CorMedix invests $5mln in Talphera, acquires 9.09mln shares.

CorMedix Inc. has made a $5 million strategic minority equity investment in Talphera Inc., acquiring 9.09 million shares. Talphera is developing Niyad, a lyophilized formulation of nafamostat, for use as an anticoagulant in the extracorporeal circuit. The investment is intended to fund the completion of Talphera's ongoing Phase 3 registrational study for Niyad and pre-launch preparations.

SAN MATEO, Calif., Sept. 2, 2025 — Talphera, Inc. (Nasdaq: TLPH), a specialty pharmaceutical company focused on innovative therapies for medically supervised settings, has announced the receipt of a strategic minority equity investment from CorMedix Inc. (Nasdaq: CRMD). The investment, totaling $5 million, is part of a broader effort to fund the completion of Talphera's ongoing Phase 3 registrational study for Niyad, a lyophilized formulation of nafamostat designed as an anticoagulant for the extracorporeal circuit.

The investment, which includes the acquisition of 9.09 million shares, will provide Talphera with the necessary capital to complete its clinical study and prepare for the potential launch of Niyad. The study, known as the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study, is designed to evaluate the efficacy of Niyad in patients undergoing renal replacement therapy who are unable to tolerate heparin or are at risk for bleeding. The primary endpoint of the study is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours.

The investment from CorMedix is part of a larger financing round that includes other institutional investors. Talphera has previously announced a private placement financing of up to $29 million, with the potential to receive an additional $12 million upon achieving the primary endpoint in the NEPHRO CRRT clinical study. This financing is expected to provide the company with sufficient capital to support the planned approval of a Niyad PMA in the second half of 2026.

Vince Angotti, CEO of Talphera, stated, "We are pleased to have secured this strategic investment from CorMedix, which recognizes the potential value of Niyad in the acute care market. This funding will enable us to complete our clinical study and prepare for the potential approval of Niyad, which would become the first available FDA-approved regional anticoagulant for CRRT."

The private placement financing is led by CorMedix and includes institutional investors Nantahala Capital, Rosalind Advisors, and Rock Springs Capital. The initial closing of the private placement is expected to occur on September 10, 2025, with the potential for a second closing of up to $12 million upon the achievement of the primary endpoint in the NEPHRO CRRT study.

CorMedix has been granted a 60-day period of exclusivity following the announcement of the primary endpoint and topline clinical study results from the NEPHRO CRRT clinical study to negotiate a definitive agreement to acquire Talphera. Additionally, CorMedix has the right to nominate a representative to the Talphera Board of Directors.

References:
[1] https://www.prnewswire.com/news-releases/talphera-announces-private-placement-financing-of-up-to-29-million-priced-at-the-market-302548706.html