CorMedix Inc. has made a $5 million strategic minority equity investment in Talphera Inc., acquiring 9,090,909 shares at $0.55 per share as part of Talphera's $29 million private placement financing announced September 8, 2025. The investment positions CorMedix as the lead investor in Talphera's ongoing Phase 3 registrational study for Niyad, a lyophilized formulation of nafamostat that has received FDA Breakthrough Device Designation status.
Strategic Partnership with Acquisition Potential
The investment includes significant strategic provisions for CorMedix. Talphera has granted CorMedix exclusive rights for a potential acquisition of the company, with a 60-day exclusive negotiation period following completion and announcement of Phase 3 study results for Niyad. Additionally, CorMedix gains the right to nominate one member to Talphera's Board of Directors.
"We are excited to announce this strategic investment and agreement with Talphera, as we see Niyad as a potential significant improvement above the current standard of care in CRRT," said Joseph Todisco, CEO of CorMedix. "The investment in Talphera is consistent with our business development strategy to invest in highly synergistic and undervalued assets."
Addressing Critical Unmet Need in Acute Care
Niyad is being developed as an anticoagulant for the extracorporeal circuit in continuous renal replacement therapy (CRRT). The therapy targets a significant patient population, with an estimated 165,000 acute kidney injury patients receiving an average 5 to 7 day course of CRRT in hospital ICU settings annually.
Talphera's randomized, double-blind, registrational study NEPHRO CRRT aims to enroll and evaluate 70 adult patients undergoing CRRT who cannot tolerate heparin or are at risk for bleeding. The study's primary endpoint is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours, with key secondary endpoints including filter lifespan, number of filter changes over 72 hours, and dialysis efficacy.
"If approved, Niyad would become the first available FDA-approved regional anticoagulant for CRRT," stated Vince Angotti, Talphera CEO. "The strong interest in this financing, particularly from CorMedix, who recognizes the potential value of Niyad in the acute care market, further enforces our strong belief that nafamostat is a valuable product for physicians as they currently have no ideal options for anticoagulation for CRRT."
Financing Structure and Timeline
The private placement includes $17 million in proceeds at first closing, with the potential to receive an additional $12 million upon achievement of the primary endpoint in the NEPHRO clinical study. Talphera expects to complete the NEPHRO CRRT study by the end of 2025, with Niyad approval anticipated in the second half of 2026.
The financing is led by CorMedix and includes institutional investors Nantahala Capital, Rosalind Advisors, and Rock Springs Capital. In the first closing, Talphera will issue 25,036,363 shares of common stock and 5,845,455 pre-funded warrants at $0.55 per share and $0.549 per pre-funded warrant, respectively.
Nafamostat's Therapeutic Profile
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat, providing a specific billable code for the procedure.
The completion of this financing is expected to provide Talphera with sufficient capital through the planned approval of a Niyad PMA in the second half of 2026, positioning the company to potentially deliver the first FDA-approved regional anticoagulant for CRRT to address a significant unmet medical need in acute care settings.
