Grace Therapeutics (GRCE) investor relations material

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.