Core Insights - Talphera, Inc. closed a $17 million first tranche financing led by CorMedix, which is expected to provide sufficient capital through a potential PMA approval of Niyad anticipated in late 2026 [1][2] - The NEPHRO study, which is crucial for the development of Niyad, is progressing with 5 of the 9 target clinical sites activated, and completion is expected in the first half of 2026 [1][2][12] Financial Highlights - As of September 30, 2025, Talphera reported cash and investments totaling $21.3 million [1][6] - The combined R&D and SG&A expenses for Q3 2025 were $3.4 million, a decrease from $3.7 million in Q3 2024, primarily due to reductions in personnel and other expenses [6][15] - The net loss from continuing operations for Q3 2025 was $4.4 million, compared to a net loss of $3.4 million in Q3 2024 [6][15] Clinical Development - The NEPHRO CRRT study is designed to evaluate Niyad as an anticoagulant for patients undergoing renal replacement therapy, with a primary endpoint focused on mean post-filter activated clotting time [12][11] - Positive feedback from principal investigators indicates a strong preference for nafamostat as an alternative to current CRRT anticoagulants, contributing to ongoing enrollment momentum in the NEPHRO study [2][12] Strategic Partnerships - CorMedix's investment includes the right to nominate a board member and an exclusive negotiation period for a potential acquisition following the Phase 3 study results for Niyad [6][2] - The financing round also included support from existing investors and new institutional investors, highlighting the market opportunity for Niyad [2][6]