Latest news with #PoolbegPharma
Daily Mail
a day ago
- Business
- Daily Mail
SMALL CAP IDEA: Poolbeg Pharma raises £4.1m to finance cancer drugs
Raising fresh capital is a familiar rhythm for early-stage biotech companies. For Poolbeg Pharma, the question is not simply whether it can fund its ambitions, but whether its pipeline can justify them. Expert opinion is broadly optimistic on this point - bolstered by a major tick in the box from the US regulator. The company recently announced a £4.1million equity raise, priced at 2.5p per share, a 12 per cent discount to the market price, to finance the next stage of development for its two lead assets. They are POLB 001, targeting cancer immunotherapy induced cytokine release syndrome (CRS), and an oral glucagon like peptide 1 (GLP-1) receptor agonist designed for obesity treatment. The latter is a next-generation, easier-to-administer upgrade to jabs such as Ozempic and Mounjaro. Tackling a major cancer therapy bottleneck POLB 001 is seen as a potential game-changer. It is being developed to tackle cytokine release syndrome, a serious complication arising in patients undergoing CAR-T or bispecific antibody therapies, where an overactive immune response can lead to high fevers, low blood pressure and organ failure. According to analysts at Shore Capital, CRS affects over 70 per cent of patients receiving such therapies and has been a major limiting factor in their wider deployment. POLB 001 is designed as an oral preventative treatment, a notable shift from existing drugs like Roche's injectable Actemra, which is approved for treating CRS after symptoms appear. Broker Cavendish notes that Poolbeg's preclinical and human challenge data already show clear suppression of key inflammatory cytokines. If Phase 2a data confirm this, the company could be first to market with an oral CRS prophylactic, a development that Cavendish estimates could unlock a market opportunity exceeding $10billion, initially in blood cancers and potentially in solid tumours too. The Phase 2a trial is expected to begin in the second half of this year. Big Pharma is reportedly providing the bispecific antibody therapy used in the trial at no cost, a move analysts at both Shore and Cavendish interpret as early validation of POLB 001's commercial promise. Crucially, the putative treatment recently received orphan drug designation from the America's Food & Drug Administration, which significantly enhances POLB 001's commercial appeal, especially when engaging prospective partners. This regulatory tick in the box can't be overstated. Seeking a slice of the weight loss boom Poolbeg's second programme enters another multibillion-dollar market: obesity. With injectable GLP-1 agonists such as Ozempic and Wegovy driving record revenues for Novo Nordisk and Eli Lilly, the race is now on to develop effective oral formulations that improve patient convenience and compliance. Poolbeg's answer is a proprietary microencapsulation technology licensed from AnaBio. A proof-of-concept study will begin this year at the University of Ulster, with topline data due in the first half of 2026. ShoreCap argues that the approach could provide a differentiated product in a market forecast to reach $150billion by the early 2030s. Cash, catalysts and credibility Cavendish notes Poolbeg ended the first quarter of 2025 with £6.2million in cash. The current raise, assuming shareholder approval, will extend the company's runway into 2027. That should be enough to reach multiple clinical milestones and, ideally, deliver the data needed to secure commercial partners. Importantly, the raise also comes with insider backing. Executive chair Cathal Friel has committed to invest £100,000, providing a measure of confidence in the company's direction. Execution Still, investors should keep their eyes on execution. While both POLB 001 and the GLP-1 asset are tackling real clinical problems with significant market potential, they remain pre-revenue and subject to trial risk. Poolbeg's ability to translate promise into partnerships will be the key driver of any future valuation shift. Cavendish maintains a 19p target on the shares, implying significant upside from the current 2.9p. But for that to materialise, the next 12 to 18 months will need to deliver more than just well-funded plans. They will need hard data. For all the latest small- and mid-cap news go to
RTÉ News
27-05-2025
- Business
- RTÉ News
Poolbeg Pharma gets FDA support for POLB 001 drug
Biopharmaceutical company Poolbeg Pharma said the US Food and Drug Administration has granted Orphan Drug Designation (ODD) to its POLB 001 product as an oral preventative therapy for Cytokine Release Syndrome (CRS). Cancer immunotherapy-induced CRS is a severe side-effect that occurs in more than 70% of patients and which may lead to multi-organ failure and death. There are currently no approved preventative therapies for CRS. Poolbeg focusses on the development of innovative medicines to address unmet medical needs and its programmes target large addressable markets including, cancer immunotherapy-induced Cytokine Release Syndrome (CRS) and metabolic conditions such as obesity. The company said the FDA grants orphan status to support the development of medicines for rare disorders affecting less than 200,000 people in the US. It provides Poolbeg with clinical development and commercialisation benefits including the potential for a seven-year period of US market exclusivity after regulatory approval of POLB 001, potential waiver exemption of Prescription Drug User Fee Act application fees and the potential for tax credits for qualifying clinical trials. Poolbeg expects the first patient to be dosed in its proposed Phase 2a in the second half of this year, with interim analysis expected in the first half of 2026 and Phase 2a topline data in the second half of 2026. Jeremy Skillington, the chief executive of Poolbeg Pharma, said that POLB 001 is potentially a breakthrough, orally delivered, preventative therapy for cancer immunotherapy-induced CRS which could significantly impact patients' lives. "We were delighted to receive Orphan Drug Designation from the FDA, which is a significant development for Poolbeg and for POLB 001, one that we believe will enhance the commercial appeal for prospective partners and help bring POLB 001 to the market faster," he said. "If approved, we believe POLB 001 has the potential to improve quality of life for patients, reduce pressure on healthcare systems, and expand access to cancer immunotherapies," the CEO added.
Business Post
27-05-2025
- Health
- Business Post
FDA grants special status to Poolbeg Pharma drug targeting cancer therapy side effect
Poolbeg Pharma said on Tuesday that US regulators have granted special status to its drug POLB 001, which is being developed to prevent a dangerous ...
