Financial Data and Key Metrics Changes - The cash operating expenses for Q1 2025 totaled 4.2 million in Q1 2024, indicating a reduction in personnel and general administrative expenses [17][18] - The company has adjusted its 2025 expected cash operating expense guidance to a range of 19 million [17] Business Line Data and Key Metrics Changes - The nephro CRRT trial has seen a reduction in study size from 166 patients to 70 patients, which is expected to shorten the study completion time [4][5] - The company has added three new clinical study sites that are actively screening patients, with five more expected by mid-year [6][12] Market Data and Key Metrics Changes - There is an ongoing inquiry from healthcare providers regarding the availability of Nefamostat due to shortages of citrate and potential supply chain issues with heparin [7] Company Strategy and Development Direction - The company is focused on completing the nephro study by the end of 2025 and believes that the new site engagement will significantly contribute to study enrollment [11][15] - The company is exploring a compassionate use IDE for Nefamostat, responding to requests from institutions for patients who do not respond well to current anticoagulants [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the low clinical, regulatory, and commercial risks associated with the nephro program, citing a strong track record of nafamostat's efficacy and safety [15] - The company anticipates that the expanded enrollment criteria will lead to increased activity at both legacy and new sites, although immediate results from legacy sites have not yet materialized [24][30] Other Important Information - The company completed a PIPE financing structured in three tranches, with the first tranche received and the remaining tranches contingent on patient enrollment milestones [19] Q&A Session Summary Question: Has the broader enrollment criteria started to translate into increased enrollment? - Management noted that while there has been increased activity at the sites due to broader criteria, it has not yet translated into new patients from legacy sites [24][25] Question: What are the challenges faced by legacy sites in enrolling patients? - The legacy sites are primarily dependent on surgical ICUs or cardiothoracic ICUs, which limits their patient pool despite the expanded criteria [29]
Talphera(TLPH) - 2025 Q1 - Earnings Call Transcript