TIDMPOLB
RNS Number : 4617D
Poolbeg Pharma PLC
03 March 2022
Poolbeg Pharma plc
Results to 31 December 2021
Poolbeg makes excellent progress post IPO and momentum
building
3 March 2022 - Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the
'Company') announces its audited results for the period ended 31
December 2021. These results follow the Company's spin-out from
Open Orphan plc and the subsequent listing on the AIM market of the
London Stock Exchange in July 2021.
Poolbeg Pharma is a clinical stage infectious disease
pharmaceutical company with a capital light model which is looking
to develop multiple products faster and more cost effectively than
the conventional biotech model. Poolbeg is targeting the growing
infectious disease market and, in the wake of the COVID-19
pandemic, infectious disease is becoming one of the fastest growing
markets with an expected value of c. $250 billion by 2025.
The Company aims to bring innovative infectious disease products
through to a value inflection point by generating early human
efficacy data before rapidly monetising through partnerships and
licensing deals with pharma and biotech. Poolbeg's model aims to
significantly reduce spend and risk compared to the conventional
biotech model and allows multiple opportunities for monetisation
through its broad portfolio. The model also enhances investor
returns as the out-licensing revenues will be reinvested into the
pipeline of additional assets which in turn, can be further
monetised rapidly and as such, substantially extending the runway
from the original GBP25m raised at IPO.
Operational Highlights since IPO - significant strategic and
operational progress
- POLB 001, a treatment for severe Influenza, remains on track
to commence its bacterial lipopolysaccharide (LPS) human challenge
trial in June 2022. Human data is expected before year end, at
which point the Company aims to monetise by partnering or out
licensing the product to pharma / biotech
- Continued expansion and diversification of the portfolio,
reducing risk due to having multiple shots on goal;
o POLB 002 - in-licensed first-in-class, intranasally
administered, RNA-based immunotherapy for respiratory virus
infections
o Option to licence and evaluate an intramuscular vaccine to
prevent Melioidosis (POLB 003), a disease predominately found in
tropical and sub-tropical regions, and five additional bacterial
vaccine candidates
o Oral Vaccine Delivery Platform - licensed access to use micro-
and nanoencapsulation technology to develop oral vaccines for
multiple disease indications
- In February 2022 the Company signed its first Artificial
Intelligence (AI) deal with OneThree Biotech Inc. to identify new
treatments for Respiratory Syncytial Virus ('RSV') through analysis
of Poolbeg's unique human challenge trial data and OneThree's
clinically validated biology driven platform
Financial & Corporate Highlights
- Well capitalised with a strong cash balance of GBP20.9m at
period end, following the IPO fundraise of GBP23.2m (after
expenses)
- Loss for the period amounted to GBP2.3m including the initial
non-recurring costs of establishing the Group
- The Company has significant financial resources and will
maintain its capital light approach to support its pipeline
expansion and development
- Scientific Advisory Board strengthened with the appointment of
Professor Daniel Hoft joining Professor Luke O'Neill and Dr Elaine
Sullivan
2022 Pipeline
- Intention to dual-list on the OTC market in the US in Q2 2022
to provide additional liquidity in the stock
- Evaluating opportunities for non-dilutive grant funding to
support the further development of existing pipeline
- Upon receipt of human data from POLB 001 study in H2 2022, the
Company will look to commence monetisation to pharma and biotech
companies via licensing or partnership agreements
- Generation of value through advancement of portfolio assets
POLB 002, POLB 003, and Oral Vaccine Delivery Platform
- Preliminary outputs from the RSV Artificial Intelligence
Discovery Programme are expected in H2 2022
- Continuous engagement and discussion with pharma and biotech
companies around the Company's portfolio including out-licensing
and product rights deals
- Continue to identify and conduct diligence on numerous new
innovative infectious disease products to add to the pipeline,
leveraging the expertise and network of our management team and
scientific advisory board. In addition, we continue to evaluate
further AI partnerships
- Continue to position the Company firmly at the cutting edge of
global R&D as the infectious disease market grows to c. $250bn
by 2025
Investor presentation
Poolbeg's Chairman, Cathal Friel and CEO, Jeremy Skillington
will provide a live presentation via the Investor Meet Company
platform on 3 March 2022 at 6:00pm.
