Poolbeg Pharma entering a very exciting phase in development

Poolbeg Pharma (LON:POLB, OTCQB: POLBF), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, today announced its unaudited interim results for the six months to 30 June 2022.

Financial & Operational Highlights

• Well capitalised with a strong cash balance of £18.9m as at 30 June 2022

• Significant progress made on developing POLB 001, a treatment for severe influenza

  • LPS human challenge trial commenced in July 2022 with initial results expected by year end 2022
  • Supply Agreement signed and GMP manufacturing completed
  • Key US patent granted in May 2022
  • Continuing to explore further disease indications beyond severe influenza

• Two AI programmes commenced to analyse Poolbeg’s unique human challenge trial data

  • Agreement signed with OneThree Biotech Inc. in February 2022 to identify new drug targets and treatments for Respiratory Syncytial Virus (RSV). The programme is progressing well with the model build and optimisation completed in June 2022, with results expected by the end of 2022
  • In March 2022 an agreement was signed with CytoReason Ltd. to identify novel drug targets for influenza. Data analysis is ongoing, and results are expected in Q2 2023

• Licensed first-in-class broad spectrum RNA-based immunotherapy (POLB 002) for respiratory virus infections from the University of Warwick in January 2022

  • Key European and US patents granted in April and May 2022 respectively

• Diligence completed on POLB 003, an intramuscular vaccine candidate to prevent Melioidosis from University College Dublin. Definitive license agreement being finalised following exclusive option agreement (signed in December 2021)

• Licensed AnaBio Technologies’ micro- and nanoencapsulation technology to develop oral vaccines in January 2022

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “I am pleased with the progress that the team has made to advance and expand our portfolio of products and platforms, and we intend to build on and accelerate this rate of progress in the remainder of 2022 and beyond.

“Poolbeg is entering a very exciting phase in its development with a number of near-term value inflection points expected before year end. This includes the initial results from our LPS human challenge trial for our severe influenza treatment, POLB 001, after which we will seek to out-licence to pharma and biotech companies, generating revenues from upfront payment and downstream milestones and royalties. In addition, the outputs from our RSV and influenza Artificial Intelligence Programmes are expected by the end of 2022 and in Q2 2023 respectively.

“We have strong financial resources available to progress our products and platforms and also to capitalise on new opportunities as we identify them which, in addition to our upcoming value inflection points, gives me confidence that we can generate strong returns for shareholders.”

CEO’s Statement

I am delighted to present the unaudited interim financial statements of Poolbeg Pharma plc for the six months to 30 June 2022. Poolbeg has made significant strides in our first 12 months since IPO on 19 July 2021.

Strong progress across the pipeline

POLB 001 – a p38 MAP Kinase inhibitor for the treatment of severe Influenza, remains on track for initial results by the end of 2022 following the commencement of the bacterial lipopolysaccharide (LPS) human challenge trial. In July 2022, Poolbeg received ethics and competent authority approval to commence the trial following completion of the various preparatory steps including executing a Clinical Trial Agreement, a GMP Supply Agreement and the subsequent completion of GMP manufacturing whilst also achieving a key US patent grant in May 2022. The trial will provide key human data on the efficacy of POLB 001 in treating patients with severe influenza, using LPS as a surrogate. The trial will efficiently, and cost effectively collect both local and systemic efficacy data creating a comprehensive data package which will be attractive to potential partners. Poolbeg then intends to partner or out-licence POLB 001 and initial interactions with potential partners is progressing positively. The Company continues to explore potential new disease indications for POLB 001 beyond severe influenza, which could greatly increase the value of the asset. 
POLB 002 – a first-in-class, intranasally administered, RNA-based immunotherapy for respiratory virus infections in-licensed in January 2022. As a nasally administered and rapidly effective prophylactic antiviral candidate, it could potentially provide an effective solution for protecting at risk patient populations. Key US and European patents were granted in H1 2022 to support the development of POLB 002. 
POLB 003 – having completed due diligence, the Company is now converting the exclusive option agreement (signed in December 2021) to a definitive agreement with University College Dublin to licence this intramuscular vaccine candidate to prevent Melioidosis, a disease predominately found in tropical and sub-tropical regions. As part of the ongoing relationship with UCD, Poolbeg retains an exclusive option agreement and continues to evaluate five additional bacterial vaccine candidates. 
Oral Vaccine Delivery Platform – in January 2022 Poolbeg licensed AnaBio Technologies’ micro- and nanoencapsulation technology to develop oral vaccines. This oral vaccine platform delivers immune stimulating antigens to specific areas of the gut with the objective of activating protective ‘mucosal immunity’ to prevent pathogens from infecting the body. Oral vaccines can significantly reduce distribution and administration challenges thereby enhancing vaccine uptake making it a very attractive platform for partnering. 
RSV Artificial Intelligence Programme – signed an agreement with OneThree Biotech Inc. in February 2022 to identify new drug targets and treatments for Respiratory Syncytial Virus (‘RSV’) through analysis of Poolbeg’s unique human challenge trial data and publicly available datasets by OneThree’s clinically validated artificial intelligence technology. The programme is progressing well with the model build and optimisation completed in June 2022, with results expected by the end of 2022. 
Influenza Artificial Intelligence Programme – signed an agreement with CytoReason Ltd, a leading AI company, in March 2022 to utilise Poolbeg’s unique repository of clinical samples and associated data from influenza human challenge trials along with CytoReason’s existing clinical data to help identify novel drug targets for influenza. Results are expected in Q2 2023 and Poolbeg looks forward to updating the market as to the progress of this programme. 
Business Development – Poolbeg continues to identify and conduct diligence on a range of other opportunities, while the management team looks to expand the existing products and platforms to new areas and evaluate other applications for its unique databank.

Corporate & Financial

Poolbeg remains well capitalised with a strong cash balance of £18.9m as at 30 June 2022. Loss for the period amounted to £1.6m; comprising R&D expenses of £0.7m, administrative expenses of £1.2m and other income & tax rebates of £0.3m.

Poolbeg successfully commenced trading on the OTCQB Venture Market in the United States in March 2022. The OTC Market allows the Company access to one of the world’s largest investment markets and fits with our long-term strategy and ambitions to be dual listed on a national securities exchange in the US, such as Nasdaq, subject to meeting their listing requirements.

Outlook

During the period, the Company has made significant strides in growing and progressing the pipeline of products and platforms and intends to build on and accelerate this progress for the remainder of 2022 and beyond.

Poolbeg is entering a very exciting phase of its development with a number of near-term value inflection points, including the initial results from our first clinical study for POLB 001, expected by the end of the year. In addition, the outputs from our RSV and influenza Artificial Intelligence Programmes are expected by year end 2022 and in Q2 2023 respectively.

The Company has strong financial resources available to progress the existing pipeline and to explore and develop new opportunities to address the growing need for new infectious disease vaccines and treatments. As such, this gives me great confidence that Poolbeg can generate strong returns for shareholders over the coming years.

Jeremy Skillington, PhD

Chief Executive Officer

6 September 2022

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