Abiopharma

GRACE THERAPEUTICS, INC. (GRCE) Reports the reporting period Financial Results GRACE THERAPEUTICS, INC. (GRCE) announced its financial results for the period ending the reporting period. Key Financial Highlights:

• Revenue: Not disclosed
• Net Income: Not disclosed
• EPS: Not disclosed
• Cash and equivalents: 13756
  • “We continue to make progress on the requirements for resubmission of our New Drug Application (NDA) for GTx
  • 104,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “As previously disclosed, the U.S. Food and Drug Administration’s (FDA) Complete Response Letter (CRL) identified no clinical safety or efficacy deficiencies—the remaining items relate to chemistry, manufacturing and controls (CMC) and non
  • clinical data. We continue to address those items while advancing two manufacturing sites toward NDA resubmission. Our current contract manufacturer is remediating the FDA’s facility
    • targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. GTx-104 has been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States if certain conditions are met at NDA approval, and additional intellectual property protection with 52 granted and pending patents. For more information, please visit: www.gracetx.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995
    • anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the timing and success of any regulatory resubmission of the NDA for GTx-104; (ii) the timing of any FDA reinspection of the Company’s current contract manufacturer, and that facility’s compliance status, which are determined by the FDA and outside the Company’s control, and the FDA’s position that it will not approve the NDA while the facility remains in an unacceptable compliance status; (iii) the ability of a second, U.S.-based contract manufacturer to generate the required stability and analytical data and to complete a product-specific pre-approval inspection; (iv) the need to complete additional non-clinical studies; (v) the requirement that any resubmission comprehensively address all items cited in the CRL and the risk of review delay; (vi) the Company’s potential need for additional capital, which may not be available on acceptable terms; (vii) changes to regulatory pathways; (viii) the Company’s ability to protect its intellectual property for GTx-104; and (ix) legislative, regulatory, political and economic developments. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2026