8-K
Grace Therapeutics, Inc. (GRCE)
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
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<br><br> <br>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) |
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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:
| Title of each class | Trading<br><br> <br>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. |
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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.
| Item 8.01 | 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
| Exhibit | Description |
|---|---|
| 99.1 | Press Release, dated November 13, 2025. |
| 99.2 | Corporate Presentation, dated November 13, 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 thereunto duly authorized.
| GRACE THERAPEUTICS, INC. | |||
|---|---|---|---|
| Date: | November 13, 2025 | By: | /s/ Prashant Kohli |
| Prashant Kohli | |||
| Chief Executive Officer |
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
| • | 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<br> 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<br> compared to orally administered nimodipine. These data were presented at the Neurocritical Care annual meeting, held in Montreal, Quebec, Canada in<br> 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<br> 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<br> 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.<br> 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<br> 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<br> 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<br> 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:
| 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 |
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GRACE THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
| March 31,2025 | |||
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| (Expressed in thousands except share data) | |||
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| Equipment, net | |||
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| Stockholders’ equity: | |||
| Preferred stock, 0.0001 par value per share; 10,000,000 authorized; none issued and outstanding as of September 30, 2025<br> and March 31, 2025 | |||
| Common stock, 0.0001 par value per share; 100,000,000 authorized; 14,128,562 and 13,718,106 shares issued and outstanding<br> as of September 30, 2025 and March 31, 2025, respectively | |||
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All values are in US Dollars.
GRACE THERAPEUTICS, INC.
Condensed Consolidated Statements of Loss and Comprehensive Loss
(Unaudited)
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| September 30, 2025 | September 30, 2024 | September 30, 2025 | September 30, 2024 | |||||
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| Research and development expenses, net of government assistance | ) | ) | ) | ) | ||||
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| Basic and diluted loss per share | ) | ) | ) | ) | ||||
| Weighted-average number of shares outstanding |
All values are in US Dollars.
Exhibit 99.2
Corporate Presentation Fall 2025
Summary 2 Forward Looking Statements Statements in this presentation 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, Inc. (the “Company”) 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 presentation. The forward-looking statements in this presentation, including, but not limited to, statements regarding the Company’s expected cash runway, the potential exercise of outstanding warrants, the future prospects of the Company’s GTx-104 drug candidate, the outcome of the Company's NDA submission for GTx-104 with the FDA, GTx-104's potential to bring enhanced treatment options to patients suffering from aneurysmal subarachnoid hemorrhage (“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 provide improved bioavailability and the potential for reduced use of rescue therapies, GTx-104’s potential to achieve pharmacoeconomic benefit over the oral form of nimodipine, GTx-104’s commercial prospects, the Company’s pre-commercial launch strategy for GTx104, the future prospects of the Company’s GTx-102 drug candidate, GTx-102’s potential to provide clinical benefits to decrease symptoms associated with Ataxia Telangiectasia, 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 Postherpetic Neuralgia (“PHN”) patients to treat severe nerve pain associated with the disease, the timing and outcomes of a Phase 3 efficacy and safety trial for GTx-101, the size of the addressable market for GTx-104 and GTx 102, and any future patent and other intellectual property filings made by the Company for new developments are based upon Grace Therapeutics, Inc.’s 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 STRIVE-ON Phase 3 safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome of the NDA submission for GTx-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) the Company’s ability to protect its intellectual property rights for its product 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, Quarterly Reports on Forms 10-Q for the quarterly periods ended June 30, 2025 and September 30, 2025 and other documents that have been and will be filed by Grace Therapeutics, Inc. from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this presentation 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.
