Ra’anana, Israel, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company developing intranasal products based on its proprietary Capture & Contain (C&C) platform, today announced encouraging results from a recent pre-clinical study evaluating the allergen-blocking performance of its PL-14 Allergy Blocker formulation. The study was designed to simulate allergen exposure conditions and assess the ability of PL-14 to prevent allergen penetration ...

Ra’anana, Israel, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced the submission of its full pre-submission (Pre-Sub) package to the U.S. Food and Drug Administration (FDA) for its PL-14 product, designed to help individuals suffering from nasal allergies. The submission includes comprehensive documentation covering manufacturing plans, clinical development strategies, ...

[Financial Statements Index](index=1&type=section&id=Financial%20Statements%20Index) This section provides an index to the company's condensed financial statements and related notes Financial Statements Listing | | Page | | :--- | :--- | | Condensed Balance Sheets | F-2 | | Condensed Statements of Comprehensive Loss | F-3 | | Condensed Statement of Changes in Shareholders' Equity | F-4 - F-5 | | Condensed Statements of Cash Flows | F-6 | | Notes to Condensed Financial Statements | F-7 - F-17 | [Condensed Balance Sheets](index=2&type=section&id=Condensed%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and shareholders' equity at specific dates Condensed Balance Sheets Overview | | As of June 30, 2025 (U.S. dollars in thousands) | As of December 31, 2024 (U.S. dollars in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $15,828 | $2,554 | | Other current assets | $204 | $99 | | Total current assets | $16,032 | $2,653 | | Property and equipment, net | $10 | $10 | | Intangible asset, net | $2,697 | $2,884 | | **Total assets** | **$18,739** | **$5,547** | | **Liabilities and Shareholders' Equity** | | | | Employees and payroll-related liabilities | $45 | $45 | | Other payables and accrued expenses | $249 | $216 | | Warrants liability | $70 | $- | | Total current liabilities | $364 | $261 | | Additional paid-in capital | $23,618 | $10,352 | | Accumulated deficit | $(5,243) | $(5,066) | | Total shareholders' equity | $18,375 | $5,286 | | **Total liabilities and shareholders' equity** | **$18,739** | **$5,547** | - Total assets increased significantly from **$5,547 thousand** as of December 31, 2024, to **$18,739 thousand** as of June 30, 2025, primarily driven by an increase in cash and cash equivalents[3](index=3&type=chunk) - Total shareholders' equity increased from **$5,286 thousand** as of December 31, 2024, to **$18,375 thousand** as of June 30, 2025[3](index=3&type=chunk) [Condensed Statements of Net Income (Loss)](index=3&type=section&id=Condensed%20Statements%20of%20Net%20Income%20(Loss)) This section details the company's financial performance, including revenues, expenses, and net loss over specific periods Condensed Statements of Net Income (Loss) Overview | | Six months ended June 30, 2025 (U.S. dollars in thousands) | Six months ended June 30, 2024 (U.S. dollars in thousands) | | :--- | :--- | :--- | | Research and development expenses | $(776) | $(137) | | General and administrative expenses | $(1,709) | $(210) | | Operating loss | $(2,485) | $(347) | | Financial income (expense), net | $2,308 | $(241) | | **Net loss** | **$(177)** | **$(588)** | | Basic and diluted net loss per share | $(0.12) | $(59.90) | | Weighted average number of shares | 1,443,182 | 10,417 | - Net loss decreased significantly from **$(588) thousand** for the six months ended June 30, 2024, to **$(177) thousand** for the same period in 2025, primarily due to a positive shift in financial income (expense), net[5](index=5&type=chunk) - Operating loss increased from **$(347) thousand** in 2024 to **$(2,485) thousand** in 2025, driven by higher R&D and G&A expenses[5](index=5&type=chunk) [Condensed Statement of Changes in Shareholders' Equity](index=4&type=section&id=Condensed%20Statement%20of%20Changes%20in%20Shareholders'%20Equity) This section outlines changes in shareholders' equity, including contributions, distributions, and net income or loss [For the Six Months Ended June 30, 2025](index=4&type=section&id=For%20the%20Six%20Months%20Ended%20June%2030%2C%202025) Shareholders' equity increased from $5,286 thousand at December 31, 2024, to $18,375 thousand at June 30, 2025, primarily due to $11,100 thousand from the exercise of warrants and $1,768 thousand from the issuance of shares and warrants, partially offset by a net loss of $(177) thousand Changes in Shareholders' Equity (2025) | | Ordinary shares (Number) | Ordinary shares (Amount) | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | | :--- | :--- | :--- | :--- | :--- | :--- | | Balance as of December 31, 2024 | 16,778 | $- | $10,352 | $(5,066) | $5,286 | | Share based payment | - | $- | $398 | $- | $398 | | Issuance of shares, warrants and pre-funded warrants, net | 141,667 | $- | $1,768 | $- | $1,768 | | Exercise of warrants | 5,722,318 | $- | $11,100 | $- | $11,100 | | Net loss | - | $- | $- | $(177) | $(177) | | Balance as of June 30, 2025 | 5,880,763 | $- | $23,618 | $(5,243) | $18,375 | - Total shareholders' equity increased by **$13,089 thousand**, from **$5,286 thousand** to **$18,375 thousand**, during the six months ended June 30, 2025[7](index=7&type=chunk) - The exercise of warrants contributed **$11,100 thousand** to additional paid-in capital[7](index=7&type=chunk) [For the Six Months Ended June 30, 2024](index=5&type=section&id=For%20the%20Six%20Months%20Ended%20June%2030%2C%202024) Shareholders' equity (deficit) improved from $(191) thousand at December 31, 2023, to $(26) thousand at June 30, 2024. This improvement was driven by share-based payments, conversion of convertible loans, issuance of shares, and classification of warrant liability to equity, partially offset by a net loss of $(588) thousand Changes in Shareholders' Equity (2024) | | Preferred shares (Number) | Preferred shares (Amount) | Ordinary shares (Number) | Ordinary shares (Amount) | Additional paid-in capital | Receivables on account of shares | Accumulated deficit | Total shareholders' deficit | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Balance as of December 31, 2023 | 419 | $248 | 10,202 | $- | $3,526 | $(196) | $(3,521) | $(191) | | Share based payment | - | $- | - | $- | $35 | $- | $- | $35 | | Conversion of convertible loan | - | $- | 794 | $- | $225 | $- | $- | $225 | | Issuance of shares | - | $- | - | $- | $- | $177 | $- | $177 | | Classification of warrant liability to equity | - | $- | - | $- | $316 | $- | $- | $316 | | Net loss | - | $- | - | $- | $- | $- | $(588) | $(588) | | Balance as of June 30, 2024 | 419 | $248 | 10,996 | $- | $4,102 | $(19) | $(4,109) | $(26) | - Total shareholders' deficit decreased from **$(191) thousand** to **$(26) thousand** during the six months ended June 30, 2024[9](index=9&type=chunk) - The classification of warrant liability to equity contributed **$316 thousand** to additional paid-in capital[9](index=9&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section summarizes cash inflows and outflows from operating, investing, and financing activities Condensed Statements of Cash Flows Overview | | For the Six Months Ended June 30, 2025 (U.S. dollars in thousands) | For the Six Months Ended June 30, 2024 (U.S. dollars in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,821) | $(337) | | Net cash used in investing activities | $(2) | $- | | Net cash provided by financing activities | $15,097 | $356 | | Change in cash and cash equivalents | $13,274 | $19 | | Cash and cash equivalents at the beginning of the year | $2,554 | $4 | | Cash and cash equivalents at the end of the year | $15,828 | $23 | - Net cash provided by financing activities significantly increased to **$15,097 thousand** in 2025 from **$356 thousand** in 2

