PLRZ News & Events

Polyrizon announced the signing of a non-binding memorandum of understanding with shareholders of Colugo Systems for the acquisition of up to 20% stake in Colugo. Established in 2016, Colugo designs and manufactures aircraft that are designed to drive advancements in aviation in the urban air mobility market. Under the terms of the MOU, two shareholders will sell to Polyrizon approximately 20% of the outstanding share capital of Colugo on a fully-diluted basis. The aggregate purchase price for the Colugo shares is up to $6M, either in cash or through the issuance of Polyrizon shares, as shall be mutually agreed upon in the definitive agreement. Polyrizon's share price will be determined at the signing of the definitive agreement. The closing of Polyrizion acquisition of the Colugo shares is expected to occur promptly following satisfaction of the conditions set forth in the MOU, including execution of a definitive agreement, required corporate approvals of both companies, and waiver or exercise of any right of first refusal or co-sale rights of certain Colugo shareholders. The MOU will terminates upon the earlier of written notice of termination by either party or September 30 if the transaction has not closed by such date.

Polyrizon signed an agreement with a global preclinical Contract Research Organization, or CRO, an expert in biocompatibility and regulatory-compliant testing. This agreement forms part of Polyrizon's ongoing efforts to advance its clinical development program, which also includes a recent manufacturing of GMP production of clinical trial material, successful completion of an FDA pre-submission meeting, and positive preclinical data demonstrating effective allergen-blocking performance. The CRO will conduct a comprehensive package of preclinical biocompatibility studies in accordance with ISO 10993 standards and GLP requirements. The studies are expected to commence in Q2 and represent a key milestone in Polyrizon's potential regulatory pathway toward initiating clinical trials, which are planned to commence later this year. The preclinical program includes cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity and pyrogenicity assessments, designed to support regulatory submissions and ensure product safety prior to human studies.

Polyrizon announced the production of a Good Manufacturing Practice batch of clinical trial material for its lead product candidate. This milestone follows the Company's previously announced manufacturing agreement with Eurofins CDMO AmatsiAquitaine established to support the supply of clinical trial material for Polyrizon's clinical development program. The GMP manufacturing milestone represents a key step in Polyrizon's clinical development program and supports the company's preparations for a planned clinical study in the United States later this year. The GMP batch was manufactured following the production of two prior development batches, which demonstrated batch-to-batch consistency and product stability over time, supporting the robustness and reproducibility of the manufacturing process.The CTM batch was produced in compliance with applicable GMP standards in collaboration with Eurofins CDMO AmatsiAquitaine S.A.S, and will be used to support upcoming clinical activities and regulatory submissions related to the study.