REG - Poolbeg Pharma PLC - Results for the year ended 31 December 2023
30/04/2024 07:00
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RNS Number : 4942M Poolbeg Pharma PLC 30 April 2024
Poolbeg Pharma plc
Results for the year ended 31 December 2023
Significant pipeline advancements
Strategic expansion into cancer immunotherapy-induced CRS unlocking a market
opportunity exceeding US$10Bn
Key senior management hires
30 April 2024 - Poolbeg Pharma (http://www.poolbegpharma.com/) (AIM: POLB,
OTCQB: POLBF, 'Poolbeg' or the 'Company'), a biopharmaceutical company
focussed on the development and commercialisation of innovative medicines
targeting diseases with a high unmet medical need, announces its audited
results for the year ended 31 December 2023.
Financial & Corporate Highlights
· Cash balance of £12.2 million as at 31 December 2023
· Industry veteran, Professor Brendan Buckley, appointed as
Non-Executive Director
· Recruitment of key management hires, former executives of Amryt
Pharma plc, a rare disease company that was acquired by Chiesi Farmaceutica
for US$1.48 billion
Operational Highlights
· Positive results from POLB 001 LPS human challenge trial revealed
potent target inhibition and major reductions in key inflammatory markers
· Strategic expansion of POLB 001 as a preventative therapy for cancer
immunotherapy-induced Cytokine Release Syndrome (CRS)
· POLB 001 patent portfolio strengthened with new patent filings and
grants
· Positive conclusion to the Immunomodulator I patent opposition with
the opposition withdrawn
· Multiple novel influenza drug targets identified as part of
Artificial Intelligence (AI) led programme with the prioritised targets
endorsed by Poolbeg's Scientific Advisory Board
· Positive outputs from the lab-based analysis and successful
prioritisation of the Respiratory Syncytial Virus ('RSV') treatment candidates
identified as part of AI-led programme
· Signed a strategic collaboration agreement with a Nasdaq listed
biopharma company for the development of an optimised oral drug to treat a
metabolic condition
· POLB 001 data presented at 65th American Society of Hematology (ASH)
Annual Meeting and Exposition and the 18th International Congress of
Immunology (IUIS), and garnered interest from global industry leaders in the
field of bispecific antibodies and CAR T cell therapies
· The Company engaged with a number of Key Opinion Leaders (KOLs) to
refine the clinical trial design for its oral GLP-1R programme and is working
towards commencement of its proof-of-technology clinical trial in 2024
Post Period End
· Positive in vivo data confirmed POLB 001's efficacy in reducing
cancer immunotherapy-induced CRS in an animal model, strengthening and
facilitating the expansion of patent applications for POLB 001 in cancer
immunotherapy-induced CRS
· Independent Advisory Board of Key Opinion Leaders, healthcare payers
and clinical trial experts, were supportive of POLB 001's potential to both
prevent and treat cancer immunotherapy-induced CRS
· Independent research confirmed a market opportunity exceeding US$10
billion( 1 ) for POLB 001 as an orally delivered preventative therapy for
cancer immunotherapy-induced CRS
· Cathal Friel, Co-Founder and significant shareholder, assumed the
role of Executive Chairman
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma,
commented: "We made excellent progress and hit multiple key milestones in
2023, the most important of all perhaps was filing patent applications which
will give us international protection over the use of POLB 001 as a
preventative therapy for cancer immunotherapy-induced CRS, in addition to the
existing severe influenza indication. With a market opportunity exceeding
US$10 billion in cancer immunotherapy-induced CRS, positive data generated,
and a robust patent portfolio - POLB 001 has great potential to generate
significant value for shareholders.
"Our disciplined approach to capital allocation has ensured that we have
maintained a robust cash position. We remain focussed and are getting good
engagement on partnering to maximise the value of our in-house programmes.
Poolbeg has the expertise to succeed in our strategy of developing, partnering
and commercialising innovative medicines to generate near-term revenues with a
goal to achieve sustainable profitability.
"Going forward, I believe we are well positioned to generate value for our
shareholders, while addressing significant unmet medical needs across multiple
disease areas."
Investor presentation
Poolbeg's management team will provide a live presentation via the Investor
Meet Company platform on Tuesday 30 April 2024 at 6pm BST.
The presentation is open to analysts and investors, those who already follow
Poolbeg on the Investor Meet Company platform will automatically be
invited. Investors can sign up to Investor Meet for free and add Poolbeg
Pharma plc to their company dashboard here
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor) .
