Nasus Pharma CEO Issues 2025 Letter to Shareholders

Core Viewpoint - 2025 has been a transformational year for Nasus Pharma, marked by significant clinical advancements and the development of innovative intranasal products aimed at treating emergency medical conditions [2][3]. Group 1: Clinical Development - Nasus Pharma presented integrated data from two early clinical trials of NS002, an intranasal epinephrine powder formulation, which showed potential for faster and higher absorption compared to traditional injectable epinephrine [3]. - The company received authorization from Health Canada to initiate a Phase 2 clinical study of NS002, with the first patient dosed in an open-label trial comparing NS002 to EpiPen® [6]. - An interim analysis of the Phase 2 clinical study is expected to be reported in early Q1 2026 [8]. Group 2: Financial Position - The company successfully completed its initial public offering in August 2025, raising $10 million in gross proceeds, which strengthened its financial position [4]. Group 3: Collaborations and Technology - Nasus Pharma expanded collaboration agreements with Aptar France S.A.S. and AptarGroup Inc. to support the clinical development and commercialization of NS002, leveraging proven technology for faster market access [5]. - The proprietary Nasax powder technology offers a fast, needle-free, and portable method for delivering life-saving medications, with broad potential applications in emergency care [8]. Group 4: Future Plans - The company aims to initiate first-in-human studies for one or two additional pipeline products during 2026, while continuing to advance the NS002 program [7]. - Key regulatory and clinical milestones for NS002 include a planned IND submission in Q3 2026 and the initiation of pivotal and pediatric studies in Q3 and Q4 2026, respectively [8].