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19-Sep-2024

Poolbeg Pharma plc - Interim results for the six months to 30 June 2024

18 September 2024- Poolbeg Pharma (AIM: POLB, 'Poolbeg' or the 'Company'), a clinical-stage biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, announces its unaudited interim results for the six months to 30 June 2024 ("H1 24").

 

Highlights, Business Update & Outlook

Cash balance of £10.1 million as at 30 June 2024, demonstrating continued prudent financial management

Independent research has confirmed a potential market opportunity of c.US$10 billion for POLB 001 as an orally delivered preventative therapy for cancer immunotherapy-induced Cytokine Release Syndrome (CRS)1

Robust data package in place for POLB 001 - efficacy demonstrated in reducing cancer immunotherapy-induced CRS in an in vivo animal model, strengthening and facilitating the expansion of patent applications

US Patent Office granted the Company's Immunomodulator II patent application covering a class of drugs, including POLB 001, to treat or prevent hypercytokinemia (cytokine storm) induced in any disease indication

Engagement continues with potential partners in relation to POLB 001

Exclusive 12-month option agreement signed for tPTX, a novel, topical, muco-adherent treatment for oral ulcers in patients suffering from Behçet's Disease, with FDA Fast Track Designation, Orphan Drug Designation and potential 505(b)(2) approval pathway in the US

Continued progress made in preparation for the upcoming orally-delivered, glucagon-like peptide 1 receptor agonist's (GLP-1R) clinical trial, expected to commence in late 2024

Engaged with partners relating to drug targets and treatments identified in the Company's Artificial Intelligence (AI) led infectious-disease programmes

Successful onboarding of a number of former Amryt Pharma senior executives. Amryt Pharma was a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercialising novel treatments for rare diseases. Previously listed on NASDAQ and AIM, it was acquired by Chiesi Farmaceutica for US$1.48 billion in 2023

The strengthened Poolbeg team has a significant and successful track record of acquiring, integrating, partnering, developing and commercialising therapies for conditions with a high unmet medical need

The Company strategy remains to partner in-house programmes to realise near-term value, while also targeting revenue generation and profitability from commercial-stage rare and orphan drugs

 

 

Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg, commented: "The value and attractiveness of POLB 001 to Pharma partners has been greatly enhanced following the independent confirmation of a potential market opportunity of c.US$10 billion as an oral preventative therapy for cancer immunotherapy-induced CRS. During the period, we also strengthened our patent and overall intellectual property portfolio with positive in vivo data. As Pharma companies seek to enhance the safety and market reach of their cancer immunotherapies, we believe that POLB 001 is well placed to generate value for shareholders while addressing a critical unmet medical need for patients.

 

"Our increasing focus on rare and orphan diseases is exemplified by the exclusive option agreement we signed to acquire tPTX, which comes with robust clinical data, FDA Fast Track Designation, Orphan Drug Designation and the potential for a 505(b)(2) approval pathway in the US. tPTX has the potential to reach patients rapidly and offers a transformative solution for those suffering from Behçet's Disease.

 

"We continue to pursue our efforts to maximise the value of our development pipeline and are seeing significant interest from potential partners. Our experienced team, bolstered by the addition of a number of the former Amryt leadership team, is well-positioned to execute on our strategy of acquiring, developing, partnering, and commercialising innovative medicines that will help improve the lives of patients with rare and orphan diseases, and where there is a high unmet medical need."

 

References

1. Independent research commissioned by Poolbeg

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Last Updated: 19-Sep-2024