GRACE THERAPEUTICS, INC.

Red flags

• The FDA’s April 2026 CRL identified additional commercial-product leachable data requirements, non-clinical toxicology risk assessments, and cGMP deficiencies at the CMO; failure to remediate could prevent NDA resubmission or approval.
• Cash and cash equivalents were $16.977 million at March 31, 2026 versus $2.146 million of current liabilities, but management says additional capital is required for ongoing operations and plans to raise it.
• FY2026 operating expenses were $11.077 million, including $8.672 million of G&A and $2.405 million of R&D, and the company has incurred operating losses and negative operating cash flow in every period since inception.
• Potential dilution includes 4.418 million immediately exercisable 2025 common warrants and 1.345 million outstanding options as of March 31, 2026; the 2025 financing generated $13.705 million of net proceeds.
• The company carries $49.266 million of intangible assets and goodwill despite having no approved product revenue, leaving material asset-value risk if GTx-104 fails or is substantially delayed.