Grace Therapeutics (GRCE) investor relations material

Executive summary

• GTx-104 remains the lead development priority; FDA meeting minutes on the April 2026 CRL identified CMC and non-clinical items, with no clinical safety or efficacy deficiencies and no additional clinical data requested.

• Dual-source manufacturing and CRL-response work are underway; NDA resubmission timing depends on which manufacturing pathway reaches readiness first.

• GTx-101 and GTx-102 internal development is deprioritized; a $13.533 million impairment fully wrote off their IPR&D, with licensing, partnerships or sale under consideration.

Financial highlights

• Q2 net loss was $2.131 million, or $0.11 per share, versus $0.9 million, or $0.06 per share, in Q2 FY2026.

• Q2 R&D expense was $885,000 versus $568,000 YoY, reflecting GTx-104 dual-source manufacturing and CRL-related non-clinical studies; G&A was $1.407 million versus $1.961 million.

• H1 net loss was $17.921 million versus $4.3 million YoY; operating loss was $18.209 million versus $5.619 million, including the $13.533 million IPR&D impairment.

• Cash and equivalents were $21.311 million at September 30, 2026, up $4.334 million from March 31, 2026.

Outlook and guidance

• Existing cash is expected to fund planned operations, including CRL-response activities, through the end of calendar 2028; additional capital will be needed beyond that period.

• Resubmission may rely on the current CMO, the second U.S.-based CMO, or both, depending on manufacturing readiness and completion of required studies and data.

• No product-sales revenue is expected before regulatory approval; future financing may include equity, debt or collaboration-based non-dilutive sources.