Grace Therapeutics (NASDAQ: GRCE) narrows 2026 loss and details FDA path for GTx-104
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Grace Therapeutics reported fiscal year 2026 results and updated progress on its lead drug GTx-104. The company recorded a net loss of $7.8 million, or $0.47 per share, for the year ended March 31, 2026, improving from a $9.6 million loss, or $0.79 per share, a year earlier.
Research and development expenses fell to $2.4 million from $9.5 million as its pivotal Phase 3 STRIVE-ON safety trial for GTx-104 was closed out, while general and administrative expenses rose to $8.7 million from $7.2 million, mainly due to legal, due diligence and pre-commercial planning costs.
Grace ended March 31, 2026 with $17.0 million in cash and cash equivalents and expects this to fund operations for at least 12 months. Following an April 2026 Complete Response Letter from the FDA on the GTx-104 NDA, the company has a Type A meeting scheduled to clarify the path to resubmission and continues disciplined pre-commercial planning in anticipation of a potential approval for treating aneurysmal subarachnoid hemorrhage.
Positive
- None.
Negative
- None.
Insights
Loss narrowed and cash runway is solid, but GTx-104 regulatory outcome remains the main swing factor.
Grace Therapeutics reported a reduced net loss of $7.8 million versus $9.6 million the prior year, driven largely by lower R&D as the Phase 3 STRIVE-ON trial for GTx-104 concluded. G&A rose on legal and pre-commercial costs, indicating the company is investing ahead of a potential launch.
Cash and equivalents of $17.0 million as of March 31, 2026 are expected to fund at least 12 months of operations, giving some financial visibility as Grace works through FDA feedback. The recent Complete Response Letter and upcoming Type A meeting keep regulatory risk front and center.
The STRIVE-ON trial met its primary endpoint, with a 19% reduction in clinically significant hypotension (28% vs. 35%) and secondary measures generally favoring GTx-104 over oral nimodipine. Future disclosures around the Type A meeting outcome and NDA resubmission timing will be key to understanding the potential path to approval.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Net loss: $7.8M
R&D expenses: $2.4M
G&A expenses: $8.7M
+5 more
8 metrics
Net loss
$7.8M
Year ended March 31, 2026; vs. $9.6M in 2025
R&D expenses
$2.4M
Fiscal 2026; down from $9.5M in fiscal 2025
G&A expenses
$8.7M
Fiscal 2026; up from $7.2M in fiscal 2025
Cash and cash equivalents
$17.0M
As of March 31, 2026; previously $22.1M
Weighted-average shares
16.5M shares
Weighted-average basic and diluted shares in fiscal 2026
STRIVE-ON primary endpoint
19% reduction
Reduction in clinically significant hypotension: 28% vs 35%
Relative dose intensity ≥95%
54% vs 8%
Patients on GTx-104 vs oral nimodipine in STRIVE-ON
Trial enrollment
102 patients
50 on GTx-104, 52 on oral nimodipine in STRIVE-ON
Key Terms
Complete Response Letter, Type A meeting, aneurysmal Subarachnoid Hemorrhage (aSAH), relative dose intensity, +2 more
6 terms
Complete Response Letter regulatory
"Since receipt of the U.S. Food and Drug Administration’s (FDA) Complete Response Letter (CRL) in April 2026..."
A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.
Type A meeting regulatory
"Type A Meeting Scheduled with FDA to Potentially Clarify Path to GTx-104 NDA Resubmission"
A Type A meeting is an urgent, short-notice session requested between a company and a regulatory agency (for example, the FDA in the U.S.) to resolve critical issues that block a development program, such as a clinical hold or safety concern. Investors care because the outcome can immediately affect whether a clinical trial or approval process resumes, changing timelines, costs and the company’s near-term value — like calling an emergency mechanic when a car won’t start so a trip can continue.
aneurysmal Subarachnoid Hemorrhage (aSAH) medical
"GTx-104... being developed for IV infusion to address significant unmet medical needs in aSAH patients"
Aneurysmal subarachnoid hemorrhage (aSAH) is bleeding into the space around the brain caused when a weakened blood vessel (an aneurysm) bursts. It is a sudden, serious medical emergency that often requires urgent surgery or specialized treatments; for investors, aSAH matters because it drives demand for emergency care, surgical devices, monitoring technologies, and drug development, and can rapidly affect hospital costs, insurer payouts, and the commercial prospects of related medical products.
relative dose intensity medical
"54% patients on GTx-104 had relative dose intensity (RDI) of 95% or higher..."
