Acasti Pharma(US:ACST)2022-06-21 18:54Financial Data and Key Metrics Changes - Research and development expenses for the year ended March 31, 2022, totaled $5.6 million, an increase from $4.2 million for the year ended March 31, 2021 [26] - General and administrative expenses for the year ended March 31, 2022, were $9.3 million, compared to $5.5 million for the year ended March 31, 2021 [27] - Net loss for the year ended March 31, 2022, was $9.8 million or $0.27 per share, compared to a net loss of $19.7 million or $1.33 per share for the year ended March 31, 2021 [28] Business Line Data and Key Metrics Changes - The company has three drug candidates in clinical development: GTX104, GTX102, and GTX101, all acquired through the Grace Therapeutics merger [8][18] - GTX104 is a novel formulation of nimodipine for IV infusion targeting patients with Subarachnoid Hemorrhage (SAH), with a total available market in the U.S. estimated at over $300 million [11][16] - GTX102 is a concentrated oral mucosal spray of betamethasone aimed at treating Ataxia-telangiectasia, with a market opportunity estimated at $150 million in the U.S. [19] - GTX101 is a non-narcotic topical bioadhesive bupivacaine spray for Postherpetic Neuralgia, addressing significant unmet needs in pain management [21] Market Data and Key Metrics Changes - SAH affects approximately 50,000 patients annually in the U.S., with a high mortality rate before reaching the hospital [10] - The current standard of care for SAH is an orally administered nimodipine, which has limitations in administration and absorption [12][16] Company Strategy and Development Direction - The company aims to reformulate and repurpose marketed medicines for rare and orphan diseases, utilizing the 505b2 regulatory pathway for faster drug approval [8][9] - The focus is on advancing clinical programs for GTX104, GTX102, and GTX101, with plans to initiate Phase 3 studies for GTX104 and GTX102 and Phase 2 for GTX101 [43][44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about fiscal year 2023 being transformative, with several important milestones expected [43] - The company anticipates submitting an NDA for GTX104 in early 2024, following the completion of a safety study [32][44] Other Important Information - The company had approximately $44 million in cash, cash equivalents, and short-term investments as of March 31, 2022, down from $60.7 million the previous year [25] - Monthly cash burn is expected to increase from $800,000 to $2 million as clinical trials ramp up [40] Q&A Session Summary Question: What is the design and number of patients for the safety study of GTX104? - The safety study is designed for 100 to 125 patients, comparing GTX104 with the oral nimodipine capsule, expected to complete in 12 to 18 months [32] Question: When are the patents expected to issue following the notice of allowances? - The company expects the patents to issue very soon [34][35] Question: Has the PK bridging study protocol for GTX102 been developed or approved? - The study protocol for GTX102 has been completed and is set to start within the next month [38] Question: What is the expected monthly cash burn as trials begin? - Monthly cash burn is expected to increase to upwards of $2 million as clinical trials commence [40]