Summary GTx-104 – novel intravenous nimodipine – well positioned to solve oral challenges and potentially displace oral as SoC Nimodipine is the SoC and clinically de-risked; however, significant unmet needs remain with its only available oral form Pivotal Phase 3 STRIVE-ON safety trial met primary endpoint; clinical evidence of GTx-104 benefit vs oral 3 Executive Summary aSAH: aneurysmal Subarachnoid Hemorrhage. All dates based on calendar year in the presentation. GTx-104 | aSAH Potential to address a severe rare disease with efficient commercial organization; concentrated patient care Orphan Drug Status with seven-year market exclusivity and additional multi-layered IP protection NDA filed June 2025; accepted for review August 22, 2025 Target PDUFA April 23, 2026
aSAH is a Rare and Severe Acute Brain Injury Subarachnoid Hemorrhage aSAH results in bleeding over the surface of the brain in the space between the brain and skull Primary cause is rupture of an aneurysm Condition can occur quickly, immediate intervention is key to survival Patients require surgical intervention and oral nimodipine therapy 4 Sources: ClearView Analysis (2025). Forian Claims Data. Fletcher Spaght market research; Becske T. (2018). Steven (2020). Occurs in Relatively Young Patients (~50% <60 yrs) Significant Mortality (~10-15% before reaching hospital) Est. Annual U.S. Hospital-Treated Patients (2023) Hospital-treated aSAH may be as high as ~70k
Oral Nimodipine – The aSAH Standard of Care for >3 Decades 5 Sources: Hoh (2023). Hernandez-Duran (2019). Sandow (2016). DCI: Delayed Cerebral Infarction The Joint Commision is a hospital accredation agency 2023 AHA/ASA GuidelinesFor the management of patients with aSAH Nimodipine is the only approved therapy to improve neurological outcomes Limited use of off-label therapies due to The Joint Commission monitoring adherence to care guidelines
Nimodipine – Consistent Drug Administration Drives Positive Patient Outcomes 6 Sources: Hoh (2023). Hernandez-Duran (2019). Sandow (2016). aOR: adjusted odds ratio; CI: Confidence Interval Nimodipine cessation or dose reduction independently associated with poor functional outcomes (aOR 0.89, 95% CI 0.80-0.99) P = 0.037 P = 0.061 Received Reduced Nimodipine Course Received Full Nimodipine Course Received Reduced Nimodipine Course Received Full Nimodipine Course Hunt Hess 1-3 Hunt Hess 4-5 Nimodipine is administered six times per day for up to 21 days Limited use of off-label therapies due to Joint Commission monitoring adherence to care guidelines
7 Substantial Shortcomings of Oral Nimodipine Sources: Nimodipine Prescribing Label, Sandow et al., Mahmoud et al., Abboud et al., Soppi et al., Rabaut et al., Ho et al., Fletcher Spaght market research. Administration Challenges High dosing burden of 60mg (2 x 30mg capsules), 6 times per day 45% of patients receive nimodipine through nasogastric tube (NGT) – often via capsule extraction Capsule extraction and administration is labor intensive Dosing Interruption Increased Hypotension Too High Fatal Medication Errors Inadvertent parenteral injection can result in death or serious life-threatening AEs Highest risk with capsule extraction NYMALIZE (oral liquid) tempers the risk of error, but has tolerability challenges (e.g., severe diarrhea) due to solubility limitations of nimodipine 3 Sub-optimal Therapeutic Benefit with Oral Administration High Pharmacokinetic Variability Inconsistent plasma concentration in both inter and intra subject High first-pass metabolism, leads to low bioavailability and frequent dosing Gastric motility issues and presence of food delay rate of absorption Potentially negligible concentration with NGT administration Hypotension drives missed doses and diminished efficacy Blood Concentration 55% of patients do not receive the full daily dose due to hypotension Sub-optimal Outcomes Too Low
GTx-104 is a Novel IV Nimodipine Designed to Overcome Oral Delivery Challenges Supported by Strong IP, Ph. III Trial Success, and a filed NDA 8 CMC: Critical micelle concentration. Orphan Drug Status with seven-year market exclusivity and additional multi-layered IP protection Drug loaded micelles Nimodipine 10– 15 nm Blank micelles Surfactant Monomers Hydrophilic Part Hydrophobic Part A novel intravenous nimodipine that is well positioned to solve oral challenges and potentially displace oral as SoC Pivotal Phase 3 STRIVE-ON safety trial met primary endpoint; clinical evidence of GTx-104 benefit vs. oral Target PDUFA April 23, 2026 GTx-104 Overcomes solubility limitations of nimodipine in current formulations Patented formulation uses non-ionic surfactant micelles as the drug carrier to solubilize nimodipine Simple to prepare in pharmacy, stable at room temperature GTx-104 drug delivery technology