The presentation is open to all existing and potential
shareholders. Investors can sign up to Investor Meet Company for
free and add to meet Poolbeg Pharma plc via:
www.investormeetcompany.com/poolbeg-pharma-plc/register-investor
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:
"This has been a period of great progress at Poolbeg. In less
than six months we have grown and diversified our portfolio of
products and platforms targeting a range of infectious diseases.
POLB 001 is on track to commence its LPS human challenge trial, we
have in-licensed an intranasal RNA-based immunotherapy POLB 002, as
well as partnering to develop an oral vaccine delivery platform and
agreeing an option to licence a late pre-clinical Melioidosis
vaccine, POLB 003.
"In addition, we are now using cutting edge Artificial
Intelligence technology to exploit our unique human challenge data,
having signed up leading AI drug development experts OneThree
Biotech to analyse and interrogate our RSV data to identify new
drug targets and treatments. This is the first time that AI is
being used to analyse RSV human challenge study data and initial
results are expected in H2 2022.
"As well as growing our operational team since July, we've also
added invaluable international academic expertise to our Scientific
Advisory Board. Our capital-light business model is working well,
leaving us with significant financial resources to invest in
growing our pipeline further and developing our offering to pharma,
without any need for further investment."
Cathal Friel, Chairman of Poolbeg Pharma said:
"As the single largest shareholder of the Company, I will make
it my duty to ensure that the share price starts performing again.
I want to make it clear that none of us are happy with where the
share price is currently given the drop since IPO. Market
conditions have been and remain extremely challenging however, I
want to reassure you that we are actively working on creating
demonstrable value as we drive the business forward.
My personal belief is that one of the biggest reasons for the
pressure on the share price is the perceived overhang from the
forthcoming end to the lock-in of the shares received as part of
the spin-out, by Open Orphan shareholders. Many shareholders are
concerned that the release of these shares may damage the share
price. I personally feel that this perception is wrong and that we
won't see a large sell-off of these dividend in specie shares.
However, I would like to reassure shareholders that we are looking
to put in place a series of actions that will reduce or eliminate
the potential for these shares to impact the market. In addition to
these specific actions, Poolbeg is also at an advanced stage of
dual listing on the OTC market in the USA with plans to complete
this within Q2. This should help provide additional liquidity in
the Company.
Furthermore, the distribution in specie shares issued to
shareholders as part of the demerger from Open Orphan are treated
as a distribution for UK tax purposes, which could be taxable as
dividend income. However, as advance clearance for a statutory
demerger was obtained from HMRC, the distribution is exempt for UK
income tax purposes, and hence there should be no UK income tax
liabilities for UK resident shareholders. The only time that UK
resident shareholder will be subject to tax on these dividend in
specie shares, will be in the event that they sell them, and in
that event there will be a capital gains tax payment due. This is a
further reason why I don't see shareholders looking to sell these
dividend in specie shares immediately upon the end of the lock
in.
In summary, I am very optimistic that in the months ahead our
share price will perform and more importantly, that we will
continue to progress our business model as outlined at IPO while we
rapidly grow Poolbeg into a unique publicly listed company which
will be a 'one-stop-shop' for pharma and biotechs seeking a range
of infectious disease assets to develop in the months and years
ahead."
The Company's Annual Report and Accounts for the period ended 31
December 2021 will be posted to shareholders in due course together
with the notice of the 2022 Annual General Meeting, and will be
available on the Company's website:
www.poolbegpharma.com/investors/documents/
Footnote: c. $250bn infectious disease market made up of the:
Diagnostics Market ( link ), Therapeutics Market ( link ), and
Vaccines Market ( link ).
- Ends -
Enquiries
Poolbeg Pharma Plc
Jeremy Skillington, CEO
Ian O'Connell, CFO +44 (0) 207 183 1499
finnCap Ltd (Nominated Adviser & Joint
Broker)
Geoff Nash, James Thompson, Charlie
Beeson,
Richard Chambers, Sunila de Silva (ECM) +44 (0) 207 220 0500
Arden Partners PLC (Joint Broker)
John Lewellyn-Lloyd, Louisa Waddell +44 (0) 207 614 5900
J&E Davy (Joint Broker)
Anthony Farrell, Niall Gilchrist +353 (0) 1 679 6363
Instinctif Partners +44 (0) 20 7457 2020
Melanie Toyne Sewell, Rozi Morris, Tim poolbeg@instinctif.com
Field
About Poolbeg Pharma
Poolbeg Pharma (AIM:POLB) is a clinical stage infectious disease
pharmaceutical company with a capital light model which is
developing multiple products faster and more cost effectively than
the conventional biotech model. The Company, headquartered in
London, is led by a team with a track record of creation and
delivery of shareholder value and aspires to become a "one-stop
shop" for Big Pharma seeking mid-stage products to licence or
acquire.