Enquiries
Poolbeg Pharma Plc +44 (0) 207 183 1499
Jeremy Skillington, CEO
Ian O'Connell, CFO
Cavendish Capital Markets Ltd (Nominated Adviser & Joint Broker) +44 (0) 207 220 0500
Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM)
Singer Capital Markets (Joint Broker) +44 (0) 207 496 3000
Phil Davies, Sam Butcher
J&E Davy (Joint Broker) +353 (0) 1 679 6363
Anthony Farrell, Niall Gilchrist
About Poolbeg Pharma
Poolbeg Pharma plc is committed to the development and commercialisation of
innovative medicines targeting diseases with a high unmet medical need, with a
growing emphasis on rare and orphan diseases. Its model focusses upon
developing its exciting clinical assets and commercialising approved and
marketed drugs to support the growth of the Company and the development of its
robust pipeline of innovative products, thereby driving significant value
creation.
Poolbeg is led by an experienced leadership team with a history of delivering
significant shareholder value. The team has been strengthened by the
appointment of three former members of the Amryt Pharma plc leadership team,
with the intention of repeating Amryt's success and generating near term
revenues.
Poolbeg's clinical programmes target large addressable markets including
cancer immunotherapy-induced CRS, infectious disease, and metabolic conditions
such as obesity with the development of an oral GLP-1R agonist. It uses a
cost-effective development philosophy to generate high quality human data to
support partnering and further development. Its AI-led infectious disease
programmes analyse unique data from human challenge trials to identify
clinically relevant drug targets and treatments, leading to faster development
and greater commercial appeal.
For more information, please go to www.poolbegpharma.com
(http://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.
Chairman'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 2023.
Overview
Poolbeg made significant strides in 2023, both in advancing our pipeline of
high value programmes and enhancing our corporate structure. We welcomed
several key industry leaders to our team, each bringing a proven track record
of delivering significant shareholder value.
At Poolbeg, we are committed to the development and commercialisation of
innovative medicines targeting diseases with a high unmet medical need, with a
growing emphasis on rare and orphan diseases. Our model focusses upon
developing and partnering our exciting R&D programmes and commercialising
approved and marketed drugs to support the growth of the Company and the
development of our robust pipeline of innovative products, thereby driving
value for the Company and its shareholders.
Positive corporate developments & industry leading team
I co-founded Amryt Pharma plc ('Amryt'), the rare disease company, in 2015,
and in the years that followed, Amryt experienced rapid growth, driving sales
revenue to more than US$261 million( 2 ) prior to its ultimate sale in 2023
for US$1.48 billion( 3 ). In November 2023, Poolbeg announced the appointment
of key former executives of Amryt to our leadership team:
· David Allmond, Chief Business Officer, previously Chief Business
Officer at Amryt, where he was instrumental in putting in place the global
commercial infrastructure which supported its revenue growth from c. US$1.5
million( 4 ) when he joined in 2016, to over US$261 million some six years
later. David played a pivotal role in acquiring both products and companies at
Amryt.
· John McEvoy, SVP, Chief Legal Officer, was Global General Counsel at
Amryt from 2017 to 2023 where he played a pivotal role in Amryt's rapid
growth, leading multiple acquisitions as well as the company's dual-listing on
Nasdaq in 2020 and its subsequent sale to Chiesi in 2023. John is a qualified
lawyer in the US (New York), England & Wales, and Ireland.
· Laura Maher, VP Clinical Operations, was Associate Director of
Clinical Operations at Amryt from 2018, where she led the clinical research
programmes for multiple products in Amryt's pipeline including Filsuvez®, the
world's first approved epidermolysis bullosa treatment. Laura has an extensive
background in clinical operations.
Poolbeg intends to follow a similar strategic approach to Amryt by developing
and partnering our existing assets and commercialising approved and marketed
drugs thereby driving significant value creation. We welcome these exceptional
individuals to the Poolbeg team as we accelerate this strategy.
In May 2023, we also welcomed Professor Brendan Buckley to the Board as a
Non-Executive Director. Brendan has over 40 years' experience in clinical
practice as a Consultant Physician and has extensive industry experience in
the CRO and biopharmaceutical space. Brendan was a member of the Board of
Directors of the Irish Medicines Board (now the Health Products Regulatory
Authority) and sat on the European Medicines Agency Scientific Advisory
Committee on diabetes and metabolism. As we increase our focus on rare and
orphan diseases, Brendan's experience as a member of the European Medicines
Agency Committee for Orphan Medicinal Products (COMP) provides invaluable
insights and greatly benefits the Company.
With POLB 001's strategic expansion into oncology, Poolbeg now has exposure to
the high growth rare and orphan drug market
At Poolbeg, we are actively increasing our focus on rare and orphan diseases,
leveraging 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 because the patients receiving T cell
engaging bispecific antibodies and CAR T cell therapy are predominantly
suffering from rare or orphan blood (haematological) cancers.
