Results for the year ended 31 December 2022
30/03/2023 07:00
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RNS Number : 6890U Poolbeg Pharma PLC 30 March 2023
Poolbeg Pharma Plc
Results for the year ended 31 December 2022
Significant milestones reached, well capitalised and positioned for future
growth
London, UK 30 March 2023 - Poolbeg Pharma Plc (AIM: POLB, OTCQB: POLBF
"Poolbeg" or the "Company") a leading biopharmaceutical company focusing on
infectious and prevalent diseases with a high unmet medical need, is pleased
to announce its audited results for the year ended 31 December 2022.
Financial & Corporate Highlights
- Well capitalised with a cash balance of £16.2m at year end
- Poolbeg-led consortium awarded €2.3m in non-dilutive funding
to progress its Oral Vaccine Platform
- Select experienced hires, bolstering the Company's capabilities
in core areas such as business development and clinical operations
Operational Highlights
· POLB 001 - potential blockbuster p38 MAP Kinase inhibitor for the
treatment of severe Influenza and other acute inflammatory conditions
- Successfully completed the bacterial lipopolysaccharide ("LPS")
human challenge trial in 2022
- Positive results from the trial were published earlier this
month. POLB 001 was shown to be safe and well tolerated and had a potent
effect on systemic and localised inflammatory response in a dose dependent
manner. This significant milestone demonstrates POLB 001's expected utility in
severe influenza and supports its continued development in other acute
inflammatory conditions
- Poolbeg continues to evaluate POLB 001's potential in additional
indications to fully unlock the potential value of the molecule and strengthen
Poolbeg's position for partnering and out-licensing
· POLB 001 - Oncology
- Strategically expanded POLB 001 in January 2023 as a potential
treatment option for Cytokine Release Syndrome (CRS), a side-effect associated
with CAR T cell therapy. Clinical trial enabling activities are underway with
trial initiation in CAR T cell patients expected in H1 2024
· Artificial Intelligence ("AI") Programmes - analysis of unique
disease progression data derived from human challenge trial samples
- Respiratory Syncytial Virus ("RSV") AI programme with partner
OneThree Biotech. Poolbeg embarked on a world first programme in February
2022 which yielded multiple novel RSV drug targets in November 2022. Following
the discovery of these drug targets, the collaboration successfully identified
a number of promising RSV drug candidates which can now be rapidly brought
forward to lab-based validation
- Influenza AI programme with leading AI company, CytoReason,
commenced in March 2022 and hit a major milestone in November 2022 as the
construction of the computational artificial intelligence influenza disease
model was completed
· Continued expansion and diversification of the pipeline
- POLB 002 - in-licensed an intra-nasally administered, RNA-based
immunotherapy for pan-respiratory virus infections
- POLB 003 - in-licensed late-preclinical stage intra-muscular
vaccine candidate for the prevention of Melioidosis, a predominantly tropical
/ subtropical disease with a high mortality rate and no approved vaccine
available
- The Company continues to evaluate five other bacterial vaccine
candidates being developed at University College Dublin ("UCD") under an
ongoing option agreement
- Oral Vaccine Platform - licensed microencapsulation and
nanoencapsulation technology aimed at triggering 'mucosal immunity' by
delivering oral vaccines to the gut, preventing infections from taking hold in
the body by counteracting them at the point of entry, both reducing
transmission and preventing serious disease
- Oral Delivery of Metabolic Disease Treatments - licensed
patented encapsulation technologies in metabolic syndrome related diseases,
including obesity, pre-diabetes and diabetes
Jeremy Skillington, PhD, Chief Executive Officer, Poolbeg Pharma, said: "As we
reflect on Poolbeg's accomplishments in 2022, we are delighted with the
progress we have made in our pipeline development, clinical programmes, and
our AI drug discovery programmes. Our strong cash position, coupled with the
excellent data achieved in our LPS human challenge trial for POLB 001,
position us well for 2023 as we work towards our first partnering transaction.
We remain committed to disciplined capital allocation, cost-effective R&D,
and strategic partnerships, as we continue to pursue our goal of becoming a
one-stop-shop for pharma and biotechs seeking products to in-license."
Investor presentation
The Company will provide a live presentation relating to the results for the
year ended 31 December 2022 via the Investor Meet Company platform on Thursday
30 March 2023 at 10:00 BST.
The presentation is open to analysts and all existing and potential
shareholders. Investors can sign up to Investor Meet Company for free and add
to meet Poolbeg Pharma here
(https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor) .
Those who already follow Poolbeg Pharma on the Investor Meet Company
platform will automatically be invited.