The Company is targeting the growing infectious disease market
which has become one of the fastest growing pharma markets and is
expected to exceed $250bn by 2025.
Poolbeg has access to extensive knowledge, experience, and
clinical data from over 20 years of human challenge trials through
Open Orphan plc , an industry leading infectious disease and human
challenge trials business. The Company is using these insights to
acquire new assets as well as reposition clinical stage products,
reducing spend and risk.
The Company continues to rapidly expand its portfolio of assets
which currently includes POLB 001, a repositioned small molecule
immunomodulator for severe Influenza. POLB 002, a first-in-class,
intranasally administered, RNA-based immunotherapy for respiratory
virus infections and POLB 003, an intramuscular Melioidosis
vaccine. The Company is also developing an oral vaccine delivery
platform and as well as progressing its AI powered drug discovery
program to identify pathways and drug candidates using its disease
progression data.
For more information, visit www.PoolbegPharma.com or follow us
@PoolbegPharma
Chairman's Statement
Dear Shareholder,
I am pleased to present the annual report and consolidated
financial statements of Poolbeg Pharma plc ("Poolbeg" or the
"Company") for the period ended 31 December 2021. The inaugural
publication of this report follows the spin-out from Open Orphan
plc and the subsequent listing on the AIM market of the London
Stock Exchange in July 2021.
The financial results comprise the results for the period from
incorporation on 19 March 2021 to 31 December 2021.
Poolbeg's Focus
Poolbeg is a clinical stage infectious disease pharmaceutical
company with a unique capital light model which is developing
multiple products faster and more cost effectively than the
conventional biotech model. Poolbeg is targeting the growing
infectious disease market, and in the wake of the COVID-19
pandemic, infectious disease is becoming one of the fastest growing
markets with an expected value of c. $250 billion by 2025.
The Company aims to bring products through a value inflection
point by generating early human efficacy data before rapidly
monetising to pharma and biotech. Poolbeg's model aims to
significantly reduce spend and risk compared to the conventional
biotech model and allows multiple opportunities for monetisation
through its broad portfolio. The model also enhances investor
returns as the out-licensing revenues will be reinvested into the
pipeline of additional assets which in turn, can be further
monetised rapidly and as such, substantially extending the runway
from the original GBP25m raised at IPO.
Given our origins as a spin-out from Open Orphan plc, which is
now a world leading infectious disease and respiratory disease
focussed CRO, we have access on a contracted basis to certain
scientific team members within Open Orphan and its subsidiaries
hVIVO and Venn Life Sciences. These experts have unparalleled
experience in infectious and respiratory disease product
development, few biotech's could replicate such valuable
relationships and knowledge base.
Pipeline Update
I am very happy to report that the Company has made substantial
progress since its IPO in July 2021. During this period, we have
rapidly added several infectious disease products to our portfolio
and we continue to explore a range of other exciting opportunities
in the rapidly growing infectious disease market.
Poolbeg continues to progress POLB 001 towards an upcoming
clinical trial due to commence in June 2022 with human data
expected later this year and hopefully early monetisation
thereafter. The current pipeline of products and platforms
corresponds to our capital light model with the goal of rapidly
generating early human efficacy data, and positioning our products
for early out-licensing or partnerships with pharma and
biotech:
-- POLB 001 - a p38 MAP Kinase inhibitor for the treatment of
severe Influenza, is on track to commence a LPS human challenge
study in June 2022. During this study, healthy volunteers' immune
systems will be stimulated with bacterial lipopolysaccharide (LPS)
in a safe and controlled clinical environment which will provide
key human data on the efficacy of POLB 001 in dampening the immune
response proving its potential efficacy in treating patients with
severe Influenza.