A rare disease is a medical condition that affects a small percentage of the
population. In the United States, a rare disease is defined as one that
affects fewer than 200,000 people( 5 ) while in the EU, it is characterised as
a disease that affects no more than one in 2,000 people( 6 ). However,
definitions can vary by region. Regulatory authorities offer incentives to
companies developing orphan drugs, which in the US includes seven years of
market exclusivity granted to the sponsor upon marketing authorisation. The
orphan drug market is expected to grow more than twice as fast as the
non-orphan market( 7 ). It is expected to grow from US$170 billion in 2023 to
US$368 billion by 2030 (11.6% CAGR)( 8 ), with orphan drug sales due to
account for 20% of all prescription drug sales by 2026( 9 ). Our leadership
team has significant knowledge and expertise in rare and orphan diseases
products, and the Directors believe that Poolbeg is well positioned to benefit
from these opportunities.
Strong progress across our pipeline of assets
We made excellent progress in advancing our innovative and attractive pipeline
during 2023.
POLB 001
POLB 001 has the potential to be an effective treatment for severe influenza,
as well as a breakthrough orally delivered preventative therapy for cancer
immunotherapy-induced CRS. The market potential is greater than US$10 billion
in the cancer setting alone, according to independent research.
Positive results from our LPS human challenge trial, including a highly
significant reduction in p38 MAPK (mitogen-activated protein kinase) driven
cytokines, and presentations at key international conferences, including ASH
(American Society of Hematology) and IUIS (International Union of
Immunological Societies), serve as strong validation for the potential of POLB
001.
We also successfully expanded and enhanced POLB 001's robust intellectual
property portfolio.
Post year end, promising in vivo animal data were generated which strengthens
our belief that POLB 001 has the potential to greatly impact the lives of
patients.
AI Programmes
Our two Artificial Intelligence (AI) led programmes with CytoReason and
OneThree Biotech achieved key milestones in 2023, yielding unparalleled
insights into influenza and Respiratory Syncytial Virus (RSV) through analysis
of unique and high-quality human challenge trial data. The global interest in
AI-led drug discovery continues to grow, with Big Pharma investing heavily in
the space. This approach to drug discovery enables faster target
identification, at lower cost and reduced risk. We are actively discussing
the exciting outputs from our AI-led drug discovery programmes with
prospective partners.
Oral Delivery
In 2023, we also progressed our Oral Glucagon-like Peptide 1 receptor (GLP-1R)
agonist programme. We engaged with a number of Key Opinion Leaders (KOLs) to
refine the clinical trial design and are working towards the commencement of
the proof-of-technology clinical trial. The trial aims to demonstrate
successful delivery of an oral GLP-1R agonist in humans and has the potential
to tap into a market in obesity and diabetes( 10 ) which is projected to reach
US$150 billion by 2031.
Financial
Our disciplined approach to capital allocation has served us well, allowing us
to make significant progress across our pipeline of assets while maintaining a
robust cash balance. We remain committed to prudent financial management,
ensuring that we have the resources necessary to fuel our growth strategy to
continue to generate shareholder value.
Poolbeg ended the year with a cash balance of £12.2 million (2022: £16.2
million). The loss for the year amounted to £3.9 million (2022: £4.7
million) and comprises R&D expenses £1.7 million (2022: £2.2 million),
administrative expenses £3.4 million (2022: £3.1 million), and tax rebates
and other income & charges of £1.1 million (2022: £0.6 million).
Outlook
2023 was an exceptional year for Poolbeg. With our growing focus on the rare
and orphan disease space, we are poised to capitalise on the significant
opportunities presented by this attractive market. Our lead programme, POLB
001, holds immense promise in addressing unmet medical needs in severe
influenza and cancer immunotherapy-induced CRS, with a market opportunity that
exceeds US$10 billion in cancer immunotherapy-induced CRS alone. Encouraging
discussions have been held with Pharma as they seek solutions for CRS to
improve the safety profile and increase the market potential of their
therapies. Our experienced team, bolstered by recent key appointments with a
track record of success at Amryt, has a wealth of knowledge and expertise to
advance our strategy of developing, partnering and commercialising innovative
medicines to generate near term revenues with a focus on achieving sustainable
profitability.
I assumed the role of Executive Chairman in February 2024 as I strongly
believe in the Company's potential, underscored by my recent share purchase.
In summary, I am highly optimistic about the potential for Poolbeg to rapidly
grow. We have a clear strategic vision and a talented team with a robust cash
balance, and a relentless focus on execution. With that in mind, we believe
that we are well-positioned to capitalise on the opportunities that lie ahead
and deliver long-term value for our shareholders.
Cathal Friel
Executive Chairman
30 April 2024
CEO's Operations Review
I am delighted to report another strong year of progress for Poolbeg Pharma
plc. Throughout 2023, Poolbeg made significant progress across our pipeline of
assets, achieving key milestones, identifying new markets, and strengthening
our intellectual property.