The Company's Annual Report and Accounts for the year ended 31 December 2022
will be posted to shareholders in due course together with the notice of the
2023 Annual General Meeting, and will be available on the Company's website:
www.poolbegpharma.com/investors/documents/
(http://www.poolbegpharma.com/investors/documents/)
- Ends -
Enquiries
Poolbeg Pharma Plc +44 (0) 207 183 1499
Jeremy Skillington, CEO
Ian O'Connell, CFO
finnCap 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
Optimum Strategic Communications +44 (0) 208 078 4357
Mary Clark, Nick Bastin, Vici Rabbetts poolbeg@optimumcomms.com (mailto:poolbeg@optimumcomms.com)
About Poolbeg Pharma
Poolbeg Pharma specialises in the development of innovative medicines to
address the unmet need in infectious and other prevalent diseases. Poolbeg has
a disciplined portfolio approach to mitigate risk, accelerate drug
development, and enhance investor returns. The Company simultaneously advances
multiple programmes in cost-effective clinical trials, rapidly generating
early human safety and efficacy data to enable early partnering /
out-licensing, with the funds generated reinvested in the pipeline. Poolbeg
also uses AI to interrogate human challenge trial data sets to quickly
identify new targets and drugs, and in-license near or in the clinic
medicines, leading to faster development and greater commercial appeal.
The Company is targeting the growing infectious disease market. In the wake of
the COVID-19 pandemic, infectious disease has become one of the fastest
growing pharma markets and is expected to exceed $250bn by 2025. Through
opportunistic identification of assets which complement Poolbeg's existing
pipeline, the Company is progressing programmes in oncology and metabolic
syndromes; adding disease areas with significant addressable markets.
With its initial assets from hVIVO plc (http://www.hvivo.com)
(formerly Open Orphan plc), an industry leading infectious disease and
human challenge trials business, Poolbeg has access to knowledge, experience,
and clinical data from over 20 years of human challenge trials. The Company is
using these insights to acquire new assets as well as reposition clinical
stage products, reducing spend and risk. Amongst its portfolio of exciting
assets, Poolbeg has a small molecule immunomodulator for severe influenza and
other acute inflammatory conditions (POLB 001) which produces a highly
significant reduction in p38 MAP kinase driven cytokines in a clinical
setting; a first-in-class, intranasally administered RNA-based immunotherapy
for respiratory virus infections (POLB 002); and a vaccine candidate for
Melioidosis (POLB 003). The Company is also developing
two Oral Delivery Programmes and is progressing
two Artificial Intelligence (AI) Programmes to add promising new assets to
its pipeline.
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.
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 2022. Our first full year
as a listed company has been one of substantial progress:
· Successfully expanded and diversified our pipeline
We have transformed and broadened our pipeline by adding complementary new
technologies and indications in infectious and other prevalent diseases. This
included securing exclusive licences for POLB 002 (an RNA-based immunotherapy
for respiratory virus infections), POLB 003 (an intramuscular vaccine
candidate to prevent Melioidosis), and for use of AnaBio Technologies's
("AnaBio") microencapsulation and nanoencapsulation technology to develop oral
vaccines and for use in metabolic syndrome related diseases, including
obesity, pre-diabetes and diabetes. In addition, Poolbeg commenced exciting
collaborations with two leading biology-driven Artificial Intelligence ("AI")
specialists.
· Significant progress on R&D programmes
During 2022, highlights include the completion of our bacterial
lipopolysaccharide "LPS" human challenge trial for POLB 001, which
demonstrated that POLB 001 was safe and well tolerated and had a potent effect
in systemic and localised inflammatory response in a dose dependent manner.
This was a milestone achievement for Poolbeg as it demonstrated POLB 001's
expected utility in severe influenza.
Following finalisation of our AI collaboration agreements in Q1 2022, we made
excellent progress on the AI programmes before year end.
- Poolbeg's novel respiratory syncytial virus ("RSV") focused AI
programme with partner OneThree Biotech yielded multiple novel RSV drug
targets. Following the discovery of these drug targets, the collaboration
identified a number of promising RSV drug candidates and we now plan to
rapidly bring these forward to lab-based validation.
- Poolbeg's Influenza focused AI programme with partner CytoReason
hit a major milestone during the year as the construction of the computational
artificial intelligence influenza disease model was completed in November
2022.
· Excellent corporate progress
In March 2022, we announced the trading of our shares on the OTCQB Venture
Market in the United States under the ticker: POLBF. We believe that this is a
useful way of raising awareness of, and access to, Poolbeg shares for US
investors.
