Talphera(US:TLPH)2025-05-14 21:32Financial Data and Key Metrics Changes - The cash operating expenses for Q1 2025 totaled $2.9 million, a decrease from $4.2 million in Q1 2024. Excluding non-cash stock-based compensation, the amounts were $2.7 million for Q1 2025 compared to $3.9 million for Q1 2024 [15][16] - The company reduced the lower end of its 2025 expected cash operating expense guidance to a range of $17 million to $19 million [15] 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 time to complete the study [4][5] - The company has added three new clinical study sites that are actively screening patients, with five more expected by mid-year [6][9] Market Data and Key Metrics Changes - There are ongoing shortages of citrate supply and potential supply chain issues with heparin, leading healthcare providers to inquire about the availability of Nefamostat [7] Company Strategy and Development Direction - The company is focused on completing the nephro study by the end of the year and has made significant progress in engaging new clinical study sites [5][10] - The company believes that NIAID, if approved, would fill a significant unmet medical need during renal replacement therapy, as it would be the only FDA-approved regional anticoagulant for use during continuous renal replacement therapy [8][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the low clinical, regulatory, and commercial risk elements for the nephro program due to the established track record of nafamostat and the clear regulatory path provided by the FDA [13][14] - The company anticipates that the changes made to the nephro CRRT study and the new sites will accelerate enrollment rates [16] Other Important Information - The company completed a PIPE financing structured in three equal tranches, with the first tranche received at the initial closing [16] - The cash balance as of March 31, 2025, was $5.4 million, or $9.8 million on a pro forma basis after the financing [16] 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 [18][19] Question: What are the challenges with legacy sites? - The legacy sites are still dependent on patient populations that may not align with the new broader criteria, which has limited their enrollment despite the changes [24][25]