I am particularly proud of the expansion of our lead asset, POLB 001, into
cancer immunotherapy-induced Cytokine Release Syndrome (CRS), a move that not
only demonstrates our teams' scientific ingenuity but also positions Poolbeg
as a leader in responding to this emerging healthcare challenge.
Furthermore, we are pleased to have started 2024 with the addition of a number
of key executives to our team, whose expertise and vision will undoubtedly
support our ambition of generating near-term revenue with a pathway to
profitability. With these developments and our unwavering focus on excellence,
I am confident that 2024 holds significant promise for Poolbeg as we continue
to drive innovation and deliver value to our shareholders and patients alike.
POLB 001
Strategic expansion of POLB 001 into oncology unlocks a market opportunity
exceeding US$10 billion
During 2023, we announced our strategic expansion of POLB 001 into oncology
for cancer immunotherapy-induced Cytokine Release Syndrome (CRS), in addition
to its potential to treat severe influenza. This strategic decision has
unlocked a market opportunity that exceeds US$10 billion. This estimate
encompasses solely Multiple Myeloma and Diffuse Large B-Cell Lymphoma due to
the rapid advancements in bispecific antibody and CAR T cell therapies for
these indications. 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.
The field of cancer immunotherapy is burgeoning and is predicted to undergo
exponential growth in the coming years to US$120 billion by
2030( 11 , 12 , 13 ).
CRS can occur in >70%( 14 ) of patients treated with T cell engaging
bispecific antibodies, or CAR T cell therapy. CRS of any grade can lead to
prolonged hospital stays and in some cases mortality risk. The administration
of these cancer immunotherapies is therefore restricted only to specialist
cancer centres which has created a "bottleneck" in providing seamless,
cost-efficient access to these treatments for the patients who need them. This
is depicted in the schematic below, where we estimate that by 2030 there will
be ~500,000( 15 ) potential eligible patients with Multiple Myeloma (MM) and
Diffuse Large B Cell Lymphoma (DLBCL) alone, across the US and EU5. If all of
these patients were to be treated with immunotherapies, the direct costs to
the healthcare systems of managing the CRS associated with these
immunotherapies would be US$5.5 billion, as illustrated below.
There are currently very few approved therapies for the management of CRS and
no approved therapies for the prevention of CRS. 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 reduce the risk of a bottleneck
occurring, and to make these life-saving therapeutics more readily accessible
to patients. However, we believe this may be understated, as immunotherapies
are being developed across a much wider range of haematologic cancers and
solid tumours and therefore the healthcare budget impact could be much
greater. We believe POLB 001 not only has great clinical potential but could
also offer a compelling economic case. We are progressing our partnering
strategy to accelerate this exciting programme.
Compelling data generated and presented at world leading scientific
conferences
Our confidence in the potential of POLB 001 was strengthened by the positive
results from our Phase 1b LPS human challenge trial which showed compelling
data, demonstrating a dose dependent reduction of pro-inflammatory cytokines,
clinical symptoms, and a strong safety profile following an inflammatory
stimulus. The data has highlighted that the drug is well tolerated and
attenuates excessive immune responses without completely ablating the immune
system, which is particularly important for an immunocompromised patient group
such as the patient groups in question for cancer immunotherapy-induced CRS.
Two abstracts showcasing POLB 001 were presented at major international
conferences in 2023, representing strong validation of the potential of the
drug:
A poster presentation by a clinical leader in Multiple Myeloma (i) releasing
further positive data from POLB 001's LPS Challenge Trial and (ii) commenting
on its significant potential in cancer immunotherapy-induced CRS was presented
at the 65(th) American Society of Hematology ('ASH') Annual Meeting and
Exposition, the world's premier conference focussing on haematological
malignancies. The poster presented the potential use of POLB 001 to treat CRS
and garnered interest from global leaders in the field of bispecific
antibodies and CAR T cell therapies.
An abstract surrounding the positive LPS human challenge trial which
highlighted POLB 001's potential as a groundbreaking therapy was presented at
the 18(th) International Congress of Immunology ('IUIS'), the world's leading
conference in the field of immunology
Post year end, we received promising in vivo results for POLB 001 which
demonstrated efficacy in reducing cancer immunotherapy-induced CRS in an
animal model. The CRS symptoms significantly improved following administration
of POLB 001, with reductions seen in all serum proinflammatory cytokines
tested. The data also strengthened and facilitated the expansion of patent
applications for POLB 001 in cancer immunotherapy-induced CRS. The product is
now Phase 2 ready and there is scientific, clinical and partner interest to
advance the programme.
Independent Key Opinion Leaders strongly supportive of POLB 001's significant
potential
We also convened an Independent Advisory Board of 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 in cancer
immunotherapy-induced CRS. Contributions from global leaders including Dr
Martin Kaiser and Prof Gareth Morgan are highlighted in the figure below.
