Grace Therapeutics (GRCE) Life Sciences Investor Forum 2024 summary

Disease overview and unmet needs

• Aneurysmal subarachnoid hemorrhage (aSAH) is a rare, life-threatening brain bleed with high mortality and morbidity, affecting about 50,000 people annually in the U.S.

• The disease strikes unexpectedly, often in younger patients, with a third not surviving and another third suffering long-term disability.

• Current standard of care includes surgical intervention and oral nimodipine, the only FDA-approved therapy, but it presents significant clinical and practical challenges.

Limitations of current therapy and new formulation

• Oral nimodipine is difficult to administer to unconscious patients, has high first-pass metabolism, and requires frequent dosing, leading to medication errors and incomplete dosing.

• The drug can cause hypotension, often resulting in dose withholding or invasive rescue therapies, and has absorption issues when given via feeding tube.

• The new IV formulation, GTX-104, uses micellar technology with safe excipients, is room temperature stable, and allows precise dosing, reducing errors and improving safety.

Clinical development and regulatory pathway

• GTX-104 completed a successful phase I pharmacokinetic bridging study and is now in a phase III safety trial (STRIVE-ON), comparing IV and oral forms in 100 patients.

• The trial's primary endpoint is the incidence of hypotension, with additional pharmacoeconomic and health outcomes data being collected.

• Over 50% of patients have been enrolled, with full enrollment expected soon and top-line data anticipated early next year, targeting NDA submission by mid-2025.