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Grace Therapeutics (GRCE) investor relations material

Grace Therapeutics Q3 Investor Summit Group Virtual Conference 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 Investor Summit Group Virtual Conference 2025 earnings summary16 Sep, 2025

Key product and clinical insights

  • Developed a novel IV formulation of amlodipine (GTX-104) for subarachnoid hemorrhage, addressing limitations of oral forms and improving dose compliance and hypotension management.

  • Pivotal phase III STRIVE-ON trial met primary endpoint, showing fewer hypotensive events, higher dose compliance, and better recovery rates compared to oral.

  • Pharmaco-economic data showed reduced ICU stay, fewer ventilation days, and lower readmission rates for IV arm.

  • No new safety signals observed; safety profile comparable to oral and existing IV forms outside the U.S.

  • Strong patent protection through 2042 and seven years of market exclusivity via orphan drug status.

Regulatory and commercialization plans

  • NDA submitted and accepted by FDA, with PDUFA goal date set for April 23, 2026.

  • Regulatory pathway aligned with FDA, utilizing 505(b)(2) approach, minimizing risk and not requiring an advisory committee.

  • Targeted commercial strategy focused on 250 U.S. hospitals, requiring a small, specialized sales force.

  • Market research indicates strong clinician and hospital administrator support for IV formulation due to clinical and economic benefits.

  • Cash runway extends past PDUFA date, with additional potential funding from warrant exercises supporting commercialization into 2027.

Market and investment outlook

  • Subarachnoid hemorrhage is a rare, high-morbidity disease affecting a younger population, with significant unmet clinical need.

  • GTX-104 positioned to become new standard of care, with no direct competitors in the clinic.

  • Strong management team with experience in acute and chronic care drug launches.

  • Anticipated major inflection point within 12 months, with clear investment thesis and attractive market opportunity.

  • Commercial launch expected to be efficient and cost-effective due to concentrated hospital market.

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