Artificial Intelligence (AI) Programmes
Poolbeg has licenced access to a repository of viral human challenge trial
data which offers unique insights into human disease. Using Artificial
Intelligence to unlock these insights and to discover potential new therapies
for patients with respiratory viral conditions has been a key focus of the
Company.
Data from human challenge trials are unique in that they track a healthy
subject through disease and recovery in carefully controlled and monitored
isolation units, collecting samples throughout the course of disease, and
vitally collecting matched baseline and follow-up samples before and after
infection. This data is unique in the depth of longitudinal virology, health,
biomarker and symptom data collected during the course of disease.
In 2023, we made significant progress across our two AI-led programmes. Having
analysed the unique human challenge trial data with the expertise of leading
AI providers CytoReason and OneThree Biotech, our AI programmes created
significant value by identifying new drug targets for influenza and new drugs
for the treatment of RSV. AI-led solutions typically enable faster target
identification, at lower cost, reduced risk, and potentially increased
likelihood of success. We continue to actively discuss the exciting outputs
from our AI-led drug discovery programmes with prospective partners.
Influenza
In June 2023, our AI-led programme with CytoReason yielded several
breakthroughs. The programme identified multiple unique drug targets that hold
the potential to block influenza disease progression and aid recovery by
focussing on the body's response to infection and identifying the processes
responsible for driving the disease. The outputs of the AI-led target
discovery were evaluated by both Poolbeg and CytoReason's team of expert
biologists and data scientists to identify the top-ranking genes potentially
suitable for the treatment of influenza. In October 2023, our Scientific
Advisory Board (SAB) endorsed the prioritisation of a select number of targets
which validated our approach and strategy going forward.
Prioritisation was based on several key criteria, including the strategic
opportunities available for Poolbeg to meaningfully progress the targets. The
members of the SAB considered the data packages and were impressed with the
outputs of the programme, and a consensus was reached on the prioritised list
of novel drug targets to bring forward. They also provided valuable insight
into how to most effectively validate the targets and maximise near term value
in the targets. We continue to discuss the data from this programme with
prospective partners.
Identification of drug targets from this unique dataset has previously been
successful as p38 MAPK, inhibited by POLB 001, was identified as a driver of
severe influenza but this required manual analysis that took several years and
significant investment. However, through the utilisation of CytoReason's
cutting-edge AI technology, Poolbeg identified multiple novel drug targets in
just 15 months. Moreover, CytoReason's analysis independently confirmed the
significance of the p38 MAPK pathway in severe influenza, providing further
validation for Poolbeg's POLB 001 programme.
Respiratory Syncytial Virus (RSV)
We successfully identified a number of drug compounds which are novel
treatment methods for RSV as part of our AI-led programme with OneThree
Biotech in 2022. These compounds with existing safety and pharmacodynamic
Phase 1 clinical data could, if successfully validated, be repositioned as
Phase 2 ready novel treatments for RSV patients. This significant breakthrough
demonstrated the power of AI in accelerating drug discovery and the
identification reaffirmed our confidence in the value of our data and our
technology driven programmes.
In Q4 2023, we announced the positive outputs from our lab-based analysis of
these drugs in RSV infection models. Our team of scientific experts reviewed
the comprehensive data package obtained from this lab-based analysis and
strategically prioritised a select number of the RSV drug candidates. We are
actively exploring the most effective way to progress the prioritised drug
candidates in order to generate value. We believe the data obtained from this
analysis is a reflection of the high potential of this AI-led programme and
supports our ongoing partnering efforts.
Oral Platform
GLP-1R agonist targeting a market due to reach US$150 billion by 2031( 16 )
Our Oral GLP-1 receptor (GLP-1R) agonist programme is based upon a delivery
system utilising Generally Regarded as Safe (GRAS) components to encapsulate
API's (active pharmaceutical ingredients) for oral 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 AnaBio Technologies, our collaborative
partner.
In 2023, we engaged with a number of Key Opinion Leaders to refine the design
of our GLP-1R agonist trial. We are currently working towards the commencement
of our proof-of-technology clinical trial in 2024 to demonstrate successful
delivery of an oral GLP-1R agonist in humans. There is currently only one oral
GLP-1R agonist on the market, which has a bioavailability of approximately
1%( 17 ), setting a very low benchmark for success for competing delivery
technology platforms. Global supply of GLP-1R agonists is currently, and
predicted to remain, constrained by manufacturing capacity. Any technology
which can improve bioavailability in patients has the potential to
significantly reduce global shortages and improve access to patients. The
global GLP-1R market is projected to reach US$150 billion by 2031 in obesity
and diabetes alone.
