TIDMPOLB
RNS Number : 2280M
Poolbeg Pharma PLC
13 September 2023
Poolbeg Pharma plc
Interim results for the six months to 30 June 2023
Significant progress made and well positioned for future
growth
13 September 2023 - Poolbeg Pharma (AIM: POLB, OTCQB: POLBF,
'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical
company targeting diseases with a high unmet medical need,
announces its unaudited interim results for the six months to 30
June 2023.
Interim Results Highlights and Business Update
-- Strong cash balance of GBP14.1 million as at 30 June 2023 (31 December 2022: GBP16.2m)
-- Positive results from the POLB 001 LPS human challenge trial.
The asset has the potential to be an effective treatment for severe
influenza and potentially other acute inflammatory conditions
-- Strategic expansion of POLB 001 into oncology, including as a
potential treatment option for Cytokine Release Syndrome (CRS), a
side-effect associated with up to 95% of CAR T cell therapies
-- Further to discussions with prospective partners interested
in this area, the Company is actively exploring a potential new
indication for POLB 001 in oncology beyond CAR T
-- The Company's artificial intelligence (AI) programme with
CytoReason provided unparalleled insights into influenza infection
and successfully identified a number of novel and valuable drug
targets
-- The lab-based validation of the Respiratory Syncytial Virus
(RSV) drug targets and treatments identified from the Company's
AI-led programme is progressing and expected to complete in H2
2023
-- The Poolbeg-led Oral Vaccine consortium (EncOVac), which was
awarded EUR2.3 million in grant funding, progressed to the next
phase of development, marked by the commencement of the
encapsulation validation process
-- Continued progress on the Oral GLP-1 agonist
proof-of-technology clinical trial preparation. As a result of
adopting recommendations from a number of Key Opinion Leaders
(KOLs), the clinical trial design has been refined and the trial is
expected to commence in H1 2024
-- Industry veteran, Professor Brendan Buckley, appointed as Non-Executive Director in May 2023
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg
Pharma, commented: "During H1 2023, we made significant progress in
advancing our pipeline, bolstered by the strong clinical trial data
for POLB 001 and breakthroughs in our AI-led drug discovery
programmes, we are building towards becoming an efficient
one-stop-shop for biopharma seeking products to in-license. With a
cost-effective R&D approach, complemented by a strong balance
sheet and multiple non-dilutive funding opportunities, we are well
positioned for ongoing development and future growth with a strong
focus on our business development activities."
Investor presentation
Jeremy Skillington, PhD, Chief Executive Officer, will be
presenting at the Master Investor Sector Focus: Healthcare Webinar
on 20 September 2023.
Register to attend here .
Change of Name of Nominated Adviser and Joint Broker
The Company also announces that its Nominated Adviser and Joint
Broker has changed its name to Cavendish Capital Markets Ltd
following completion of its own corporate merger.
- Ends -
Enquiries
Poolbeg Pharma Plc
Jeremy Skillington, CEO
Ian O'Connell, CFO +44 (0) 207 183 1499
Cavendish Capital Markets Ltd (Nominated
Adviser & Joint Broker)
Geoff Nash, Charlie Beeson, Nigel
Birks, Harriet Ward (ECM) +44 (0) 207 220 0500
Singer Capital Markets (Joint Broker)
Phil Davies, Sam Butcher +44 (0) 207 496 3000
J&E Davy (Joint Broker)
Anthony Farrell, Niall Gilchrist +353 (0) 1 679 6363
Optimum Strategic Communications +44 (0) 208 078 4357
Nick Bastin, Hana Malik, Vici Rabbetts 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 Pharma 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 Pharma also uses AI to interrogate human challenge trial
data sets to quickly identify new targets and drugs, 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 Pharma'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 , an industry leading
infectious disease and human challenge trials business, Poolbeg
Pharma 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 Pharma 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 progressing
two A rtificial I ntelligence (AI) P rogrammes to add promising new
assets to its pipeline as well as developing an Oral Vaccine
Programme and an Oral Delivery Programme focussing on metabolic
syndrome related diseases.
For more information, please go to www.poolbegpharma.com or
follow us on Twitter and LinkedIn @PoolbegPharma.
CEO Statement
I am delighted to present the unaudited interim financial
statements of Poolbeg Pharma plc ("Poolbeg" or the "Company") for
the six months to 30 June 2023. Throughout this period, we've
achieved substantial advancements across our programmes as outlined
below.
