Grace Therapeutics (GRCE) investor relations material

Executive summary and market context

• GTX-104 is a novel intravenous nimodipine designed to address unmet needs in aneurysmal subarachnoid hemorrhage (aSAH), aiming to overcome limitations of oral formulations and potentially replace them as standard of care.

• Orphan Drug Status provides potential for seven years of market exclusivity and multi-layered intellectual property protection, with a robust patent portfolio extending exclusivity to at least 2037.

• aSAH is a severe, acute brain injury with high mortality and disability rates, affecting up to 70,000 U.S. patients annually, and is associated with significant healthcare costs and resource utilization.

• Oral nimodipine, the current standard, faces challenges including high dosing burden, inconsistent bioavailability, and administration difficulties, especially in unconscious or dysphagic patients.

Clinical development and trial results

• The pivotal Phase 3 STRIVE-ON trial met its primary safety endpoint, showing GTX-104 reduced clinically significant hypotension by 19% compared to oral capsules.

• GTX-104 enabled 54% of patients to receive at least 95% of the prescribed dose, compared to only 8% with oral capsules, indicating improved dose intensity.

• Patients on GTX-104 had a 29% relative increase in good recovery at 90 days and reported better quality of life scores.

• GTX-104 reduced ICU stay by 1.5 days, mechanical ventilation by 5 days, and ICU readmissions by 48% compared to oral nimodipine.

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

Regulatory and manufacturing strategy

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

• Remediation at the current contract manufacturer and technology transfer to a second U.S.-based CDMO are underway to address compliance and reduce single-source risk.

• Required non-clinical studies are being completed, with plans to resubmit the NDA once all CRL items are addressed.