In line with our strategy of targeting non-dilutive funding to assist in
progressing our pipeline products, in November 2022 a Poolbeg-led consortium
was awarded €2.3m in non-dilutive funding to progress an Oral Vaccine
Platform.
During the year, Poolbeg also added select experienced hires to our team which
has bolstered our capabilities in core areas such as business development and
will help drive further rapid development of the Company.
Financial
Poolbeg is well capitalised for our current needs, with a cash balance of
£16.2m at year end. The loss for the year amounted to £4.7m and comprises
R&D expenses £2.2m, administrative expenses £3.1m and other income and
tax rebates of £0.6m. Poolbeg's model seeks to efficiently allocate capital
to high potential opportunities which we can secure on attractive terms, that
can be de-risked effectively, are in a market and indication where there is a
clear opportunity for onward licensing / partnering and which we believe can
generate a strong return on the capital invested.
Outlook
The momentum generated during 2022 has continued into the current year. Post
year end, we have made important progress on POLB 001, reporting positive data
from the LPS human challenge trial with a marked reduction in both systemic
and localised inflammatory response in a manner that suggests expected utility
in treating life-threatening infections, such as severe influenza, and
supports continued development in the Cytokine Release Syndrome ("CRS")
associated with other acute inflammatory conditions.
A long-term objective for Poolbeg continues to be to evaluate POLB 001's
potential in additional indications to fully unlock the potential value of the
molecule and strengthen Poolbeg's position for partnering and
out-licensing. In line with this objective, in January 2023, we announced the
strategic expansion of POLB 001 into oncology, as a potential treatment option
for CRS experienced by up to 95% of cancer patients receiving CAR T cell
therapy. Clinical trial enabling activities are underway to progress towards
trial initiation in CAR T cell patients in 2024.
2022 was a year of significant progress for Poolbeg, we strategically expanded
our pipeline and successfully achieved our stated objectives on time and in
line with our disciplined capital allocation approach. We enter 2023 well
capitalised with a fully diversified pipeline and positive data from our first
clinical trial for our potential blockbuster treatment for severe influenza.
Poolbeg is poised to maximise the opportunities within its portfolio to
deliver sustainable value for shareholders by becoming a one-stop-shop for
pharma and biotechs seeking programmes to in-license. We look forward to
continued progress in 2023.
Cathal Friel
Chairman
29 March 2023
CEO's Operations Review
Poolbeg's Focus and Positioning
Poolbeg specialises in the development of innovative medicines to address the
unmet need in infectious and other prevalent diseases. Poolbeg has a
disciplined portfolio approach to mitigate risk, accelerate drug development
and enhance investor returns. We aim to simultaneously advance multiple
programmes faster and more cost effectively than the conventional biotech
model. By advancing multiple programmes concurrently in smart, cost-effective
clinical trials, we can rapidly generate early human safety and efficacy data
to enable partnering or out-licensing to pharma / biotech, with the funds
generated reinvested into the pipeline.
In the wake of the COVID-19 pandemic, global biopharma has refocused upon
developing vaccines and treatments targeting infectious diseases and it has
become one of the fastest growing pharma markets; expected to
exceed $250bn by 2025. Through opportunistic identification of assets which
complement Poolbeg's existing pipeline, we are now progressing programmes in
oncology and metabolic syndromes; adding disease areas with significant
addressable markets to our pipeline.
Poolbeg, with its growing pipeline, is well positioned to capitalise on the
themes within global pharma; pharma recognise the need to fill their pipelines
with de-risked drug candidates across many disease areas, particularly as many
existing blockbuster drugs are reaching the end of their patent lives. There
is a clear trend for more in-licensing, with a focus on drug candidates with
existing human data.
Poolbeg is determined to capitalise on this opportunity by leveraging the most
cutting-edge technology and utilising smart clinical trial design to generate
strong early human efficacy data in order to attract pharma and biotech
partners for its assets. Global pharma trends highlight that over 90% of
licensing deals occur in pre-Phase II assets and Poolbeg aims to become a
one-stop-shop for pharma and biotech companies seeking these de-risked assets.
Poolbeg continues to engage with pharma and biotech companies with regards to
potential out-licensing opportunities for our assets.
The team are also evaluating potential in-licensing options to add to our
pipeline. Key selection criteria include compelling data, the ability to
license on attractive terms, the opportunity to quickly de-risk and create
value with near term value inflection points; the market opportunity, the
appeal of the asset to future partners, and the potential future return
expected from partnering. Additionally, the potential for non-dilutive grant
funding to support development is also a key selection criterion and Poolbeg
proved its ability to secure such funding in 2022, as a Poolbeg-led consortium
was awarded €2.3m in non-dilutive funding to progress its Oral Vaccine
Platform.
