Grace Therapeutics Inc
For the period ended Mar 31, 2025. Filed Jun 23, 2025.
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FY2025 · Filed Jun 23, 2025
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Notes to the Consolidated Financial Statements
(Expressed in thousands except share and per share data)
- Nature of Operations
General
Grace Therapeutics, Inc. (formerly known as Acasti Pharma Inc.) (“Acasti Delaware” or “the Company”), is a Delaware corporation that, as further described below, previously existed under the laws of the Province of Québec, Canada (“Acasti Québec”), before changing its jurisdiction on October 1, 2024 to the Province of British Columbia, Canada (“Acasti British Columbia”). On October 7, 2024, Acasti British Columbia changed its jurisdiction to the State of Delaware. Effective October 28, 2024, the Company changed its corporate name to Grace Therapeutics, Inc.
Continuance and Domestication
On October 1, 2024, Acasti Québec changed its jurisdiction of incorporation from the Province of Québec in Canada to the Province of British Columbia in Canada pursuant to a “continuance” effected in accordance with Chapter XII of the Business Corporations Act (Québec) (the “Continuance”). Subsequently on October 7, 2024 (the “Effective Date”), Acasti British Columbia changed its jurisdiction of incorporation from the Province of British Columbia in Canada to the State of Delaware in the United States of America pursuant to a “continuance” effected in accordance with Section 308 of the Business Corporations Act (British Columbia) and a “domestication” (the “Domestication”) under Section 388 of the General Corporation Law of the State of Delaware. Both the Continuance and the Domestication were approved by the Company’s shareholders at the Company’s Annual and Special Meeting of Shareholders held on September 30, 2024.
Prior to the Continuance and Domestication, the Company’s Class A common shares, without par value per share (“Common Shares”), were listed on The Nasdaq Stock Market LLC (“Nasdaq”) under the symbol “ACST.” Upon the effectiveness of the Continuance, each outstanding Class A common share of Acasti Québec at the time of the Continuance remained issued and outstanding as a common share, without par value per share, of Acasti British Columbia. Upon effectiveness of the Domestication, each outstanding common share of Acasti British Columbia at the time of the Domestication automatically becameone outstanding share of common stock, par value $0.0001 per share, of Acasti Delaware (“Common Stock”). The Common Stock continues to be listed for trading on Nasdaq and in connection with its corporate name change to Grace Therapeutics, Inc., commenced trading under the symbol “GRCE” on October 28, 2024.
The Continuance and Domestication has been accounted for as an exchange of equity interest among entities under common control resulting in a change in reporting entity, and has been retroactively reflected in the accompanying consolidated financial statements and notes thereto. All assets and liabilities of Acasti British Columbia were deemed assumed by the Company at the Effective Date, resulting in the retention of the historical basis of accounting as if they had always been combined for accounting and financial reporting purposes. Any excess resulting from the automatic conversion of each outstanding Common Share of Acasti British Columbia intoone outstanding share of Common Stock of Acasti Delaware, is presented as Additional Paid-in Capital in the equity section of the accompanying consolidated financial statements and notes thereto. All per share amounts for all periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect the effect of the change in par value.
Liquidity and Financial Condition
The Company has incurred operating losses and negative cash flows from operations in each period since its inception. The Company expects to incur significant expenses and continued operating losses for the foreseeable future.
In May 2023, the Company implemented a strategic realignment plan to enhance shareholder value that resulted in the Company engaging a new management team, streamlining its research and development activities, and greatly reducing its workforce. Following the realignment, the Company is a smaller, more focused organization, based in the United States, and concentrated on its development of its lead product candidate GTx-104. Further development of GTx-102 and GTx-101 will occur at such a time when the Company is able to secure additional funding or enters into strategic partnerships for license or sale with third parties.
In February 2025, the Company completed a private placement of Company securities with certain institutional and accredited investors. Net proceeds to the Company were $13,705. Refer to Note 8,2025 Private Placement, for additional information.
