Company: GRCE
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001140361-25-041804
Chunk: 26

Company: Grace Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Item 8
Chunk 26
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 date.

   Commercialization Strategy

   If we receive regulatory approval for GTx-104 in the U.S., we plan to commercialize GTx-104 with a highly experienced and targeted hospital-based sales force. We may seek commercial partnerships to fully exploit the market potential of GTx-104 in the U.S. and in territories outside the U.S.

   A recent market research analysis we conducted assessed the commercial potential of GTx-104 if approved by the FDA. A third-party research firm conducted interviews, primary research, and market data analysis, and concluded that GTx-104 is seen as a valuable addition to the treatment of aSAH patients, with broad potential for formulary inclusion by hospital Pharmacy and Therapeutics (P&T) committees. The research identified three primary perceived benefits among survey respondents:

     ●

     Efficacy – respondents emphasized that the reduction in hypotension with GTx-104 is meaningful, as it allows more patients to remain on therapy and avoid dose limiting side effects

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     Pharmacoeconomic - Health care providers  highlighted that even modest reductions in ICU or ventilator time can have a significant impact on hospital costs, suggesting GTx-104’s potential to deliver value beyond drug price—particularly given the high-cost aSAH care settings

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     Route of Administration - GTx-104’s immediate usability without nasogastric tube tube   placement was seen as an advantage, enabling earlier intervention, especially in unstable or intubated patients where time sensitive dosing is key

   These results were obtained from a survey of 45 healthcare professionals,
including neuro-intensivist, neurosurgeons, P&T committee members, and
hospital pharmacists, during the summer of 2025. 

   GTx-102 Overview

   GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of A-T for which there are currently no FDA-approved therapies. GTx-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients, can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed.

We
have licensed the data from the multicenter, double-blinded, randomized,
placebo-controlled crossover trial from Azienda Ospedaliera Universitaria
Senese, Siena, Italy, where Dr. Zannolli et al. studied the effect of oral