GTx-104 Value Proposition 9 Risk of Fatal Parenteral Use Requires Feeding Tube Excipient Intolerance Hemodynamic Control Dose Compliance Markets Nimodipine Capsules Yes Yes No Poor Poor U.S. / WW NYMALIZE (Oral Liquid) Yes (Reduced) Yes Yes Poor Poor U.S. / Select WW NIMOTOP (Injectable) No No Yes * Unknown Rescue Only EU / China GTx-104 No No No Optimal Optimal Global Rights NDA Submission 1H:25 Sources: Nimodipine capsule packaging insert. Fletcher Spaght market research. Soppi V. (2007). * High alcohol content (~24% volume/volume) also requires central catheter for administration WW: Worldwide DDI: drug-drug internation Predictable drug concentration & dose compliance Reduced drug intake, reduced DDIs & no food effects More effective hypotension management Clinical Value Hospital Value Reduced hospital resources The Joint Commission compliance to aSAH care guidelines Reduced medication errors & nursing burden Patient Value Lower disease burden & faster recovery Safer & more convenient treatment Improved functional outcomes
Phase 1 Trial Established Scientific Bridge between GTx-104 and Oral Nimodipine 10 Source: GTx-104-002 CSR; results announced May 2022 Significantly lower dose variability relative to oral capsule Consistent and predictable plasma concentrations GTx-104 IV infusion vs Oral capsule: AUC Day_3 0-24hr GTx-104 Oral Capsule 0 100 200 300 400 500 600 700 800 900 1000 AUC dav-3 0-24hour GTx-104 Trial met all primary and secondary endpoints; enabling the 505(b)2 regulatory pathway
STRIVE-ON Phase 3 Trial
GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design 12 mRS: modified Rankin Scale STRIVE-ON (NCT05995405) is a ~100-patient prospective, open-label, randomized (1:1 ratio), parallel group trial of GTx-104 compared with oral nimodipine in patients hospitalized for aSAH Screening Period (within 96 hours of aSAH onset) Day 1 Treatment Period Day 2-21 Onset of aSAH Follow up Period Day 30 and Day 90 Primary Endpoint Incidence of subjects with at least one episode of clinically significant hypotension Informed Consent Inclusion/exclusion Randomize Initiate investigational product Hypotension events Relative dose intensity Safety Adverse events Functional outcomes (mRS) Pharmacoeconomic outcomes Trial complete and reported topline data in January 2025
13 STRIVE-ON Trial Data Demonstrates Key Clinical, Pharmacoeconomic, and Dosing / Administration Benefits over Current SoC, Oral Nimodipine CLINICAL IMPROVED 90-DAY OUTCOMES (MRS*) +29% relative increase in patients with good recovery at 90 days vs. oral nimodipine FEWER HYPOTENSION EVENTS -19% reduction from oral nimodipine BETTER RELATIVE DOSE INTENSITY 54% vs. 8% with oral nimodipine receive >95% prescribed dose PHARMACOECONOMIC FEWER ICU DAYS -1.5 days reduction from oral nimodipine LESS TIME ON VENTILATION -5 days reduction from oral nimodipine REDUCED ICU READMISSION RATES -48% reduction from oral nimodipine DOSING & ADMIN. IMPROVED PATIENT REST No need to disrupt patient sleep every 4 hours EASIER ADMINISTRATION No feeding tube or swallowing of large pills required LESS LABOR-INTENSIVE TREATMENT PREP No nimodipine capsule extraction and administration (laborious for staff) * mRS – modified Rankin Score
14 Demographics & Baseline Characteristics GTX-104 (N = 50) Oral Nimodipine (N = 52) Age (mean) 55 56 Sex, n (%) Female Male 33 (66.0%) 17 (34.0%) 33 (63.5%) 19 (36.5%) Hunt & Hess Grade, n (%) I II III IV V 10 (20%) 15 (30%) 15 (30%) 6 (12%) 4 (8%) 8 (15%) 15 (29%) 16 (31%) 12 (23%) 1 (2%) Demographics well-balanced, except higher proportion of most severe with worst prognosis (Grade V) in GTx-104
15 Primary Endpoint – Clinically Significant Hypotension ~19% relatively fewer patients with clinically significant hypotension in GTx-104 GTX-104 (N = 50) n (%) Oral Nimodipine (N = 52) n (%) Clinically Significant Hypotension 14 (28%) 18 (35%) Clinically significant hypotension: decrease in systolic BP > 20 mm Hg or diastolic BP > 10 mm Hg or systolic BP <= 100 confirmed by two consecutive readings within five minutes AND requiring medical intervention.
16 Relative Dose Intensity (RDI) 54% of patients on GTx-104 had RDI of 95% or higher versus 8% on Oral Nimodipine GTx-104 Oral Nimodipine RDI = (total dose administered / total amount of expected dose) * 100.