The Company plans to use its current cash to further the regulatory review process for GTx-104, pre-commercial planning, commercial team buildout, and product launch if GTx-104 is approved, 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 issuance date of these consolidated financial statements included in the Company’s Annual Report on Form 10-K.
The Company will require additional capital to fund its daily operating needs. The Company does not expect to generate revenue from product sales unless and until it successfully completes drug development and obtains regulatory approval, which is subject to significant uncertainty. To date, the Company has financed its operations primarily through public offerings and private placements of its common equity, warrants and convertible debt and the proceeds from research tax credits. Until such time that the Company can generate significant revenue from drug product sales, if ever, it will require additional financing, which is expected to be sourced from a combination of public or private equity or debt financing or other non-dilutive sources, which may include fees, milestone payments and royalties from collaborations with third parties. Arrangements with collaborators or others may require the Company to relinquish certain rights related to its technologies or drug product candidates. Adequate additional financing may not be available to the Company on acceptable terms, or at all. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and its ability to pursue its business strategy. The Company plans to raise additional capital in order to maintain adequate liquidity. Negative results from studies or trials, if any, the timing and ability to receive U.S. Food and Drug Administration (“FDA”) approval for marketing our drug candidates or depressed prices of the Company’s stock could impact the Company’s ability to raise additional financing. Raising additional equity capital is subject to market conditions that are not within the Company’s control. If the Company is unable to raise additional funds, the Company may not be able to realize its assets and discharge its liabilities in the normal course of business.
The Company remains subject to risks similar to other development stage companies in the biopharmaceutical industry, including compliance with government regulations, protection of proprietary technology, dependence on third-party contractors and consultants and potential product liability, among others. Please refer to the risk factors included in Part 1, “Item 1A – Risk Factors” of this Annual Report on Form 10-K.
- Summary of significant accounting policies
Basis of presentation
These consolidated financial statements of Grace Therapeutics, Inc., which include the accounts of its subsidiary, have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP"). All intercompany transactions and balances are eliminated on consolidation.
Use of estimates
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, income, and expenses. Actual results may differ from these estimates.
Estimates are based on management’s best knowledge of current events and actions that management may undertake in the future. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Estimates and assumptions include the measurement of stock-based compensation, derivative warrant liabilities, accruals for research and development contracts and contract organization agreements, and valuation of intangibles and goodwill. Estimates and assumptions are also involved in determining the extent to which research and development expenses qualify for research and development tax credits. The Company recognizes tax credits once it has reasonable assurance that they will be realized.
Reclassifications
The Company reclassified sales and marketing expenses to general and administrative expenses to conform to the current period reporting classifications. This reclassification did not have an impact on previously reported results of operations.
Cash equivalents
Cash equivalents comprise of highly liquid investments purchased with original maturities of 90 days or less. Cash equivalents consist of United States Treasury bills.
Equipment
Equipment is measured at cost less accumulated depreciation and accumulated impairment losses, if any. Cost includes expenditures that are directly attributable to the acquisition of the asset, including all costs incurred in bringing the asset to its present location and condition. Gains and losses on disposal of equipment are determined by comparing the proceeds from disposal with the carrying amount of the equipment.
Depreciation is recognized on a declining basis over the estimated useful lives of equipment, since this most closely reflects the expected pattern of consumption of the future economic benefits embodied in the asset. Items of equipment are depreciated from the date that they are available for use or, in respect of assets not yet in service, from the date they are ready for their intended use.
Intangible assets - acquired in-process research and development
In a business combination, the fair value of in-process research and development (“IPR&D”) acquired is capitalized and accounted for as indefinite-lived intangible assets, and not amortized until the underlying project receives regulatory approval, at which point the intangible assets will be accounted for as definite-lived intangible assets and amortized over the remaining useful life or discontinued. If discontinued, the intangible asset will be written off. Research and development (“R&D”) costs incurred after the acquisition are expensed as incurred.
