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Grace Therapeutics Announces Abstract Accepted for Presentation at Society of Vascular and Interventional Neurology Annual Meeting

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Grace Therapeutics (Nasdaq: GRCE) announced that an abstract from its Pivotal Phase 3 STRIVE-ON safety trial of GTx-104 (nimodipine injection for IV infusion) was accepted as a late-breaking presentation at the Society of Vascular and Interventional Neurology annual meeting, Nov 19-22, 2025 in Orlando, FL.

Dr. Thomas P. Bleck will present oral results on Nov 21, 2025 at 10:55 AM (Abstract No. 697). The randomized trial (NCT05995405) compares safety and tolerability of GTx-104 versus oral nimodipine in aneurysmal subarachnoid hemorrhage (aSAH) patients. aSAH accounts for ~5% of strokes with an estimated 42,500 U.S. hospital-treated patients.

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STRIVE-ON Results Accepted for Late-Breaking Presentation

PRINCETON, N.J., Nov. 11, 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 IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that an abstract of the Company’s Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH (the STRIVE-ON trial–NCT05995405) has been accepted for presentation as a late breaking trial at the Society of Vascular and Interventional Neurology (SVIN) annual meeting, to be held November 19-22, 2025 in Orlando, FL.

Thomas P Bleck, MD, Professor, Neurology (Neurocritical Care and Epilepsy/Clinical Neurophysiology) at Northwestern University Feinberg School of Medicine, will present results of the trial in an oral presentation held November 21, 2025.

Presentation Details

Abstract Number: 697
Title:Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage: a Prospective, Randomized Trial
Session: 11/21/2025 10:30:00 AM - 12:00 PM
Presentation: 11/21/2025 10:55:00 AM - 11:05 AM


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 Therapeutics’ 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.

For more information, please visit: www.gracetx.com

For more information, please contact:

Grace Therapeutics Contact:

Prashant Kohli
Chief Executive Officer
Tel: 450-686-4555
Email: info@gracetx.com
www.gracetx.com

Investor Relations:

LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com


FAQ

What will Grace Therapeutics (GRCE) present at SVIN on November 21, 2025?

An oral late-breaking presentation of the STRIVE-ON Phase 3 safety trial comparing GTx-104 IV nimodipine to oral nimodipine (Abstract No. 697) at 10:55 AM ET on Nov 21, 2025.

What is the STRIVE-ON trial NCT number for GRCE's Phase 3 study?

The pivotal Phase 3 STRIVE-ON trial is registered as NCT05995405.

Who will present Grace Therapeutics' STRIVE-ON results at the SVIN meeting?

Thomas P. Bleck, MD, Professor of Neurology at Northwestern University Feinberg School of Medicine, will deliver the oral presentation.

What endpoints are being compared in the STRIVE-ON Phase 3 trial (GRCE)?

The trial compares the safety and tolerability of GTx-104 nimodipine injection for IV infusion versus oral nimodipine in aSAH patients.

When and where is the SVIN annual meeting where GRCE will present STRIVE-ON results?

The SVIN annual meeting runs Nov 19–22, 2025 in Orlando, Florida, with the STRIVE-ON oral presentation on Nov 21, 2025.

How common is aneurysmal subarachnoid hemorrhage (aSAH) mentioned in the GRCE release?

aSAH accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital-treated patients.
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