Acceleration of NEPHRO Study Enrollment
The NEPHRO study enrollment has more than doubled since May, with a strong acceleration in the enrollment rate over the last 6 weeks, primarily from new target profile sites. The number of enrolled patients increased significantly due to strategic changes, including reducing the study size and adjusting site profiles.
Reduction in Cash Operating Expenses
Talphera reduced its 2025 expected cash operating expense guidance to $16-17 million from the previous $17-19 million. The cash operating expenses for Q2 2025 were $3.7 million, a decrease from $4.3 million in Q2 2024, mainly due to reductions in personnel and administrative expenses.
Progress in Compassionate Use IDE
Talphera is advancing a compassionate use IDE for nafamostat with institutions interested in using it for patients not responding well to other anticoagulants. This indicates growing interest and potential market demand for nafamostat.
Breakthrough Designation from FDA
Nafamostat has a breakthrough designation from the FDA, which facilitates efficient access to the agency and quick review and response times, minimizing regulatory risks.