Grace Therapeutics, Inc. (formerly Acasti Pharma Inc.) reported its financial results for the quarter ended September 30, 2024, highlighting significant developments in its operations and financial performance. The company, which focuses on developing treatments for rare and orphan diseases, is prioritizing its lead drug candidate, GTx-104, aimed at managing hypotension in patients with aneurysmal subarachnoid hemorrhage (aSAH).

As of September 30, 2024, Grace Therapeutics had cash and cash equivalents of $15.2 million, a decrease from $23.0 million as of March 31, 2024. Total current assets also fell to $16.1 million from $24.0 million in the previous quarter. The company reported total assets of $65.3 million, down from $73.3 million, while total current liabilities increased to $2.7 million from $1.7 million. Shareholders' equity decreased to $56.1 million from $61.7 million.

The company incurred a net loss of $3.4 million for the three months ended September 30, 2024, compared to a loss of $3.3 million in the same period of 2023. For the six months ended September 30, 2024, the net loss was $6.0 million, a decrease from $7.3 million in the prior year. The basic and diluted loss per share improved to $(0.30) from $(0.43) for the three months and to $(0.53) from $(0.97) for the six months.

Research and development expenses surged to $3.0 million for the three months ended September 30, 2024, up from $460,000 in the same period of 2023, primarily due to increased activities related to the pivotal Phase 3 trial of GTx-104. General and administrative expenses also rose to $1.9 million from $1.6 million year-over-year.

Strategically, the company has deprioritized the development of GTx-102 and GTx-101, focusing resources on GTx-104. A significant workforce reduction was implemented in May 2023 as part of a realignment plan to enhance shareholder value. The company is also exploring options to maximize the value of the deprioritized candidates through potential licensing or sales.

In terms of corporate restructuring, Grace Therapeutics transitioned its jurisdiction from Québec to British Columbia on October 1, 2024, and subsequently to Delaware on October 7, 2024. The name change to Grace Therapeutics, Inc. became effective on October 28, 2024, with trading under the symbol "GRCE" on Nasdaq.

The company anticipates that its existing cash will fund operations into the second quarter of 2026, although additional capital will be necessary for ongoing operational needs. The anticipated NDA submission for GTx-104 is planned for the first half of 2025, following the completion of the STRIVE-ON trial, which enrolled patients in late 2023.