Specialist CRO Engaged to Manage European Human Study Operations and Regulatory Submissions for Polyrizon’s NASARIX™ Allergy Blocker

• Polyrizon Ltd. (Nasdaq: PLRZ) has contracted a specialized CRO to oversee study operations and regulatory submissions for a human nasal residence time study of its NASARIX™ (PL-14) Allergy Blocker, to be conducted at a leading European university medical center — marking the CRO’s role as the operational and regulatory bridge enabling European health authority and ethics committee submissions ahead of study commencement.

• The engagement reflects a broader multi-CRO outsourcing strategy from Polyrizon, which has now contracted separate CRO partners for GLP preclinical biocompatibility work, U.S. clinical site execution, and European study operations — across a coordinated development program designed to support dual FDA and European regulatory pathways for the NASARIX™ device.

Polyrizon Ltd. (Nasdaq: PLRZ) has engaged a specialized CRO to manage study operations and regulatory processes for a human performance study of its NASARIX™ (PL-14) Allergy Blocker at a leading European university medical center, announced June 15, 2026, from Raanana, Israel. The CRO appointment is the operational enabler for the study: without it, Polyrizon would be unable to initiate submissions to European health authorities and ethics committees required for study authorization, making the CRO engagement a prerequisite for the program’s progression on the European regulatory track.

The human study is designed to evaluate nasal residence time — how long the NASARIX™ intranasal hydrogel formulation remains within the nasal cavity following administration — using repeated measurements and serial endoscopic visualization in healthy participants at a single European university medical center site. Nasal residence time is a core functional parameter for the NASARIX™ allergy blocker, which works by forming a thin hydrogel-based protective barrier in the nasal cavity to prevent airborne allergens from contacting nasal epithelial tissue. Quantitative human residence time data directly underpins product performance claims, dosing rationale, and the regulatory submission package required to support the company’s FDA pathway. The CRO’s regulatory operations role encompasses preparation and submission of the necessary documentation to European health authorities and ethics committees prior to study commencement.

The European CRO engagement is the third distinct CRO relationship Polyrizon has established as part of a structured, multi-track outsourcing strategy for the NASARIX™ program. In March 2026, the company contracted a leading global preclinical CRO to conduct a comprehensive GLP biocompatibility package under ISO 10993 standards — covering cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity assessments — to support regulatory submissions and confirm product safety ahead of human studies. In parallel, Polyrizon has been building its U.S. clinical trial infrastructure, signing its first Clinical Trial Agreement with a Texas-based allergy research site in May 2026 and expanding to three confirmed U.S. sites by June 2026 for a multi-center study evaluating NASARIX™ safety, tolerability, and efficacy in patients with seasonal allergic rhinitis.

Taken together, the three CRO engagements reflect a deliberate outsourcing architecture in which each CRO partner is assigned a distinct functional role across the NASARIX™ development program: preclinical safety data generation, U.S. clinical site network management, and European study operations and regulatory coordination. This model allows Polyrizon, as a development-stage company, to pursue concurrent regulatory tracks in Europe and the United States without building corresponding internal operational infrastructure — compressing the timeline between preclinical validation and multi-regional clinical evidence generation.

“This study is an important step in quantitatively characterizing a core functional property of NASARIX™ and strengthening our regulatory package. Understanding the nasal residence time of our formulation in human subjects provides critical data that supports both our FDA pathway and our broader efforts to validate the performance of our protective barrier technology.”

Tomer Izraeli, Chief Executive Officer, Polyrizon