Significant progress made
POLB 001 - Severe Influenza - We reported the positive results
from our LPS human challenge trial for POLB 001 in March 2023 (see
Figure 1) and the Clinical Study Report has been finalised. These
findings demonstrated a significant reduction in both systemic and
localised inflammatory responses in a manner that suggests expected
utility in treating life-threatening infections, such as severe
influenza, and supports continued development as a treatment for
the Cytokine Release Syndrome ("CRS") associated with other acute
inflammatory conditions.
Figure 1
POLB 001 - Oncology - Expanding the potential of POLB 001 beyond
severe influenza remains a key objective for the Company to fully
unlock the potential value of the molecule and strengthen Poolbeg's
position for partnering and out-licensing. In line with this
objective, we strategically expanded POLB 001 into oncology in
January 2023 with the filing of a patent application for the use of
POLB 001 as a treatment option for the Cytokine Release Syndrome
(CRS) side-effect associated with CAR T cell therapy. CRS affects
up to 95% of cancer patients receiving CAR T cell therapy, which,
in its severe form, can be life threatening.
A potential new indication in oncology beyond CAR T is being
actively explored further to discussions with prospective partners
with interest in this area.
Clinical trial enabling activities to advance POLB 001 in
oncology are progressing.
Influenza Artificial Intelligence Programme - In June 2023, our
AI-led programme with CytoReason yielded a significant
breakthrough. The programme identified multiple novel influenza
drug targets by leveraging our unique disease progression data from
human challenge trials combined with CytoReason's curated disease
data and advanced AI platform. The insights gained offer an
unparalleled understanding of influenza infection, focusing on the
body's immune responses by identifying the drivers of disease, and
identified multiple unique drug targets that hold the potential to
block disease and aid recovery. The Company is actively exploring
the most effective way to further develop the novel drug targets in
order to generate value and is progressing towards drug target
validation which is expected to complete in 2024.
RSV Artificial Intelligence Programme - In Q4 2022, the Company
announced the successful identification of novel drug targets and
treatments by our AI partner, OneThree Biotech. This significant
breakthrough demonstrated the power of AI in accelerating drug
discovery and identification and reaffirmed our confidence in the
value of our data and our technology driven programmes. The
lab-based validation of these treatments is expected to complete in
H2 2023.
Oral Vaccine Programme - The Poolbeg-led Oral Vaccine consortium
(EncOVac), which was awarded EUR2.3 million in grant funding,
advanced into its next phase of development as the validation of
the encapsulation process commenced in June 2023. The research
plan, Consortium and Grant agreements have been completed and the
programme is progressing well with validation expected to complete
in H2 2023. This programme holds the potential to address a wide
range of infectious diseases, contributing positively to global
health.
Oral Delivery of Metabolic Disease Treatments - The Company
continues to make progress on the Oral GLP-1 agonist
proof-of-technology clinical trial preparation. We actively engaged
with a number of KOLs to refine the clinical trial design and, as a
result of adopting these recommendations, the trial is now expected
to commence in H1 2024. The trial aims to determine that a
Glucagon-like Peptide 1 receptor ("GLP-1") agonist can be
successfully delivered orally in humans using our licensed
technology. GLP-1 agonists such as Wegovy(R) (semaglutide) are used
to treat obesity and diabetes, and this trial has the potential to
tap into an industry that will be worth an estimated $150 billion
by 2031(1) .
Other Updates - The Company continues to review partnering
opportunities as well as actively exploring further non-dilutive
funding opportunities to progress its programmes, including POLB
002 and POLB 003. The Company has taken another proactive step in
enhancing its robust intellectual property by submitting a patent
application for POLB 003 in the first half of this year.
As announced in March 2023, we successfully strengthened the
patent portfolio of POLB 001 with another patent grant in the US,
covering the use of certain p38 MAP kinase inhibitors for the
treatment of hypercytokinaemia. Further to this, in January 2023 we
filed patent applications for the use of POLB 001 in addressing the
impact of CRS associated with CAR T cell therapy, as well as other
oncology indications beyond CAR T. 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.
Business Development - We continue to evaluate partnering
opportunities for a number of our programmes in line with our
operating model. With more than 50% of late-stage programmes
originating from partnering within the pharmaceutical industry,
there is significant scope to aid companies in their mission to
accelerate the development of unique medicines that address
diseases with high unmet medical need.
We have seen great progress in a number of our programmes since
the start of 2023, including the positive data from our POLB 001
LPS human challenge trial, completion of the Clinical Study Report,
the strategic expansion of POLB 001 into oncology, and the
discovery of multiple novel drug targets and treatments using AI.
