Acasti Pharma(US:ACST)2020-02-14 23:23Financial Data and Key Metrics Changes - Research and development (R&D) expenses decreased to $4.2 million for the quarter ended December 31, 2019, from $8.8 million for the same period in 2018, primarily due to a $5.6 million decrease in research contracts as the Phase 3 clinical program neared completion [26] - General and administrative expenses increased to $1.6 million for the quarter ended December 31, 2019, compared to $800,000 for the same period in 2018 [27] - The net loss for the quarter was $15.7 million or $0.18 per share, compared to a net loss of $4.6 million or $0.07 per share for the quarter ended December 31, 2018, mainly due to a noncash financial loss of $7.9 million [27][28] Business Line Data and Key Metrics Changes - The decrease in R&D expenses was attributed to the Phase 3 clinical program getting closer to completion, indicating a shift in focus towards finalizing clinical trials [26] Company Strategy and Development Direction - The company is cautiously optimistic about the potential path forward with the FDA following the unexpected TRILOGY 1 results and is focused on investigating the unusually high placebo response observed in the trial [9][18] - A meeting with the FDA is planned to discuss the findings from TRILOGY 1 and to potentially adjust the statistical analysis plan for TRILOGY 2, which is crucial for the success of the upcoming trial [20][22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the volatility in the stock price and emphasized the importance of the final data from the trials over short-term fluctuations [24] - The company anticipates unblinding the top-line results for TRILOGY 2 in Q3 of 2020, with further guidance to be provided based on the progress of audits and FDA feedback [22] Other Important Information - As of December 31, 2019, the company had $25.7 million in cash, cash equivalents, and marketable securities, which is projected to fund operations through at least December 2020 [23] - The company has no plans to raise additional capital until after the FDA meeting and the unblinding of TRILOGY 2 [23][24] Q&A Session Summary Question: What is the FDA's potential sensitivity to a more rigorous P value for TRILOGY 2? - Management indicated that the investigation will need to clearly describe the phenomena observed in TRILOGY 1, and while a significant P value is desired, being close to it could still be beneficial for discussions with the FDA [30][32] Question: What was the placebo effect in the other sites of TRILOGY 1? - Management stated that details regarding the other 49 sites have not been disclosed yet, as the focus remains on the five sites with the highest placebo response [40] Question: What are the objectives for the FDA meeting? - The meeting aims to share findings from the investigation and seek guidance on the statistical analysis plan for TRILOGY 2, given the unusual placebo effect observed [42][44]