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Grace Therapeutics Announces First Quarter 2027 Financial Results, Provides Business Update

GRCE
  • Grace Therapeutics announced financial results for the three months ended June 30, 2026, reporting a net loss of $15.8 million or $0.91 per share.
  • The increase in net loss was primarily driven by a $13.5 million impairment of in-process research and development (IPR&D) related to the deprioritized candidates GTx-101 and GTx-102.
  • The Company announced a $10 million private placement financing with new and existing investors to support manufacturing and regulatory work for GTx-104.
  • Grace Therapeutics intends to use the net proceeds to address FDA Complete Response Letter (CRL) items related to chemistry, manufacturing, controls (CMC), and non-clinical data for the GTx-104 New Drug Application (NDA) resubmission.
  • The FDA CRL issued on April 23, 2026, identified no clinical safety or efficacy deficiencies, citing only facility-level cGMP compliance issues at the current contract manufacturer and requests for additional leachables data.
  • The Company initiated a dual-source manufacturing strategy for GTx-104, including technology transfer to a second U.S.-based contract manufacturer to mitigate remediation risks.
  • NDA resubmission timing will depend on whichever manufacturing site reaches readiness first, either through remediation of the current site or completion of a 12-month stability program at the new site.
  • Research and development expenses decreased to $0.7 million from $1.0 million in the prior year period due to the completion of the pivotal STRIVE-ON safety trial for GTx-104.
  • General and administrative expenses decreased to $1.7 million from $2.1 million, largely due to reduced pre-commercial planning activities and lower stock-based compensation.
  • Cash and cash equivalents were $22.2 million as of August 11, 2026, with the Company projecting its cash runway will extend through the end of calendar 2028.
  • GTx-104 is a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), holding Orphan Drug Designation from the FDA.