Grace Therapeutics (GRCE) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Key presentations and announcements

• Lead asset GTX-104 is a novel IV nimodipine formulation targeting subarachnoid hemorrhage, aiming to replace oral forms as standard of care.

• STRIVE-ON pivotal safety trial is over 50% enrolled, with full enrollment expected by late 2024 or early 2025 and NDA filing targeted for the first half of 2025.

• GTX-104 holds orphan drug designation, robust global patent protection, and a strong cash position funding operations into Q2 2026.

• Market research shows high hospital interest, with 80% of surveyed P&T committees likely to add GTX-104 to formularies.

• No competing therapies are near GTX-104’s stage, and the company is considering both direct commercialization and partnerships, especially in Europe and China.

Industry analysis and clinical insights

• Subarachnoid hemorrhage is a life-threatening condition with high mortality and morbidity, affecting about 50,000 people annually in the US, mostly women.

• Oral nimodipine, the current standard, is problematic due to dosing burden, poor bioavailability, and risk of fatal medication errors, especially in ICU settings.

• IV GTX-104 offers 100% bioavailability, predictable drug levels, and easier management of hypotension, a key side effect.

• Phase 1 data show IV GTX-104 achieves equivalent exposure at a fraction of the oral dose, with less variability and a favorable safety profile.

• STRIVE-ON trial’s primary endpoint is comparable hypotension rates between IV and oral arms, with additional health economic and outcomes data being collected.

Forward-looking statements and strategic plans

• NDA submission is planned for the first half of 2025, with commercial launch preparations underway.

• Post-approval, the company aims to gather real-world evidence to support inclusion in AHA/ASA guidelines, which typically requires 18–24 months of data.

• The company’s experienced team and advisory board are positioned to drive adoption and guideline updates.

• Commercial strategy includes a focused hospital sales force and potential global partnerships.

• Strong anecdotal feedback from trial sites highlights ease of use and enthusiasm among clinicians.