Financial Data and Key Metrics Changes - Cash operating expenses for Q3 2024 totaled 3 million in the same period last year, attributed to the NEPHRO CRRT clinical study [20] - Year-to-date cash operating expenses reached 15 million to 11.1 million, with an additional capital injection likely required before the completion of the NEPHRO study [21] Business Line Data and Key Metrics Changes - The NEPHRO CRRT study has onboarded five active clinical trial sites, with two additional sites expected to begin screening, totaling seven by the end of the year [7][8] - The primary endpoint of the NEPHRO trial is the mean activated clotting time measured over the first 24 hours, with patient participation lasting 72 hours [9] Market Data and Key Metrics Changes - The FDA has expanded the maximum number of trial sites from 10 to 14, indicating a proactive approach to enhance patient enrollment [15] - The company is focusing on high-volume CRRT sites with broader ICU populations to optimize patient recruitment [13] Company Strategy and Development Direction - The company is committed to improving enrollment rates at existing sites and onboarding new productive sites to expedite the NEPHRO trial [8][14] - There is a strong emphasis on leveraging breakthrough designation from the FDA to facilitate study enrollment and completion [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in nafamostat's potential clinical utility, citing a long track record of efficacy and safety in Japan and South Korea [17] - The company anticipates having more information on the clinical trial's progress early next year, indicating a positive outlook for future developments [16] Other Important Information - The company is consulting regulatory experts to implement potential changes to study design elements to facilitate enrollment [14] - Management highlighted the need for an alternative anticoagulant in CRRT, reinforcing the market opportunity for nafamostat [15] Q&A Session Summary Question: Can you walk through the optimization on the screening to drive enrollment? - Management discussed the need for improved site engagement and automated notifications to capture patients before CRRT begins, addressing previous enrollment challenges [26][27] Question: What percentage of patients are screened and successfully enrolled? - Management noted that screening percentages fluctuate by site, and feedback from physicians has been positive regarding patient experiences in the trial [40][41] Question: Will data from the NEPHRO study be available next year? - Management confirmed that the goal is to have data available next year, with a short timeline from study completion to PMA submission [44] Question: What measures are planned to accelerate enrollment? - Management mentioned ongoing evaluations of study design and the implementation of new site strategies to enhance patient identification and enrollment [46][47]
Talphera(TLPH) - 2024 Q3 - Earnings Call Transcript