We have attended several global partnering conferences so far in
2023 which have facilitated further engagement with potential
partners. With excellent relationships across the sector, and the
positive outputs to hand from a number of our programmes, we look
forward to continuing deal making discussions and providing updates
to our shareholders in due course.
Corporate & Financial
Poolbeg had a strong cash balance of GBP14.1m as at 30 June
2023. Loss for the period amounted to GBP1.8m; comprised of R&D
expenses of GBP0.9m, administrative expenses of GBP1.4m and other
income of GBP0.5m.
We welcomed Professor Brendan Buckley to the Board as
Non-Executive Director in May 2023. Brendan's significant
contributions to Poolbeg as a member of the Scientific Advisory
Board, and his extensive industry experience, greatly benefits the
Company.
Outlook
Poolbeg has continued to make significant strides in progressing
our pipeline of products and platforms during H1 2023 and we are
continuing at pace towards our aim of becoming a one-stop-shop for
pharma and biotech's seeking programmes to in-license. With strong
data from our POLB 001 clinical trial and novel drug targets and
treatments identified using our cutting-edge AI-led programmes, we
are excited by the future of Poolbeg. Our robust cash balance, cost
effective R&D approach, and multiple near term value inflection
points position Poolbeg to generate strong returns for shareholders
over the coming years.
Jeremy Skillington, PhD
Chief Executive Officer
12 September 2023
Consolidated Statement of Comprehensive Income
For the six months to 30 June 2023
Unaudited Unaudited Audited
Six months Six months Year ended
to to 31 December
30 June 30 June 2022 2022
2023
Note GBP'000 GBP'000 GBP'000
------------------------------------------ ----- ----------- -------------- -------------
Revenue - - -
Cost of sales - - -
------------------------------------------ ----- ----------- -------------- -------------
Gross profit - - -
------------------------------------------ ----- ----------- -------------- -------------
Administrative expenses (1,395) (1,228) (3,060)
Other operating income 177 133 278
Research and development expenses (865) (657) (2,204)
------------------------------------------ ----- ----------- -------------- -------------
Operating loss (2,083) (1,752) (4,986)
------------------------------------------ ----- ----------- -------------- -------------
Finance income 272 45 209
Loss before income taxation (1,811) (1,707) (4,777)
------------------------------------------ ----- ----------- -------------- -------------
Taxation 2 - 100 91
------------------------------------------ ----- ----------- -------------- -------------
Loss and total comprehensive loss
for the period attributable to the
equity holders of the Company (1,811) (1,607) (4,686)
------------------------------------------ ----- ----------- -------------- -------------
Loss per share:
Loss per share - basic and diluted,
attributable to ordinary equity holders
of the parent (pence) 3 (0.36) (0.32) (0.94)
Consolidated Statement of Financial Position
As at 30 June 2023
Unaudited Unaudited Audited
30 June 30 June 2022 31 December
2023 2022
Note GBP'000 GBP'000 GBP'000
------------------------------- ----- ---------- ------------- ------------
Assets
Non-current assets
Intangible assets 4 2,183 1,935 2,134
Total non-current assets 2,183 1,935 2,134
------------------------------- ----- ---------- ------------- ------------
Current assets
Trade and other receivables 5 767 1,185 962
Cash and cash equivalents 14,120 18,894 16,193
Total current assets 14,887 20,079 17,155
------------------------------- ----- ---------- ------------- ------------
Total assets 17,070 22,014 19,289
------------------------------- ----- ---------- ------------- ------------
Equity and liabilities
Equity attributable to owners
of the parent
Share capital 100 100 100
Share premium 23,100 23,100 23,100
Other reserves 2,192 1,930 2,145
Accumulated deficit (8,833) (3,943) (7,022)
------------------------------- ----- ---------- ------------- ------------
Total equity 16,559 21,187 18,323
------------------------------- ----- ---------- ------------- ------------
Current liabilities
Trade and other payables 6 511 827 966
------------------------------- ----- ---------- ------------- ------------
Total current liabilities 511 827 966
------------------------------- ----- ---------- ------------- ------------
Total liabilities 511 827 966
------------------------------- ----- ---------- ------------- ------------
Total equity and liabilities 17,070 22,014 19,289
------------------------------- ----- ---------- ------------- ------------
Consolidated Statement of Changes in Equity
For the six months to 30 June 2023
Share
Share Share based payment Merger Accumulated
capital premium reserve reserve deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
