Poolbeg Pharma, a clinical-stage biopharmaceutical company focused on developing innovative medicines for unmet medical needs, has announced a conditional fundraising to secure approximately £4.1 million in gross proceeds through the issuance of new ordinary shares.
The fundraising consists of a placing of new ordinary shares to raise not less than £2.655 million via an accelerated bookbuild process, direct subscriptions for new ordinary shares to raise approximately £1.345 million, and a conditional offer to existing eligible retail investors to raise up to £100,000.
The new shares will be issued at a price of 2.5 pence per share, representing a discount of approximately 12% to the closing mid-market price of 2.85 pence on May 19, 2025.
Strategic Funding for Clinical Advancement
The net proceeds will be used to achieve key value inflection points while extending the company's financial runway into 2027. Specifically, the funds will support:
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POLB 001's Phase 2a trial: First patient dosing is expected in the second half of 2025, with Phase 2a topline data anticipated in the second half of 2026, including an interim analysis in the first half of 2026. POLB 001 is an orally delivered p38 MAPK inhibitor designed to prevent cancer immunotherapy-induced Cytokine Release Syndrome (CRS), a severe and potentially life-threatening side effect of cancer immunotherapies.
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Oral GLP-1 proof of concept trial: This trial is expected to commence in the coming months, with topline proof of concept data expected in the first half of 2026. The program utilizes a proprietary encapsulation technology to potentially offer an effective oral alternative for the growing obesity market and overcome delivery challenges associated with peptide-based biologicals.
Market Opportunity and Industry Validation
Poolbeg's strategic expansion of POLB 001 into oncology has unlocked a significant market opportunity expected to exceed US$10 billion, according to independent research commissioned by the company. This estimate encompasses solely Multiple Myeloma and Diffuse Large B-Cell Lymphoma due to rapid advancements in bispecific antibody and CAR T cell therapies for these indications.
The company has received strong indications from major pharmaceutical companies to provide the necessary bispecific antibody, free of charge, to support the Phase 2a trial. This represents significant validation of industry interest in POLB 001 and its potential. Poolbeg sees opportunities for partnering following positive data from this trial.
Director Participation and Governance
Cathal Friel, Executive Chair of Poolbeg Pharma, has indicated his intention to participate in the fundraising by subscribing for new ordinary shares with an investment of £100,000. The company's directors (excluding Cathal Friel and Ian O'Connell) consider the terms of this participation to be fair and reasonable for shareholders.
Conditional Approval and Timeline
The fundraising is conditional upon shareholder approval of resolutions to be proposed at a general meeting scheduled for June 23, 2025. Application will be made for the new ordinary shares to be admitted to trading on AIM, with admission expected to occur on June 25, 2025.
Pipeline Overview
Poolbeg Pharma's pipeline targets areas of high unmet medical need:
POLB 001 for Cancer Immunotherapy-Induced CRS
POLB 001 is a Phase 2-ready asset with strong preclinical and clinical data. It is an oral small molecule p38 MAPK inhibitor that was safe and well-tolerated in two Phase I trials and has demonstrated potent inhibition of CRS-related cytokines, such as TNF-α and IL-6, in clinical and preclinical studies.
CRS is an acute inflammatory reaction that can occur following administration of cancer immunotherapies. Currently, more than 70% of patients treated with T cell engaging bispecific antibodies or CAR T cell therapy experience CRS, which can lead to prolonged hospital stays and mortality risk. There are few approved therapies for CRS management and no approved preventative treatments.
As an oral therapy to prevent or treat CRS, POLB 001 has the potential to enable broader use of cancer immunotherapies, potentially in an outpatient setting. The company estimates that by 2030, approximately 500,000 potential eligible patients with Multiple Myeloma and Diffuse Large B Cell Lymphoma alone will exist across the US and EU.
Oral Encapsulated GLP-1 Program
The company's oral encapsulated GLP-1 program leverages a delivery system that encapsulates active pharmaceutical ingredients using Generally Regarded as Safe (GRAS) components. This approach targets delivery to specific areas of the gut and into systemic circulation for treating metabolic disorders such as diabetes and obesity.
The global GLP-1R market is projected to reach US$150 billion by 2031 in obesity and diabetes alone. Currently, oral GLP-1R options remain limited, with only one oral GLP-1R agonist on the market with a bioavailability of just approximately 1%.
AI Programs and Additional Opportunities
Poolbeg has also developed artificial intelligence programs targeting respiratory syncytial virus (RSV) and influenza, both representing large market opportunities. These programs integrate proprietary multi-parametric clinical data to identify novel host response targets. Several potential targets and clinical-stage repurposing drug candidates have been identified, with discussions ongoing regarding potential collaborations.
Additionally, POLB 001 has potential as a treatment for severe influenza, representing a valuable life cycle opportunity for the drug. It targets the host immune response rather than the virus itself, making it unaffected by viral variance.
Financial Position
The company is debt-free with approximately £6.2 million cash as of March 31, 2025. The net proceeds from the fundraising are expected to extend the cash runway into 2027, through meaningful expected value inflection points.
Poolbeg Pharma remains well-positioned for success, leveraging its proven leadership team's track record and expertise in the pharmaceutical industry as it progresses its high-value pipeline to address critical unmet medical needs for patients and generate shareholder value.
