Grace Therapeutics (GRCE) Corporate presentation summary

Disease background and unmet need

• Aneurysmal subarachnoid hemorrhage (aSAH) is a severe, acute brain injury with high mortality and long-term disability, affecting relatively young patients and requiring immediate intervention and nimodipine therapy.

• Oral nimodipine, the standard of care for over 30 years, is associated with significant administration challenges, high dosing burden, and suboptimal therapeutic benefit due to pharmacokinetic variability and frequent hypotension.

• Approximately 45% of patients require nasogastric tube administration, and 55% do not receive the full daily dose due to hypotension, leading to poor outcomes.

GTX-104 product profile and clinical development

• GTX-104 is a novel intravenous nimodipine formulation designed to overcome oral delivery challenges, offering predictable drug concentration, improved dose compliance, and easier administration.

• The pivotal Phase 3 STRIVE-ON trial met its primary endpoint, showing a 19% reduction in clinically significant hypotension and a 29% relative increase in good recovery at 90 days compared to oral nimodipine.

• GTX-104 demonstrated better relative dose intensity (54% vs. 8% received >95% prescribed dose), fewer ICU days, less time on ventilation, and reduced ICU readmissions.

• Safety profile was comparable to oral nimodipine, with no deaths attributed to GTX-104 and similar rates of adverse events.

• NDA was filed in June 2025, accepted for review in August 2025, with a target PDUFA date of April 23, 2026.

Market opportunity and commercialization

• U.S. addressable aSAH patient population is estimated at 42,500–70,000 annually, with high unmet needs in dose compliance and blood pressure control.

• GTX-104 is expected to deliver clinical, hospital, and patient value through improved outcomes, reduced resource utilization, and easier administration.

• Market research indicates strong physician interest in GTX-104 for its efficacy, pharmacoeconomic benefits, and IV route of administration, especially for critically ill patients.

• Efficient commercialization is possible due to patient concentration in a limited number of centers; a 15-rep sales force could reach ~50% of patients.