Company Overview

Name and Incorporation

• Name: Grace Therapeutics, Inc. (formerly Acasti Pharma Inc.)
• Incorporation: Delaware, USA
• Headquarters: 103 Carnegie Center, Suite 300, Princeton, New Jersey 08540

Business Focus

• Developing and commercializing products for rare and orphan diseases.
• Uses proprietary drug delivery technologies to create reformulations of existing pharmaceutical compounds.
• Aims to improve clinical outcomes with:
  • Enhanced efficacy
  • Faster onset of action
  • Reduced side effects
  • More convenient drug delivery
  • Increased patient compliance

Development Strategy

• Focuses on applying Section 505(b)(2) regulatory pathway leveraging existing safety and efficacy data.
• Targets diseases with significant unmet medical needs, especially rare disorders.
• Seeks orphan drug designation to benefit from market exclusivity (7 years in US) and other incentives.

Pipeline and Drug Candidates

1. GTx-104

   • Stage: Clinical (Phase 3 pending NDA filing in 2025)
   • Formulation: Injectable, nanoparticle formulation of nimodipine for intravenous infusion.
   • Indication: Aneurysmal subarachnoid hemorrhage (aSAH)
   • Unmet needs: Improve management of blood pressure and reduce side effects compared to oral nimodipine.
   • Clinical data: Completed Phase 3 STRIVE-ON trial showing reduced incidence of hypotension, comparable safety, and pharmacoeconomic advantages.

2. GTx-102

   • Stage: Early clinical
   • Formulation: Concentrated oral mucosal spray of betamethasone
   • Indication: Ataxia-telangiectasia (A-T)
   • Evidence: Positive results from multicenter trial showing reduction in ataxia severity.
   • Next steps: Planning for efficacy and safety trial after FDA discussions.

3. GTx-101

   • Stage: Preclinical/early clinical
   • Formulation: Topical bio-adhesive bupivacaine spray.
   • Indication: Postherpetic Neuralgia (PHN)
   • Data: Completed Phase I trials showing safety and absorption; plan for further trials.
   • Focus: Rapid onset and prolonged pain relief in nerve pain management.

Market and Commercial Strategy

• GTx-104: Priority for development and potential U.S. commercialization via hospital-based sales force or licensing outside the U.S.
• GTx-102 and GTx-101: Potential development for licensing or sale, especially if development is deprioritized.
• Market potential:
  • Approximately 42,500 aSAH patients in the U.S. annually; higher estimates suggest up to 70,000.
  • GTx-101 market size estimated at up to $2.5 billion globally.
• Distribution: Will rely on third-party manufacturing and licensing for international markets.

Intellectual Property

• Over 40 patents granted or pending worldwide.
• Patents include composition and method-of-use patents.
• Several patents granted for GTx-104, GTx-101, and GTx-102 in key jurisdictions such as the U.S., Europe, Japan, Australia, and India.

Financial and Operational Highlights

• Employees: 6 full-time employees (as of March 31, 2025).
• Market Capitalization: Approximate market value of $24.0 million (as of September 30, 2024).
• Outstanding Shares: 13,828,562 shares (as of June 19, 2025).
• No revenue or income figures provided directly; the company is in development stage with no approved products yet.
• No dividends expected in the foreseeable future.

Summary

Grace Therapeutics is focused on creating reformulated, biotech drug candidates for rare diseases, using proprietary delivery technologies and pathway optimization (Section 505(b)(2)). Its lead candidate, GTx-104, targets aSAH and has shown promising clinical results, with an NDA planned for 2025. The company also develops product candidates for ataxia-telangiectasia and postherpetic neuralgia, with clinical and preclinical data supporting further development or licensing.