Core Insights - Polyrizon Ltd. is advancing its clinical strategy for PL-14, an intranasal allergy blocker aimed at treating seasonal allergic rhinitis, in preparation for regulatory approval and commercialization [1][2][3] Clinical Strategy - The company is structuring its clinical plan to support a pre-submission meeting with the U.S. FDA, which will be followed by the initiation of clinical trials [2] - Comprehensive clinical studies will assess efficacy, safety, user experience, and nasal residence time of PL-14 [5] Clinical Trials Timeline - Polyrizon expects to begin clinical trials in the U.S. and Europe between late 2025 and early 2026, after completing preclinical work and the upcoming FDA consultation [2] Product Technology - Polyrizon specializes in innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens in the nasal cavity [3] - The proprietary Capture and Contain (C&C) hydrogel technology is designed to function as a "biological mask" [3] Additional Development - The company is also developing the Trap and Target (T&T) technology for nasal delivery of active pharmaceutical ingredients, which is currently in pre-clinical development [3]

Core Viewpoint - Polyrizon Ltd. has initiated preclinical studies for intranasal Benzodiazepines (BZDs) aimed at improving emergency treatment options for acute repetitive seizures and status epilepticus using its proprietary drug delivery platform [1][5][8]. Company Summary - Polyrizon is a development stage biotech company focused on innovative intranasal hydrogels and drug delivery systems, including its Trap and Target™ (T&T) platform for administering BZDs [1][8]. - The company is collaborating with Professor Fabio Sonvico from the University of Parma, an expert in intranasal drug delivery solutions, to conduct these preclinical studies [4]. Industry Summary - The global acute repetitive seizures market was valued at approximately USD 3.15 billion in 2024 and is projected to grow at a CAGR of 12.7% from 2025 to 2030 [2]. - The global epilepsy treatment devices market was valued at around USD 526.8 million in 2023 and is expected to reach approximately USD 787.3 million by 2033, growing at a CAGR of about 4.1% from 2024 to 2033 [3].

Raanana, Israel, March 14, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announced today that it has signed a non-binding Letter of Intent (LOI) with a biotech company focused on psychedelic-derived therapeutics (“the psychedelic company”), to develop a novel intranasal formulation for psychedelic-based treatment applications. This agreement aims to leverage Polyri ...

Core Viewpoint - Polyrizon Ltd. is advancing its development of intranasal Naloxone, a treatment for opioid overdose, through preclinical studies utilizing its Trap and Target™ platform, which aims to enhance drug delivery and effectiveness [1][3][4]. Company Overview - Polyrizon is a development stage biotech company focused on innovative medical device hydrogels delivered as nasal sprays, which create a barrier in the nasal cavity against viruses and allergens [6]. - The company is also developing its Capture and Contain (C&C) hydrogel technology, which aims to improve bioadhesion and retention for drug delivery [6]. Industry Context - The opioid crisis is a significant global public health emergency, with a rise in overdose fatalities largely driven by synthetic opioids like fentanyl [4]. - The global Naloxone market is projected to reach $2.47 billion by 2032, with a compound annual growth rate (CAGR) of 11% [4]. - The intranasal Naloxone spray market is expected to reach $1.4 billion by 2030 [4]. Product Development - The preclinical studies will evaluate key parameters such as drug loading capacity, release kinetics, nasal deposition, and stability, which are essential for future safety and efficacy testing [3]. - The proprietary T&T platform is designed to optimize drug delivery, potentially increasing bioavailability and ensuring rapid opioid reversal in emergency situations [4][5].

Company Overview - Polyrizon Ltd. is a development stage biotech company focused on innovative intranasal hydrogels [3] - The company specializes in medical device hydrogels delivered as nasal sprays, creating a barrier against viruses and allergens [3] - Polyrizon's proprietary technology, Capture and Contain (C&C), aims to function as a "biological mask" in the nasal cavity [3] Recent Developments - Polyrizon has filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2024, with the U.S. SEC [1] - The report is accessible on the SEC's website and Polyrizon's Investor Relations website [2] Technology and Research - The company is developing its C&C hydrogel technology to enhance bioadhesion and retention for drug delivery [3] - An additional technology, Trap and Target (T&T), is in pre-clinical development for nasal delivery of active pharmaceutical ingredients [3]