17 Clinical Outcomes – mRS (day 90) ~29% relative increase in patients with good recovery in GTx-104 ~29% * 3 patients did not complete physician-conducted mRS at day-90. However, all 3 were confirmed alive at day-90 ** 6 patients did not complete physician-conducted mRS at day-90. 5 were confirmed alive at day-90, and 1 survival status was unknown
18 Clinical Outcomes – QoL (Quality of Life; day 90) Patient-reported health scores favor GTx-104 QoL GTx-104 (N = 381) Oral Nimodipine (N = 402) Your Health Today Score mean (0 = being worst -> 100 = great) 75 70 Mobility, n (%) I have no or some problems I am confined to bed 38 (100%) 0 35 (88%) 5 (12%) Self-Care, n (%) I have no or some problems I am unable to wash/dress 37 (97%) 1 (2.6%) 35 (88%) 5 (12%) Usual Activities, n (%) I have no or some problems I am unable to perform 35 (92%) 3 (8%) 33 (84%) 7 (16%) Pain/Discomfort, n (%) I have no or moderate pain I have extreme pain 36 (95%) 2 (5%) 38 (95%) 1 (2%) Anxiety/Depression, n (%) I am not or moderately I am extremely 36 (95%) 2 (5%) 36 (90%) 3 (7%) 1 GTx-104: patient did not complete survey (4), dead (8 – all due to underlying disease, none were GTx-104 related). 2 Oral Nimodipine: patient did not complete survey (8), dead (4 – all due to underlying disease, none were Oral Nimodipine related). Oral also had 2 incomplete (pain, anxiety).
19 Safety Overall safety was comparable between the two groups Summary of Adverse Events (AEs) (entire study duration of 90 days) GTx-104 (N = 50) Oral Nimodipine (N = 52) All AEs, n (%) # of events 44 (88%) 157 43 (83%) 193 All AEs, events per n 3.6 4.5 All SAEs1, n (%) # of events 18 (36%) 34 25 (48%) 48 All SAEs, events per n 1.9 1.9 Treatment-Related SAEs, n (%) # of events2 0 2 (4%) 2 Mortality3, n (%) 8 (16%) 4 (8%) Cause of death4 (n) All deaths were due to severity of underlying disease No deaths due to GTx-104 aSAH (5), ICH (1), rebleed (1), cardiac arrest (1) No deaths due to Oral Nimodipine aSAH (2), rebleed (1), cardiac arrest (1) 1 A few include sepsis, deep vein thrombosis, ICH, hydrocephalus, cerebral infarction, urinary tract infection, C. difficile, systemic inflammatory response, acute kidney injury, as well as death 2 Oral Nimodipine: bradycardia, vasospasm 3 Mortality rate is equivalent or lower than previous well-controlled clinical trials (Oral NIMOTOP NDA) 4 Based on investigator assessment SAEs: Serious Adverse Events; ICH: Intracerebral Hemorrhage; DCI: Delayed Cerebral Hemorrhage
20 ICU Length of Stay (los), Mechanical Ventilator & Readmissions 1.5 fewer ICU days, 5 fewer ventilator days, and 48% relatively fewer ICU readmissions in GTx-104 GTx-104 (N = 50) Oral Nimodipine (N = 52) ICU los, days Mean (SD) 16.4 (6.7) 17.9 (10.4) Mechanical Ventilation days Mean (SD) 5.6 (5.7) 10.6 (13.9) Hospital Readmissions* One readmission, n (%) Two readmissions, n (%) Three readmissions, n (%) 6 (12%) 0 0 7 (14%) 0 1 (2%) ICU Readmissions One readmission, n (%) Two readmissions, n (%) 2 (4%) 0 3 (6%) 1 (2%) * Hospital Readmissions includes ICU readmissions. Readmissions were due to sequelae of aSAH e.g., UTI (urinary tract infection), DVT (deep vein thrombosis), Pneumonia, Seizures, Hydrocephalus, Cranioplasty. SD: standard deviation
21 Pharmacoeconomics Major patient resource utilization drivers in aSAH favor GTx-104 GTx-104 (N = 50) n* Oral Nimodipine (N = 52) n* Day 1 Day 14 % change Day 1 Day 14 % change Mechanical Ventilation 14 1 -93% 12 7 -42% External Ventricular Drain 32 10 -69% 35 17 -51% Deep Sedation 5 1 -80% 8 5 -38% Comatose 4 0 -100% 5 2 -60% * Excludes patients that died before Day 14 for this analysis.
