http://www.poolbegpharma.com/investors/documents/)

 

 

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