Grace Therapeutics Inc 2026年季度报告

FORM 10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2026 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from toCommission file number: 001-35776 Grace Therapeutics, Inc. (Exact name of registrant as specified in its charter) State of Delaware98-1359336(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification Number) 103 Carnegie Center Suite 300Princeton, New Jersey 08540(Address of principal executive offices, including zip code) 609-322-1602(Registrant’s telephone number, including area code) Securities registered pursuant to Section12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has beensubject to such filing requirements for the past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant toRule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant wasrequired to submit such files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”and “emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ The number of outstanding shares of common stock of the registrant, par value per share of $0.0001, as of August 11, 2026, was21,035,930. GRACE THERAPEUTICS, INC. QUARTERLY REPORT ON FORM 10-Q For the Quarter Ended June 30, 2026 Table of Contents Item 1.Financial Statements6Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations21Item 3.Quantitative and Qualitative Disclosures About Market Risk36Item 4.Controls and Procedures36PART II. OTHER INFORMATIONItem 1.Legal Proceedings36Item 1A.Risk Factors37Item 2.Unregistered Sales of Equity Securities and Use of Proceeds37Item 3.Defaults Upon Senior Securities37Item 4.Mine Safety Disclosures37Item 5.Other Information37Item 6.Exhibits37 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This quarterly report contains information that may be forward-looking statements within the meaning of U.S. federal securities laws andforward-looking information within the meaning of Canadian securities laws, both of which we refer to in this quarterly report as forward-looking information. Forward- looking statements can be identified by the use of terms such as “may,” “will,” “should,” “expect,” “plan,”“anticipate,” “believe,” “intend,” “estimate,” “predict,” “potential,” “continue” or other similar expressions concerning matters that are notstatements about historical facts. Forward-looking statements in this quarterly report include, among other things, information, or statementsabout: •••our ability to build a late-stage pharmaceutical company focused in rare and orphan diseases and, on developing andcommercializing products that improve clinical outcomes using our novel drug delivery technologies;our ability to apply new proprietary formulations to existing pharmaceutical compounds to achieve enhanced efficacy, fasteronset of action, reduced side effects, and more convenient drug delivery that can result in increased patient compliance;the potential for our drug candidates to receive exclusivity from the U.S. Food and Drug Administration (“FDA”) orregulatory approval under the Section 505(b)(2) regulatory pathway under the Federal Food, Drug and Cosmetic Act(“FDCA”); ••••••••••••Table of Contentsour ability, plan and timing to address the items cited in the Complete Response Letter (“CRL”) from the FDA related toGTx-104; our resubmission of a new drug application (“NDA”) for GTx-104 under Section 505(b)(2) of the FDCA; theacceptance of such resubmission of an NDA by the FDA; and the timing and ability to receive FDA approval for marketingGTx-104;the future prospects of our GTx-104 drug candidate, including but not limited to GTx-104’s potential to be administered toimprove the management of hypotension in patients with aneurysmal subarachnoid hemorrhage (“aSAH”); the ability ofGTx-104 to achieve a pharmac