TALPHERA, INC. Q3 FY2024 earnings call

• Vince Angotti provided an update on the NEPHRO CRRT study, noting 5 active clinical trial sites screening patients with plans to add 2 more by year-end, aiming to complete the study next year.
• Dr. Shakil Aslam discussed optimizing screening processes, including automated text notifications to PIs, targeting high-volume CRRT sites, and consulting regulatory experts.
• Raffi Asadorian mentioned Q3 cash operating expenses totaled $3.5M (vs $3M last year), year-to-date $11.5M, with full-year 2024 expenses expected $15M to $17M, and need for additional capital injection.

No specific product segments discussed; focus is on clinical trial for nafamostat and NEPHRO CRRT study.

• Anticipate the NEPHRO study to be completed next year.
• Full-year 2024 cash operating expenses expected in the $15 million to $17 million range.
• Likely additional capital injection will be required prior to completion of the NEPHRO study.

• Activation of original sites and early enrollment rates did not meet timing expectations.
• Patients with active bleeding or on systemic heparin are excluded from the study, impacting enrollment.

Q: Walk through optimization on screening, ex-U.S. data relevance, and enrollment distribution across sites.

A: Vince and Shakil discussed screening optimizations like site engagement, automated notifications, targeting high-volume sites; ex-U.S. data considered in study design; enrollment distribution expected with some sites contributing more.

Q: Discuss enrollment percentages, physician feedback, data availability, and enrollment acceleration measures for NEPHRO CRRT study.

A: Enrollment percentages fluctuate by site; physicians gave positive feedback on titration; aim to have data next year and are evaluating measures to accelerate enrollment like new site targeting and study design evaluations.