Talphera's 2025 Q2 Earnings Call: Unraveling Key Contradictions in Enrollment Rates and Site Activations

Enrollment rate and targets, impact of heparin and citrate shortages on enrollment, enrollment rates and milestones, site selection and activations are the key contradictions discussed in Talphera's latest 2025Q2 earnings call.



NEPHRO Study Enrollment Acceleration:
- Talphera reported a significant acceleration in NEPHRO study enrollment, with the number of total enrolled patients more than doubling since May.
- The acceleration was driven by changing the target profile of clinical sites to include nephrologist principal investigators and institutions screening patients at medical ICUs, leading to higher enrollment rates and increased interest from institutions in having nafamostat available if approved.

Expense Management and Cash Position:
- Talphera reduced its 2025 expected cash operating expense guidance to $16 million to $17 million, with second-quarter cash operating expenses totaling $3.7 million compared to $4.3 million in the previous year.
- The decrease in expenses was due to reductions in personnel and general administrative expenses, while the cash balance at June 30, $6.8 million, including proceeds from financing, supports the company through the study's completion.

Compassionate Use IDE and Market Opportunities:
- Talphera is advancing a compassionate use IDE with a large institution, providing alternative anticoagulation for patients with contraindications to currently available options.
- The company is addressing a market need due to recurrent shortages of citrate and heparin, with healthcare providers inquiring about the timely availability of nafamostat.

Clinical Study Site Composition and Outcomes:
- Talphera shifted its clinical study sites to focus on nephrologist principal investigators and medical ICUs, resulting in over 90% of the 15 patients enrolled to date originating from new target profile sites.
- The change in site composition led to a substantially higher enrollment rate and enthusiastic engagement from institutions, validating the strategy of altering the target site profile.