Strategic collaboration with a Nasdaq listed biopharma company
We signed a strategic collaboration with a Nasdaq listed biopharma company in
October 2023 to develop an optimised oral drug to treat a metabolic condition.
Under the agreement, our partner provided funding for the development of a
prototype drug utilising Poolbeg's licensed oral delivery technology to
improve the formulation, shelf life and effectiveness of their therapy.
Poolbeg oversaw the development of a prototype product using the
collaborator's Investigational Medicinal Product designed to tailor and
improve specific aspects of the drug for oral delivery. The project was an
endorsement of the value of the technology to drug developers seeking
effective oral delivery solutions, and in Poolbeg's ability to rapidly produce
novel improved products using the platform. There is potential for us to agree
similar partnerships given the broad use case of this technology across all
metabolic diseases.
Oral Vaccine - €2.3 million non-dilutive grant funding
The Poolbeg-led Oral Vaccine consortium (EncOVac) was awarded €2.3
million in non-dilutive grant funding and in 2023, the research plan,
Consortium and Grant agreements were completed. The consortium advanced into
its next phase of development as the validation of the encapsulation process
commenced and the programme is progressing well. This programme represents a
significant commercial opportunity as it holds the potential to tackle a broad
range of infectious diseases, contributing positively to global health.
Poolbeg's part of the grant award is settled annually in arrears based on
matching eligible expenditure incurred by Poolbeg over the 3-year project
term. Utilising the highly skilled expertise from across the consortium, it
intends to develop a Phase 1 clinical trial ready oral vaccine candidate.
The consortium includes leaders in their respective fields; AnaBio
Technologies, University College Dublin (UCD), and Trinity College Dublin
(TCD). By delivering oral vaccines to the gut, 'mucosal immunity' can be
triggered resulting in a protective response in the areas of the body where a
pathogen would be inhaled or ingested such as the nose and digestive tracts.
This approach prevents infections from taking hold in the body by
counteracting them at the point of entry, both reducing transmission and
preventing serious disease.
Intellectual property
Poolbeg has a worldwide licence for POLB 001 for all uses in humans. In
January 2023, we applied for patent protection for POLB 001 in the treatment
of Cytokine Release Syndrome (CRS) arising from cancer immunotherapy
generally, and for treatment of CRS arising from CAR T therapy specifically.
If granted, protection will run until January 2044; extensions of term may
also be available.
Additionally, in November 2023, we applied for patent protection for dosage
regimens arising from the results of our LPS trial. This is not tied to any
specific indication but refers to inflammation generally in any disease
indication. If granted, protection will run to November 2044; extensions of
term may also be available.
Since inception, we have had a keen focus upon strengthening and broadening
our IP portfolio, filing for patents in key global territories to protect our
product pipeline. We have developed a strong IP portfolio with US patent
protection in place covering the use of a wide range of p38 MAPK inhibitors
for the treatment of symptoms of severe influenza and the use of POLB 001, and
structurally related analogues, for the treatment of hypercytokinemia. We also
have a European patent for the class of p38 MAPK inhibitors for use in the
treatment of severe influenza. This portfolio includes two families of patent
applications to protect the use of POLB 001, and indeed the use of p38 MAPK
inhibitors more generally, in the treatment of severe Influenza running until
at least 2037 ("Immunomodulator I") and the treatment or prevention of severe
influenza or hypercytokinemia until 2038 ("Immunomodulator II"). The
Immunomodulator II application also includes claims to the use of POLB 001 and
other p38 MAPK inhibitors in combination with an antiviral therapy.
The Company continuously assesses its patent portfolio and is vigilant in
monitoring for instances of IP infringement. It is not unusual in the
pharmaceutical industry for patents to be challenged. The Immunomodulator I
European patent was opposed by a third party in September 2021. Further to
engaging with the opposing party, Poolbeg reached an amicable conclusion in
relation to the patent dispute in September 2023 without any financial
compensation between the parties. This resulted in the opposing party agreeing
to withdraw its opposition to the Immunomodulator I European patent and
agreeing not to challenge any of Poolbeg's Immunomodulator I or
Immunomodulator II patents in the future. Following the opposition withdrawal,
the European Patent Office concluded that there was no need to proceed with a
previously scheduled hearing, concluding the matter.
In March 2023, we were notified that we had been granted a patent by the US
Patent and Trademark Office (USPTO) for our Immunomodulator II patent
application and in November 2023, our Immunomodulator II patent was granted by
the Japanese Patent Office. Post year end, in March 2024, we received a Notice
of Allowance from the USPTO in relation to our Immunomodulator II patent
application. A Notice of Allowance is a precursor to the expected formal grant
of a patent. The claims which the US Patent Office have deemed acceptable to
grant cover 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 induced in any disease indication.
We are also looking at filing patents to cover other aspects of our portfolio,
in particular those generated through our AI discovery programme.
