Final Results

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 £25m 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 £20.9m at period end, following the IPO fundraise of £23.2m (after expenses)

-  Loss for the period amounted to £2.3m 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	[phone]
finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson, Richard Chambers, Sunila de Silva (ECM)	[phone]
Arden Partners PLC (Joint Broker) John Lewellyn-Lloyd, Louisa Waddell	[phone]
J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist	[phone]
Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field	[phone] [e-mail]

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 £25m 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 £20.9m at period end, following the completion of our £23.2m (after expenses) fundraise in July 2021. The loss for the period amounted to £2.3m 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 £20.9m 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		£'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	£'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	£'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 capital	Share premium	Share based payment reserve	Merger reserve	Accumulated deficit	Total
	Note	£'000	£'000	£'000	£'000	£'000	£'000
Loss and total comprehensive loss for the period		-	-	-	-	(2,336)	(2,336)
Issue of shares as part of demerger	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 AccountingStandards 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 £ which is the functional and presentational currency of the Company. Balances in the Financial Statements are rounded to the nearest thousand (£'000) except where otherwise indicated.

Summary of Significant Accounting Policies

Research and development expenses

The costs relating to the development of products are accounted for in accordance with IAS 38 "Intangible Assets", where they meet the criteria for capitalisation.

Development costs are capitalised as an intangible asset if all of the following criteria are met:

1.  The technical feasibility of completing the asset so that it will be available for use or sale;

2.  The intention to complete the asset and use or sell it;

3.  The ability to use or sell the asset;

4.  The asset will generate probable future economic benefits and demonstrate the existence of a market or the usefulness of the asset if it is to be used internally;

5.  The availability of adequate technical, financial and other resources to complete the development and to use or sell it; and

6.  The ability to measure reliably the expenditure attributable to the intangible asset.

Research costs are expensed when they are incurred.

The assessment whether development costs can be capitalised requires management to make significant judgements. Management has reviewed the facts and circumstances of each project in relation to the above criteria and in management's opinion, the criteria prescribed under IAS 38.57 "Intangible Assets" for capitalising development costs as assets have not yet been met by the Company in relation to its current product candidates which are all pre Phase II. Accordingly, all of the Company's costs related to research and development projects are recognised as expenses in the income statement in the period in which they are incurred with £414,000 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 £1,250,000 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 £250,000 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

Share Issue Details	Number of shares	Weighted average shares
19 March 2021 - Issue of shares on incorporation	5,000 A
20 May 2021 - Issue of shares - share placing	24,992,500
18 June 2021 - Issue of shares on acquisition of ORPH Pharma IP Company 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 £1 issued on incorporation of the Company was subdivided into 5,000 ordinary shares of 0.02p each

The calculation of loss per share is based on the following:

	Period to 31 December 2021
Loss after tax attributable to equity holders of the Company (£'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 Licences & Data	Patents & Trademarks	Total
Group	£'000	£'000	£'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:

Share issue date				Number of ordinary shares	Share  Capital £'000	Share Premium £'000	Costs charged against share premium £'000	Merger Reserve £'000
19 March 2021 - on incorporation, 1 share of £1				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 £1,829,000 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 £1 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 £5,000.

On 18 June 2021, 225,002,500 ordinary shares of 0.02p were issued at a valuation of £1,500,000 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 £2,301,000 (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 £22,699,000 (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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