Core Points - Polyrizon Ltd. has regained compliance with Nasdaq listing requirements, allowing it to continue trading under the ticker symbol "PLRZ" [1][2] - The company demonstrated compliance with the minimum bid price requirement as per Nasdaq Listing Rule 5550(a)(2) [2] Company Overview - Polyrizon is a biotechnology company focused on developing intranasal products, specifically innovative medical device hydrogels delivered as nasal sprays [3] - The company's proprietary technology, Capture and Contain TM (C&C), creates a hydrogel-based barrier in the nasal cavity to protect against viruses and allergens [3] - Polyrizon is also developing Trap and Target TM (T&T) technology for the nasal delivery of active pharmaceutical ingredients (APIs) [3]

Core Insights - Polyrizon Ltd. announced promising preclinical results for its PL-14 Allergy Blocker, indicating its potential as a barrier-forming treatment for allergic rhinitis [1][3] - The study, conducted with the University of Parma, showed over 60% deposition of PL-14 in the nasal vestibule, crucial for blocking allergen contact [2][3] - The global allergen blocker market is projected to grow from USD 0.14 billion in 2024 to USD 0.21 billion by 2033, with a CAGR of 4.4% [4] Company Overview - Polyrizon specializes in developing intranasal products, particularly hydrogel-based nasal sprays that create a barrier against allergens and viruses [6] - The company's proprietary Capture & Contain (C&C) platform aims to deliver a high concentration of hydrogel to the nasal vestibule, enhancing its effectiveness [4][5] - Polyrizon is advancing its C&C platform towards clinical trials following successful preclinical validation [5]

Core Viewpoint - Polyrizon Ltd. has received approval from the Nasdaq Hearings Panel to continue its listing on the Nasdaq Capital Market, following a plan to address concerns regarding its capital structure and compliance with listing standards [1][3]. Group 1: Nasdaq Listing and Compliance - The Nasdaq Listing Qualifications Department previously issued a public interest determination under Listing Rule 5101 due to the company's issuance of securities in a private placement, particularly concerning Series A warrants [2]. - A hearing was held on June 26, 2025, where Polyrizon presented its plan to avoid complex financing instruments in future capital-raising activities [3]. - The Panel's determination on July 9, 2025, allows the company to maintain its listing, contingent upon regaining compliance with the Minimum Bid Price Rule by October 17, 2025 [3]. Group 2: Financial Position and Capital Structure - Following the private placement, the company reported a cash balance of approximately $15.68 million, and all warrants issued in the transaction have been exercised, simplifying its capital structure [4]. - The elimination of a significant source of potential dilution is expected to enhance long-term shareholder value [4]. Group 3: Internal Controls and Future Plans - The company is implementing a formal internal control framework to govern future securities issuances and ensure compliance with Nasdaq standards, including enhanced oversight and quarterly internal compliance reviews [5]. Group 4: Company Overview - Polyrizon is a development stage biotech company focused on innovative intranasal hydrogels that create a barrier against viruses and allergens in the nasal cavity [5]. - The proprietary Capture and Contain hydrogel technology is designed to function as a "biological mask," and the company is also developing the Trap and Target technology for nasal delivery of active pharmaceutical ingredients [5].

