Grace Therapeutics Reports Reduced Net Loss and Focus on GTx-104 Development

Grace Therapeutics, Inc. reported a net loss of $938,000 for the three months ending September 30, 2025, a significant decrease from the $3.4 million loss recorded in the same period last year. This translates to a loss per share of $0.06, compared to $0.30 in the prior year. For the six-month period, the company’s net loss was $4.3 million, down from $6.0 million in the previous year. The reduction in losses is attributed primarily to a decrease in research and development expenses, which fell to $568,000 from $2.98 million year-over-year, as the company completed its pivotal Phase 3 clinical trial for its lead product candidate, GTx-104.

In terms of financial position, Grace Therapeutics reported total assets of $66.6 million as of September 30, 2025, down from $72.0 million at the end of the previous fiscal year. The company’s cash and cash equivalents decreased to $16.9 million from $22.1 million, reflecting ongoing operational expenditures. Current liabilities also decreased to $1.2 million from $1.9 million, indicating improved management of short-term obligations. The company’s accumulated deficit increased to $225 million, up from $220.7 million, reflecting the ongoing investment in product development.

Strategically, Grace Therapeutics has focused on its lead candidate, GTx-104, an injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH). The company submitted a New Drug Application (NDA) for GTx-104 to the FDA in June 2025, which was accepted for review in August 2025, with a target decision date set for April 23, 2026. The company has also strengthened its intellectual property portfolio with the issuance of a new patent covering the dosing regimen for GTx-104, extending protection until 2043.

Operationally, the company has streamlined its workforce and management structure as part of a strategic realignment initiated in May 2023, which has resulted in a more focused organization. The total employee headcount has been reduced significantly, allowing for a concentrated effort on GTx-104's development. The company plans to utilize its existing cash reserves to support regulatory review processes, pre-commercial planning, and potential product launch activities, while also seeking additional funding to sustain operations beyond the next 12 months.

Looking ahead, Grace Therapeutics remains optimistic about the potential of GTx-104 to address significant unmet medical needs in the treatment of aSAH. The company anticipates that, if approved, GTx-104 could transform the standard of care for patients suffering from this condition. However, the company acknowledges the need for additional capital to fund ongoing operations and development of its other drug candidates, GTx-102 and GTx-101, which are currently deprioritized pending further funding or strategic partnerships.