Grace Therapeutics (GRCE) TD Cowen 45th Annual Healthcare Conference summary

Disease background and market opportunity

• Subarachnoid hemorrhage is a rare, life-threatening condition with high mortality and disability rates, affecting a younger population and more women.

• Quick intervention and specialized neurocritical care are essential for survival.

• Recent claims data estimate about 70,000 patients are hospitalized annually in the US, higher than older literature estimates.

• The disease has orphan drug designation, and the market size is based on updated population data.

Current standard of care and unmet needs

• Nimodipine is the only FDA-approved drug for subarachnoid hemorrhage, administered orally or via nasogastric tube.

• Oral administration faces challenges: high dosing frequency, pharmacokinetic variability, low bioavailability, and hypotension risk.

• Over half of patients do not receive the full therapeutic dose due to hypotension or missed doses.

GTX-104 clinical development and results

• GTX-104 is a novel intravenous nimodipine formulation designed to address oral administration challenges.

• The phase 3 STRIVE-ON trial was a comparative safety study versus oral nimodipine, focusing on hypotension as the primary endpoint.

• GTX-104 showed nearly 20% fewer clinically significant hypotensive events and met the primary endpoint.

• More patients on GTX-104 received higher relative dose intensity, with 54% achieving 95% or higher, compared to 8% for oral.

• Neurological outcomes and quality of life were superior with GTX-104, including better modified Rankin Scale scores and fewer bedridden patients at 90 days.

• Pharmacoeconomic benefits included 1.5 fewer ICU days and five fewer ventilator days for GTX-104 patients.