Form 8-K

8-K — Grace Therapeutics, Inc.

Accession: 0001140361-26-025667

Filed: 2026-06-18

Period: 2026-06-18

CIK: 0001444192

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ef20076145_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20076145_ex99-1.htm)

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8-K

8-K (Primary)

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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): June 18, 2026

GRACE THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

State of 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 2.02

Results of Operations and Financial Condition.

The following information is furnished pursuant to Item 2.02 “Results of Operations and Financial Condition.”

On June 18, 2026, Grace Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal year ended March 31,

2026. 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.

Item 9.01

Exhibits.

(d)

Exhibits

Exhibit

Description

99.1

Press Release, dated June 18, 2026.

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 thereunto duly authorized.

GRACE THERAPEUTICS, INC.

Date: June 18, 2026

By:

/s/ Prashant Kohli

Prashant Kohli

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20076145_ex99-1.htm · Sequence: 2

Exhibit 99.1

Grace Therapeutics Announces 2026 Fiscal Year-End Financial Results,

Provides Business Update

Type A Meeting Scheduled with FDA to Potentially Clarify Path to GTx-104 NDA Resubmission

Phase 3 STRIVE-ON Safety Trial Data Presented at Multiple Medical Conferences

Company Continues Disciplined Pre-Commercial Planning in Anticipation of Potential FDA Approval of NDA

Resubmission for GTx-104 for the Treatment of Patients with aSAH

Princeton, NJ, June 18, 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 fiscal year ended March 31, 2026.

“Since receipt of the U.S. Food and Drug Administration’s (FDA) Complete Response Letter (CRL) in April 2026, we have been working

diligently on addressing the cited items, and we look forward to a constructive discussion with the FDA as we continue to prepare our resubmission,” said Prashant Kohli, CEO of Grace Therapeutics. “FDA approval of our New Drug Application (NDA)

for GTx-104 for the treatment of aSAH would represent the first meaningful innovation in the standard of care for these patients in more than 40 years. As evidenced by the response among researchers, practitioners and industry leaders to the

presentation of our Phase 3 STRIVE-ON trial results at major medical conferences throughout the fiscal year, we believe there is a significant desire in the marketplace for an intravenously administered nimodipine. We are confident in the

robust data package supporting our NDA, and that the issues identified by the FDA can be successfully addressed in our resubmission.”

Fiscal 2026 and Recent Corporate Highlights

•

On April 23, 2026, the FDA issued a CRL for the Company’s NDA for GTx-104

for the treatment of patients with aSAH. In the CRL, the FDA referenced certain items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections of the application, which Grace believes it can address in a

resubmission of its NDA. The cited items are related to additional leachable data time points for commercial product, non-clinical product toxicology risk assessments, and current Good Manufacturing Practices (cGMP) deficiencies with

our contract manufacturing organization. No clinical deficiencies were identified. A Type A meeting with the FDA has been scheduled to potentially clarify the path forward and determine the appropriate next steps. The Company expects to provide a regulatory update after the receipt of official

meeting minutes.

•

Phase 3 STRIVE-ON trial results were presented at multiple major medical conferences over the last twelve months:

•

2026 American Academy of Neurology, (April

18-22, 2026, Chicago, IL)

•

Society of Critical Care Medicine’s Critical Care Congress (March 22-24, 2026, Chicago, IL)

•

American Association of Neuroscience Nurses

(March 21-24, 2026, Dallas, TX)

•

Society of Vascular and Interventional Neurology (November 19-22, 2025, Orlando, FL)

•

2025 Neurocritical Care Society (September

18-21, 2025, Montreal, Quebec)

•

The U.S. Patent and Trademark Office issued a U.S. Patent No. 12,414,943, titled “Nimodipine

Parenteral Administration”. The method of use patent, published on September 16, 2025, 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. GTx-104 has also been granted Orphan Drug Designation from the FDA, which provides seven years of

marketing exclusivity in United States if certain conditions are met upon FDA approval of the NDA.

Fiscal Year 2026 Financial Results

The Company reported a net loss of $7.8 million, or $0.47 loss per share for the fiscal year ended March 31, 2026, representing a $1.8 million decrease

in net loss from $9.6 million, or $0.79 loss per share, for the fiscal year ended March 31, 2025.

Total research and development expenses were $2.4 million for the fiscal year ended

March 31, 2026, compared with $9.5 million, for the fiscal year ended March 31, 2025. The decrease of $7.1 million was primarily due to the decrease in research activities of $7.5 million driven by the close-out of the GTx-104 pivotal

Phase 3 safety clinical trial during the first calendar quarter of 2026, offset by a $0.4 million increase in external consulting and data management costs incurred in support of the NDA of GTx-104, which was submitted to the FDA in June 2025.

