REG - Poolbeg Pharma PLC - Interim results for the six months to 30 June 2023
13/09/2023 07:15
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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 (http://www.poolbegpharma.com/) (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 £14.1 million as at 30 June 2023 (31 December
2022: £16.2m)
· 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
€2.3 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
(https://us02web.zoom.us/webinar/register/5516886314498/WN_erJuKCvnRNeiF5D_ngEuWg#/registration)
.
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 +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
Optimum Strategic Communications +44 (0) 208 078 4357
Nick Bastin, Hana Malik, 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
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 (http://www.hvivo.com/) , 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 Artificial Intelligence (AI) Programmes 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
(http://www.poolbegpharma.com/) or follow us on Twitter
(https://twitter.com/PoolbegPharma) and LinkedIn
(https://www.linkedin.com/company/poolbeg-pharma/) @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 €2.3 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® (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 £14.1m as at 30 June 2023. Loss for the
period amounted to £1.8m; comprised of R&D expenses of £0.9m,
administrative expenses of £1.4m and other income of £0.5m.
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 to Six months to Year ended
30 June 2023 30 June 2022 31 December 2022
Note £'000 £'000 £'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 (1,811) (1,607) (4,686)
holders of the Company
Loss per share:
Loss per share - basic and diluted, attributable to ordinary equity holders of (0.36) (0.32) (0.94)
the parent (pence)
3
Consolidated Statement of Financial Position
As at 30 June 2023
Unaudited Unaudited Audited
30 June 2023 30 June 2022 31 December 2022
Note £'000 £'000 £'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 based payment reserve
Share Share premium Merger reserve Accumulated deficit
capital Total
£'000 £'000 £'000 £'000 £'000 £'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 to Six months to Year ended
30 June 2023 30 June 2022 31 December 2022
Note £'000 £'000 £'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 £ which is the functional and
presentational currency of the Company. Balances are rounded to the nearest
thousand (£'000) except where otherwise indicated.
The Interim Results were approved by the Board of Directors on 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 ended Six months ended Year ended
30 June 2023 30 June 2022 31 December 2022
Loss after tax attributable to equity holders of the Company (£'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 Licences & Data Patents & Trademarks
Total
£'000 £'000 £'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 2023 30 June 2022 31 December 2022
£'000 £'000 £'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 2023 30 June 2022 31 December 2022
£'000 £'000 £'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/
(http://www.poolbegpharma.com/investors/documents/)
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