---------------------- ---------- ---------- ---------------- ---------- -------------- --------
At 1 January
2022 100 23,100 261 1,455 (2,336) 22,580
---------------------- ---------- ---------- ---------------- ---------- -------------- --------
Loss and total
comprehensive
loss for the
period - - - - (1,607) (1,607)
Share based payments - - 214 - - 214
---------------------- ---------- ---------- ---------------- ---------- -------------- --------
Balance at 30
June 2022 100 23,100 475 1,455 (3,943) 21,187
---------------------- ---------- ---------- ---------------- ---------- -------------- --------
Loss and total
comprehensive
loss for the
period - - - - (3,079) (3,079)
Share based payments - - 215 - - 215
---------------------- ---------- ---------- ---------------- ---------- -------------- --------
Balance at 31
December 2022 100 23,100 690 1,455 (7,022) 18,323
---------------------- ---------- ---------- ---------------- ---------- -------------- --------
Loss and total
comprehensive
loss for the
period - - - - (1,811) (1,811)
Share based payments - - 47 - - 47
---------------------- ---------- ---------- ---------------- ---------- -------------- --------
Balance at 30
June 2023 100 23,100 737 1,455 (8,833) 16,559
---------------------- ---------- ---------- ---------------- ---------- -------------- --------
Consolidated Statement of Cash Flows
For the six months to 30 June 2023
Unaudited Unaudited Audited
Six months Six months Year ended
to to 31 December
30 June 30 June 2022 2022
2023
Note GBP'000 GBP'000 GBP'000
------------------------------------------ ----- ------------ -------------- -------------
Cash flows from operating activities
Loss on ordinary activities
before taxation (1,811) (1,707) (4,777)
Adjustments for:
Finance income (272) (45) (209)
Amortisation 4 13 13 26
Share based payment expense 47 214 429
SME R&D tax credit 2 - - 91
Movements in working capital
and other adjustments:
Change in trade and other receivables 5 195 (579) (456)
Change in trade and other payables 6 (455) 389 528
Net cash flow used in operating
activities (2,283) (1,715) (4,368)
------------------------------------------ ----- ------------ -------------- -------------
Cash flow from investing activities
Payments for intangible assets 4 (62) (385) (597)
Interest received from bank 272 45 209
Net cash flow generated/(used)
in investing activities 210 (340) (388)
------------------------------------------ ----- ------------ -------------- -------------
Net cash flow from financing - - -
activities
------------------------------------------ ----- ------------ -------------- -------------
Net change in cash and cash
equivalents (2,073) (2,055) (4,756)
Cash and cash equivalents at
beginning of period 16,193 20,949 20,949
------------------------------------------ ----- ------------ -------------- -------------
Cash and cash equivalents at
end of period 14,120 18,894 16,193
------------------------------------------ ----- ------------ -------------- -------------
Notes to the Interim Results
1. General information
Poolbeg Pharma plc ("Poolbeg" or the "Company") is a public
limited company incorporated in England and Wales with company
number 13279507. The Company is quoted on the AIM market of the
London Stock Exchange (ticker: POLB.L, ISIN: GB00BKPG7Z60) and
traded 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
The Interim Results of the Company for the six months to 30 June
2023 comprise those of the Company and its subsidiaries (together
the "Group"). The Interim Results have been prepared on the going
concern basis under the historical cost convention in accordance
with the recognition and measurement requirements of United Kingdom
adopted International Financial Reporting Standards ("IFRS") and
their interpretations issued by the International Accounting
Standards Board ("IASB"), and in accordance with those parts of the
Companies Act 2006 applicable to companies reporting under IFRS. As
is permitted by the AIM rules, the Directors have not adopted the
requirements of IAS 34 "Interim Financial Reporting" in preparing
the financial statements. Accordingly, the financial statements are
not in full compliance with IFRS and have neither been audited nor
reviewed pursuant to guidance issued by the Auditing Practices
Board.
The financial information for the six months to 30 June 2023 and
30 June 2022 is unaudited. The information for the year ended 31
December 2022 has been extracted from the Company's audited
accounts on which the auditors issued an unqualified audit opinion.
The information presented for that period does not constitute full
accounts for that period. The 31 December 2022 audited accounts
have been delivered to the Companies House.
The financial information is presented in GBP which is the
functional and presentational currency of the Company. Balances are
rounded to the nearest thousand (GBP'000) except where otherwise
indicated.
