Grace Therapeutics (GRCE), a late-stage biopharmaceutical company, on Thursday, announced financial results and business highlights for the quarter ended December 31, 2024.
The company's lead drug candidate is GTx-104, a novel injectable formulation of nimodipine for aneurysmal subarachnoid hemorrhage or aSAH.
Recently, the company announced its Phase 3 trial comparing GTx-104 against oral nimodipine in patients hospitalized with aSAH, dubbed STRIVE-ON, successfully met its primary endpoint, demonstrating clinical benefits over the oral formulation of nimodipine.
The promising data supports GTx-104's potential as a breakthrough treatment for aSAH patients.
Looking ahead, Grace Therapeutics plans to submit a New Drug Application or NDA for GTx-104 by mid-2025.
Early this week, the company secured a private placement financing of up to $30 million to fund its pre-commercial activities and product launch preparations, contingent on FDA approval.
For the third quarter of fiscal year 2025, Grace Therapeutics reported a net loss of $4.2 million, or $0.36 per share, compared to a net loss of $2.4 million, or $0.21 per share, for the same period in 2024.
This increase in net loss was primarily due to higher research and development expenses related to the Phase 3 STRIVE-ON trial for GTx-104.
Research and development expenses for the quarter were $2.2 million, reflecting a $0.8 million increase from the previous year, driven by costs associated with the ongoing clinical trial.
General and administrative expenses were $1.5 million, slightly lower than the $1.6 million reported last year, due to reduced professional fees and stock-based compensation.
As of December 31, 2024, the company had cash and cash equivalents of $11.1 million. This balance is expected to support operations through mid-2025.
GRCE closed Friday's (Feb.14 2025) trading at $3.48 up by 0.29%.
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