Poolbeg Pharma plc (LON:POLB) has announced 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

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, Therapeutics Market, and Vaccines Market.