-- POLB 002 - in-licensed first-in-class, intranasally
administered, RNA-based immunotherapy for respiratory virus
infections. It achieves its therapeutic effect by both preventing
the virus from replicating as well as by provoking elements of the
immune system responsible for fighting viral infections.
-- POLB 003 - option to licence and evaluate an intramuscular
vaccine to prevent Melioidosis, a disease predominately found in
tropical and sub-tropical regions, and five additional bacterial
vaccine candidates.
-- Oral Vaccine Delivery Platform - licensed access to micro-
and nanoencapsulation technology which we will use to develop an
oral vaccine delivery platform - delivering immune stimulating
antigens to specific areas of the gut with the objective of
activating protective 'mucosal immunity' to prevent pathogens from
infecting the body.
-- Artificial Intelligence Powered Drug Programme - In February
2022 the Company signed its first Artificial Intelligence (AI) deal
with OneThree Biotech Inc. to identify new treatments for
Respiratory Syncytial Virus (RSV) through analysis of Poolbeg's
unique human challenge trial data and OneThree's clinically
validated biology driven platform.
-- Additional Opportunities - continue to identify and conduct
diligence on numerous new innovative infectious disease products to
add to the pipeline, leveraging the expertise and network of our
management team and scientific advisory board. In addition, we
continue to evaluate further AI partnerships.
Corporate & Financial
Poolbeg is well capitalised with a strong cash balance of
GBP20.9m at period end, following the completion of our GBP23.2m
(after expenses) fundraise in July 2021. The loss for the period
amounted to GBP2.3m which included the initial non-recurring costs
of establishing the group.
Our POLB 001 clinical development programme aligns with our
cost-efficient objectives and we are exploring similarly efficient
development plans for our newly in-licensed products and platforms
with the objective to rapidly progress these assets through the
clinic to attain early human efficacy data.
We successfully expanded our pipeline in 2021 and early 2022 and
we have significant financial resources to maintain our capital
light approach to support our pipeline expansion and development.
The Company continues to evaluate new in-licensing and partnership
opportunities and we are evaluating opportunities for non-dilutive
grant funding to support the development of our pipeline.
The Scientific Advisory Board was strengthened in November 2021
with the appointment of Professor Daniel Hoft joining Professor
Luke O'Neill and Dr Elaine Sullivan.
Outlook
We are exceptionally confident for the prospects of Poolbeg for
the coming 12 months and beyond and we are delighted to share our
intentions to dual list on the OTC market in the US in Q2 2022 to
provide additional liquidity to the stock. This is a market that is
proving to be attractive for London listed life sciences companies
to generate additional liquidity.
Since IPO, we have developed an excellent pipeline of assets and
we will generate value through developing these assets and any
further assets that we will add in the future. Given our extensive
network of relationships and contacts, we are in continuous
engagement and discussion with pharma and biotech companies around
the potential to monetise our portfolio including worldwide
out-licensing or alternatively out-licensing individual
territories. Upon receipt of human data from our POLB 001 clinical
trial in H2 2022, we will look to monetise this asset to pharma and
biotech companies. We also expect the preliminary outputs from the
RSV Artificial Intelligence Discovery Programme in H2 2022. We
continue to identify and conduct diligence on new assets to add to
the pipeline. Our experienced team is currently reviewing
interesting and innovative in-licensing, collaboration and
acquisition opportunities.
We have a strong cash position with GBP20.9m as at period end
and have efficiently managed costs while we continue to evaluate
opportunities for non-dilutive grant funding to support the
development of the pipeline. Post-pandemic, infectious diseases is
one of the hottest, most important sectors of the pharmaceutical
industry because for 30 years, there has been significant
underinvestment by Big pharma and governments around the world in
this sector. It is clear that to avoid future pandemics,
significant investment will flow into the infectious disease market
with many pharma and biotechs now actively looking to acquire
early-stage infectious disease products to restock their depleted
infectious disease pipelines. This market is expected to be valued
at c. $250bn by 2025. We continue to position Poolbeg firmly at the
cutting edge of global R&D and we are well placed to capitalise
on this in the months and years ahead.
We are aware of the headwinds faced by the entire biotech
industry in Q1-2022 as a significant sell off has coincided with
investors revising capital allocation strategies as central banks
seek to raise interest rates to tackle growing inflation. Despite
these challenges, I encourage shareholders to bear with us while we
continue to build out the company and rapidly achieve the goals set
out at IPO and in turn generate substantial returns for
investors.
