Grace Therapeutics (GRCE) Corporate presentation summary

Executive summary and market opportunity

• GTX-104 is a novel intravenous nimodipine designed to address significant unmet needs in aneurysmal subarachnoid hemorrhage (aSAH), with potential to displace oral nimodipine as standard of care.

• Pivotal Phase 3 STRIVE-ON trial met its primary endpoint, showing clinical benefit over oral capsules, including improved dose intensity and reduced hypotension.

• Orphan Drug Status provides potential for seven years of market exclusivity and multi-layered IP protection, with a robust patent portfolio extending to 2043.

• The U.S. addressable aSAH market is estimated at 42.5K–70K hospital-treated patients annually, with high unmet needs in unconscious/dysphagic patients and those with poor dose compliance.

• Efficient commercialization is possible due to patient concentration in a limited number of centers, requiring a small sales force to reach most patients.

Clinical data and benefits

• STRIVE-ON Phase 3 trial demonstrated a 19% relative reduction in clinically significant hypotension and a 29% relative increase in good recovery at 90 days for GTX-104 versus oral nimodipine.

• 54% of GTX-104 patients received ≥95% of prescribed dose, compared to 8% for oral capsules, indicating improved dose intensity.

• GTX-104 patients had 1.5 fewer ICU days, 5 fewer ventilator days, and 48% fewer ICU readmissions, supporting pharmacoeconomic benefits.

• Quality of life scores at day 90 favored GTX-104, with comparable overall safety and mortality rates between groups.

• GTX-104’s IV formulation overcomes oral delivery challenges, including high dosing burden, pharmacokinetic variability, and risk of fatal medication errors.

Regulatory and manufacturing update

• FDA Complete Response Letter (CRL) cited only CMC and manufacturing issues, not clinical safety or efficacy deficiencies.

• Dual-source manufacturing strategy underway: remediation at current CDMO and technology transfer to a second U.S.-based CDMO to reduce single-source risk.

• Required non-clinical studies are being completed, with resubmission planned once all CRL items are addressed.

• Cash and cash equivalents as of March 31, 2026, were $17.0M, with potential for $15.0M in additional proceeds from warrant exercises.