GRCE 8-K
Grace Therapeutics, Inc. (GRCE)
8-K
2025-11-13
For: 2025-11-13
View Original
Added on
April 11, 2026
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): November 13, 2025
(Exact name of Registrant as Specified in Its Charter)
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State of
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of Principal Executive Offices)
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(Zip Code)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s)
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Name of each exchange on which registered
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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 2.02 |
Results of Operations and Financial Condition.
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The following information is furnished pursuant to Item 2.02 “Results of Operations and Financial Condition.”
On November 13, 2025, Grace Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three months ended
September 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
The information in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any filing or other document pursuant to the Securities Act of 1933, as amended, or the Exchange Act,
regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing or document.
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Item 8.01
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Other Events.
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On November 13, 2025, the Company updated its corporate presentation, which includes its updated cash position as of October 31, 2025. A copy of
the updated corporate presentation is attached hereto as Exhibit 99.2 to this Form 8-K and is incorporated by reference into this Item 8.01.
| Item 9.01 |
Exhibits.
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(d) Exhibits
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Exhibit
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Description
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Press Release, dated November 13, 2025.
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Corporate Presentation, dated November 13, 2025.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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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 thereunto
duly authorized.
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GRACE THERAPEUTICS, INC.
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Date:
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November 13, 2025
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By:
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/s/ Prashant Kohli
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Prashant Kohli
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Chief Executive Officer
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Exhibit 99.1
Grace Therapeutics Announces Second Quarter 2026 Financial Results,
Provides Business Update
Announced U.S. Food and Drug Administration (FDA) Acceptance for Review
of New Drug Application (NDA) for GTx-104
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 Neurocritical Care Annual Meeting
Granted Sixth U.S. Patent Covering IV Dosing Regimen for GTx-104
Princeton, NJ, November 13, 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 aSAH patients, today announced the financial results and business highlights for the
quarter ended September 30, 2025.
“During our second quarter of 2026 we continued to execute on our clinical and corporate goals, led by FDA acceptance for review of our NDA for GTx-104 for the
treatment of aSAH,” said Prashant Kohli, CEO of Grace Therapeutics. “Acceptance of our NDA for review is another significant milestone for the Company and further demonstrates our ability to execute as we continue to advance this important
innovation for aSAH patients. 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 presentation at the Neurocritical Care
annual meeting, where the results were well received by the conference attendees. Also this quarter, the U.S. Patent and Trademark Office issued a new method of use patent covering the dosing regimen for IV administration of nimodipine used in our
STRIVE-ON trial for GTx-104. This new patent coverage on the dosing regimen should be included in the label for GTx-104 if it is approved by the FDA, adding a new layer and extending the duration of our intellectual property protections. 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.”
Second Quarter 2026 Corporate Highlights
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On August 22, 2025, the FDA accepted the Company’s NDA for GTx-104 for formal review, establishing April 23, 2026 as its PDUFA target date. The
application is supported by a comprehensive data package, including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, whereby it met its primary endpoint and provided evidence of clinical benefit when
compared to orally administered nimodipine. These data were presented at the Neurocritical Care annual meeting, held in Montreal, Quebec, Canada in
September 2025.
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| • |
On September 16, 2025, U.S. Patent and Trademark Office issued a U.S. Patent No. 12,414,943, titled “Nimodipine Parenteral Administration”. The new method of use patent covers the
dosing regimen for IV administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104. Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including five patents on the
composition of the Company’s formulation of nimodipine, which provide patent protection to 2037. The new patent on the IV dosing regimen for GTx-104 strengthens the Company’s intellectual property position and extends protection to 2043.
Grace has also been granted Orphan Drug Designation from the FDA, which provides GTx-104 with seven years of marketing exclusivity in United States upon FDA approval of the Company’s NDA.
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On October 23, 2025, the Company announced that 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 expired as the 60th day after the FDA’s acceptance for review of the Company’s NDA for GTx-104 has passed. The Company estimates that its cash and cash equivalents were approximately $20.0
million as of October 31, 2025.
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Second Quarter 2026 Financial Results
The Company reported a net loss of $0.9 million, or $0.06 per share, for the three months ended September 30, 2025, a decrease of $2.5 million from
a net loss of $3.4 million, or $0.30 per share, for the three months ended September 30, 2024. The decrease in net loss was primarily due to a $2.4 million decrease in research and development expenses and a $1.1 million difference in the
change in fair value of derivative warrant liabilities, partially offset by a $0.9 million decrease in income tax benefit and a $0.1 million increase in general and administrative expenses.
Total research and development expenses for the three months ended September 30, 2025, were $0.6 million, compared to $3.0 million for the three months ended September
30, 2024. The decrease of $2.4 million was primarily due to a $2.5 million decrease in research activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON safety trial, partially offset by an increase in salaries and benefits due
to merit increases.
General and administrative expenses were $2.0 million for the three months ended September 30, 2025, an increase of $0.1 million from $1.9 million for the three months
ended September 30, 2024. The increase was primarily a result of an increase in other general and administrative expenses primarily due to costs for GTx-104 pre-commercial planning.
Cash Runway
As of September 30, 2025, cash and cash equivalents were $16.9 million, a net decrease of $5.2 million compared to cash and
cash equivalents of $22.1 million at March 31, 2025.
In October 2025, the Company received $4.0 million in gross proceeds from exercises of common warrants that were previously issued in a private
placement in September 2023. 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.
While the Company believes that current cash and cash equivalents provide cash runway through at least the next twelve months, the runway could extend into the second
quarter of calendar 2027 if all of the common warrants issued in connection with the Company’s February 2025 private placement are exercised at the election of the investors.
