Grace Therapeutics narrows FY26 net loss to $7.8 million
Grace Therapeutics narrowed its fiscal year 2026 net loss to $7.8 million, driven by lower R&D expenses following the close-out of a Phase 3 trial. The company reported Q4 EPS of $(0.06), beating analyst estimates, while maintaining $17.0 million in cash to fund operations.
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Grace Therapeutics, Inc. reported a net loss of $7.8 million, or $0.47 per share, for the fiscal year ended March 31, 2026, representing a decrease from a net loss of $9.6 million, or $0.79 per share, in the prior year. For the fourth quarter, the company reported a loss of $(0.06) per share, beating the analyst consensus estimate of $(0.15) by 60 percent. Management stated that existing cash and cash equivalents of $17.0 million are sufficient to sustain planned operations for at least 12 months.
Financial Performance
The reduction in the full-year net loss was driven by a substantial decrease in research and development expenses, which fell to $2.4 million from $9.5 million in the fiscal year ended March 31, 2025. The company attributed this $7.1 million decline primarily to the close-out of the GTx-104 pivotal Phase 3 safety clinical trial during the first calendar quarter of 2026. This decrease was partially offset by a $0.4 million increase in external consulting and data management costs related to the NDA submission.
General and administrative expenses rose to $8.7 million from $7.2 million in the prior year. The $1.5 million increase was largely due to $0.8 million in non-recurring legal and due diligence costs for strategic initiatives, alongside $0.9 million in professional fees for pre-commercial planning for GTx-104. These increases were partly mitigated by a $0.2 million reduction in salaries and benefits resulting from decreased headcount.
Regulatory and Business Updates
On April 23, 2026, the FDA issued a Complete Response Letter (CRL) for the GTx-104 NDA, referencing specific items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections. The company believes these items, which include additional leachable data time points, non-clinical product toxicology risk assessments, and current Good Manufacturing Practices (cGMP) deficiencies with a contract manufacturing organization, can be addressed in a resubmission. No clinical deficiencies were identified. A Type A meeting with the FDA has been scheduled to clarify the path forward.
During the fiscal year, the company presented Phase 3 STRIVE-ON trial results at several medical conferences, including the 2026 American Academy of Neurology and the Society of Critical Care Medicine's Critical Care Congress. Additionally, the U.S. Patent and Trademark Office issued U.S. Patent No. 12,414,943, covering the dosing regimen for IV administration of nimodipine used in the trial, extending intellectual property protection to 2043.
Consolidated Balance Sheet Data
| Item | March 31, 2026 ($) | March 31, 2025 ($) |
|---|---|---|
| Assets | ||
| Cash and cash equivalents | 16,977 | 22,133 |
| Total current assets | 17,380 | 22,712 |
| Total assets | 66,654 | 71,993 |
| Liabilities and Stockholders' Equity | ||
| Total current liabilities | 2,146 | 1,930 |
| Total liabilities | 2,758 | 5,383 |
| Total stockholders' equity | 63,896 | 66,610 |
Consolidated Statements of Loss Data
| Item | Year Ended March 31, 2026 ($) | Year Ended March 31, 2025 ($) |
|---|---|---|
| Operating Expenses | ||
| Research and development expenses | 2,405 | 9,511 |
| General and administrative expenses | 8,672 | 7,168 |
| Loss from operating activities | (11,077) | (16,679) |
| Total other income, net | 1,584 | 3,912 |
| Net loss | (7,793) | (9,568) |
| Basic and diluted loss per share | (0.47) | (0.79) |
What is the estimated timeline and cost to address the CMC and non-clinical deficiencies outlined in the FDA's Complete Response Letter?
With $17 million in cash sustaining operations for only 12 months, will the company need to raise capital before completing the GTx-104 resubmission process?
How will the Type A meeting with the FDA influence the strategic path forward and the likelihood of a successful NDA resubmission?
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