CorMedix Reveals Strategic Minority Stake Acquisition in Talphera
CorMedix Investment in Talphera: CorMedix Inc. has made a $5 million strategic minority equity investment in Talphera, acquiring 9,090,909 shares at $0.55 each, aimed at supporting Talphera's Phase 3 study for its anticoagulant product, Niyad™.
Niyad's Development and Potential: Niyad, a formulation of nafamostat, is being studied for use in continuous renal replacement therapy (CRRT) and has received Breakthrough Device Designation from the FDA, with the potential to become the first FDA-approved regional anticoagulant for CRRT if successful.
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Talphera Announces Third Quarter 2025 Financial Results and Provides Corporate Update
Financing Update: Talphera, Inc. closed a $17 million first tranche financing led by CorMedix, Inc., with expectations of sufficient capital through a potential PMA approval of their product Niyad in late 2026.
Clinical Study Progress: Five out of nine target clinical sites for the NEPHRO study are activated, with completion expected in the first half of 2026, and positive enrollment momentum reported.
Financial Performance: For Q3 2025, Talphera reported a net loss of $4.4 million, slightly higher than the previous year, with cash and investments totaling $21.3 million as of September 30, 2025.
Future Guidance: The company anticipates cash operating expenses for 2025 to be between $14 million and $15 million, a reduction from previous estimates, as they continue to advance the NEPHRO CRRT registration trial.
Talphera to Host Third Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, November 12, 2025
Financial Results Announcement: Talphera, Inc. will release its third quarter 2025 financial results on November 12, 2025, followed by a live webcast and conference call at 4:30 p.m. ET to discuss the results and business updates.
Webcast and Conference Call Details: The webcast can be accessed through Talphera's website, and a replay will be available for 90 days. Investors can join the conference call using specific dial-in numbers and a conference ID.
Company Overview: Talphera, Inc. is a specialty pharmaceutical company focused on developing innovative therapies for medically supervised settings, with its lead product candidate, Niyad™, currently under investigation as an anticoagulant.
Regulatory Status: Niyad™ has received Breakthrough Device Designation from the FDA, highlighting its potential significance in medical applications.