As Poolbeg's largest shareholder, I remain excited by Poolbeg's
ambition to commence monetisation of its assets within 12-18
months. We continue to engage with pharma and biotech companies
regarding potential out-licensing opportunities and work towards
building the Company's value in a similar manner to that achieved
in past ventures.
We have made excellent operational and strategic progress with
Poolbeg to date and we look forward to updating the market on
further progress as we continue to successfully develop the
business.
Cathal Friel
Chairman
2 March 2022
Consolidated Statement of Comprehensive Income
For the period from incorporation on 19 March 2021 to 31
December 2021
For the
period
ended
31 December
2021
Note GBP'000
--------------------------------------------------- --------------
Revenue -
Cost of sales -
---------------------------------------------- ---- --------------
Gross profit -
---------------------------------------------- ---- --------------
Administrative expenses (2,031)
Other operating income 109
Research and development expenses (414)
Loss on ordinary activities before taxation (2,336)
---------------------------------------------- ---- --------------
Tax on loss on ordinary activities -
---------------------------------------------- ---- --------------
Loss and total comprehensive loss for
the period attributable to the equity
holders of the Company (2,336)
---------------------------------------------- ---- --------------
Loss per share:
Loss per share - basic and diluted,
attributable to ordinary equity holders
of the parent (pence) 3 (0.74)
The loss for the period arises from continuing operations.
There were no other items of comprehensive income for the period
and therefore the loss for the period is also the total
comprehensive loss for the period.
Consolidated Statement of Financial Position
As at 31 December 2021
31 December
2021
Note GBP'000
-------------------------------------- ----- ------------
Assets
Non-current assets
Intangible assets 4 1,563
Total non-current assets 1,563
-------------------------------------- ----- ------------
Current assets
Trade and other receivables 506
Cash and cash equivalents 20,949
Total current assets 21,455
-------------------------------------- ----- ------------
Total assets 23,018
-------------------------------------- ----- ------------
Equity and liabilities
Equity attributable to owners of the
parent
Share capital 5 100
Share premium 5 23,100
Other reserves 1,716
Accumulated deficit (2,336)
-------------------------------------- ----- ------------
Total equity 22,580
-------------------------------------- ----- ------------
Current liabilities
Trade and other payables 438
-------------------------------------- ----- ------------
Total current liabilities 438
-------------------------------------- ----- ------------
Total liabilities 438
-------------------------------------- ----- ------------
Total equity and liabilities 23,018
-------------------------------------- ----- ------------
Consolidated Statement of Cash Flows
For the period from incorporation on 19 March 2021 to 31
December 2021
For the
period
ended
31 December
2021
Note GBP'000
--------------------------------------------- ----- --------------
Cash flows from operating activities
Loss on ordinary activities before taxation (2,336)
Amortisation 18
Share based payment expense 240
Movements in working capital and other
adjustments:
Change in trade and other receivables (506)
Change in trade and other payables 438
Net cash flow used in operating activities (2,146)
--------------------------------------------- ----- --------------
Cash flow from investing activities
Payments for intangible assets 4 (81)
Net cash flow used in investing activities (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 20,949
Cash and cash equivalents at beginning -
of period
--------------------------------------------- ----- --------------
Cash and cash equivalents at end of
period 20,949
--------------------------------------------- ----- --------------
Consolidated Statement of Changes in Equity
For the period from incorporation on 19 March 2021 to 31
December 2021
Share
Share Share based Merger Accumulated
capital premium payment reserve deficit Total
reserve
Note GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------------ ----- ---------- ---------- ---------- ---------- -------------- --------
Loss and total comprehensive
loss for the period - - - - (2,336) (2,336)
Issue of shares as part
of demerger 5 45 - - 1,455 - 1,500
Issue of shares for
cash 5 55 24,950 - - - 25,005
Costs charged against
share premium 5 - (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
------------------------------ ----- ---------- ---------- ---------- ---------- -------------- --------
The merger reserve was created on the acquisition of ORPH Pharma
IP Company Limited as part of the demerger from Open Orphan plc.