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 or were comparable to GTx-104, including: 54% patients had relative dose intensity (RDI) of 95% or higher compared to only 8% on oral nimodipine, and 29% more patients 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.
GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are
currently no FDA-approved therapies. GTx-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient
and is rapidly absorbed. The Company received written responses to its End of Phase 1 meeting in GTx-102 where the FDA made recommendations on the path toward an NDA. The FDA provided guidance on the design of a single pivotal efficacy and safety
trial, including the neurological assessment scale for the primary endpoint, that could, with appropriate confirmatory evidence, support an NDA. The further development of GTx-102 has been deprioritized in favor of focusing on development of
GTx-104. It is also possible that the Company may license or sell GTx-102.
GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN).
GTx-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic
bottles. Unlike oral gabapentin and lidocaine patches, which are used for the treatment of PHN, the Company believes that the biphasic delivery mechanism of GTx-101 has the potential for rapid onset of action and continuous pain relief for up to
eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTx-101 has been deprioritized in favor of focusing on development of GTx-104. It is also possible that the Company may license or sell GTx-101.
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 IV 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.
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 Company’s cash runway and
cash position, the future prospects of the Company’s GTx-104 drug candidate, the outcome of the Company’s NDA submission for GTx-104, 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, GTx-104’s potential to achieve medical and
pharmacoeconomic benefit, GTx-104’s commercial prospects, the future prospects of the Company’s GTx-102 drug candidate, GTx-102’s potential to provide clinical benefits to decrease symptoms associated with A-T, the timing and outcomes of a Phase
3 efficacy and safety trial for GTx-102, the timing of an NDA filing for GTx-102, the future prospects of the Company’s GTX-101 drug candidate, GTX-101’s potential to be administered to PHN patients to treat the severe nerve pain associated with
the disease and any future patent and other intellectual property filings made by the Company for new developments 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 success and timing of
regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome of the Company’s NDA application for GTx-104; (iii) changes to regulatory pathways; (iv) our ability to protect
our intellectual property for our drug candidates; and (v) 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 and
the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 to be 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:
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Grace Therapeutics Contact:
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| Prashant Kohli |
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Chief Executive Officer
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Tel: 609-322-1602
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Email: [email protected]
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www.gracetx.com
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Investor Relations:
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| LifeSci Advisors | |
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Mike Moyer
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Managing Director
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Phone: 617-308-4306
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Email: [email protected]
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---tables to follow---
GRACE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
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September 30,2025
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March 31,2025
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(Expressed in thousands except share data)
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$
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$
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Assets
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Current assets:
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Cash and cash equivalents
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16,862
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22,133
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Receivables
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20
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126
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Prepaid expenses
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416
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453
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Total current assets
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17,298
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22,712
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Equipment, net
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12
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15
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Intangible assets
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41,128
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41,128
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Goodwill
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8,138
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8,138
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Total assets
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66,576
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71,993
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Liabilities and Stockholders’ equity
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Current liabilities:
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Trade and other payables
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1,245
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1,930
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Total current liabilities
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1,245
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1,930
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Derivative warrant liabilities
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201
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1,141
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Deferred tax liability
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2,312
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2,312
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Total liabilities
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3,758
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5,383
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Commitments and contingencies
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Stockholders’ equity:
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Preferred stock, $0.0001 par value per share; 10,000,000 authorized; none issued and outstanding as of September 30, 2025
and March 31, 2025
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—
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—
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Common stock, $0.0001 par value per share; 100,000,000 authorized; 14,128,562 and 13,718,106 shares issued and outstanding
as of September 30, 2025 and March 31, 2025, respectively
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1
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1
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Additional paid-in capital
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293,842
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293,334
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Accumulated other comprehensive loss
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(6,038
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)
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(6,038
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Accumulated deficit
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(224,987
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)
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(220,687
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)
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Total stockholders’ equity
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62,818
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66,610
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Total liabilities and stockholders’ equity
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66,576
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71,993
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GRACE THERAPEUTICS, INC.
Condensed Consolidated Statements of Loss and Comprehensive Loss
(Unaudited)
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Three months ended
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Six months ended
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September 30, 2025
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September 30, 2024
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September 30, 2025
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September 30, 2024
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(Expressed in thousands, except share and per share data)
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$
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$
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$
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$
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Operating expenses
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Research and development expenses, net of government assistance
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(568
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(2,976
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(1,523
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)
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(5,684
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)
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General and administrative expenses
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(1,961
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)
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(1,855
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)
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(4,096
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)
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(4,109
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)
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Loss from operating activities
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(2,529
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)
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(4,831
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)
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(5,619
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)
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(9,793
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)
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Foreign exchange (loss) gain
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(8
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)
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13
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3
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5
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Change in fair value of derivative warrant liabilities
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1,427
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362
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940
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1,756
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Interest and other income, net
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172
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172
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375
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407
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Total other income, net
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1,591
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547
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1,318
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2,168
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Loss before income tax recovery
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(938
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)
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(4,284
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)
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(4,301
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)
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(7,625
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)
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Income tax benefit
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—
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852
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—
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1,576
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Net loss and total comprehensive loss
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(938
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)
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(3,432
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)
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(4,301
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)
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(6,049
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)
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Basic and diluted loss per share
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(0.06
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)
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(0.30
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)
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(0.27
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)
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(0.53
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)
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Weighted-average number of shares outstanding
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15,924,522
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11,506,234
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15,924,522
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11,506,234
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Exhibit 99.2
