EXHIBIT 99.1
Published on October 23, 2025
Exhibit 99.1
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Grace Therapeutics Secures Approximately $4.0 Million through Common Warrant Exercises Following Acceptance of New
Drug Application for GTx-104 for formal FDA Review
Princeton, NJ, October 23, 2025 (GLOBE NEWSWIRE)—Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma
company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for I.V. infusion to address
significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced it has secured approximately $4.0 million in additional funding through exercises of
common warrants that were previously issued in a private placement that the Company closed in September 2023. The Company issued 1,345,464 new shares of common stock at an exercise price of $3.003 per share. The remaining 1,190,927 common
warrants issued in the 2023 private placement have expired as the 60th day after the U.S. Food and Drug Administration’s (FDA) acceptance for review of the Company’s New Drug Application for GTx-104 has passed.
The FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23,
2026 for its review of the Company’s NDA submission for GTx-104. The application seeks
approval for GTx-104 for the treatment of patients with aSAH, and is supported by a comprehensive data package including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104.
About aneurysmal Subarachnoid Hemorrhage (aSAH)
aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the
brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is a relatively uncommon type of stroke (aSAH) that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.
About GTx-104
GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for I.V. infusion in aSAH patients to address significant
unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral I.V. infusion.
GTx-104 provides a convenient I.V. delivery of nimodipine in the Intensive Care Unit, potentially eliminating the need for nasogastric tube
administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better
manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.
About Grace Therapeutics
Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace
Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace
Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40
granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an I.V. infusion 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.
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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, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of
Canadian securities laws (collectively, forward-looking statements). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially
different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements
containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates," "potential," "should," "may," "will," "plans," "continue," "targeted" or other similar expressions to be uncertain and forward-looking. Readers are
cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding, the future prospects of the
Company’s GTx-104 drug candidate, the timing and the outcome of the FDA’s review of the Company’s NDA submission for GTx-104, benefits of GTx-104’s Orphan Drug Designation, GTx-104’s potential to bring enhanced treatment options to patients
suffering from aSAH, GTx-104’s potential to be administered to improve the management of hypotension in patients with aSAH, the ability of GTx-104 to achieve a pharmacokinetic and safety profile similar to the oral form of nimodipine, are based
upon Grace Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, including, without limitation: (i) the outcome of the Company’s NDA for GTx-104; (ii) changes to regulatory pathways; (iii) the Company’s ability to maintain effective patent rights and
other intellectual property protection for its product candidates and (iv) 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, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended
June 30, 2025 filed with the Securities and Exchange Commission (SEC) and other documents that have been and will be filed by Grace Therapeutics from time to time with the SEC and Canadian securities regulators. All forward-looking statements
contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were
made, except as required by applicable securities laws.
For more information, please contact:
Grace Therapeutics Contact:
Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com
Investor Relations:
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com