Pipeline Development
POLB 001 - Severe Influenza
A potential blockbuster small molecule immunomodulator being developed to
address the unmet medical need arising from severe influenza and other acute
inflammatory conditions. In 2022, Poolbeg successfully completed an LPS human
challenge trial to provide key human data on its potential in selectively
inhibiting the hyperinflammatory response which can often be life threatening
in severe Influenza and other acute inflammatory conditions.
Unlike other influenza treatments, POLB 001 targets the hosts immune response
rather than the viral infection itself by selectively inhibiting the body's
overwhelming inflammatory response (Cytokine Storm) while leaving the
necessary immune functions intact to fight the infection. This contrasts from
other immunomodulatory approaches, such as steroids, which affect both the
beneficial and the damaging immune responses. Cytokines, produced to stimulate
and shape the immune response, can result in a Cytokine Storm or Cytokine
Release Syndrome ("CRS") when overexpressed, sweeping through the body
re-programming white blood cells and resulting in tissue damage, shutting down
circulation and other essential organs and potentially leading to death.
A randomised, double-blind, placebo-controlled, multiple dose, bacterial
lipopolysaccharide ("LPS") human challenge trial in 36 healthy volunteers to
assess the potential efficacy of POLB 001 in treating the hyperinflammatory
responses associated with severe influenza and other acute inflammatory
conditions completed in December 2022. The positive initial results from the
trial were received in January 2023 and the full results were made available
in March 2023. These showed that treatment with POLB 001 resulted in a highly
significant reduction in p38 MAP kinase driven cytokines and caused a marked
reduction in multiple markers of systemic and local inflammation compared with
placebo in a dose dependent manner. POLB 001 was shown to be safe and well
tolerated, with the results demonstrating POLB 001's expected utility in
severe influenza.
Systemic Inflammatory Response
The typical LPS-induced increase in plasma cytokine levels (TNF-α, IL-6, and
IL-8) was reduced by between 57-81% across all cytokines in subjects treated
with 70 mg or 150 mg POLB 001 (all highly significant P values <0.0003).
POLB 001 was shown to have the following dose dependent effects:
- blunted the LPS associated rise in heart rate across all dose
groups (P<0.001)
- reduced body temperature and C-reactive protein ("CRP") levels,
a clinically used nonspecific marker of inflammation
- target engagement causing a dose dependent reduction in p38
phosphorylation activation status in white blood cells
Localised Inflammatory Response
POLB 001 infiltration into inflamed tissues blocked localised cytokine release
and reduced invasion of tissue damaging inflammatory cells as reflected by:
- complete ablation of tissue damaging neutrophil accumulation
within the inflamed tissue
- LPS-induced rise in intermediate monocytes (inflammatory
mediators) was substantially lower in subjects treated with 70 mg or 150 mg
POLB 001
- a highly significant reduction in TNF-α in subjects treated
with 150 mg POLB 001 of 65.1% (P<0.0009)
POLB 001 - Oncology
Post year-end, we announced a strategic expansion of POLB 001 into oncology as
a potential treatment option for the CRS experienced by cancer patients as a
side effect of this type of immunotherapy. A significant number of CAR T cell
patients suffer treatment related side effects, including Cytokine Release
Syndrome (which can be life threatening) with some cell therapies inducing
these effects in up to 95% of patients. Although this extends beyond Poolbeg's
infectious diseases focus, the potential benefit of POLB 001 to these patients
merited a strategic expansion of the asset into this field.
A long-term strategic objective continues to be the evaluation of POLB 001's
potential in further indications in order to fully unlock the value of the
molecule. This expansion to oncology unlocks a significant new market
opportunity for POLB 001 in addition to severe influenza and strengthens our
position in partnering and out-licensing discussions. We are now progressing
oncology clinical trial enabling activities with the aim of initiating a trial
in CAR T cell patients during 2024. Further oncology-related data, regulatory
feedback and non-clinical development updates are expected during 2023.
POLB 002
We successfully in-licensed a first-in-class broad spectrum RNA-based
immunotherapy for respiratory virus infections from the University of Warwick,
which is being developed by Poolbeg as POLB 002. Administered intra-nasally,
this RNA-based immunotherapy works by triggering nasal cells into an antiviral
state to protect against an infecting virus. At the same time, it also blocks
the cells from making more virus by directly preventing its replication. The
combination of these actions can reduce infectious viral loads and improve
disease symptoms. Importantly, in-vivo data confirms that POLB 002 targets a
broad spectrum of respiratory virus infections, offering pan-viral protection
from respiratory virus infections including influenza, respiratory syncytial
virus ("RSV"), SARS-CoV-2 and others.
