Successful FDA Approvals
The FDA approved a reduction in the NEPHRO CRRT study size from 166 patients to 70, while maintaining 90% power for the primary endpoint. Additionally, two major protocol changes were approved, improving patient enrollment criteria.
Private Placement Investment Secured
Talphera secured a private placement investment of up to $14.8 million, contingent on achieving certain milestones, providing necessary capital for the NEPHRO study completion.
Reduction in Operating Expenses
Operating expenses were reduced, with combined R&D and SG&A expenses for Q4 2024 totaling $3 million, down from $4.6 million in Q4 2023.
Expansion of Enrollment-Ready Sites
Talphera increased enrollment-ready sites to eight, with plans to reach 13 by mid-year 2025, potentially increasing patient enrollment rates.