FDA Established April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH)

Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Society of Vascular and Interventional Neurology Annual Meeting

Company Continues Pre-Commercial Planning in Anticipation of Potential FDA Approval of NDA Submission for GTx-104 for the Treatment of Patients with aSAH

PRINCETON, N.J., Feb. 12, 2026 (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 aSAH patients, today announced the financial results and business highlights for the quarter ended December 31, 2025.

"During our third quarter of fiscal 2026 we continued to execute on our clinical and corporate goals, led by our pre-commercial planning in anticipation of potential FDA approval of our New Drug Application (NDA) for GTx-104 for the treatment of aSAH," said Prashant Kohli, CEO of Grace Therapeutics. "Our NDA is supported by a robust data package, including positive results from our STRIVE-ON trial, which provided evidence of improved clinical outcomes in aSAH patients treated with GTx-104 as well as potential medical and pharmacoeconomic benefits of GTx-104 in the treatment of aSAH. We were pleased to see these data highlighted in a late breaking presentation at the Society of Vascular and Interventional Neurology annual meeting in November 2025. Our STRIVE-ON trial results continue to be well received by researchers, practitioners and industry leaders. We believe that if our NDA for GTx-104 is approved by the FDA, our strong U.S. and international patent estate will help to maximize the long-term market value of GTx-104 and correspondingly deliver value for our shareholders. The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe that if GTx-104 is approved, our STRIVE-ON trial results point to a very promising role for GTx-104 in the treatment of these patients. We look forward to continuing to engage with the FDA during their review as they work toward the PDUFA target date of April 23, 2026."

Third Quarter 2026 and Recent Corporate Highlights

   -- During our third fiscal quarter we provided grant support for the 
      development of a Continuing Medical Education $(CME)$ program for 
      healthcare professionals in medical specialties related to the care of 
      aSAH patients. Content for the CME program was independently developed by 
      leading providers of CME content and is intended to educate Health Care 
      Professionals on the current challenges in treating aSAH patients. 
 
   -- On November 21, 2025, the Company presented data from its pivotal Phase 3 
      STRIVE-ON Safety Trial of GTx-104 in aSAH as a late breaking trial at the 
      Society of Vascular and Interventional Neurology annual meeting. The 
      presentation titled 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, was 
      presented by Thomas P. Bleck, MD, Professor, Neurology (Neurocritical 
      Care and Epilepsy/Clinical Neurophysiology) at Northwestern University 
      Feinberg School of Medicine. 
 
   -- On October 23, 2025, the Company announced that it had 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 
      expired on October 21, 2025. 

Third Quarter 2026 Financial Results

The Company reported a net loss of approximately $2.3 million, or $0.14 per share, for the three months ended December 31, 2025, a decrease of approximately $1.8 million from the net loss of $4.2 million, or $0.36 per share, for the three months ended December 31, 2024. The decrease in net loss was primarily due to a $1.7 million decrease in research and development expenses and a $1.1 million decrease in the change of fair value of derivative warrant liabilities, partially offset by increases in general administrative expenses of $0.5 million and a decrease in income tax benefit of $0.6 million.

Total research and development expenses for the three months ended December 31, 2025, were $0.5 million, compared to $2.2 million for the three months ended December 31, 2024. The decrease of $1.7 million was primarily due to a $1.8 million decrease in research activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial, partially offset by a $0.1 million increase in salaries and benefits due to merit increases.

General and administrative expenses were $2.0 million for the three months ended December 31, 2025, an increase of $0.5 million from $1.5 million for the three months ended December 31, 2024. The increase was primarily a result of an increase in professional fees and other general and administrative expenses primarily due to costs for GTx-104 pre-commercial planning.

Cash Runway

As of December 31, 2025, cash and cash equivalents were $18.7 million, a net decrease of $3.4 million compared to cash and cash equivalents of $22.1 million at March 31, 2025.

The private placement the Company completed in February 2025 included common warrants exercisable for shares of common stock (or pre-funded warrants in lieu thereof) at an exercise price of $3.395 per share. Each common warrant is immediately exercisable and will expire on the earlier of (i) the 60th day after the date the FDA approves the NDA for GTx-104 and (ii) September 25, 2028. Potential gross proceeds from the exercise of the February 2025 common warrants are $15.0 million.

The Company plans to use its current cash and cash equivalents to further the regulatory review process for GTx-104, pre-commercial planning, commercial team buildout, and product launch if GTx-104 is approved, working capital and other general corporate purposes. The Company believes its existing cash and cash equivalents will be sufficient to sustain planned operations through at least 12 months from the date of this press release.

About the STRIVE-ON Trial

The STRIVE-ON trial (NCT05995405) was a prospective, randomized open-label trial of GTx-104 compared with oral nimodipine in patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored GTx-104 or were comparable between GTx-104 and oral nimodipine, including: 54% patients on GTx-104 had relative dose intensity $(RDI)$ of 95% or higher compared to only 8% on oral nimodipine, and 29% more patients on GTx-104 than on oral nimodipine had favorable functional outcomes at 90 days. In addition, there were fewer intensive care unit $(ICU)$ readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral nimodipine. Adverse events were comparable between the two arms and no new safety issues were identified with patients receiving GTx-104. All deaths in both arms of the trial were due to severity of the patient's underlying disease. There were eight deaths on the GTx-104 arm compared to four deaths on the oral nimodipine arm. The survival status of one patient on the oral nimodipine arm was unknown. No deaths were determined to be related to GTx-104 or oral nimodipine.

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 aSAH, a relatively uncommon type of stroke that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.

About the Grace Therapeutics Asset Portfolio

GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV 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 IV infusion. GTx-104 provides a convenient IV 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.

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