Commercial Preparation
~45% of treated patients are unconscious or dysphagic (nasogastric tube) >25% of treated patients have poor dose compliance / blood pressure control aSAH Market Opportunity 23 Literature, typically limited to basal cistern aSAH (~80% of aSAH), suggests ~42.5K U.S. hospital-treated patients Claims analysis suggests incidence of hospital-treated aSAH may be as high as ~70K Addressable Patients ~50% of patients who survive the initial month remain permanently dependent on a caregiver to maintain daily living Hospitalization charges can be up to ~$530k for an aSAH patient aSAH is among the most highly reimbursed Diagnosis-Related Groups (DRGs) in neuro ICU 70% of aSAH Cases Result in Death or Permanent Disability Most Critical Unmet Needs Sources: ClearView Analysis (2025). Forian Claims Data. Becske T. (2018). Steven (2020). Hoh (2023). Etminan. JAMA Neurol. 2019; Fegin. The Lancet Neurology. 2009; Labovitz. Neuroepidemiology. 2006; Shea. Neurosurgery. 2007, Linn. Stroke. 1996; Anderson. Stroke. 2000; Daniere. J de Radiologie Diagnostique. 2015; Ingall. Stroke. 1989; Giordan et al. J Neurosurg. 2021; Rinkel et al. Lancet Neurol. 2011; Intl Study of Unruptured Intracranial Aneurysms Investigators. NEJM. 1998.
24 GTx-104 is seen as valuable for its improved tolerability, cost savings, and easy IV use – with broad formulary inclusion by P&T committee EFFICACY PHARMACOECONOMIC ROA (route of admin) “… The pro of Product X is certainly the efficacy endpoint. The fact that there is a reduction in hypotensive events. That is a pretty significant, 19% reduction …” - Neurointensivist, Stanford University “… The reduction in hypotensive events is meaningful. I could use it for patients who can not take nimodipine due to hypotensive episodes …” - Neurointensivist, Mount Sinai “… I would prefer to use Product X in every patient because one of the biggest reasons to not continue nimodipine is because of hypotension …” - Neurointensivist, Atlantic Health System Respondents emphasized that the reduction in hypotension with GTx-104 is meaningful, as it allows more patients to remain on therapy and avoid dose-limiting side effects HCPs highlighted that even modest reductions in ICU or ventilator time can have a significant impact on hospital costs, suggesting GTx-104’s potential to deliver value beyond drug price—particularly given the high-cost aSAH care settings GTx-104’s immediate usability without NG tube placement was seen as an advantage, enabling earlier intervention, especially in unstable or intubated patients where time sensitive dosing is key “… From an economic standpoint, fewer days in the ICU or on a ventilator certainly could justify the cost of the drug. Even a reduction of a single day is relevant. When it gets to be 2 or 3 days, then it’s very impressive ...” - Neurosurgeon, USC “… A reduction in ventilator days is great for the patient in reducing their risk of infections and benefitting their financial bottom line. It’s also good for hospital costs …” - Critical Care Specialist, Intermountain Health “… Most hospitals are over capacity right now. Any reduction in ICU or ventilator days typically translates to shorter hospital days, which will benefit hospitals overall in terms of costs and resources …” - Neurointensivist, Boston Medical Center “… I definitely prefer IVs for critically ill patients than oral. You don’t have to worry about placing down an NG tube …” - Neurosurgeon, Westchester Medical Center “… Blood levels are more consistent from one dose to the other, which makes a whole lot of sense since it’s IV. It’s mostly maintaining a therapeutic level and being at the peak of concentration that is a major advantage of IV …” - Neurosurgeon, UCSF “… IV would be great because then you don’t have the NG tube anymore or you don’t need to rush for the NG tube because it’s such a pain every time …” - Neurosurgeon, UCSF Primary Market Research Insights (2Q 2025) Sources: Third party conducted interviews, research, and analysis
Concentration of aSAH Care – Efficient Commercialization 25 aSAH-Treating Institutions Concentration PatientVolume Analysis includes n = 3,227 institutions where at least one aneurysmal SAH patient is treated Concentration of aSAH Patients % of Institutions % of Patients ~80% of aSAH patients spread across 880 centers ~15 rep sales force to reach ~50% of aSAH patients, concentrated in 242 centers 1 Assumes each sales rep manages ~15 accounts. Sources: ClearView Analysis (2025). Forian Claims Data.
