Grace Therapeutics (GRCE) investor relations material

Disease background and unmet need

• aSAH is a critical care disease with high mortality and morbidity, often requiring specialized stroke centers for treatment.

• Nimodipine is the only FDA-approved drug for aSAH but has significant limitations in oral form, including high dosing burden and poor pharmacokinetics.

• Over 90% of patients do not receive the full therapeutic dose of oral nimodipine due to hypotension and other complications.

• Oral nimodipine's absorption is highly variable, especially in unconscious patients, leading to unpredictable drug exposure.

• ICU workload is increased by oral nimodipine due to side effects and complex management needs.

GTx-104 innovation and value proposition

• GTx-104 is the first aqueous IV formulation of nimodipine, overcoming solubility challenges.

• IV formulation addresses hypotension, improves dose compliance, and offers more reliable drug exposure.

• STRIVE-ON trial data show IV GTx-104 leads to fewer hypotensive events and higher relative dose intensity compared to oral.

• IV arm showed better functional recovery and quality of life outcomes, with zero bedridden patients at day 90 versus 15-16% for oral.

• Pharmacoeconomic data favor IV, with reduced ICU stay and mechanical ventilation days.

Clinical trial design and outcomes

• STRIVE-ON was a 100-patient, randomized safety trial comparing IV and oral nimodipine across 30 high-volume centers.

• Primary endpoint was hypotension; IV arm had nearly 20% fewer clinically relevant hypotensive events.

• 55% of IV patients achieved ≥95% relative dose intensity versus 8% for oral.

• Functional recovery and quality of life measures favored IV, despite more severe baseline patients in the IV arm.

• Safety profile was comparable between IV and oral, with mortality rates lower than historical nimodipine data.