Financial Performance - The company reported a net loss of $0.9 million, or $0.06 per share, for Q2 2026, a decrease of $2.5 million from a net loss of $3.4 million, or $0.30 per share, in Q2 2025[6] - As of September 30, 2025, Grace Therapeutics reported cash and cash equivalents of $16.862 million, a decrease from $22.133 million as of March 31, 2025, representing a decline of approximately 24%[21] - The net loss for the three months ended September 30, 2025, was $0.938 million, compared to a net loss of $3.432 million for the same period in 2024, indicating a 73% improvement year-over-year[22] - The company reported a basic and diluted loss per share of $0.06 for the three months ended September 30, 2025, compared to $0.30 for the same period in 2024, showing a significant improvement[22] - Total liabilities decreased to $3.758 million from $5.383 million, a reduction of approximately 30%[21] Research and Development - Research and development expenses decreased to $0.6 million in Q2 2026 from $3.0 million in Q2 2025, primarily due to the completion of the STRIVE-ON trial[7] - Research and development expenses for the three months ended September 30, 2025, were $0.568 million, down from $2.976 million in the same period of 2024, a reduction of approximately 81%[22] - Grace Therapeutics is focused on the development of GTx-102, which aims to provide clinical benefits for patients with A-T, with a Phase 3 trial expected to commence soon[20] Drug Development and Regulatory Status - FDA accepted the NDA for GTx-104 for aSAH treatment, with a PDUFA target date of April 23, 2026[4] - The STRIVE-ON trial showed a 19% reduction in clinically significant hypotension for patients treated with GTx-104 compared to oral nimodipine[12] - GTx-104 has received Orphan Drug Designation from the FDA, granting seven years of marketing exclusivity upon NDA approval[4] - The company anticipates the potential of its GTx-104 drug candidate to enhance treatment options for patients suffering from aSAH, with ongoing regulatory submissions expected to impact future performance positively[20] Financial Position and Assets - Cash and cash equivalents were approximately $20.0 million as of October 31, 2025, following $4.0 million in funding secured from warrant exercises[5] - Total assets decreased to $66.576 million from $71.993 million, reflecting a reduction of about 7.5%[21] Intellectual Property - The company holds five patents on the composition of GTx-104, providing protection until 2037, with a new patent extending protection for the IV dosing regimen to 2043[4] - Grace Therapeutics continues to evaluate its intellectual property strategy to protect its drug candidates and enhance its market position[20] Market Performance - GTx-104 has been administered to over 200 patients and was well tolerated, showing lower pharmacokinetic variability compared to oral nimodipine[14] - The company estimates a cash runway through at least the next twelve months, potentially extending into Q2 2027 if all common warrants are exercised[11] - The company has reported a change in fair value of derivative warrant liabilities, resulting in a gain of $1.427 million for the three months ended September 30, 2025, compared to a gain of $0.362 million in the same period of 2024[22]
Grace Therapeutics, lnc.(GRCE) - 2026 Q2 - Quarterly Results