Acasti Pharma(ACST)2023-02-14 20:53Financial Data and Key Metrics Changes - The company ended the third fiscal quarter with 34.9 million as of September 30, 2022 [9][35] - Research and development expenses for the quarter totaled 2.2 million in the same quarter of the previous year [33] - General and administrative expenses decreased to 1.8 million year-over-year, attributed to reduced professional fees [33] - The net loss for the quarter was 3.8 million [34] Business Line Data and Key Metrics Changes - GTX-101, a topical spray for postherpetic neuralgia, successfully met all primary outcome measures in its pharmacokinetic study, allowing advancement to the next clinical stage [11][18] - GTX-102 also met all primary outcome measures in its PK bridging study, paving the way for a Phase 3 safety and efficacy trial [19][24] - GTX-104, aimed at treating aneurysmal subarachnoid hemorrhage, is awaiting FDA guidance to initiate its Phase 3 safety study [25][28] Market Data and Key Metrics Changes - The total addressable market for GTX-101 is estimated at 200 million for PHN pain and 150 million, affecting around 4,300 patients annually in the U.S. [22] - The market for GTX-104 addresses a critical need in the care of aSAH patients, a condition with high mortality rates and limited treatment options [26] Company Strategy and Development Direction - The company is focused on leveraging its drug delivery capabilities by reformulating and repurposing marketed drugs for orphan indications with significant unmet medical needs [29][30] - All three drug candidates have received orphan drug designation from the FDA, which may facilitate expedited development and market exclusivity [30] - The strategy includes engaging with key opinion leaders and building relationships with major medical centers to prepare for market adoption upon approval [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, anticipating the initiation of Phase 3 studies for GTX-104 and GTX-102 [36] - The company is awaiting FDA guidance on its proposed Phase 3 study designs, which is crucial for moving forward with clinical trials [28] - The management emphasized the importance of addressing the unmet needs of patients with rare diseases through innovative treatments [59] Other Important Information - The company has completed three successful clinical trials, with two reporting results in December 2022 [36] - The company plans to submit a draft protocol to the FDA for GTX-102's Phase 3 study following the final clinical trial report [40] Q&A Session Summary Question: Enrollment timelines and potential timing for GTX-102 - Management is waiting for the final clinical trial report before submitting to the FDA and expects to initiate study startup activities in the second half of the year [40] Question: Clarification on Type C meeting with the FDA for GTX-104 - The company is still waiting for guidance from the FDA and has not yet had the meeting [42][46] Question: Commercial relationships for GTX-104 - The company is building relationships with key opinion leaders and major medical centers to prepare for market adoption [51][52] Question: Update on GTX-101's pharmacodynamics data - The final clinical report is expected in May, and while pharmacodynamics data will be shared, it was not a primary endpoint of the study [56]