Impairment of long-lived assets
The Company reviews the recoverability of its finite long-lived assets whenever events or changes in circumstances indicate that it is carrying amount may not be recoverable. The carrying amount is first compared with the undiscounted cash flows. If the carrying amount is higher than the sum of undiscounted cash flows, then the Company determines the fair value of the underlying asset group. Any impairment loss to be recognized is measured as the difference by which the carrying amount of the asset group exceeds the estimated fair value of the asset group.
Goodwill and indefinite-lived assets are not amortized but are subject to an impairment review annually and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeds the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value.
The Company tests its goodwill for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the Company concludes it is more likely than not that fair value of the reporting unit is less than its carrying amount, a quantitative impairment test is performed.
The Company tests indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the Company concludes it is more likely than not that the fair value is less than it's carrying amount, a quantitative impairment test is performed. The Company's annual impairment test is performed in the fourth quarter of the fiscal year.
Research and development costs
Research and developments expenditures are expensed as incurred. These costs consist of employees’ salaries and benefits related to research and development activities, contractors and consultants that conduct the Company’s clinical trials, laboratory material and small equipment, clinical trial materials, stock-based compensation expense, and other non-clinical costs and regulatory fees. Advance payments for goods and services that will be used in future research and development are recognized in prepaids or other assets and are expensed when the services are performed, or the goods are used.
Stock-based compensation
The Company has in place a stock option plan for directors, officers, employees, and consultants of the Company, with grants under the stock option plan approved by the Company’s Board of Directors. The plan provides for the granting of options to purchase Common Stock and the exercise price of each option equals the closing trading price of Common Stock on the day prior to the grant. The Company accounts for stock-based compensation arrangements in accordance with provisions of Accounting Standards Codification (“ASC”) 718,Compensation—Stock Compensation(“ASC 718”). ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based payments including stock options. ASC 718 requires companies to estimate the fair value of share-based payment awards on the date of grant using an option-pricing model. The Company measures the cost of such awards based on the fair value of the award at grant date and recognizes stock-based compensation expense in the consolidated statements of operations and comprehensive loss on a tranche by tranche basis. The fair value of options is estimated for each tranche of an award that vests on a graded basis. The fair value of options is estimated using the Black-Scholes option pricing model, which uses various inputs including fair value of the Common Stock at the grant date, expected term, historical volatility, risk-free interest rate and expected dividend yields of the Common Stock. The Company applies an estimated forfeiture rate derived from historical employee termination behavior in determining compensation expense. If the actual forfeitures differ from those estimated by management, adjustment to compensation expense may be required in future periods.
Government grants
Government grants are recorded as a reduction of the related expenses or costs of the asset acquired. Government grants are recognized when there is reasonable assurance that the Company has met the requirements of the approved grant program and there is reasonable assurance that the grant will be received.
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement. Operating lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. The Company has elected not to recognize leases with an original term of one year or less on the consolidated balance sheet. The Company typically only includes an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. The Company’s lease expense is recognized in research and development expenses. The Company does not have financing leases.
In accordance with FASB ASC 842—Leases (“Topic 842”), components of a lease should be split into three categories: lease components, non-lease components and non-components. The fixed and in-substance fixed contract consideration (including any consideration related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. Entities may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together as a single lease component for all underlying assets and allocate all of the contract consideration to the lease component only.
Income taxes
Income taxes comprise of current and deferred taxes. The provision for income taxes is computed using the asset and liability method.
Current tax is the expected tax payable or receivable on the taxable income or loss for the year, using tax rates enacted at the reporting date, and any adjustment to tax payable in respect of previous years.
Deferred tax is recognized in respect of temporary differences between the carrying amounts (tax base) of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax assets and liabilities are measured at the tax rate expected to apply when the underlying asset or liability is realized (settled) based on the rates that are enacted at the reporting date. Deferred tax assets and liabilities are offset if the Company has the right to set off the amount owed by with the amount owed by the other party, the Company intends to set off and the offset right is enforceable at law. A deferred tax asset is recognized for unused tax losses, and tax credits, reduced by a valuation allowance. A valuation allowance is recorded to reduce the carrying amount of deferred income tax assets when it is more likely than not that these assets will not be realized. tax benefits related to tax positions not deemed to meet the “more-likely-than-not” threshold are not permitted to be recognized in the consolidated financial statements.