This contributes to the global interest in developing a pan-viral product
which can be easily administered and distributed to treat a variety of
respiratory virus infections. As a nasally administered and rapidly effective
prophylactic antiviral candidate, it could potentially provide an effective
solution for protecting at risk patient populations (e.g. the elderly, COPD
patients, and asthmatics).
POLB 003
POLB 003 is a late preclinical stage vaccine candidate for Melioidosis, an
infectious disease with a high mortality rate for which there is no approved
vaccine available. The Company initially acquired an option over this vaccine
candidate before successfully in-licensing POLB 003 in September 2022 from
University College Dublin ("UCD") through NovaUCD, the University's knowledge
transfer office.
The vaccine candidate, developed by Associate Professor Siobhán McClean and
her team at UCD, is at a late pre-clinical stage and has shown promising early
efficacy data in preclinical studies. Melioidosis is already widespread in
South- East Asia, Northern Australia and India, but the warming climate is
having a substantial impact on the spread of the disease to new areas such
as Brazil and traditionally non-tropical areas. As a US Centers for Disease
Control and Prevention ("CDC") designated biothreat, there is an increasing
global need to develop effective vaccines and antibiotics to prevent and treat
this disease.
Poolbeg also has the option to license a further five bacterial vaccine
candidates being developed by Associate Professor McClean and her team. This
includes Escherichia coli (O157); a powerful toxin that can severely harm
children and the elderly, leaving lasting kidney damage; Pseudomonas
aeruginosa; a highly antibiotic resistant bacteria, which is the leading
cause of morbidity and mortality in cystic fibrosis patients. As well
as Klebsiella pneumoniae which is a prevalent issue in US Defence and
healthcare settings resulting in burdensome management of complications;
Burkholderia cepacia complex, a significant cause of hospital-acquired
infections with large impact on health budgets; and Acinetobacter
baumannii which poses a threat to immuno- compromised patients in care
settings, such as cystic fibrosis patients.
Oral Vaccine Platform
The COVID-19 pandemic highlighted the shortcomings of traditional
intramuscular vaccines. These include the need for cold chain delivery, the
requirement for skilled medical staff to administer the vaccines, public
access to designated administration sites, needle phobia and localised side
effects, such as pain, numbness and subsequent infection.
In January 2022, Poolbeg partnered with microencapsulation and
nanoencapsulation specialist AnaBio to develop an oral vaccine delivery
platform, to safeguard the future of infectious disease prevention by
encouraging increased vaccine uptake. Poolbeg licensed AnaBio's
microencapsulation and nanoencapsulation technologies aimed at triggering
'mucosal immunity' by delivering oral vaccines to the gut, 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.
This collaboration has resulted in the creation of the EncOVac consortium, led
by Poolbeg with partners AnaBio, Trinity College Dublin, and UCD. In November
2022, the consortium was awarded €2.3m in non-dilutive grant funding by the
Irish Government's Disruptive Technologies Innovation Fund ("DTIF") for the
development of an oral vaccine candidate to a Phase I ready state.
Oral Delivery Platform - Metabolic Diseases
Drawing on our growing understanding of the encapsulation technology from the
Oral Vaccine Platform, Poolbeg signed an exclusive licence with InsuCaps
Limited, a sister company of AnaBio Technologies to develop their patented
microencapsulation and nanoencapsulation technologies in metabolic syndrome
related diseases, including obesity, pre-diabetes and diabetes. We are
currently working towards a proof-of-technology clinical trial to determine
that a Glucagon-like Peptide 1 receptor ("GLP-1") agonist can be successfully
delivered orally in humans and trial planning activities have commenced post
year end. GLP-1 agonists are used to treat obesity and diabetes, and this
trial has the potential to tap into an industry that will be worth an
estimated $150bn by 2031.
Artificial Intelligence ("AI") Programme - Respiratory Syncytial Virus
During 2022, we have seen ground-breaking developments in our efforts to use
AI technologies to identify drug targets and potential treatments. It has
proved a low-cost and effective way of exploring new avenues for existing and
potential pipeline assets.
In February 2022, Poolbeg signed an agreement with OneThree Biotech, a
biology-driven AI company, to identify new drug targets and treatments for
Respiratory Syncytial Virus ("RSV"). Since initiating the collaboration,
Poolbeg's scientific team has worked closely with OneThree Biotech to build a
tailored AI approach that leverages Poolbeg's unique RSV human challenge trial
data in order to identify disease-relevant biological pathways and potential
drug targets. This is a world first programme - the first time that AI
analysis has been undertaken on RSV human challenge trial data with new drug
targets and candidates successfully identified.