The Interim Results were approved by the Board of Directors on
12 September 2023.
The accounting policies used in the preparation of the Interim
Results are consistent with those used in the Company's audited
financial statements for the year to 31 December 2022. The
application of the accounting policies can involve significant
estimation, uncertainty and critical judgement. The most
significant judgement made in relation to the Interim Results
is:
Research and development ("R&D") tax credits: R&D tax
claims can be complex and require management to make significant
assumptions in building the methodology for the claim, interpreting
research and development tax legislation to the Group's specific
circumstances, and agreeing the basis of the tax computations with
HM Revenue & Customs or other tax authorities. 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 period and prior year has not been recognised in the Income
Statement. R&D tax claims in relation to the 2022 tax year have
been submitted by the Group and rebates in relation to that period
are anticipated.
3. Loss per share - basic and diluted
The Group presents basic and diluted loss per share ("LPS") data
for its ordinary shares. Basic LPS is calculated by dividing the
loss attributable to ordinary shareholders of the Company by the
weighted average number of ordinary shares outstanding during the
period. Diluted LPS is determined by adjusting the loss
attributable to ordinary shareholders and the weighted average
number of ordinary shares outstanding for the effects of all
dilutive potential ordinary shares, which comprise warrants and
share options granted by the Company.
The calculation of loss per share is based on the following:
Unaudited Unaudited Audited
Six months Six months Year ended
ended ended 31 December
30 June 30 June 2022 2022
2023
------------------------------------------ ------------- --------------- --------------
Loss after tax attributable to equity
holders of the Company (GBP'000) (1,811) (1,607) (4,686)
Weighted average number of ordinary
shares in issue 500,000,000 500,000,000 500,000,000
Fully diluted average number of ordinary
shares in issue 500,000,000 500,000,000 500,000,000
------------------------------------------ ------------- --------------- --------------
Basic and diluted loss per share
(pence) (0.36) (0.32) (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 and comparative periods, the effect of options would be
to reduce the loss per share and as such the basic and diluted LPS
are the same. There were 36,829,181 share options and warrants
outstanding as at 30 June 2023 (30 June 2022 and 31 December 2022:
36,829,181) and these are potentially dilutive.
4. Intangible assets
Acquired Patents
Licences & Trademarks Total
& Data
GBP'000 GBP'000 GBP'000
-------------------------------- ----------- --------------- --------
Cost
At 31 December 2021 1,500 81 1,581
Additions 435 162 597
-------------------------------- ----------- --------------- --------
At 31 December 2022 1,935 243 2,178
-------------------------------- ----------- --------------- --------
Additions - 62 62
-------------------------------- ----------- --------------- --------
At 30 June 2023 1,935 305 2,240
-------------------------------- ----------- --------------- --------
Accumulated amortisation
At 31 December 2021 18 - 18
Amortisation charge 25 1 26
-------------------------------- ----------- --------------- --------
At 31 December 2022 43 1 44
-------------------------------- ----------- --------------- --------
Amortisation charge 13 - 13
-------------------------------- ----------- --------------- --------
At 30 June 2023 56 1 57
-------------------------------- ----------- --------------- --------
Net book value
-------------------------------- ----------- --------------- --------
Net book value at 30 June 2023 1,879 304 2,183
-------------------------------- ----------- --------------- --------
Net book value at 31 December
2022 1,892 242 2,134
-------------------------------- ----------- --------------- --------
Additions in the period relate to patent applications. Patents
are measured initially at purchase cost and are amortised on a
straight-line basis over their life from the date that they are
available for use.
5 Trade and other receivables
Unaudited Unaudited Audited
30 June 30 June 31 December
2023 2022 2022
GBP'000 GBP'000 GBP'000
------------------------------------- ------------ ------------ --------------
Trade receivables 6 - -
Prepayments and accrued income 718 990 878
VAT and corporation tax receivables 43 195 84
Trade and other receivables 767 1,185 962
------------------------------------- ------------ ------------ --------------
6 Trade and other payables
Unaudited Unaudited Audited
30 June 30 June 31 December
2023 2022 2022
GBP'000 GBP'000 GBP'000
--------------------------------------- ------------ ------------ --------------
Trade payables 124 295 293
Accrued expenses 321 489 623
Other payables 11 9 4
Social security costs and other taxes 55 34 46
Trade and other payables 511 827 966
--------------------------------------- ------------ ------------ --------------
7. Events after the reporting period
None to report.
8. Copy of the interim results
A copy of the Company's Interim Results for the six months to 30
June 2023 is available on the Company's website,
www.poolbegpharma.com/investors/documents/
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IR GPUWABUPWGMP
(END) Dow Jones Newswires
September 13, 2023 02:00 ET (06:00 GMT)
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