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Grace Therapeutics (GRCE) investor relations material
Grace Therapeutics Q2 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2026 earnings summary13 Nov, 2025
Executive summary
Focused on developing and commercializing products for rare and orphan diseases using novel drug delivery technologies, with three clinical-stage candidates and a robust IP portfolio of over 40 patents worldwide.
Lead candidate GTx-104 (IV nimodipine) completed Phase 3 STRIVE-ON trial, NDA submitted and accepted by FDA with PDUFA date set for April 23, 2026.
STRIVE-ON Phase 3 trial met primary endpoint, showing reduced hypotension and improved outcomes vs. oral nimodipine, with clinical and pharmacoeconomic benefits presented at a major neurocritical care meeting.
New U.S. patent issued for GTx-104 dosing regimen, extending IP protection to 2043; Orphan Drug Designation provides seven years of U.S. marketing exclusivity upon approval.
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.
Financial highlights
Net loss for Q2 FY2026 was $0.9M ($0.06/share), down from $3.4M ($0.30/share) in Q2 FY2025, mainly due to a $2.4M decrease in R&D expenses.
Net loss for the six months ended September 30, 2025, was $4.3M ($0.27/share), down from $6.0M ($0.53/share) in the prior year period.
Cash and cash equivalents as of September 30, 2025, were $16.9M, a decrease from $22.1M at March 31, 2025.
Completed a $13.7M private placement in February 2025 and received $4.0M from warrant exercises in October 2025, bringing estimated cash to $20.0M by October 31, 2025.
General and administrative expenses for Q2 FY2026: $2.0M, up slightly from $1.9M in Q2 FY2025, reflecting pre-commercial planning costs.
Outlook and guidance
Existing cash is expected to sustain planned operations for at least 12 months from the financial statement issuance date, potentially extending into Q2 2027 if all warrants are exercised.
Additional capital will be required to fund operations beyond that period; no revenue expected until regulatory approval and commercialization of GTx-104.
Plans to raise further capital through equity, debt, or strategic partnerships.
Focus remains on advancing GTx-104 through regulatory review and potential commercialization.
GTx-104 death rate difference impact?
Feb 2025 warrant exercise confidence?
Timeline for GTx-101/102 monetization?
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Next Grace Therapeutics earnings date
Q3 202611 Feb, 2026
Next Grace Therapeutics earnings date
Q3 202611 Feb, 2026
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Acasti Pharma Inc is a biopharmaceutical company focused on developing and commercializing therapies for rare and orphan diseases. The company utilizes proprietary delivery platforms for small molecule drug candidates targeting neurological and cardiovascular conditions. The company is headquartered in Laval, Canada, and its shares are listed on the NASDAQ.
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