Core Viewpoint - Grace Therapeutics is advancing GTx-104, a novel injectable formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH), with a PDUFA target date set for April 23, 2026, for FDA review of its NDA submission [1][2]. Company Developments - The company is engaged in pre-commercial planning in anticipation of potential FDA approval for GTx-104, supported by positive results from the STRIVE-ON trial, which demonstrated improved clinical outcomes for aSAH patients [2][4]. - The STRIVE-ON trial results were presented at the Society of Vascular and Interventional Neurology annual meeting in November 2025, highlighting the safety and tolerability of GTx-104 compared to oral nimodipine [5][11]. - The company secured approximately $4.0 million in additional funding through the exercise of common warrants, enhancing its financial position for ongoing operations [5]. Financial Performance - For the quarter ended December 31, 2025, the company reported a net loss of approximately $2.3 million, a decrease from a net loss of $4.2 million in the same quarter of the previous year, primarily due to reduced research and development expenses [4][22]. - Research and development expenses for the same period were $0.5 million, significantly lower than $2.2 million in the prior year, reflecting the completion of the STRIVE-ON trial [6]. - General and administrative expenses increased to $2.0 million, up from $1.5 million, attributed to costs associated with GTx-104 pre-commercial planning [7]. Cash Position - As of December 31, 2025, the company had cash and cash equivalents of $18.7 million, a decrease from $22.1 million at the end of March 2025, indicating a need for careful cash management moving forward [8][10]. Market Context - aSAH is a rare and serious condition that has not seen significant innovation in treatment for nearly 40 years, positioning GTx-104 as a potentially transformative therapy if approved [2][12]. - The company holds a strong patent estate that could enhance the long-term market value of GTx-104, benefiting shareholders [2].
Grace Therapeutics Announces Third Quarter 2026 Financial Results, Provides Business Update