Company: GRCE
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001140361-25-030398
Chunk: 22

Company: Grace Therapeutics, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Item 8
Chunk 22
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GTx-104 is designed to address
significant unmet medical needs for patients with aSAH. We believe that our
novel nimodipine IV formulation may offer a potential value to physicians,
hospitals, and their patients. 

  23
  

GTx-104 Market Opportunity

Approximately 42,500 patients in the
United States are affected by aSAH per year. Company sponsored third party
market research including claims analysis suggests that aSAH incidence may be
as high as approximately 70,000 per year in the United States. Outside of the
United States, annual cases of aSAH are estimated at approximately 60,000 in
the European Union, and approximately 150,000 in China. 

The unmet needs in the treatment of
aSAH patients and the potential of GTx-104 to address the limitations of the
current standard of care were the subject of a Key Opinion Leader event we
hosted in November 2024. In an independent market research survey we conducted
of hospital administrators and critical and neuro intensive care physicians at
institutions with Comprehensive or Advanced Stroke Center certification who are
involved in purchasing decisions for their institutions/units, respondents
reported 80% likelihood of adopting an IV formulation of nimodipine, assuming
100% bioavailability, better safety, no food effects, effective hypotension
management, potential hospital value and patient value.

   Clinical Data

   Pivotal Phase 3 STRIVE-ON Randomized Safety Trial

The STRIVE-ON trial was a prospective,
randomized open-label Phase 3 trial of GTx-104 compared with oral nimodipine in
patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52
patients received oral nimodipine. The primary endpoint was the number of
patients with at least one episode of clinically significant hypotension
reasonably considered to be caused by the drug, and additional endpoints
included safety, clinical, and pharmacoeconomic outcomes. Each patient was
evaluated for up to 90 days inclusive of the 21-day treatment period. There was
a higher proportion of the most severe cases of aSAH (Hunt & Hess Grade V)
with the worst prognosis in the GTx-104 arm (8%) compared to the oral
nimodipine arm (2%). 

  24
  

   On September 25, 2024, we announced the