Consideration on the acquisition was satisfied by the issuance of
shares. Under section 612 of the Companies Act 2006, the premium on
these shares has been included in a merger reserve.
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).
Poolbeg is a clinical stage infectious diseases pharmaceutical
company, with a capital light model which aims to develop multiple
products faster and more cost effectively than the conventional
biotech model.
2 Basis of preparation
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 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.
The financial information for the period ended 31 December 2021
has been extracted from the Company's audited financial statements
which were approved by the Board of Directors on 2 March 2022. The
31 December 2021 accounts will be delivered to the Companies House
within the filing deadline and have received an unqualified audit
opinion.
Consolidation
The consolidated Financial Statements comprise the Financial
Statements of the Company and its subsidiaries as at and for the
period to 31 December 2021. 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.
One of the subsidiaries consolidated in these consolidated
financial statements, ORPH Pharma IP Company Limited ("ORPH IP")
was acquired via group re-organisation and as such merger
accounting principles have been applied. ORPH IP's financial
figures are included for their entire financial period since
incorporation on 19 March 2021 rather than from the date the
company took control of them. The assets and liabilities of ORPH IP
have been recognised and measured in these consolidated financial
statements at their pre-combination carrying values. ORPH IP
prepares their accounts to 31 December under FRS101, there are no
deviations from the accounting standards implemented by the
Company.
The current period merger reserve was created on the acquisition
of ORPH IP by Poolbeg Pharma plc. Ordinary shares in Poolbeg Pharma
plc were issued to acquire the entire issued share capital of ORPH
IP. Under section 12 of the Companies Act 2006, the premium on
these shares has been included in a merger reserve.
Presentation of Balances
The Financial Statements are presented in GBP which is the
functional and presentational currency of the Company. Balances in
the Financial Statements are rounded to the nearest thousand
(GBP'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 GBP414,000
expensed in the current period. 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.
Intangible assets acquired during the current period as part of
the acquisitions of ORPH Pharma IP Company Limited comprised
GBP1,250,000 of assets that are currently not being amortised as it
is the Company's policy not to amortise assets in development that
are not ready for use. The remaining GBP250,000 of assets acquired
which relates to licences for certain data and samples are being
amortised over a 10 year period from the date of acquisition.
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 period has been charged to administrative
expenses in the Statement of Comprehensive Income.
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
Weighted
average
Share Issue Details Number of shares 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 Limited 225,002,500
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
-------------------------------------------------- ----------------- ------------
(A) On 20 May 2021 the one ordinary share of GBP1 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:
Period
to
31 December
2021
-------------------------------------------------------------- -------------
Loss after tax attributable to equity holders of the Company
(GBP'000) (2,336)
Weighted average number of ordinary shares in issue 317,227,413
Fully diluted average number of ordinary shares in issue 317,227,413
-------------------------------------------------------------- -------------
Basic and diluted loss per share (pence) (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 period, 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 2021
totalled 36,829,181 and are potentially dilutive.
4 Intangible Assets
Acquired Patents
Licences & Trademarks Total
& Data
Group GBP'000 GBP'000 GBP'000
-------------------------------------- ----------- --------------- --------
Cost
Acquired from hVIVO Services Limited 1,500 - 1,500
Other additions - 81 81
At 31 December 2021 1,500 81 1,581
Accumulated amortisation
Amortisation charge 18 - 18
At 31 December 2021 18 - 18
-------------------------------------- ----------- --------------- --------
Net book value
-------------------------------------- ----------- --------------- --------
Net book value at 31 December 2021 1,482 81 1,563
-------------------------------------- ----------- --------------- --------
The acquired licences & data additions relates to the value
of intangible assets acquired from hVIVO Services Limited by ORPH
Pharma IP Company Limited as part of the demerger process from Open
Orphan plc.
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 period the Group did
not identify any potential changes in the assumptions used in the
assessment of the carrying value of the assets.