Financial Performance - The company reported operating losses of $1.302 million and $635,000 for the years ended December 31, 2024, and December 31, 2023, respectively, with an accumulated deficit of approximately $5.06 million as of December 31, 2024[56]. - The company reported a net loss of approximately $1,545,000 for the year ended December 31, 2024, and $600,000 for the year ended December 31, 2023, indicating ongoing financial challenges[69]. - The company has substantial doubt about its ability to continue as a going concern, which may hinder its ability to raise additional funds on reasonable terms[69]. - The company has incurred significant losses since inception and expects to continue doing so for the foreseeable future, impacting its ability to achieve profitability[56]. - The company expects to satisfy future cash needs through debt or equity financing until it can generate significant recurring revenues[69]. Regulatory and Approval Challenges - The company is subject to significant regulatory oversight, which may delay or disrupt the development and commercialization of its product candidates[56]. - The company has not yet obtained regulatory approval to market any product in the United States or other jurisdictions, which limits market opportunities[11]. - The company has not conducted a pre-submission meeting with the FDA's CDRH regarding the potential Class II medical device path for its PL-15 and PL-16 product candidates, which may lead to a lengthier approval process[79]. - The FDA's 510(k) clearance process typically takes from three to twelve months, while the PMA process can take one to three years or longer, impacting the timeline for product launches[74]. - The company faces significant risks associated with successfully completing clinical trials and obtaining regulatory approvals for its product candidates[13]. Clinical Trials and Development - The company anticipates significant increases in expenses as it plans to begin clinical trials for its C&C product candidates in the fourth quarter of 2025 and seeks regulatory approvals[57]. - Clinical trials are lengthy and expensive, with uncertain outcomes, and the company may experience delays due to various factors including patient recruitment and regulatory approvals[102]. - The company may face difficulties in patient enrollment for clinical trials due to various factors, which could delay or terminate trials and increase costs[71]. - The company may need to conduct additional preclinical experiments and clinical trials if it cannot pursue anticipated regulatory pathways, increasing time and financial resources required for approval[110]. - The company anticipates conducting clinical trials outside the United States, which presents additional risks that may delay completion[106]. Financing and Capital Structure - As of December 31, 2024, the company had cash and cash equivalents of $2.55 million and will require significant additional financing to fund its operations[63]. - The company relies on equity securities sales, convertible loans, and grants from the Israeli Innovation Authority to finance its operations[58]. - The company may experience dilution of ownership interest if it raises capital through the sale of equity or convertible debt securities[67]. - The company may need to significantly curtail, delay, or discontinue research, development, or commercialization efforts if funding is not obtained on acceptable terms[68]. Intellectual Property and Competition - The company’s patent portfolio consists of a single patent family as of March 10, 2025, with uncertainties regarding the issuance and enforceability of patents[169]. - The company’s commercial success depends on avoiding infringement of third-party patents, with numerous existing patents in the biotechnology and pharmaceutical industries[180]. - The company may face substantial litigation expenses and resource diversion if it is involved in defending against claims of intellectual property infringement[184]. - The company may not successfully identify, discover, or license additional product candidates, which could adversely affect its business operations[200]. - The company faces intense competition from both domestic and international pharmaceutical and medical device companies, which may develop more effective or cost-efficient products[142]. Market Acceptance and Reimbursement - The commercial success of product candidates depends on acceptance by the medical community, including physicians and healthcare payors, which is influenced by clinical safety and efficacy demonstrated in trials[220][221]. - Coverage and reimbursement from third-party payors are crucial for the acceptance and utilization of product candidates in medical procedures[223][224]. - The company anticipates pricing pressures due to trends in managed healthcare and cost containment measures, which may affect the commercialization of new product candidates[226]. - Obtaining coverage and reimbursement approval is a time-consuming process that may require extensive scientific and clinical data[228]. Operational Risks - The company currently lacks a marketing and sales organization, which may hinder its ability to generate revenue from product candidates[215]. - The company faces risks related to political, economic, and military instability in Israel, which could adversely affect its business and financial condition[242]. - The company incurs expenses in multiple currencies, including Euros and New Israeli Shekels, exposing it to foreign currency exchange fluctuations[248]. - The company’s commercial insurance does not cover losses from events associated with the security situation in the Middle East, which could materially affect its financial condition[246]. - Employee misconduct or noncompliance with regulatory standards could result in significant fines or sanctions, impacting the company's reputation and financial performance[205].

Core Viewpoint - Polyrizon Ltd. has initiated preclinical studies for intranasal Naloxone, aiming to enhance opioid overdose treatment through its innovative Trap and Target™ platform [1][3][4] Company Overview - Polyrizon is a development stage biotech company focused on innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [6] - The company is advancing its proprietary Capture and Contain (C&C) hydrogel technology and the Trap and Target (T&T) platform for nasal delivery of active pharmaceutical ingredients [6] Industry Context - The opioid crisis is a global public health emergency, with a significant rise in overdose fatalities driven by synthetic opioids like fentanyl [4] - The global Naloxone market is projected to reach $2.47 billion by 2032, growing at a CAGR of 11%, while the intranasal Naloxone spray market is expected to reach $1.4 billion by 2030 [4] Research and Development - The preclinical studies will evaluate key parameters such as drug loading capacity, release kinetics, nasal deposition, and stability, which are essential for further safety and efficacy testing [3] - The T&T platform is designed to optimize drug delivery, potentially enhancing the bioavailability and effectiveness of intranasal Naloxone [4]

