Financial Performance - The company reported a net loss of approximately $2.3 million, or $0.14 per share, for Q3 2026, a decrease of $1.8 million from a net loss of $4.2 million, or $0.36 per share, in Q3 2025[5]. - The net loss for the three months ended December 31, 2025, was $2.315 million, compared to a net loss of $4.155 million for the same period in 2024, indicating an improvement of approximately 44.5%[20]. - The company reported a basic and diluted loss per share of $0.14 for the three months ended December 31, 2025, compared to $0.36 for the same period in 2024, showing a decrease of approximately 61.1%[20]. Research and Development - Total research and development expenses for Q3 2026 were $0.5 million, down from $2.2 million in Q3 2025, primarily due to the completion of the GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial[6]. - Research and development expenses for the three months ended December 31, 2025, were $462 thousand, significantly lower than $2.194 million for the same period in 2024, a reduction of about 78.9%[20]. - The company anticipates potential clinical benefits from GTx-102 in decreasing symptoms associated with A-T, with a Phase 3 trial planned[18]. Cash and Funding - As of December 31, 2025, cash and cash equivalents were $18.7 million, a decrease of $3.4 million compared to $22.1 million at March 31, 2025[8]. - The company secured approximately $4.0 million in additional funding through the exercise of common warrants at an exercise price of $3.003 per share[4]. - The company plans to utilize its cash reserves for regulatory review, pre-commercial planning, and potential product launch of GTx-104 if approved[10]. - Grace Therapeutics is actively managing its cash runway and exploring opportunities for market expansion and new product development[18]. Assets and Liabilities - Total assets decreased to $68.488 million as of December 31, 2025, down from $71.993 million on March 31, 2025, reflecting a reduction of about 4.3%[19]. - Total liabilities decreased to $3.596 million as of December 31, 2025, down from $5.383 million on March 31, 2025, a decline of about 33.2%[19]. - The accumulated deficit increased to $227.302 million as of December 31, 2025, compared to $220.687 million on March 31, 2025, reflecting an increase of approximately 3%[19]. Product Development and Market Position - The STRIVE-ON trial demonstrated a 19% reduction in clinically significant hypotension for patients treated with GTx-104 compared to oral nimodipine (28% vs. 35%) and showed improved functional outcomes at 90 days[11]. - The company anticipates potential FDA approval of GTx-104 by the PDUFA target date of April 23, 2026, supported by a robust data package from the STRIVE-ON trial[3]. - GTx-104 is positioned to address significant unmet medical needs in aSAH patients, with the standard of care having seen no meaningful innovation in nearly 40 years[3]. - Grace Therapeutics is focused on the development of GTx-104 and GTx-102 drug candidates, with ongoing regulatory submissions and trials expected to impact future performance[18]. - The company has over 40 granted and pending patents, enhancing the long-term market value of GTx-104[16].
Grace Therapeutics, lnc.(GRCE) - 2026 Q3 - Quarterly Results