Grace is a clinical-stage, biotechnology company focused on rare disease. Its lead program, GTX-104, is a novel injectable formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH). Other programs include GTX-102 for Ataxia Telangiectasia & GTX-101 for postherpetic neuralgia. GTX-104 is formulated from a previously approved product and a patented technology that employs non-ionic surfactant micelles to overcome delivery shortcomings. Nimodipine is a lipophilic calcium channel blocker that has been shown to be effective in improving outcomes following aSAH surgery. Its FDA approved oral formulation presents several drawbacks especially for patients that have difficulty swallowing. An IV formulation using safe excipients can address many of these challenges and is represented by GTX-104. GTX-104 has completed enrollment in its pivotal Phase III safety trial and is expected to report data in early 2025. Results will contribute to an NDA submission to the FDA later in 1H:25. Other candidates are ready for Phase III (GTX-102) & Phase II (GTX-101) and are available for partnering or further development if additional capital becomes available.