Core Viewpoint - Polyrizon Ltd. has initiated preclinical studies for intranasal Naloxone, aimed at improving opioid overdose treatment through its innovative Trap and Target™ platform [1][3][4]. Company Overview - Polyrizon is a development stage biotech company focused on creating intranasal hydrogels, including a proprietary hydrogel technology called Capture and Contain™ [6]. - The company is advancing its Trap and Target™ technology for the nasal delivery of active pharmaceutical ingredients [6]. Industry Context - The opioid crisis is a significant global public health emergency, with a notable increase in overdose fatalities driven by synthetic opioids like fentanyl [4]. - The global Naloxone market is projected to reach $2.47 billion by 2032, with a compound annual growth rate (CAGR) of 11% [4]. - The intranasal Naloxone spray market alone is expected to reach $1.4 billion by 2030 [4]. Research Collaboration - The preclinical studies will be conducted in collaboration with Professor Fabio Sonvico from the University of Parma, an expert in intranasal drug delivery [2]. Study Objectives - The studies will evaluate key parameters such as drug loading capacity, release kinetics, nasal deposition, and stability, which are essential for further safety and efficacy testing [3]. Advantages of Intranasal Delivery - Intranasal delivery of Naloxone offers several benefits, including ease of administration, reduced need for trained personnel, and increased accessibility for emergency responders and at-risk individuals [5].

Core Viewpoint - Polyrizon Ltd. has filed a divisional patent application for its Trap & Target (T&T) platform technology, aimed at enhancing intranasal drug delivery and improving medication effectiveness [1][2]. Company Overview - Polyrizon is a development-stage biotech company focused on innovative intranasal hydrogels, specifically designed to create a barrier against viruses and allergens while delivering medications effectively [8]. Patent Application Details - The divisional patent application is specifically for the T&T platform, which is part of a broader strategy to secure intellectual property for its two core technologies: Capture and Contain (C&C) and Trap and Target (T&T) [1][5]. - The T&T platform aims to improve the bioavailability of active pharmaceutical ingredients (APIs) and address challenges in local and systemic drug delivery [2]. Key Features of the T&T Platform - Prolonged Residence Time: Enhances the duration drugs remain at the nasal absorption site for better absorption and efficacy [7]. - Improved Bioavailability: Increases the amount of drug reaching systemic circulation, potentially improving therapeutic outcomes [7]. - Controlled Release: Allows for precise management of API release kinetics [7]. - Prevention of Dripping: Designed to prevent formulation from dripping out of the nasal cavity [7]. - Biodegradable Components: Utilizes safe and environmentally friendly biodegradable polymers [7]. - Versatility: Compatible with various drug types, including small molecules, proteins, peptides, and antibodies [7]. CEO Commentary - The CEO of Polyrizon emphasized that the patent application is a significant step in strengthening the company's global intellectual property portfolio and believes the T&T platform can transform intranasal drug delivery, improving efficacy and safety for a range of medications [4].

Core Viewpoint - Polyrizon Ltd. has filed a divisional patent application for its Trap & Target (T&T) platform technology, aimed at enhancing intranasal drug delivery and improving medication effectiveness [1][2]. Company Overview - Polyrizon is a development-stage biotech company focused on innovative intranasal hydrogels, specifically designed for drug delivery through nasal sprays [6][7]. Patent Application Details - The divisional patent application is intended to protect the advanced intranasal drug delivery system, which increases the residence time of medications and ensures close contact with mucosal tissues [1][2]. - This application aligns with a recently announced U.S. patent application covering Polyrizon's two core technologies: Capture and Contain (C&C™) and Trap and Target (T&T) [1][5]. Trap & Target (T&T) Platform Features - The T&T platform aims to improve the bioavailability of active pharmaceutical ingredients (APIs) and address challenges in local and systemic drug delivery [2]. - Key features of the T&T platform include: - Prolonged residence time for better absorption and efficacy [6]. - Improved bioavailability by bypassing first-pass metabolism [6]. - Controlled release of APIs for optimal therapeutic levels [6]. - Prevention of dripping to maximize efficacy and patient comfort [6]. - Use of biodegradable components for safety and environmental friendliness [6]. - Versatility to accommodate various drug types, including small molecules, proteins, peptides, and antibodies [6]. CEO Commentary - The CEO of Polyrizon emphasized that the patent filing is a significant step in strengthening the company's intellectual property portfolio and believes the T&T platform can transform intranasal drug delivery, enhancing the efficacy and safety of various medications [4].