Company: GRCE
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001140361-25-041804
Chunk: 20

Company: Grace Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Item 8
Chunk 20
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 were presented at the 2025
Neurocritical Care Society annual meeting, held in Montreal, Quebec,
Canada. The Neurocritical Care Society is the only professional society
representing multi-disciplinary teams of neurocritical care providers around
the world whose mission is to improve outcomes for patients with
life-threatening neurological illnesses. In an oral presentation titled Safety
and Tolerability of GTx-104 (Nimodipine Injection for I.V. Infusion) Compared
with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage: a
Prospective, Randomized Trial, Dr. H. Alex Choi (Professor of Neurosurgery
and Neurology at UT Health Houston McGovern Medical School, member of the Grace
Scientific Advisory Board) highlighted the trial results demonstrating the
safety and tolerability of GTx-104 in the treatment of aSAH. 

During
our second fiscal quarter, we conducted market research analysis to update our
assessment of the GTx-104 commercial opportunity and to guide our commercialization planning. We believe the results
of this research confirm that GTx-104 is seen as valuable for its improved
tolerability, potential cost savings, and simpler route of I.V. administration
compared to the oral form of nimodipine. 

   Our Pipeline

     •

     GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.

     •

     GTx-102 is targeted as the first potential therapy for the treatment of ataxia-telangiectasia (“A-T”) in