Grace Therapeutics (GRCE) Q3 2026 earnings summary

Executive summary

• Focused on developing and commercializing products for rare and orphan diseases using novel drug delivery technologies, with three clinical-stage drug candidates and a robust patent portfolio extending to 2043 for lead asset GTx-104.

• GTx-104 NDA submitted to FDA in June 2025, accepted for review in August 2025 with a PDUFA target date of April 23, 2026; pivotal Phase 3 trial met primary endpoint, showing reduced hypotension and improved outcomes versus oral nimodipine.

• Strategic realignment in May 2023 led to a streamlined organization, prioritizing GTx-104 and deprioritizing GTx-102 and GTx-101 pending additional funding or partnerships; possible licensing or sale considered.

• Pre-commercial planning underway for potential GTx-104 launch, supported by positive Phase 3 STRIVE-ON trial data.

Financial highlights

• Net loss for the quarter ended December 31, 2025 was $2,315 ($0.14/share), down from $4,155 ($0.36/share) year-over-year; nine-month net loss was $6,615 ($0.41/share), down from $10,204 ($0.89/share) year-over-year.

• Research and development expenses for the quarter were $462, down from $2,194 year-over-year, reflecting completion of the GTx-104 Phase 3 trial; general and administrative expenses increased to $1,987 from $1,510 due to pre-commercial planning.

• Cash and cash equivalents as of December 31, 2025 were $18,672, a decrease from $22,133 at March 31, 2025.

• Net cash used in operating activities for the nine months was $7,174, down from $11,950 year-over-year.

• Weighted-average shares outstanding increased to 16,933,620 from 11,500,000 year-over-year.

Outlook and guidance

• Cash runway expected to sustain planned operations for at least 12 months from the financial statement or press release date.

• Additional capital will be required to fund operations beyond that period; no revenue expected until regulatory approval and commercialization of GTx-104.

• Commercialization strategy for GTx-104 includes a targeted hospital-based sales force and potential partnerships for U.S. and ex-U.S. markets.

• Plans to use cash for regulatory review, pre-commercial planning, commercial buildout, and potential GTx-104 launch.