General and administrative expenses were $8.7 million for the fiscal year ended March

31, 2026, compared to $7.2 million for the fiscal year ended March 31, 2025. The increase of $1.5 million was primarily driven by $0.8 million in non-recurring legal and due diligence costs incurred in connection with strategic

initiatives evaluated during the period, as well as increased professional fees and other general and administrative costs of $0.9 million primarily related to

pre-commercial planning for GTx-104, offset in part by a decrease in salaries and benefits of $0.2 million primarily a result of decreased headcount.

Cash Runway

At March 31, 2026, the Company had cash and cash equivalents of $17.0 million, a net decrease of $5.1 million compared to cash and cash equivalents

of $22.1 million at March 31, 2025. The Company plans to use its current cash towards resolving the items cited in the FDA’s Complete Response Letter, 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 nimodipine oral capsules (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 the GTx-104 arm and the oral nimodipine arm, 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 in the GTx-104 arm compared to four deaths in

the oral nimodipine arm. The survival status of one patient in 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 GTx-104

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 nimodipine oral capsules.

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 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. GTx-104 has been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States if certain conditions are met at NDA approval, and

additional intellectual property protection with 52 granted and pending patents.

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 Company’s belief that there is a significant desire in the marketplace for an alternative to orally administered nimodipine; the Company’s belief that the issues

identified by the FDA in the CRL can be successfully addressed in the Company’s resubmission of an NDA for GTx-104; the expected timing and outcome of the Type A meeting with the FDA; the Company’s expectations that the Type A meeting with the

FDA will clarify the path forward and determine next steps; the Company’s plans to provide a regulatory update after the receipt of official meeting minutes from such Type A meeting; GTx-104’s potential to bring enhanced treatment options to

patients suffering from aSAH; the ability of GTx-104 to potentially eliminate the need for nasogastric tube administration in unconscious or dysphagic patients; the potential of GTx-104 to lower food effects, drug-to-drug interactions, and to

eliminate potential dosing errors; the potential of GTx-104 to better manage hypotension in aSAH patients; and the Company’s intellectual property estate for GTx-104, 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 any Type A meeting with the FDA related to GTx-104; (ii) the timing and success of any regulatory resubmission of the NDA for GTx-104; (iii) changes to regulatory pathways; (iv) the Company’s ability to protect its

intellectual property for GTx-104; 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, 2026, 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:

Grace Therapeutics Contact:

Prashant Kohli

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

---tables to follow---

GRACE THERAPEUTICS, INC.

Consolidated Balance Sheets

March 31, 2026

March 31, 2025

(Expressed in thousands except share data)

Assets

Current assets:

Cash and cash equivalents

16,977

22,133

Receivables

126

Prepaid expenses

383

453

Total current assets

17,380

22,712

Equipment, net

Intangible assets

41,128

Goodwill

8,138

Total assets

66,654

71,993

Liabilities and stockholders’ equity

Current liabilities:

Trade and other payables

2,146

1,930

Total current liabilities

2,146

1,930

Derivative warrant liabilities

—

1,141

Deferred tax liability

612

2,312

Total liabilities

2,758

5,383

Commitments and contingencies

Stockholders’ equity:

Preferred stock, $0.0001 par value per share; 10,000,000 authorized, none issued and outstanding as of March 31, 2026

and 2025

—

Common stock, $0.0001 par value per share; 100,000,000 authorized; 16,024,026 and 13,718,106 shares issued and

outstanding as of March 31, 2026 and 2025, respectively

Additional paid-in capital

298,413

293,334

Accumulated other comprehensive loss

(6,038

)

(6,038

)

Accumulated deficit

(228,480

)

(220,687

)

Total stockholders’ equity

63,896

66,610

Total liabilities and stockholders’ equity

66,654

71,993

GRACE THERAPEUTICS, INC.

Consolidated Statements of Loss and Comprehensive Loss

Year Ended

March 31, 2026

Year Ended

March 31, 2025

(Expressed in thousands, except share and per share data)

Operating expenses

Research and development expenses

2,405

9,511

General and administrative expenses

8,672

7,168

Loss from operating activities

(11,077

)

(16,679

)

Foreign exchange loss

)

(17

)

Change in fair value of derivative warrant liabilities

900

3,218

Interest and other income, net

685

711

Total other income, net

1,584

3,912

Loss before income tax benefit

(9,493

)

(12,767

)

Income tax benefit

1,700

3,199

Net loss and total comprehensive loss

(7,793

)

(9,568

)

Basic and diluted loss per share

(0.47

)

(0.79

)

Weighted-average number of shares outstanding

16,510,632

12,087,270

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dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration