Grace Therapeutics (GRCE) investor relations material

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 oral 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.

• Hospitalization charges for aSAH can reach $530k per patient, and 70% of cases result in death or permanent disability.

GTX-104: Product profile and clinical data

• GTX-104 is a novel intravenous nimodipine formulation designed to overcome oral delivery challenges, with orphan drug status and multi-layered IP protection.

• 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 higher dose compliance (54% vs. 8% received ≥95% prescribed dose), fewer ICU days (1.5 fewer), and reduced ICU readmissions (48% lower) than oral nimodipine.

• Quality of life scores and patient-reported outcomes favored GTX-104, with comparable safety profiles between groups.

• NDA for GTX-104 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 42.5K–70K annually, with most patients concentrated in a limited number of centers, enabling efficient commercialization.

• GTX-104 is valued by clinicians for its efficacy, reduced hypotension, pharmacoeconomic benefits, and ease of IV administration, especially in critically ill patients.

• A 15-rep sales force could reach about 50% of aSAH patients, concentrated in 242 centers.

• Orphan drug status provides 7 years of exclusivity, with patents extending protection to 2043.