Outlook and Summary
Building on the momentum of 2023, we have made significant strides across our
pipeline of assets while maintaining a robust cash position through our
disciplined approach to capital allocation. Our assets target large
addressable markets which are attractive areas for partnering purposes
including cancer immunotherapy-induced CRS, infectious diseases, and metabolic
conditions, such as obesity.
Looking ahead to the remainder of 2024 and beyond, Poolbeg Pharma is
well-positioned for further growth and value creation. We have made
significant strides in advancing our pipeline of innovative medicines and
strengthening our corporate structure, laying a solid foundation for future
growth. We are focused on near term revenue generation by maximising the value
of our in-house programmes through partnering and exploring new opportunities
to expand our product portfolio. With a strong pipeline of assets, an industry
leading team, and a robust cash position, we are well-positioned to deliver
long-term value for our shareholders while making a meaningful impact on
patients' lives.
Jeremy Skillington,
PhD
CEO
30 April 2024
Consolidated Statement of Comprehensive Income
For the year ended 31 December 2023
2023 2022
Note £'000 £'000
Revenue - -
Cost of sales - -
Gross profit - -
Administrative expenses (3,376) (3,060)
Other operating income 367 278
Research and development expenses 2 (1,677) (2,204)
Impairment of intangible assets 4 (353) -
Operating loss (5,039) (4,986)
Finance income 534 209
Loss before income tax (4,505) (4,777)
Taxation 2 574 91
Loss and total comprehensive loss for the year attributable to the equity (3,931) (4,686)
holders of the Company
Loss per share:
Loss per share - basic and diluted, attributable to ordinary equity holders of 3
the parent
(0.79)p (0.94)p
Consolidated Statement of Financial Position
As at 31 December 2023
2023 2022
Note £'000 £'000
Assets
Non-current assets
Intangible assets 4 1,930 2,134
Total non-current assets 1,930 2,134
Current assets
Trade and other receivables 5 1,327 962
Cash and cash equivalents 12,171 16,193
Total current assets 13,498 17,155
Total assets 15,428 19,289
Equity and liabilities
Equity attributable to owners of the parent
Share capital 100 100
Share premium 23,100 23,100
Other reserves 2,195 2,145
Accumulated deficit (10,953) (7,022)
Total equity 14,442 18,323
Current liabilities
Trade and other payables 986 966
Total current liabilities 986 966
Total liabilities 986 966
Total equity and liabilities 15,428 19,289
Consolidated Statement of Changes in Equity
For the year ended 31 December 2023
Share based payment reserve
Share Share premium Merger reserve Accumulated deficit
capital Total
Note £'000 £'000 £'000 £'000 £'000 £'000
Balance at 31 December 2021 100 23,100 261 1,455 (2,336) 22,580
Loss and total comprehensive loss for the year - - - - (4,686) (4,686)
Share based payments - - 429 - - 429
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 - - 50 - - 50
Balance at 31 December 2023 100 23,100 740 1,455 (10,953) 14,442
Consolidated Statement of Cash Flows
For the year ended 31 December 2023
2023 2022
Note £'000 £'000
Cash flows from operating activities
Loss on ordinary activities before taxation (4,505) (4,777)
Amortisation 4 26 26
Impairment of intangible assets 4 353 -
Share based payment expense 50 429
Finance income (534) (209)
SME R&D tax credit - 91
Movements in working capital and other adjustments:
Change in trade and other receivables 209 (456)
Change in trade and other payables 20 528
Net cash flow used in operating activities (4,381) (4,368)
Cash flow from investing activities
Payments for intangible assets 4 (175) (597)
Interest received from bank 534 209
Net cash flow used in investing activities 359 (388)
Net cash flow from financing activities - -
Net change in cash and cash equivalents (4,022) (4,756)
Cash and cash equivalents at beginning of year 16,193 20,949
Cash and cash equivalents at end of year 12,171 16,193
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) and trade on the OTCQB Venture Market ("OTCQB") in the United
States under the ticker POLBF.
Poolbeg is a biopharmaceutical company committed to the development and
commercialisation of innovative medicines that address critical unmet medical
needs with a growing emphasis on rare and orphan diseases.
2. Basis of preparation
The Results Announcement does not constitute the Company's statutory accounts
for the years ended 31 December 2023 and 31 December 2022, 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 2022
have been filed with the Registrar of Companies, and those for 31 December
2023 will be delivered following the Company's Annual General Meeting.
Auditors have reported on the statutory accounts for 31 December 2023 and 31
December 2022.
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 Financial Reporting 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 2023.
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.
Comparative period
The comparative period is for the year to 31 December 2022.
