Grace Therapeutics (GRCE) investor relations material

Executive summary

• Focused on developing and commercializing products for rare and orphan diseases using novel drug delivery technologies, with a pipeline of three clinical-stage drug candidates and over 79 patents worldwide.

• Strategic realignment in May 2023 led to a streamlined organization and prioritization of lead candidate GTx-104; internal development of GTx-102 and GTx-101 discontinued in June 2026.

• GTx-104, an IV nimodipine formulation for aSAH, completed a pivotal Phase 3 trial, met primary endpoints, and showed clinical and pharmacoeconomic benefits over oral nimodipine.

• Progress continues on NDA resubmission for GTx-104, addressing FDA CMC and non-clinical requirements; no clinical safety or efficacy deficiencies were cited by the FDA.

• Dual-source manufacturing strategy initiated to mitigate risks and expedite NDA resubmission, with technology transfer underway to a second U.S.-based contract manufacturer.

Financial highlights

• Net loss for the most recent quarter was $15.8 million ($0.91 per share), up from $3.4 million ($0.21 per share) in the prior year, mainly due to a $13.5 million impairment of GTx-101 and GTx-102 IPR&D assets.

• Research and development expenses decreased to $697,000 from $955,000 year-over-year, reflecting completion of the GTx-104 Phase 3 trial.

• General and administrative expenses decreased to $1.7 million from $2.1 million, primarily due to lower pre-commercial planning and stock-based compensation.

• Cash and cash equivalents were $13.8 million as of June 30, 2026, increasing to $22.2 million after August private placement.

• Cash used in operations was approximately $3.2 million for the quarter.

Outlook and guidance

• Cash and cash equivalents expected to sustain planned operations, including activities to address the FDA CRL, through at least the end of calendar 2028.

• NDA resubmission timing will depend on which manufacturing site achieves readiness first.

• Additional capital will be required to fund operations beyond that period; no revenue expected until regulatory approval and commercialization.

• Plans to maximize value of GTx-102 and GTx-101 through out-licensing or partnerships.