TALPHERA, INC. Q4 FY2024 earnings call

• Announced a private placement investment of up to $14.8 million in gross proceeds if milestones are achieved, with support from Nantahala Capital and Rosalind Advisors.
• FDA approved reduction of NEPHRO trial size from 166 to 70 patients, with primary endpoint still powered at 90%.
• FDA approved protocol changes: removal of exclusion criterion for patients on CRRT over 48 hours and removal of inclusion criterion requiring documentation of heparin intolerance for most sites.
• Focus on selecting clinical sites with specific characteristics: nephrologist principal investigators, medical ICUs, and efficient administration. Currently, 8 enrollment-ready sites with plans to have 13 by mid-year.
• Nafamostat has extensive clinical use in Japan and South Korea, supporting its safety and efficacy for CRRT anticoagulation.

No product segments discussed in terms of financial performance as the transcript focuses on the NEPHRO CRRT study and financing.

• Anticipate completing the NEPHRO CRRT study by the end of 2025 and submitting the PMA in Q1 2025.
• Expect cash operating expenses (SG&A and R&D, excluding stock-based compensation) to be in the range of $18 million to $19 million in 2025.
• The private placement financing should provide capital to support the study completion by year-end.

• Clinical trial execution risk related to study enrollment and site activation.
• Regulatory risk associated with obtaining FDA approval.
• Commercial risk regarding market acceptance of Niyad compared to existing products like heparin and citrate.

Q: Regarding changes in inclusion criteria, what were the original thoughts?

A: Shakil Aslam explained that the 48-hour CRRT exclusion was possibly due to concern about clinical endpoints, but time on CRRT doesn't impact Niyad's response. The heparin contraindication was required because FDA thought heparin should be used, but most sites didn't use it.

Q: On private placement milestones, any time limits?

A: Raffi Asadorian said no time limits, funding triggers on enrollment and stock price.

Q: Enrollment rate with new criteria?

A: Vincent Angotti and Shakil Aslam discussed that new sites with nephrologists and medical ICUs have higher CRRT volumes, expecting enrollment to increase.

Q: Confidence in data by end of 2025?

A: Vincent Angotti and Shakil Aslam highlighted nephrologists' engagement and the level of interest in Niyad, giving confidence in meeting the timeline.