Plus Therapeutics(US:PSTV)2021-04-23 11:55Financial Data and Key Metrics Changes - As of March 31, 2021, cash and cash equivalents were $14.4 million, an increase from $8.3 million as of December 31, 2020 [21] - Cash used in operations for Q1 2021 was approximately $3 million, compared to $1.5 million in Q1 2020, primarily due to timing differences in accounts payable and accrued expenses [21] - Revenues for Q1 2021 were approximately $118,000, a decrease attributed to the closeout of the BARDA contract [22] - Net loss for Q1 2021 was $2.7 million, compared to a net loss of $1.1 million in Q1 2020, consistent year on year when excluding book gains on warrants reported in the previous year [23] Business Line Data and Key Metrics Changes - Research and development expenses were $1.1 million for Q1 2021, up from $0.9 million in Q1 2020, mainly due to additional RNL development costs [22] - General and administrative expenses decreased to $1.12 million in Q1 2021 from $1.6 million in Q1 2020, driven by reduced professional fees and recruiting expenses [22] Market Data and Key Metrics Changes - The lead drug, RNL, targets recurring glioblastoma, affecting approximately 12,000 patients in the US and a similar number in the EU [8] - The ongoing RESPECT trial is evaluating RNL's safety and efficacy, with interim results showing it can deliver significantly higher radiation doses compared to standard treatments [12][14] Company Strategy and Development Direction - The company aims to expand RNL's clinical development into additional indications, including leptomeningeal metastases and pediatric brain cancers, with pre-IND meetings planned for 2021 [18][19] - A Master Services Agreement was entered into with Piramal Pharma Solutions for the development and manufacturing of RNL, indicating a focus on establishing a robust supply chain [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing RESPECT trial, noting that the trial is progressing well and that they are on track to complete pivotal trial planning with the FDA [25] - The company is focused on maximizing clinical outcomes through enhanced delivery mechanisms and is preparing for potential registration trials by the end of 2021 [31][32] Other Important Information - The company is developing a mathematical model to predict the distribution of RNL, which may enhance delivery accuracy in future trials [17] - Management highlighted the importance of patient and physician collaboration in clinical trials, emphasizing their commitment to addressing rare cancers [42] Q&A Session Summary Question: Regarding the RESPECT study and Cohort Six - Management indicated that the absence of dose-limiting toxicity in Cohort Six suggests that the doses used may be taken forward, but they are also considering increasing flow rates to target microscopic disease [28] Question: Timeline for the next update on Cohort Six - Management expects to provide updates either before the next earnings call or during it, as patient screening is ongoing [30] Question: CMC timeline and drug readiness for pivotal study - Management confirmed they are on track to have the drug ready for registration trials by the end of 2021, with preparations for both Phase 1 and Phase 2 supply chains [31][32] Question: Design thoughts for the next initial clinical study - Management stated that the Phase 1/2 trial is fairly locked in, with overall survival as a primary endpoint, and they are considering a synthetic control arm for Phase 3 [34] Question: Status of clinical sites and COVID-19 impact - Management reported that patient screening is back to normal, and they are considering expanding trial sites for future cohorts [39]