Drug targets were successfully identified in November 2022 and based on those
newly discovered drug targets; the collaboration identified a number of
promising drug candidates in December 2022 to rapidly bring forward to
lab-based validation to determine the full potential of these assets. This
significant breakthrough has demonstrated the power of AI in speeding up drug
discovery and identification and has re-emphasised our confidence in the value
of our data and our technology driven programmes for our pipeline going
forward.
Poolbeg has prioritised compounds with existing Phase I clinical data and
which could, if successfully validated, be repositioned as novel treatments
for RSV infection. Candidates with solid safety and pharmacodynamic data in
humans are well positioned to rapidly enter a clinical trial to generate early
human efficacy data for RSV. This is in line with Poolbeg's efficient, capital
light clinical development strategy that is at the core of its ambitious
growth model.
Artificial Intelligence Programme - Influenza
In March 2022, Poolbeg signed an agreement with leading AI company,
CytoReason, to provide analysis of Poolbeg's unique influenza disease
progression data derived from human challenge trial samples. CytoReason has
built world-class validated AI models which can extrapolate immune cell
behaviour based on bulk transcriptomics, making it an ideal partner to
maximise the insights of our influenza data. To date, five of the world's top
ten pharma companies use CytoReason's technology including Pfizer, Sanofi,
Merck KgaA and Roche.
In November 2022, the construction of the computational disease model was
completed and is on track to deliver outputs in Q2 2023, which will present
novel influenza drug targets.
This innovative programme is the first time that AI is being used to analyse
influenza human challenge trial data. This unique data has already been used
to successfully identify POLB 001 in a process which took many years to
complete through manual analysis of data. AI analysis has the capacity to
significantly accelerate this process.
Intellectual property
Poolbeg has a strong focus upon continually strengthening and broadening its
IP portfolio; filing patents in key global territories to protect our product
pipeline.
Poolbeg continuously assesses its patent portfolio and is vigilant in
monitoring for instances of IP infringement. Poolbeg has a worldwide licence
for POLB 001 for all uses in humans and is developing a strong IP portfolio
with US patent protection in place covering the use of a wide range of p38 MAP
kinase (mitogen-activated protein kinase) inhibitors for the treatment of
symptoms of severe influenza and the use of POLB 001 and structurally related
analogues for the treatment of hypercytokinemia and a European patent for the
class of p38 MAP kinase inhibitors for use in the treatment of severe
influenza.
Its patent protection 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 until 2037 ("Immunomodulators I") and the
treatment of hypercytokinemia until 2038 ("Immunomodulators II"). The
Immunomodulators II application also includes claims to the use of POLB 001
and other p38 MAPK inhibitors in combination with an antiviral.
The Immunomodulators I family of patents include granted patents in Europe and
the US further pending patents in the EU, the US and Japan. Even wider
geographical coverage is sought via the Immunomodulators II application
extending to Australia, Brazil, Canada, China, Hong Kong, Israel and Korea. In
May 2022, the United States Patent & Trademark Office ("USPTO") issued a
Notice of Allowance on the Immunomodulators II application and the full
granting of a patent was received in March 2023. The company will seek patent
term extensions (or equivalents) upon marketing approval of POLB 001, to
extend further the term of protection. This means that there is ample
opportunity for POLB 001 to generate substantial long--term value over the
next 15 years at least, and this length of patent should be attractive to
prospective acquirers / in- licensees of POLB 001. The Immunomodulators I and
Immunomodulators II families of patents continue to progress through the
examination process in multiple jurisdictions.
It is not unusual in the pharmaceutical industry for patents to be challenged.
The Immunomodulators I European patent was opposed by an anonymous third party
in September 2021. The European Patent Office's ("EPO") preliminary opinion on
the opposition was received in March 2023, identifying a number of items to be
discussed at a hearing set for November 2023. Based on specialist advice
received, and the fact that the patent went through an extensive examination
process prior to being granted by the EPO, Poolbeg continues to have full
confidence in the validity and strength of the patent and will vigorously
defend its intellectual property to the extent required.
POLB 002 was also granted a European patent in January 2022, and a US patent
was granted in May 2022 for the identification of defective interfering
("DI") RNA-based influenza viruses for use against infection by influenza,
that provides a drug candidate with both antiviral prophylactic and
therapeutic applications.
