Poolbeg Pharma H1 2024 results: POLB 001 on track with positive data and $10bn market opportunity

Poolbeg Pharma (POLB) Follow | POLB, a clinical-stage biopharma company focused on infectious diseases, issued a trading update for the 6 months to June 30, 2024 (H1 2024).

Poolbeg detailed significant operational progress during the half. Its flagship asset POLB 001, a Phase 2-ready anti-inflammatory candidate, proved effective in reducing Cytokine Release Syndrome (CRS) associated with cancer immunotherapies in an in vivo model. The positive data advanced the candidate's pathway and facilitated expansion of patent applications. The US Patent Office has already granted POLB a patent to treat or prevent hypercytokinemia.

Poolbeg also signed an exclusive 12-month option agreement for tPTX, a topical treatment for oral ulcers in patients suffering from Behçet's Disease, with an FDA Fast Track Designation, Orphan Drug Designation, and potential 505(b)(2) approval pathway in the US. POLB also advanced preparations for the clinical trial of its oral GLP-1R candidate for metabolic disorders, expected in late 2024.

On the corporate side, Poolbeg brought in a team from Amryt Pharma, a rare disease specialist sold for €1.48bn to Chiesi Farmaceutica last year. The man behind Amryt and other companies including hVIVO, Cathal Friel, also joined Poolbeg as executive Chairman.

POLB ended the half with a comfortable £10.1m cash balance. Loss for the period amounted to £2.3m, comprised of R&D expenses of £0.7m, admin expenses of £2.1m, and tax rebates and other income and charges of £0.6m.

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Poolbeg delivers another half-year of significant operational progress and positive financial performance as the group remains well-funded with over £10m in cash despite significant investment in its candidates. POLB shares have rallied 44% in the past year as the group has advanced an ambitious pipeline, including POLB 001, which has a 3rd-party confirmed $10bn opportunity as a preventative therapy for cancer immunotherapy-induced CRS, and an oral GLP-1R agonist addressing metabolic conditions like obesity and diabetes.

The successful commercialisation of POLB 001 will be a major value inflection point for Poolbeg. Recent data from POLB 001 has been highly positive and major pharmas have already expressed interest in the candidate as the field of cancer immunotherapies continues to grow, estimated to reach US$100bn by 2030. POLB 001's patent and IP base continued to advance in H1. Poolbeg reported continued engagement with partners, though nothing specific was detailed in today's release.

Poolbeg's strategy is to partner its in-house programmes to realise near-term value, while also targeting revenue generation and profitability from commercial-stage rare and orphan drugs. The group has increasingly focused on the latter, as demonstrated during the period by its agreed acquisition of tPTX. The treatment 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. It shows significant promise as an effective near-term solution for patients suffering from Behçet's Disease.

Poolbeg also continued to advance its AI-led programmes in partnership with CytoReason and OneThree Biotech. The two programmes have identified drug targets with significant commercial appeal within drastically reduced timelines compared to traditional methods. Both projects - for influenza and RSV - are supported by extensive, high-quality datasets ideal for AI analysis. Both are in the preclinical stage with significant near-term upside and offtake discussions in progress.

The addition of the Amryt team should further facilitate Poolbeg's partnering discussions. The team, including Cathal Friel, has a significant track record of acquiring, partnering, developing and commercialising therapies where there is high unmet medical need, such as Poolbeg's POLB 001.

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