Presentation of Balances
The Financial Statements are presented in £ which is the functional and
presentational 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 II. 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 £1,677,000 (2022: £2,204,000)
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 licences & data - 10 years
· Patents & 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. From 1 April 2023 the UK main corporation tax rate is 25%,
increasing from 19%. This will increase the Company's future tax charge
accordingly. The unrecognised deferred tax asset as at 31 December 2023 has
been calculated based on the increased rate of 25%.
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.
The tax credit of £574,000 in the current year relates to (1) the receipt in
2024 of R&D tax credits (£424,000) for returns submitted for the 2022 tax
year and (2) an estimation for SME R&D tax credits (£150,000) to be
received relating to 2023 tax year.
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 2022 500,000,000 500,000,000
31 December 2023 500,000,000 500,000,000
The calculation of loss per share is based on the following:
2023 2022
Loss after tax attributable to equity holders of the Company (£'000) (3,931) (4,686)
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) (0.79) (0.94)
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 2023 totalled 36,829,181 (2022: 36,829,181) and are potentially
dilutive.
4. Intangible Assets
Acquired Licences & Data Patents & Trademarks
Total
Group £'000 £'000 £'000
Cost
At 1 January 2022 1,500 81 1,581
Additions 435 162 597
At 31 December 2022 1,935 243 2,178
Additions 29 146 175
At 31 December 2023 1,964 389 2,353
Amortisation and impairment
At 1 January 2022 18 - 18
Amortisation charge 25 1 26
At 31 December 2022 43 1 44
Amortisation charge 25 1 26
Impairment 250 103 353
At 31 December 2023 318 105 423
Net book value
Net book value at 31 December 2023 1,646 284 1,930
Net book value at 31 December 2022 1,892 242 2,134
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 current year an impairment charge of £353,000 (2022: nil) 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 impairment includes all carrying values in
relation to the ViralPredict Biomarker Platform and the Vaccine Discovery
Platform.
5. Trade and other receivables
2023 2022
£'000 £'000
Prepayments and accrued income 669 878
Grant receivable 31 -
VAT recoverable 53 84
R&D tax credit 574 -
Trade and other receivables 1,327 962
6. Events after the reporting period
On the 15 February 2024, Cathal Friel assumed the role of Executive Chairman
at the Company. Cathal was Non-Executive Chairman prior to the role change.
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 February 14, 2024). The EIP Options are also
subject to acceleration in certain scenarios including a change of control of
the Company.
Directors of the Company were awarded EIP Options as detailed in the table
below:
Director EIP Options Grant Date Expiry Date
Cathal Friel 4,639,175 14/02/2024 06/02/2031
Jeremy Skillington 4,639,175 14/02/2024 06/02/2031
Ian O'Connell 4,639,175 14/02/2024 06/02/2031
13,917,525
Other key employees were also issued 14,329,894 EIP Options.
On 19 February 2024, the Directors of the Company purchased ordinary shares of
0.02p as follows:
Director Number
Cathal Friel 830,000
Total 830,000
On 22 February 2024, the Directors of the Company purchased ordinary shares of
0.02p as follows:
Director Number
Jeremy Skillington 154,764
Total 154,764
On 20 March 2024, the Company announced that it received a Notice of Allowance
from the US Patent Office in relation to its Immunomodulator II patent
application. A Notice of Allowance is a precursor to the expected formal grant
of a patent in due course.
7. Annual Report and Annual General Meeting
The Company's Annual Report and Accounts for the year ended 31 December
2023 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/
(http://www.poolbegpharma.com/investors/documents/)
( 1 ) Independent research commissioned by Poolbeg
( 2 ) Amryt Pharma Annual Report & Accounts FY22
( 3 ) Chiesi Farmaceutica, 2023
( 4 ) Amryt Pharma, 2017
( 5 ) FDA
( 6 ) European Commission
( 7 ) European Pharmaceutical Review, May 2022
( 8 ) Fortune Business Insights, July 2023
( 9 ) European Pharmaceutical Review, May 2022
( 10 ) The Economist, March 2023
( 11 ) Grand View Research. CAR T-Cell Therapy Market Analysis 2023-2030
( 12 ) Grand View Research. Bispecific Antibodies Market Size, Share &
Trends Analysis Report
( 13 ) Datamonitor Healthcare. Forecast: Diffuse Large B-Cell Lymphoma and
Multiple Myeloma, 2023
( 14 ) Average rate from Summary of Product Characteristics (SmPCs) for
Yescarta, Tecartus, Abecma, Kymriah, Carvykti, Breyanzi, Elrexfio, Columvi,
Epkinly, Tecvayli and Talvey
( 15 ) Datamonitor Healthcare. Forecast: Diffuse Large B-Cell Lymphoma and
Multiple Myeloma, 2023
( 16 ) The Economist, March 2023
( 17 ) EMA Product information 2020
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. END FR QKCBQCBKDDQBRecent news on Poolbeg Pharma
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