TALPHERA, INC. Q1 FY2025 earnings call

• Began 2025 with strong momentum, NEPHRO CRRT trial had FDA approval with decreased study size, removed exclusion criteria, and activated more sites. - Completed PIPE financing. - Study protocol changed to reduce patient count to 70 from 166, added nephrologist-led sites in medical ICUs. - Added 3 new activated sites, with 5 more expected by mid-year, all fitting new target profile with efficient contracting. - Exploring compassionate use IDE for nafamostat due to institutions seeking alternative to existing anticoagulants. - Continued citrate shortages and heparin supply chain issues create interest in nafamostat. - Niyad would be only FDA-approved regional anticoagulant for CRRT, filling unmet need.

• Reduced 2025 cash operating expense guidance to $17 million to $19 million. - Cash balance at March 31, 2025 was $5.4 million, pro forma $9.8 million post-PIPE financing. - $14.8 million commitment expected later this year due to enrollment acceleration.

• Clinical risk related to study execution, but nafamostat has track record in Japan/South Korea. - Regulatory risk mitigated by FDA breakthrough designation. - Commercial risk exists but mitigated by disadvantages of current CRRT anticoagulants (heparin, citrate).

Q: Was broader enrollment criteria translating into increased enrollment and any color?

A: Yes, more activity at sites with broader criteria, but legacy sites not yet seeing new patients. New sites with different patient populations will yield higher eligible patients once up and running. For legacy sites, other factors besides enrollment criteria impeded enrollment, related to patient population from surgical/cardiothoracic ICUs where heparin use is high.