Additionally, the Company accrues interest and penalties, if any, related to unrecognized tax benefits as a component of income tax expense. The unrecognized tax benefits, including accrued interest and penalties, if any, are included in income taxes payable in the accompanying Consolidated Balance Sheets.
Earnings per share
The Company presents basic and diluted earnings per share ("EPS") data for its Common Stock. Basic EPS is calculated by dividing the net income or loss attributable to the holders of Common Stock by the weighted average number of Common Stock outstanding during the year. Diluted EPS is determined by adjusting the net income or loss attributable to the holders of Common Stock and the weighted average number of Common Stock outstanding adjusted for the effects of all dilutive potential Common Stock, which comprise warrants and share options granted to employees. The basic and diluted EPS are the same due to loss position.
Segment reporting
In November 2023, the FASB issued ASU 2023-07,Improvements to Reportable Segment Disclosures (“ASU 2023-07”). The ASU includes enhanced disclosure requirements, primarily related to significant segment expenses that are regularly provided to and used by the chief operating decision maker ("CODM"). The amendments are to be applied retrospectively to all prior periods presented in the financial statements. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. As discussed further in Note 12, the Company’s adoption of the requirements of ASU 2023-07 at March 31, 2025 annual financial reporting did not result in material impact on its consolidated financial statements and disclosures. Refer to Note 12 for detailed discussions.
Derivative warrant liabilities
Derivative warrant liabilities are recognized initially at fair value. Subsequent to initial recognition, derivative warrant liabilities are measured at fair value, with changes in fair value recognized in the consolidated statement of operations and comprehensive loss.
Fair value measurements
Certain of the Company’s accounting policies and disclosures require the determination of fair value, for both financial assets and liabilities.
In establishing fair value, the Company uses a fair value hierarchy based on levels as defined below:
Level 1: defined as observable inputs such as quoted prices in active markets.
Level 2: defined as inputs other than quoted prices in active markets that are either directly or indirectly observable.
Level 3: defined as inputs that are based on little or no observable market data, therefore requiring entities to develop their own assumptions.
The Company has determined that the carrying values of its short-term financial assets and liabilities (cash and cash equivalents and trade and other payables) approximate their fair value given the short-term nature of these instruments. The Company measured its derivative warrant liabilities at fair value on a recurring basis using level 3 inputs.
Financial Instruments
Concentration of credit risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist primarily of cash and cash equivalents. Cash and cash equivalents are all invested in accordance with the Company’s Investment Policy with the primary objective being the preservation of capital and the maintenance of liquidity, which risk is managed by dealing only with highly rated U.S. and Canadian institutions. The Company maintains its cash and cash equivalents at accredited financial institutions in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Recent accounting pronouncements
On November 4, 2024, the FASB issued ASU 2024-03,*Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40),*to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization and depletion) in commonly presented expense captions (such as cost of sales, SG&A and research and development).
ASU 2024-03 applies to all public business entities and is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods within annual reporting periods beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company is currently evaluating the effect of adopting this new guidance on its consolidated financial statements and disclosures. The Company does not expect that the adoption of ASU 2024-03 will have a material impact on its consolidated financial statements and disclosures.
The Company has considered all other recent accounting pronouncements and concluded that they are either not applicable to the Company’s business or that the effect is not expected to be material to the consolidated financial statements as a result of future adoption.
