[8-K] Grace Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Grace Therapeutics announced that the U.S. Patent and Trademark Office issued Patent No. 12,414,943, titled "Nimodipine Parenteral Administration." The method-of-use patent, published on September 16, 2025 and issued on September 18, 2025, covers the dosing regimen for intravenous administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104 and extends patent protection for GTx-104 to 2043. GTx-104 is described as a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to treat aneurysmal subarachnoid hemorrhage patients. The company attached a press release as Exhibit 99.1 to this Current Report.

Positive

• Issued U.S. patent (No. 12,414,943) for nimodipine parenteral administration
• Patent covers the IV dosing regimen used in the Phase 3 STRIVE-ON safety trial for GTx-104
• Patent extends protection for GTx-104 to 2043, providing long-term method-of-use exclusivity
• GTx-104 is positioned as a clinical-stage injectable nimodipine targeting aneurysmal subarachnoid hemorrhage unmet needs
• Company filed a press release as Exhibit 99.1 to the Current Report

Negative

• None.

Insights

Biotech R&D Analyst

TL;DR: Issuance of a method-of-use patent for the IV dosing regimen supports clinical program protection through 2043.

The patent covers the specific intravenous dosing regimen used in the Phase 3 STRIVE-ON safety trial for GTx-104, which helps protect the company's clinical approach to treating aneurysmal subarachnoid hemorrhage with an injectable nimodipine formulation. For a clinical-stage product, securing method-of-use IP tied to a Phase 3 regimen can reduce immediate competitive risk to that dosing strategy and may strengthen the company's negotiating position for partnerships or licensing related to clinical use. The announcement also confirms the company views GTx-104 as central to its pipeline and has formalized protection through 2043.

Intellectual Property / M&A Specialist

TL;DR: A granted method-of-use patent extending protection to 2043 increases asset visibility and potential transaction leverage.

Issuance of Patent No. 12,414,943 for nimodipine parenteral administration formalizes proprietary rights over the IV dosing regimen used in a Phase 3 study, which can be a material asset in licensing or partnership discussions. Method-of-use patents tied to a clinical regimen may not block all competing formulations or routes, but they do provide enforceable exclusivity for the claimed use and timing parameters, enhancing the company's IP portfolio and commercial negotiating power.

false000144419200014441922025-09-182025-09-18

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 18, 2025

GRACE THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-35776	98-1359336
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

103 Carnegie Center Suite 300 Princeton, New Jersey		08540
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (609) 322-1602

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	GRCE	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Item 8.01. Other Events.

On September 18, 2025, Grace Therapeutics, Inc. issued a press release announcing that the U.S. Patent and Trademark Office issued a Patent No. 12,414,943, titled “Nimodipine Parenteral Administration.” The new method of use patent, published on September 16, 2025, covers the dosing regimen for I.V. administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104 and extends patent protection for GTx-104 to 2043. GTx-104 is a clinical-stage, novel, injectable formulation of nimodipine being developed for I.V. infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage patients.

A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.

Item 9.01.
Financial Statements and Exhibits.

(d) Exhibits

Exhibit		Description
99.1		Press Release, dated September 18, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			GRACE THERAPEUTICS, INC.
Date:	September 18, 2025	By:	/s/ Prashant Kohli
			Prashant Kohli Chief Executive Officer

FAQ

What patent did Grace Therapeutics (GRCE) announce?

Grace Therapeutics announced U.S. Patent No. 12,414,943, titled "Nimodipine Parenteral Administration."

What does the patent for GRCE cover?

The patent covers the dosing regimen for IV administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104.

How long does the new patent extend protection for GTx-104?

The filing states the patent extends patent protection for GTx-104 to 2043.

What is GTx-104 as described in the filing?

GTx-104 is described as a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to treat aneurysmal subarachnoid hemorrhage patients.

Was a press release included with the 8-K?

Yes, a copy of the press release announcing the patent was attached as Exhibit 99.1 to the Current Report.