Grace Therapeutics (GRCE) Q3 Investor Summit Group Virtual Conference 2025 earnings summary

Investment thesis and market opportunity

• Targeting subarachnoid hemorrhage, a rare disease with high morbidity and mortality, using a novel IV formulation of amlodipine.

• IV formulation (GTX-104) addresses clinical liabilities of oral amlodipine, such as poor dose compliance and hypotension.

• Strong patent protection with exclusivity until 2042 and orphan drug designation.

• Focused commercial strategy targets 250 hospitals with a small, experienced sales force.

• Market research indicates strong clinician and hospital administrator interest due to clinical and economic benefits.

Clinical and regulatory progress

• Pivotal phase III STRIVE-ON trial met primary endpoint, showing fewer hypotensive events and higher dose compliance with IV vs. oral.

• IV arm showed 30% of patients with good recovery at 90 days, zero bedridden patients, and strong safety profile.

• Pharmaco-economic data: 1.5 fewer ICU days, five fewer ventilation days, and 50% reduction in ICU readmission for IV.

• NDA submitted and accepted by FDA, with PDUFA goal date of April 23, 2026.

• Regulatory pathway is de-risked, with FDA alignment and no expected advisory committee.

Financial position and outlook

• $20 million cash on hand as of June, with runway past PDUFA date into Q3 2025.

• Two warrant tranches could provide an additional $23 million, extending runway into 2027 revenue territory.

• Management team has extensive experience in drug development and commercialization.

• Anticipates major inflection point with upcoming FDA decision and commercial launch.