Grace Therapeutics Reports Increased Net Loss of $4.2 Million for December Quarter

Grace Therapeutics, Inc., formerly known as Acasti Pharma Inc., reported a net loss of $4.2 million, or $0.36 per share, for the quarter ending December 31, 2024, an increase from a net loss of $2.4 million, or $0.21 per share, in the same period the previous year. For the nine months ended December 31, 2024, the company recorded a net loss of $10.2 million, compared to a loss of $9.7 million for the same period in 2023. The increase in losses was attributed primarily to a $4.9 million rise in research and development expenses, driven by the ongoing pivotal Phase 3 clinical trial for its lead product candidate, GTx-104.

Total operating expenses for the quarter were $3.7 million, up from $3.0 million in the prior year, with research and development expenses reaching $2.2 million, compared to $1.4 million in the same quarter of 2023. General and administrative expenses were slightly lower at $1.5 million, down from $1.6 million. The company’s cash and cash equivalents decreased to $11.1 million as of December 31, 2024, from $23.0 million at the end of the previous fiscal year, reflecting the increased operational expenditures.

In terms of strategic developments, Grace Therapeutics has focused on advancing GTx-104, a novel injectable formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH). The company completed enrollment in its Phase 3 STRIVE-ON trial in September 2024, which subsequently met its primary endpoint in February 2025, demonstrating clinical benefits compared to orally administered nimodipine. The company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2025.

The company has also undergone significant organizational changes, including a strategic realignment plan initiated in May 2023, which involved a reduction in workforce and a shift in focus towards GTx-104. This realignment has resulted in a more streamlined operation, with the company now prioritizing the development of GTx-104 while deferring further development of its other drug candidates, GTx-102 and GTx-101, until additional funding is secured.

Looking ahead, Grace Therapeutics anticipates that its existing cash and the net proceeds from a recent private placement, which raised approximately $13.8 million in February 2025, will be sufficient to sustain operations for at least the next 12 months. However, the company acknowledges the need for additional capital to fund ongoing operations and clinical trials beyond that period, as it does not expect to generate revenue from product sales until it successfully completes drug development and obtains regulatory approval.