Orphan Drug Designation regulatory
"GTx-104 has been granted Orphan Drug Designation by the FDA..."
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
derivative warrant liabilities financial
"Change in fair value of derivative warrant liabilities"
Derivative warrant liabilities are the obligation a company records for outstanding warrants—contracts that give holders the right to receive cash or shares based on the company’s stock price. They matter to investors because these liabilities signal potential future cash outflows or share dilution that can reduce earnings per share, change available cash, and increase stock volatility; think of them as outstanding IOUs that may force a company to pay money or issue more shares.
Earnings Snapshot
Net loss: $7.8M
Fiscal year ended March 31, 2026
Net loss
$7.8M
improved from $9.6M prior year
R&D expenses
$2.4M
down from $9.5M prior year
G&A expenses
$8.7M
up from $7.2M prior year
Cash and cash equivalents
$17.0M
down from $22.1M prior year
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
(Exact name of Registrant as Specified in Its Charter)
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(Address of Principal Executive Offices)
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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
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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. ☐
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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 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.
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Exhibits
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Exhibit
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Description
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99.1
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Press Release, dated June 18, 2026.
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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: June 18, 2026
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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 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
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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.
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Phase 3 STRIVE-ON trial results were presented at multiple major medical conferences over the last twelve months:
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2026 American Academy of Neurology, (April
18-22, 2026, Chicago, IL)
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Society of Critical Care Medicine’s Critical Care Congress (March 22-24, 2026, Chicago, IL)
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American Association of Neuroscience Nurses
(March 21-24, 2026, Dallas, TX)
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Society of Vascular and Interventional Neurology (November 19-22, 2025, Orlando, FL)
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2025 Neurocritical Care Society (September
18-21, 2025, Montreal, Quebec)
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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.
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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:
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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: info@gracetx.com
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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: mmoyer@lifesciadvisors.com
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---tables to follow---
GRACE THERAPEUTICS, INC.
Consolidated Balance Sheets
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March 31, 2026
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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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Assets
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Current assets:
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Cash and cash equivalents
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16,977
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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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383
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453
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Total current assets
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17,380
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22,712
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Equipment, net
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8
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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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66,654
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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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2,146
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1,930
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Total current liabilities
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2,146
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1,930
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Derivative warrant liabilities
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—
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1,141
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Deferred tax liability
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612
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2,312
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Total liabilities
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2,758
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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 March 31, 2026
and 2025
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—
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—
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Common stock, $0.0001 par value per share; 100,000,000 authorized; 16,024,026 and 13,718,106 shares issued and
outstanding as of March 31, 2026 and 2025, respectively
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1
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1
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Additional paid-in capital
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298,413
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293,334
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Accumulated other comprehensive loss
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(6,038
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)
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(6,038
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Accumulated deficit
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(228,480
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)
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(220,687
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Total stockholders’ equity
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63,896
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66,610
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Total liabilities and stockholders’ equity
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66,654
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71,993
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GRACE THERAPEUTICS, INC.
Consolidated Statements of Loss and Comprehensive Loss
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Year Ended
March 31, 2026
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Year Ended
March 31, 2025
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(Expressed in thousands, except share and per share data)
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$ |
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$ | |||||
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Operating expenses
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||||||||
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Research and development expenses
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2,405
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9,511
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General and administrative expenses
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8,672
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7,168
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Loss from operating activities
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(11,077
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)
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(16,679
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)
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Foreign exchange loss
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(1
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)
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(17
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)
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Change in fair value of derivative warrant liabilities
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900
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3,218
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Interest and other income, net
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685
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711
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Total other income, net
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1,584
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3,912
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Loss before income tax benefit
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(9,493
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)
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(12,767
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)
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Income tax benefit
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1,700
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3,199
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Net loss and total comprehensive loss
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(7,793
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)
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(9,568
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)
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Basic and diluted loss per share
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(0.47
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)
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(0.79
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)
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Weighted-average number of shares outstanding
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16,510,632
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12,087,270
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