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RAANANA, Israel - Polyrizon Ltd. (NASDAQ:PLRZ), a biotech firm focused on intranasal hydrogel technology, has announced the formulation of its clinical strategy for PL-14, a novel intranasal allergy blocker aimed at treating seasonal allergic rhinitis. The company’s clinical plan, structured in anticipation of a forthcoming pre-submission meeting with the U.S. Food and Drug Administration (FDA), is a significant step toward initiating clinical trials and seeking regulatory approval. With a current market capitalization of just $1.97 million and trading near its 52-week low of $0.45, InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 10.16.
The planned clinical studies for PL-14 include a natural exposure efficacy and safety evaluation during peak allergy season, a Human Factors study to assess user experience, and an additional study to determine the nasal residence time of the formulation. Tomer Izraeli, CEO of Polyrizon, expressed optimism about the potential of PL-14 to "provide meaningful value to millions suffering from allergic rhinitis." According to InvestingPro analysis, the company’s stock has experienced significant pressure, with a year-to-date decline of 78.34% and a current price of $0.47.
Clinical trials in the United States and Europe are expected to commence between late 2025 and early 2026, following the completion of preclinical work and consultation with the FDA. The clinical strategy is designed to produce robust data to support the efficacy, safety, and user experience of PL-14. While the company holds more cash than debt on its balance sheet, InvestingPro reports negative earnings with a basic EPS of -$0.54 for the last twelve months. Subscribers can access 8 additional ProTips and comprehensive financial metrics to better evaluate the company’s potential.
Polyrizon specializes in developing medical device hydrogels delivered as nasal sprays, which create a hydrogel-based barrier in the nasal cavity. This barrier is intended to protect against viruses and allergens contacting the nasal epithelial tissue. The company’s proprietary Capture and Contain™ (C&C) hydrogel technology consists of natural components and aims to function as a biological mask by forming a thin shield in the nasal cavity.
Additionally, Polyrizon is developing a separate technology, Trap and Target™ (T&T), which is in the pre-clinical development stage and focuses on the nasal delivery of active pharmaceutical ingredients (APIs).
The press release contains forward-looking statements, which are based on current expectations and projections about future events. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated. Polyrizon cautions that forward-looking statements should not be regarded as guarantees of future performance and that the company does not undertake any obligation to update these statements as new information becomes available.
The information in this article is based on a press release statement from Polyrizon Ltd.
In other recent news, Polyrizon Ltd. has initiated preclinical studies for an intranasal delivery system for Benzodiazepines, aimed at treating acute repetitive seizures. This development is part of their Trap and Target™ platform, which is designed to enhance the efficacy of seizure treatments. Additionally, the company is progressing in preclinical studies for an intranasal formulation of Naloxone, crucial for reversing opioid overdoses. The studies, in collaboration with Professor Fabio Sonvico, focus on optimizing drug delivery to improve bioavailability and effectiveness. Polyrizon has also partnered with an unnamed biotech company to develop an intranasal formulation for psychedelic-based treatments, utilizing their hydrogel technology. This partnership, under a non-binding Letter of Intent, aims to improve drug absorption and bioavailability. Furthermore, Polyrizon has filed a divisional patent application in Israel for their Trap & Target (T&T) platform technology, aiming to protect their advanced intranasal drug delivery system. This filing complements their recent U.S. patent application, reflecting the company’s commitment to securing its intellectual property.
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