Acasti Pharma reports Q1 EPS (54c) vs (61c) last year

Cash and cash equivalents as of June 30, 2023, totaled $21.6 million, a decrease of $6.2 million compared to cash and cash equivalents totaling $27.8 million at March 31, 2023, primarily due to ongoing research and development activities, and funding the restructuring expense. “During our first quarter we made substantial progress executing on the strategic vision we laid out in April, moving with full speed to prioritize development of GTX-104, streamline our operations, extend our cash runway to fully fund the clinical development of GTX-104, and strengthen our leadership team with industry leaders in our sector,” said Prashant Kohli, CEO of Acasti. “With FDA alignment of our proposed protocol and dosing regimen for our pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial) now in hand, we are completing our advanced preparations for the trial, and plan to initiate it in the coming weeks. We expect to dose the first patient in this trial in the fourth quarter of this calendar year and, if successful, potentially submit an NDA for GTX-104 in the first half of calendar 2025. With the efficiencies gained through our operational realignment, we reiterate that our projected cash runway now extends to the second quarter of 2025, inclusive of the potential NDA submission. We are excited about the progress we have made and look forward to presenting the data highlighting the potential of GTX-104 at the NCS conference later next week.”