Grace Therapeutics (GRCE) investor relations material

Executive summary and key highlights

• GTX-104 is a novel intravenous nimodipine designed to address limitations of oral formulations for aneurysmal subarachnoid hemorrhage (aSAH), with pivotal Phase 3 trial meeting its primary endpoint and showing clinical benefits over oral capsules.

• The FDA Complete Response Letter for GTX-104 cited manufacturing and data completeness issues, but no clinical deficiencies; remediation and resubmission plans are underway.

• STRIVE-ON Phase 3 trial demonstrated GTX-104 reduced hypotension events by 19%, improved dose intensity, and led to better functional recovery and quality of life at 90 days compared to oral nimodipine.

• GTX-104 showed pharmacoeconomic advantages, including fewer ICU and ventilator days, and lower ICU readmission rates, with comparable safety to oral nimodipine.

• The addressable U.S. aSAH market is estimated at 42.5K–70K patients annually, with high unmet needs and significant commercial opportunity; GTX-104 benefits are recognized by clinicians and supported by strong IP protection.

Clinical and pharmacoeconomic outcomes

• GTX-104 led to a 29% relative increase in good recovery at 90 days and higher patient-reported quality of life scores.

• 54% of GTX-104 patients received ≥95% of prescribed dose versus 8% for oral capsules, indicating improved dosing consistency.

• ICU stays were reduced by 1.5 days and ventilator use by 5 days with GTX-104; ICU readmissions dropped by 48%.

• Major resource utilization drivers, such as mechanical ventilation and deep sedation, decreased more sharply with GTX-104.

• Safety profiles were comparable between GTX-104 and oral nimodipine, with no deaths attributed to GTX-104.

Market opportunity and commercialization

• aSAH is a severe, acute brain injury with high mortality and disability; 45% of patients are unconscious or dysphagic, and over 25% have poor dose compliance.

• GTX-104's IV formulation addresses key unmet needs, including administration in critically ill patients and consistent drug delivery.

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

• Orphan drug status and a multi-layered patent portfolio provide up to 7 years of exclusivity and patent protection through at least 2037.

• Cash and equivalents were $17M as of March 31, 2026, with potential for $15M in additional proceeds from warrant exercises.