Company: GRCE
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001140361-25-030398
Chunk: 20

Company: Grace Therapeutics, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Item 8
Chunk 20
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odipine.

     •

     GTx-102 is targeted as the first potential therapy for the treatment of ataxia-telangiectasia (“A-T”) in a pediatric population. A-T is caused by mutations in the ataxia telangiectasia mutated gene. Children with A-T experience cerebellar ataxia and other motor dysfunctions, oculomotor apraxia, dysarthria, and dysphagia. A Phase-1 pharmacokinetic study was successfully completed and GTx-102 was well tolerated with no serious events reported.

     •

     GTx-101 is a topical bio adhesive film-forming bupivacaine spray for Postherpetic Neuralgia (“PHN”), which can be persistent and often causes debilitating pain following infection by the shingles virus. Four single-dose Phase 1 studies to evaluate the PK, safety, dose proportionality and
tolerability of GTx-101 have been performed. In these trials, no serious
adverse events were reported and GTx-101 was well tolerated. We believe that
GTx-101 could be administered to patients with PHN to treat pain associated
with the disease. 

  21
  

In May 2023, we implemented a strategic
realignment plan to enhance shareholder value that resulted in engaging a new
management team, streamlining our research and development activities, and
greatly reducing our workforce. Following the realignment, we are a smaller,
more focused organization, based in the United States, and concentrated on the development
of our lead product candidate GTx-104. Further development of GTx-102 and
GTx-101 will occur at such a time when we are able to secure additional funding
or enter strategic partnerships for license or sale with third parties. 

   GTx-104 Overview

   About aneurysmal Subarachnoid Hemorrhage (aSAH)

   aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is a relatively uncommon type of stroke that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients per year.

   Unmet Needs with Oral Nimodipine

   Nimodipine was granted FDA approval in