5 Issued share capital and other reserves
Details of ordinary shares of 0.02p each issued are in the table
below:
Number Costs charged
of Share Share against share Merger
ordinary Capital Premium premium Reserve
Share issue date shares GBP'000 GBP'000 GBP'000 GBP'000
-------------------------------------- ------------ --------- --------- --------------- ---------
19 March 2021 - on incorporation,
1 share of GBP1 1 - - - -
-------------------------------------- ------------ --------- --------- --------------- ---------
20 May 2021 - Subdivision
of share issued on incorporation 5,000 - - - -
20 May 2021 - share
placing 24,992,500 5 - - -
18 June 2021 - on acquisition
of ORPH Pharma IP Company
Limited 225,002,500 45 - - 1,455
16 July 2021 - EIS/VCT
share placing 23,010,000 5 2,296 (168) (A) -
19 July 2021 - IPO share
placing 226,990,000 45 22,654 (1,661) (A) -
-------------------------------------- ------------ --------- --------- --------------- ---------
Subtotal 500,000,000 100 24,950 (1,829) 1,455
-------------------------------------- ------------ --------- --------- --------------- ---------
Share based payments
charged to share premium - - - (21) -
-------------------------------------- ------------ --------- --------- --------------- ---------
At 31 December 2021 500,000,000 100 24,950 (1,850) 1,455
-------------------------------------- ------------ --------- --------- --------------- ---------
(A) Total costs incurred of GBP1,829,000 has been allocated
based on the proportion of shares issued on each placing compared
to the overall amount of shares issued in the period from 16 July
2021 to 19 July 2021
On 20 May 2021 the one ordinary share of GBP1 issued on
incorporation of the Company was subdivided into 5,000 ordinary
shares of 0.02p each.
On 20 May 2021, 24,992,500 ordinary shares of 0.02p were issued
at 0.02p per share raising GBP5,000.
On 18 June 2021, 225,002,500 ordinary shares of 0.02p were
issued at a valuation of GBP1,500,000 as part of the completion of
the acquisition of ORPH Pharma IP Company Limited as part of the
demerger from Open Orphan plc. Under section 612 of the Companies
Act 2006, the premium on these shares has been included in a merger
reserve.
On 16 July 2021, 23,010,000 ordinary shares of 0.02p were issued
at 10p per share as part of a GBP2,301,000 (before expenses) fund
raising to EIS/VCT investors.
On 19 July 2021, 226,990,000 ordinary shares of 0.02p were
issued at 10p per share as part of a GBP22,699,000 (before
expenses) fund raising.
Other reserves
Share capital represents the cumulative par value arising upon
issue of ordinary shares of 0.02p each.
Share premium represents the consideration that has been
received in excess of the nominal value on issue of share
capital.
Share-based payment reserve relates to the charge for share
based payments in accordance with IFRS 2.
The merger reserve was created on the acquisition of ORPH Pharma
IP Company Limited as part of the demerger from Open Orphan plc.
Consideration on the acquisition was satisfied by the issuance of
shares. Under section 612 of the Companies Act 2006, the premium on
these shares has been included in a merger reserve.
Accumulated deficit represents losses accumulated in the current
period.
6 Events after the reporting period
In January 2022, Poolbeg obtained an exclusive worldwide licence
to a novel, late-pre-clinical development stage, first-in-class
RNA-based immunotherapy for respiratory virus infections developed
at the University of Warwick. The candidate will be developed by
Poolbeg as POLB 002.
In January 2022, Poolbeg signed a licence with AnaBio
Technologies ("AnaBio") to develop an oral vaccine delivery
platform using AnaBio's microencapsulation and nanoencapsulation
technologies. Poolbeg will use this technology as a platform to
complement its existing and growing pipeline of assets by
developing oral vaccines for multiple disease indications.
In February 2022, Poolbeg signed an artificial intelligence
agreement with OneThree Biotech Inc. ("OneThree") to identify new
drug targets and treatments for Respiratory Syncytial Virus
("RSV"). Under the terms of the agreement, OneThree's
state-of-the-art AI analysis tools will identify drug assets which
target immune system pathways, have a higher probability of
clinical success and have the potential to prevent and/or treat
infectious diseases. The analysis will prioritise drugs with
existing Phase I safety data, reducing spend and risk. The analysis
is expected to commence in Q1 2022 with preliminary outputs from
this work expected in H2 2022.
7 Annual Report and Annual General Meeting ("AGM")
The Company's Annual Report and Accounts for the period ended 31
December 2021 will be posted to shareholders in due course together
with the notice of the 2022 Annual General Meeting, and will be
available on the Company's website,
www.poolbegpharma.com/investors/documents/
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END
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