CorMedix Invests $5 Million in Talphera for Niyad Anticoagulant Study

CorMedix has made a $5 million strategic minority equity investment in Talphera, acquiring 9.09 million shares at $0.55 per share. Talphera is developing Niyad, a lyophilized formulation of nafamostat, as an anticoagulant for the extracorporeal circuit, which has received Breakthrough Device Designation from the FDA. CorMedix has granted Talphera the exclusive right of first negotiation for a potential acquisition following completion and announcement of Niyad's Phase 3 study results.

Talphera, Inc., a specialty pharmaceutical company focused on innovative therapies for medically supervised settings, has announced the completion of a private placement financing round. The company raised $17 million in the first closing, with the potential to receive an additional $12 million upon achieving the primary endpoint in its NEPHRO clinical study. The financing round was led by CorMedix Inc., with several institutional investors including Nantahala, Rosalind, and Rock Springs Capital participating.

The funds will provide Talphera with sufficient capital to support the planned approval of its Niyad PMA in the second half of 2026. Niyad is a lyophilized formulation of nafamostat, currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit. The drug has received Breakthrough Device Designation from the FDA.

CorMedix, a commercial-stage pharmaceutical company, made a strategic investment in Talphera common stock priced at the market. The institutional investors purchased common stock and pre-funded warrants in lieu thereof, priced at the market. The first closing occurred on September 10, 2025, with Talphera issuing 25,363,363 shares of common stock and 5,845,455 pre-funded warrants at a price of $0.55 per share and $0.549 per pre-funded warrant, respectively.

In the second closing, upon the achievement of the primary endpoint in the NEPHRO CRRT study, Talphera expects to issue additional shares of common stock and pre-funded warrants in the amount of $12 million, at a price of $0.55 per share and $0.549 per pre-funded warrant, respectively. CorMedix has been granted a 60-day period of exclusivity following the announcement of the achievement of the primary endpoint and topline clinical study results to negotiate a definitive agreement to acquire Talphera.

The NEPHRO CRRT study is a prospective, double-blinded trial designed to evaluate 70 adult patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk for bleeding. The primary endpoint is the mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours.

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