Core Insights - Polyrizon Ltd. announced positive preclinical results for its hydrogel-based Trap & Target (T&T) platform, indicating effective drug delivery to the upper nasal cavity, which is crucial for central nervous system (CNS) applications [1][4] Group 1: Study Results - The study, conducted with the University of Parma, showed that Polyrizon's hydrogel formulation achieved over 60% preferential accumulation in the middle and upper turbinates, enhancing nose-to-brain transport [3] - The results suggest potential applications for CNS indications, such as opioid overdose treatment and seizure management, where rapid brain access is critical [3][4] Group 2: Technology Validation - The CEO of Polyrizon emphasized the validation of the T&T technology's ability to achieve localized deposition in favorable nasal regions, which could lead to new therapies for acute neurological and psychiatric conditions [4] - The hydrogel demonstrated consistent delivery to upper nasal segments while maintaining favorable handling characteristics, supporting further preclinical development [4] Group 3: Future Plans - Polyrizon plans to validate these preclinical results in animal models and initiate safety studies as part of its translational roadmap for the T&T technology [5]

Core Viewpoint - Polyrizon Ltd. has received a notification from Nasdaq regarding potential delisting due to shareholder dilution concerns related to a recent securities issuance [1][2] Group 1: Company Overview - Polyrizon is a development stage biotech company focused on innovative intranasal hydrogels that create a barrier against viruses and allergens in the nasal cavity [3] - The company's proprietary technology, Capture and Contain (C&C), is designed to function as a "biological mask" and is delivered via nasal sprays [3] - Polyrizon is also developing Trap and Target (T&T) technology for the nasal delivery of active pharmaceutical ingredients, which is currently in pre-clinical development [3] Group 2: Nasdaq Notification Details - Nasdaq's Listing Qualifications Department has determined that the issuance of Series A warrants under a securities purchase agreement raises public interest concerns due to substantial dilution for shareholders [1] - The company has the option to request a hearing before a Hearings Panel to contest the delisting, which would stay any suspension or delisting actions pending the outcome of the hearing [2]

Core Insights - Polyrizon Ltd. has announced significant results from ex vivo studies demonstrating the mucoadhesive strength and extensive nasal surface coverage of its proprietary formulation platform [1][2][3] Group 1: Study Findings - The studies were conducted in collaboration with Prof. Fabio Sonvico's laboratory, using excised rabbit nasal mucosa to simulate human nasal tissues [2] - Advanced ex vivo studies showed that Polyrizon's formulation spreads rapidly and uniformly across the nasal mucosa, forming a consistent surface layer [3] - Mucoadhesion testing indicated that the formulation maintains strong attachment to nasal tissue, even under conditions simulating physiological nasal fluid flow, supporting prolonged efficacy [3][4] Group 2: Product Overview - Polyrizon specializes in developing innovative medical device hydrogels delivered as nasal sprays, which create a hydrogel-based barrier in the nasal cavity to protect against viruses and allergens [5] - The proprietary Capture and Contain (C&C) hydrogel technology is designed to function as a "biological mask" and is being further developed for enhanced bioadhesion and prolonged retention for drug delivery [5] - An additional technology, Trap and Target (T&T), is in pre-clinical development focused on nasal delivery of active pharmaceutical ingredients [5]

Company Overview - Polyrizon Ltd. is a development stage biotech company focused on innovative intranasal hydrogels and has initiated preclinical studies for intranasal Benzodiazepines (BZDs) targeting acute repetitive seizures and status epilepticus [1][4] - The company utilizes its proprietary Trap and Target™ (T&T) platform for the intranasal administration of BZDs, aiming to provide rapid and patient-friendly seizure rescue therapy [4][6] Industry Context - According to the World Health Organization, epilepsy affects approximately 50 million people globally, with many existing therapies failing to adequately control acute repetitive seizures [2] - The global market for acute repetitive seizures was valued at USD 3.15 billion in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 12.7% from 2025 to 2030 [2] Research Collaboration - The preclinical studies will be conducted in collaboration with Professor Fabio Sonvico from the University of Parma, an expert in intranasal and pulmonary drug delivery solutions [3] Advantages of Intranasal Delivery - Intranasal delivery of BZDs offers several advantages over traditional administration routes, including ease of use and increased accessibility, allowing for rapid administration of life-saving medication in out-of-hospital settings [5]