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Grace Therapeutics Inc. (GRCE-4.13%) has submitted its 10-Q filing for the quarterly period ended December 31, 2024.
The filing details the company's focus on developing and commercializing products for rare and orphan diseases, with a particular emphasis on its lead product candidate, GTx-104. GTx-104 is a clinical-stage, injectable formulation of nimodipine for intravenous infusion in patients with aneurysmal subarachnoid hemorrhage (aSAH).
The company reported a net loss of $4.2 million for the quarter, compared to a net loss of $2.4 million in the same quarter the previous year. This increase in net loss was primarily attributed to higher research and development expenses related to the GTx-104 pivotal Phase 3 safety clinical trial.
Research and development expenses for the quarter were $2.2 million, up from $1.4 million in the same quarter the previous year. The increase was mainly due to the ongoing clinical development of GTx-104.
General and administrative expenses were $1.5 million for the quarter, slightly down from $1.6 million in the previous year. This decrease was primarily due to lower professional fees and stock-based compensation.
The company completed a private placement of securities in February 2025, raising approximately $13.8 million in net proceeds. These funds are intended to support the clinical trial expenses for GTx-104, pre-commercial planning, and general corporate purposes.
As of December 31, 2024, Grace Therapeutics reported cash and cash equivalents of $11.1 million, a decrease from $23.0 million at the end of March 2024. The company expects its existing cash and the proceeds from the recent private placement to sustain operations through at least 12 months from the issuance date of the financial statements.
Grace Therapeutics plans to submit a New Drug Application (NDA) for GTx-104 to the FDA in the first half of 2025, following the completion of its Phase 3 STRIVE-ON trial, which met its primary endpoint.
The company continues to explore strategic partnerships or licensing opportunities for its other drug candidates, GTx-102 and GTx-101, as it prioritizes resources towards the development and potential commercialization of GTx-104.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Grace Therapeutics Inc. quarterly 10-Q report dated February 13, 2025. To report an error, please email earnings@qz.com.