Grace Therapeutics (GRCE) Q4 2026 earnings summary

Executive summary

• Fiscal year ended March 31, 2026, saw continued advancement of GTx-104, an IV nimodipine formulation for aSAH, with a focus on regulatory resubmission after an FDA Complete Response Letter (CRL) in April 2026.

• Phase 3 STRIVE-ON safety trial results were presented at major medical conferences, showing favorable outcomes for GTx-104.

• Pre-commercial planning intensified in anticipation of potential FDA approval.

Financial highlights

• Net loss for fiscal 2026 was $7.8 million ($0.47 per share), a $1.8 million improvement year-over-year.

• Research and development expenses dropped to $2.4 million from $9.5 million, reflecting the close-out of the pivotal Phase 3 trial.

• General and administrative expenses rose to $8.7 million, driven by non-recurring legal and due diligence costs and increased pre-commercial planning.

• Cash and cash equivalents stood at $17.0 million as of March 31, 2026, down from $22.1 million a year prior.

Outlook and guidance

• Existing cash is expected to fund operations for at least 12 months from the press release date.

• A Type A meeting with the FDA is scheduled to clarify the NDA resubmission path for GTx-104.

• Regulatory update anticipated after receipt of official FDA meeting minutes.