8-K - Grace Therapeutics, Inc. | StockGist

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Grace Therapeutics announced its third quarter fiscal 2026 financial results for the period ended December 31, 2025, reporting a net loss of $2.3 million. The company also provided a business update, highlighting the FDA's PDUFA target date of April 23, 2026, for its NDA for GTx-104 in the treatment of aneurysmal subarachnoid hemorrhage.

Key Takeaways

1The FDA established a PDUFA target date of April 23, 2026, for its review of the NDA submission for GTx-104 for the treatment of aSAH.

2The company reported a net loss of $2.3 million, or $0.14 per share, for the three months ended December 31, 2025, a decrease from a net loss of $4.2 million for the same period in 2024.

3As of December 31, 2025, cash and cash equivalents were $18.7 million, which the company believes is sufficient to sustain planned operations for at least 12 months from February 12, 2026.

4The Phase 3 STRIVE-ON safety trial for GTx-104 met its primary endpoint, showing a 19% reduction in clinically significant hypotension compared to oral nimodipine.

5On October 23, 2025, the company secured approximately $4.0 million in additional funding through the exercise of common warrants.

Current Report Details

Event Type

Financial Results

Exhibits Only

Disclosure

Mandatory

Variant

8-K

Items Reported

2.02

, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchan

Financial Results

9.01

Exhibits. (d) Exhibits Exhibit Description 99.1 Press Release, dated February 12, 2026. 104 Cover Page Interactive Data File (embedded within the Inline XBRL do

Exhibits Only

Source Document

Results of Operations

Third Quarter 2026

Metric	Value	Prior Period
Net Loss	$2.30	$4.20
Diluted EPS	$-0.14	$-0.36
Research and Development Expenses	$0.50	$2.20
General and Administrative Expenses	$2.00	$1.50

Exhibits (2)

8-K

99.1

EXHIBIT 99.1