Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal administrated solutions,  announced the signing of an agreement with a leading global preclinical Contract Research Organization (CRO), a recognized 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.

Under the agreement, 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 the second quarter of 2026 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.

“This agreement marks an important step in the advancement of our development program,” said Tomer Izraeli, CEO of Polyrizon. “We believe that engaging a globally recognized preclinical partner strengthens our regulatory strategy and supports our expected timeline toward initiating clinical trials later this year.”

Polyrizon continues to execute its development roadmap as it advances its proprietary nasal medical device technology platform toward clinical validation.