Poolbeg Pharma PLC announced that independent research conducted on behalf of Poolbeg confirms a >$10 billion market opportunity for POLB 001 in Cancer Immunotherapy-Induced CRS as an orally delivered preventative therapy. Cancer immunotherapies have been approved in rare and orphan blood cancers and so the Company can see potential for POLB 001 in one or more of these cancer types. POLB 001 in cancer immunotherapy-induced CRS will be developed alongside Poolbeg's existing portfolio of assets including its influenza programme; its AI drug discovery programmes; and oral delivery of GLP-1 for obesity and other metabolic diseases.

Rare and orphan diseases represent a significant value creation opportunity for the Company and its shareholders as they are underserved and there remains a substantial opportunity for innovative medicines to treat these severe and often chronic conditions. It is anticipated that acquiring and commercialising rare and orphan drugs could potentially lead to attractive revenue generation opportunities. Poolbeg will draw on the expertise of the wider team, including the individuals of the former Amryt team, who have a proven track record of successfully building and commercialising orphan drugs.

Regulatory authorities offer incentives to companies developing orphan drugs, such as reduced filing fees, tax breaks and market exclusivity post approval and the Company Directors believe that Poolbeg is well positioned to benefit from these opportunities. The Company also announced further detail on the significant market opportunity for POLB 001 CRS induced by CAR-T and bispecific antibody treatments (BsAb), where CRS can affect the majority of patients and can lead to extended hospital stays, discontinuation of treatment and mortality risk. There are currently few approved therapies for the management of acute CRS and no preventative therapies indicated for CRS.

The size and attractiveness of this market has encouraged the Company, as the field of cancer immunotherapies, including CAR-T and BsAb, is burgeoning and is expected to grow to USD 100 billion - USD 140 billion by 2030. CRS occurs in the majority of CAR-T and BsAb treatments frequently impacting >70% [iv] of patients and cannot be predicted. All grades of CRS can lead to extended hospital stays, causing an estimated USD 5.5 billion of hospitalisation costs to healthcare systems, and further indirect costs through patient treatment and follow up.

An effective oral preventative therapy for cancer immunotherapy-induced CRS has the potential to significantly reduce direct costs in the healthcare system and improve patient access to these therapeutics, potentially including access to these therapies outside of specialist centres, while further augmenting wider market uptake. Poolbeg recently announced promising in vivo results for POLB 001 in addressing cancer immunotherapy-induced CRS, where CRS clinical symptoms were significantly improved by administration of POLB 001. Dose dependent reductions were seen in all serum proinflammatory cytokines measured.