Outlook and Summary
We made substantial advancements in 2022, hitting key milestones in our
programmes; particularly with the completion of our POLB 001 human challenge
trial, as well as the validation of our world first AI drug discovery
programme. Our intellectual property has also been further protected by
securing a number of patents in multiple territories, while successful and
strategic in-licensing has created opportunities in exciting new areas with
significant addressable markets. Having achieved excellent data in our first
clinical trial and with a strong business development focus and a well
capitalised business, we are excited to enter this next stage of development
as we seek to partner our first programme.
Jeremy Skillington,
PhD
CEO
29 March
2023
Consolidated Statement of Comprehensive Income
For the year ended 31 December 2022
Year to Period to
31 December 31 December
2022 2021
Note £'000 £'000
Revenue - -
Cost of sales - -
Gross profit - -
Administrative expenses (3,060) (2,031)
Other operating income 278 109
Research and development expenses (2,204) (414)
Operating loss (4,986) (2,336)
Finance income 209 -
Loss before income tax (4,777) (2,336)
Taxation 91 -
Loss and total comprehensive loss for the period attributable to the equity (4,686) (2,336)
holders of the Company
Loss per share:
Loss per share - basic and diluted, attributable to ordinary equity holders of
the parent (pence)
3 (0.94) (0.74)
The loss for the year arises from continuing operations.
There were no other items of comprehensive income for the year and therefore
the loss for the year is also the total comprehensive loss for the year.
Consolidated Statement of Financial Position
As at 31 December 2022
31 December 31 December
2022 2021
Note £'000 £'000
Assets
Non-current assets
Intangible assets 4 2,134 1,563
Total non-current assets 2,134 1,563
Current assets
Trade and other receivables 962 506
Cash and cash equivalents 16,193 20,949
Total current assets 17,155 21,455
Total assets 19,289 23,018
Equity and liabilities
Equity attributable to owners of the parent
Share capital 100 100
Share premium 23,100 23,100
Other reserves 2,145 1,716
Accumulated deficit (7,022) (2,336)
Total equity 18,323 22,580
Current liabilities
Trade and other payables 966 438
Total current liabilities 966 438
Total liabilities 966 438
Total equity and liabilities 19,289 23,018
Consolidated Statement of Changes in Equity
For the year ended 31 December 2022
Share based payment reserve
Share Share premium Merger reserve Accumulated deficit
capital Total
Note £'000 £'000 £'000 £'000 £'000 £'000
Loss and total comprehensive loss for the period - - - - (2,336) (2,336)
Issue of shares as part of demerger 45 - - 1,455 - 1,500
Issue of shares for cash 55 24,950 - - - 25,005
Costs charged against share premium - (1,829) - - - (1,829)
Share based payments - (21) 261 - - 240
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
Consolidated Statement of Cash Flows
For the year ended 31 December 2022
Year to Period to
31 December 2022 31 December 2021
Note £'000 £'000
Cash flows from operating activities
Loss on ordinary activities before taxation (4,777) (2,336)
Amortisation 4 26 18
Share based payment expense 429 240
Finance income (209) -
SME R&D tax credit 2 91 -
Movements in working capital and other adjustments:
Change in trade and other receivables (456) (506)
Change in trade and other payables 528 438
Net cash flow used in operating activities (4,368) (2,146)
Cash flow from investing activities
Payments for intangible assets 4 (597) (81)
Interest received from bank 209 -
Net cash flow used in investing activities (388) (81)
Cash flow from financing activities
Proceeds from issue of equity instruments - net of expenses - 23,176
Short term loans received - 225
Repayment of short term loans - (225)
Net cash flow from financing activities - 23,176
Net change in cash and cash equivalents (4,756) 20,949
Cash and cash equivalents at beginning of period 20,949 -
Cash and cash equivalents at end of period 16,193 20,949
Notes
1. General information
Poolbeg Pharma plc ("Poolbeg" or the "Company") is a public limited company
incorporated in England and Wales with company number 13279507. Details of the
registered office, the officers and advisers to the Company are presented on
the Company Information page at the end of this report. 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 specialises in the development of innovative medicines to address the
unmet need in infectious and other prevalent diseases. Poolbeg has a
disciplined portfolio approach to mitigate risk, accelerate drug development
and enhance investor returns.
2. Basis of preparation
Compliance with applicable law and IFRS
The consolidated Financial Statements comprise those of the Company and its
subsidiaries (together the "Group"). The consolidated Financial Statements of
the Group and the individual Financial Statements of the Company have been
prepared on the going concern basis and under the historical cost convention
in accordance with United Kingdom adopted International 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 2022.
