Polyrizon advances nasal allergy blocker safety study

RAANANA, Israel - Polyrizon Ltd. (NASDAQ:PLRZ), a biotech firm focused on developing intranasal hydrogels, reported a successful preliminary safety study for its PL-14 Allergy Blocker. The study, leveraging the MucilAir™ model on human nasal tissue, showcased the product’s strong local tolerability, a key step in its development pathway. With a market capitalization of just $1.46 million and negative EBITDA of $1.18 million in the last twelve months, the company is currently in its development phase, as indicated by InvestingPro data.

The PL-14 Allergy Blocker, designed as a mucoadhesive nasal gel spray, aims to provide a physical barrier in the nasal cavity against airborne allergens and is intended to remain effective for approximately four hours following application. The safety evaluation covered several indicators such as tissue integrity, cytotoxicity, cilia beating frequency, mucociliary clearance, and inflammatory response. Compared to untreated and vehicle control groups, the results indicated no significant difference in tissue viability or function, and no inflammatory activation or impairment to nasal epithelial activity was detected. Financial analysis from InvestingPro shows the company maintains a strong balance sheet with a current ratio of 10.16, indicating robust short-term liquidity.

Tomer Izraeli, CEO of Polyrizon, commented on the findings, stating, "These results represent an important milestone in validating the local safety of a formulation of PL-14 3D polymeric network and provide foundational support for advancing our clinical development." He highlighted the company’s ambition to offer a drug-free, well-tolerated nasal spray that forms a stable barrier against daily allergen exposure.

This development is part of Polyrizon’s broader verification and validation program ahead of planned clinical trials and a pre-submission meeting with the FDA. The data are expected to bolster the company’s regulatory strategy and support its forthcoming FDA pre-submission meeting, which is a precursor to clinical trials in the U.S. and Europe anticipated to start in late 2025 or early 2026. Investors tracking this development should note that Polyrizon’s next earnings report is scheduled for May 21, 2025. For deeper insights into Polyrizon’s financial health and additional investment metrics, including 8 key ProTips, consider subscribing to InvestingPro.

Polyrizon specializes in creating medical device hydrogels for nasal sprays, which act as a barrier to viruses and allergens. Its proprietary Capture and Contain™ technology, along with ongoing development of its Trap and Target™ technology for nasal delivery of active pharmaceutical ingredients, underline its commitment to innovation in intranasal treatment solutions.

The company’s forward-looking statements, including the advancement of clinical development and trial commencement timelines, are subject to risks and uncertainties that may cause actual results to differ. These statements are based on current expectations and projections and are made in good faith by the management. This news is based on a press release statement and does not constitute an endorsement of Polyrizon’s claims.

In other recent news, Polyrizon Ltd. has successfully raised approximately $17 million through a private placement involving the sale of Ordinary Shares and investor warrants. This capital will support the company’s general corporate purposes and working capital needs. Additionally, Polyrizon has announced a strategic partnership with a branding consultancy to establish a brand identity for its Capture and Contain™ hydrogel technology, which is designed to protect against allergens and viruses. The branding process will align with the company’s clinical and regulatory milestones.

In terms of product development, Polyrizon is advancing its clinical strategy for PL-14, an intranasal allergy blocker, with plans to initiate clinical trials in the United States and Europe between late 2025 and early 2026. The company has also begun preclinical studies for a new intranasal delivery system for Benzodiazepines, aimed at treating acute repetitive seizures. This research involves collaboration with Professor Fabio Sonvico from the University of Parma.

Polyrizon’s innovative Trap and Target™ technology is in the pre-clinical stage, focusing on the nasal delivery of active pharmaceutical ingredients. These developments are part of Polyrizon’s ongoing efforts to bring its hydrogel-based medical devices to market, offering potential solutions for various medical needs.

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