Grace Therapeutics Announces Second Quarter 2027 Financial Results, Provides Business Update
Key Highlights
- ➤Grace Therapeutics (GRCE) reports Q2 net loss of $2.1 million, or $0.11 per share
- ➤$10 million private placement funds GTx-104 manufacturing and regulatory work
- ➤FDA identified no clinical safety or efficacy deficiencies and requested no additional clinical data
- ➤Cash and equivalents of $21.3 million extend planned operations through calendar 2028
- ➤Dual-source manufacturing strategy advances NDA resubmission readiness for GTx-104
Expert Statements
Prashant Kohli, Chief Executive Officer of Grace Therapeutics
“With no clinical safety or efficacy deficiencies identified in the U.S. Food and Drug Administration’s (FDA) Complete Response Letter (CRL), we continue to execute our plan to address the chemistry, manufacturing and controls (CMC) and non-clinical data items, and are making progress toward resubmission of our New Drug Application (NDA) for GTx-104.”
Prashant Kohli, Chief Executive Officer of Grace Therapeutics
“Our dual-source manufacturing strategy to address potential remediation issues at our current contract manufacturer is progressing, and the timing of our NDA resubmission will reflect whichever manufacturing site reaches readiness first.”
Prashant Kohli, Chief Executive Officer of Grace Therapeutics
“The financing concluded in August extends our expected cash runway through the end of calendar 2028, and positions us well as we work toward NDA resubmission.”
Prashant Kohli, Chief Executive Officer of Grace Therapeutics
“We look forward to reporting our progress as we work toward achieving these important milestones.”
PRINCETON, N.J., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage biopharma company advancing GTx-104, a novel, injectable formulation of nimodipine that has completed a Phase 3 clinical trial and is being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced the financial results and business highlights for the three months ended September 30, 2026.
“With no clinical safety or efficacy deficiencies identified in the U.S. Food and Drug Administration’s (FDA) Complete Response Letter (CRL), we continue to execute our plan to address the chemistry, manufacturing and controls (CMC) and non-clinical data items, and are making progress toward resubmission of our New Drug Application (NDA) for GTx-104,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “Our dual-source manufacturing strategy to address potential remediation issues at our current contract manufacturer is progressing, and the timing of our NDA resubmission will reflect whichever manufacturing site reaches readiness first. The financing concluded in August extends our expected cash runway through the end of calendar 2028, and positions us well as we work toward NDA resubmission. We look forward to reporting our progress as we work toward achieving these important milestones.”
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