Intellectual Property Portfolio 26 Multi-layered intellectual property protection strategy GTx-104 received orphan drug status designation from the FDA Potential 7 years of marketing exclusivity in US upon NDA approval US and international patent estate Consists primarily of formulation and method-of-use patents to extend exclusivity beyond what is granted through the orphan drug designation. Multiple patents granted worldwide, including five patents in the US Long patent shelf-life First patent expiry 2037 Newest patent expiry 2042 Continue building our patent portfolio by filing for patent protection on new developments
Recent Financing and Warrant Exercise with Potential Exercise of Outstanding Warrants Provides Expected Cash Runway to Calendar Q2 2027 Grace Therapeutics, Inc. (GRCE) Cap Table (as of October 31, 2025) Cash & Cash Equivalents Balance USD $20.0 M3 Outstanding Common Stock 15,474,026 Debt NONE Stock options granted and outstanding 1,309,703 Total Fully Diluted Shares Outstanding1 22,997,981 27 1 Includes Pre-Funded Warrants, Common Warrants, Outstanding Stock Options 2 Represents warrants exercisable for 4,418,292 shares of common stock (or pre-funded warrants in lieu thereof) issued on February 11, 2025, with an aggregate exercise price of approximately $15.0 million. The warrants are immediately exercisable at an exercise price of $3.395 per share and will expire on the earlier of (i) the 60th day after the date the FDA approves the New Drug Application for GTx-104 and (ii) September 25, 2028. 3 The preliminary unaudited financial information presented is an estimate based on information available to management as of October 31, 2025, has not been reviewed or audited by the Company’s independent registered accounting firm, and is subject to change. Potential Gross Proceeds from Exercise of Outstanding Warrants Feb-25 Private Placement2: Potential Warrant Exercise Gross Proceeds $15.0 M
Experienced Leadership Team 28 Carrie D'Andrea VP Clinical Operations Loch Macdonald, MD, PhD Chief Medical Officer Prashant Kohli Chief Executive Officer Amresh Kumar, PhD VP Program Management Robert J. DelAversano Principal Financial Officer and Principal Accounting Officer Alejandro A. Rabinstein, MD Alex Choi, MD Andrew Ducruet, MD Sherry H-Y Chou, MD W. Taylor Kimberly, MD, PhD Management Team Scientific Advisory Board Deep aSAH Expertise in Research, Commercial, Drug & AHA Care Guidelines Development
Appendix (Deprioritized Programs)
30 GTx-102 Program Overview & Regulatory Update GTx-102 Novel oral spray formulation of betamethasone intended to improve neurological symptoms of A-T patients Proof of concept supported by well-controlled Phase 1 trial with A-T patients PK bridging study topline results announced on 12/18/22 met all outcome measures Sources: Fletcher Spaght market research; National Organization for Rare Disorders (NORD); Lefton-Greif (2000); U.S. National Cancer Institute, A-T (2015). Unmet Need (No drugs approved) Treatment primarily directed toward control of symptoms Limited to speech, occupational and physical therapy Less than 20% of patients on any type of drug therapy for A-T symptoms Ataxia-Telangiectasia Complex genetic neurodegenerative disorder diagnosed during infancy Inherited as an autosomal recessive trait, often affects more than one child in a family Average lifespan ~25 years Potential addressable market ~$150 million Regulatory FDA’s written responses to EoP1 provides feedback on design of a single pivotal efficacy trial to support NDA Guidance includes primary endpoint scale and appropriate confirmatory evidence Plan to discuss with SAB potential trial design
31 GTx-101 Program Overview GTx-101 Non-narcotic, topical, bio-adhesive, transparent film-forming bupivacaine spray Biphasic drug release expected to provide immediate and continuous relief Potential Addressable market ~$200m (PHN) to ~$2.5b (lidocaine patch replacement) PHN: Postherpetic Neuralgia Sources: Fletcher Spaght, Inc. analysis (2022); CDC MMWR June 6, 2008. UK and several US states have reclassified gabapentin as a scheduled drug Unmet Need Oral therapies (gabapentin, anticonvulsants, opioids) can have side effects and insufficient to manage pain in many cases Can be prone to abuse Lidocaine patches are hard to place, can cause skin irritation, are 12-hour on / off ~40% experience insufficient pain relief Postherpetic Neuralgia (rare disease) Caused by nerve damage from the herpes zoster virus which causes shingles Burning, painful, itchy, loss of feeling, sensitivity to touch or temperature, feeling worn out Symptoms can last for several years or may be permanent Regulatory Completed Phase 1 (single dose) in 2022 Met all primary outcome measures Clinical roadmap includes Phase 1 (multiple ascending dose) and Phase 2 (POC)