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. The prior period merger reserve was created on the acquisition of
ORPH Pharma IP Company Limited by Poolbeg Pharma plc.
Comparative period
The comparative period is for the period from incorporation on 19 March 2021
to 31 December 2021.
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 £2,204,000 (2021: £414,000) 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.
Taxes
Tax comprises current and deferred tax. Current tax is the expected tax
payable on the taxable income for the period, using tax rates enacted or
substantially enacted at the reporting date. Deferred tax assets or
liabilities are recognised where the carrying value of an asset or liability
in the Statement of Financial Position differs to its tax base, and is
accounted for using the statement of financial position liability method.
Recognition of deferred tax assets is restricted to those instances where it
is probable that taxable profit will be available against which the difference
can be utilised.
Where eligible the Group applies for R&D tax credits in the jurisdictions
in which it operates. As the Group has not yet 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 not been recognised in the Income
Statement. The tax credit of £91,000 in the current year relates to the
receipt of a SME R&D tax credit for a return submitted for the 2021 tax
year. This is the first R&D tax credit received by the Group.
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
19 March 2021 - Issue of shares on incorporation 5,000 (A)
20 May 2021 - Issue of shares - share placing 24,992,500
18 June 2021 - Issue of shares on acquisition of ORPH Pharma IP Company 225,002,500
Limited
16 July 2021 - Issue of shares - EIS/VCT 23,010,000
19 July 2021 - Issue of shares - share placing on IPO 226,990,000
31 December 2021 500,000,000 317,227,413
31 December 2022 500,000,000 500,000,000
(A) On 20 May 2021 the one ordinary share of £1 issued on incorporation of
the Company was subdivided into 5,000 ordinary shares of 0.02p each
The calculation of loss per share is based on the following:
Year to Period to
31 December 31 December 2021
2022
Loss after tax attributable to equity holders of the Company (£'000) (4,686) (2,336)
Weighted average number of ordinary shares in issue 500,000,000 317,227,413
Fully diluted average number of ordinary shares in issue 500,000,000 317,227,413
Basic and diluted loss per share (pence) (0.94) (0.74)
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 2022 totalled 36,829,181 (2021: 36,829,181) and are potentially
dilutive.
4. Intangible Assets
Acquired Licences & Data Patents & Trademarks
Total
Group £'000 £'000 £'000
Cost
Additions 1,500 81 1,581
At 31 December 2021 1,500 81 1,581
Additions 435 162 597
At 31 December 2022 1,935 243 2,178
Accumulated amortisation
Amortisation charge 18 - 18
At 31 December 2021 18 - 18
Amortisation charge 25 1 26
At 31 December 2022 43 1 44
Net book value
Net book value at 31 December 2022 1,892 242 2,134
Net book value at 31 December 2021 1,482 81 1,563
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.
During the year the Group did not identify any potential changes in the
assumptions used in the assessment of the carrying value of the assets.
5. Events after the reporting period
Poolbeg's Immunomodulators I European patent (EP3478322) was opposed by an
anonymous third party in September 2021. In March 2023, Poolbeg received the
preliminary opinion on the opposition from The European Patent Office's
("EPO"), which identified a number of items to be discussed at a hearing set
for November 2023. Based on specialist advice received, and the fact that the
patent went through an extensive examination process prior to being granted by
the EPO, Poolbeg continues to have full confidence in the validity and
strength of the patent and will vigorously defend its intellectual property to
the extent required.
In January 2023 & March 2023, Poolbeg announced positive results from the
POLB 001 LPS Human Challenge Trial. Treatment with POLB 001 resulted in a
highly significant reduction in p38 MAP kinase driven cytokines and exhibited
a marked reduction in multiple markers of systemic and local inflammation
compared with placebo. The trial results demonstrate expected utility in
severe influenza.
In January 2023, Poolbeg announced the strategic expansion of POLB 001 into
oncology and the filing of a patent application to protect use of POLB 001 for
new oncology indication. Scientific findings indicate POLB 001 has the
potential to dampen the pro-inflammatory cytokine release syndrome affecting
patients receiving CAR T cell therapies.
In March 2023, Poolbeg announced that an additional POLB 001 was granted in by
the US Patent and Trademark Office, for use of certain p38 MAP kinase
inhibitors for treatment of hypercytokinemia.
6. Annual Report and Annual General Meeting
The Company's Annual Report and Accounts for the year ended 31 December
2022 will be posted to shareholders in due course together with the notice of
the 2023 Annual General Meeting, and will be available on the Company's
website, www.poolbegpharma.com/investors/documents/
(http://www.poolbegpharma.com/investors/documents/)
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