Talphera, Inc. Q2 FY2025 earnings call

• Vincent Angotti discussed the acceleration of the NEPHRO study enrollment, including restructuring the study, changing clinical sites' target profile, reducing study size, and adjusting processes. The enrollment rate has doubled since May with new target profile sites. • Dr. Shakil Aslam mentioned the acceleration in enrollment, new sites joining the study, and advancing a compassionate use IDE for nafamostat. • Vincent Angotti reiterated low clinical, regulatory, and commercial risks for the nafamostat program due to nafamostat's track record, trial design agreement with FDA, breakthrough designation, and need for an FDA-approved regional anticoagulant.

• Reduced 2025 expected cash operating expense guidance to $16 million to $17 million from $17 million to $19 million. • Cash operating expenses for Q2 2025 totaled $3.7 million, down from $4.3 million in Q2 2024. • Discussed financings with conditions related to 17 and 35 patients enrolled and stock price, with investors having the right to waive conditions.

• Supply chain issues with heparin and citrate, with ongoing shortages. • Commercial risk, but low clinical, regulatory, and commercial risks for nafamostat program due to its track record, trial design, regulatory path, and need for an FDA-approved regional anticoagulant.

Q: Get a sense for the acceleration to the 70 enrollment target by year-end given recent enrollment.

A: Vincent Angotti said enrollment rates are increasing, with new sites enrolling at a steady rate, and 2 new sites with the new profile have come on board, expecting to have all 9 target profile sites up and running by end of quarter.

Q: Status of heparin and citrate shortages and second tranche financing.

A: James Molloy was told heparin is episodic with supply chain challenges, citrate has shortages possibly due to manufacturing and other supply issues; Raffi mentioned investors can waive conditions for financings, focusing on 17-patient milestone.

Q: New site initiations and patient enrollment trepidation.

A: Naz Rahman was informed Shakil Aslam vetted sites with criteria on site initiation time lines, 2 new sites activated, and patient enrollment acceleration due to nephrologists' passion and right patient population, not just supply shortages.