- Fair value measurements
Assets and liabilities measured at fair value on a recurring basis as of March 31, 2025 are as follows:
| Total | Quoted prices in active markets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | |
|---|---|---|---|---|
| $ | $ | $ | $ | |
| Assets | ||||
| Treasury bills classified as cash equivalents | 21,304 | 21,304 | — | — |
| Total assets | 21,304 | 21,304 | — | — |
| Liabilities | ||||
| Derivative warrant liabilities | 1,141 | — | — | 1,141 |
| Total liabilities | 1,141 | — | — | 1,141 |
Assets and liabilities measured at fair value on a recurring basis as of March 31, 2024 are as follows:
| Total | Quoted prices in active markets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | |
|---|---|---|---|---|
| $ | $ | $ | $ | |
| Assets | ||||
| Guaranteed investment certificates and term deposits classified as cash equivalents | 19,725 | 19,725 | — | — |
| Total assets | 19,725 | 19,725 | — | — |
| Liabilities | ||||
| Derivative warrant liabilities | 4,359 | — | — | 4,359 |
| Total liabilities | 4,359 | — | — | 4,359 |
There were no changes in valuation techniques or transfers between Levels 1, 2 or 3 during the years ended March 31, 2025 and 2024. The Company’s derivative warrant liabilities are measured at fair value on a recurring basis using unobservable inputs that are classified as Level 3 inputs. Refer to Note 8,Stockholders’ Equity, for the valuation techniques and assumptions used in estimating the fair value of the derivative warrant liabilities.
- Receivables
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| $ | $ | |
| Sales tax receivables | 106 | 316 |
| Government assistance | — | 356 |
| Interest receivable | — | 15 |
| Other receivables | 20 | 35 |
| Total receivables | 126 | 722 |
Government assistance is comprised of research and development investment tax credits from the Québec provincial government, which relate to quantifiable research and development expenditures under the applicable tax laws. The amounts recorded as receivables are subject to a government tax audit and the final amounts received may differ from those recorded.
- Equipment
The following is a summary of equipment, net:
| March 31, 2025 | Cost | Accumulated depreciation | Write-off | Net book value |
|---|---|---|---|---|
| $ | $ | $ | $ | |
| Furniture and office equipment | 2 | (1) | (1) | — |
| Computer equipment | 5 | (2) | (1) | 2 |
| Software | 19 | (6) | — | 13 |
| 26 | (9) | (2) | 15 |
| March 31, 2024 | Cost | Accumulated depreciation | Write-off | Net book value |
|---|---|---|---|---|
| $ · $ · $ | ||||
| Furniture and office equipment | 18 | (13) | (4) | 1 |
| Computer equipment | 114 | (76) | (34) | 4 |
| Laboratory equipment | 571 | (519) | (52) | — |
| Software | 19 | 0 | 0 | 19 |
| 722 | (608) | (90) | 24 | |
Depreciation expense was $7 and $11 for the years ended March 31, 2025 and 2024, respectively.
- Intangible assets and goodwill
Individual IPR&D projects and goodwill are tested for impairment on an annual basis in the fourth quarter, and in between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of each technology or our reporting unit below its carrying value. The impairment assessments resulted in the following activity during the years ended March 31, 2025 and 2024:
| GTx-104 | GTx-102 | GTx-101 | Total | |
|---|---|---|---|---|
| $ | $ | $ | $ | |
| Intangible assets – in-process research and development | ||||
| Balance, March 31, 2023 | 27,595 | 9,196 | 4,337 | 41,128 |
| Impairment | — | — | — | — |
| Balance, March 31, 2024 | 27,595 | 9,196 | 4,337 | 41,128 |
| Impairment | — | — | — | — |
| Balance, March 31, 2025 | 27,595 | 9,196 | 4,337 | 41,128 |
| $ | |
|---|---|
| Goodwill | |
| Balance, March 31, 2023 | 8,138 |
| Impairment | — |
| Balance, March 31, 2024 | 8,138 |
| Impairment | — |
| Balance, March 31, 2025 | 8,138 |
The Company's IPR&D projects, consistent with others in our industry, have risks and uncertainties associated with the timely and successful completion of the development and commercialization of product candidates, including our ability to confirm safety and efficacy based on data from clinical trials, our ability to obtain necessary regulatory approvals and our ability to successfully complete these tasks within budgeted costs. It is not permitted to market a human therapeutic without obtaining regulatory approvals, and such approvals require the completion of clinical trials that demonstrate that a product candidate is safe and effective. In addition, the availability and extent of coverage and reimbursement from third-party payers, including government healthcare programs and private insurance plans as well as competitive product launches, affect the revenues a product can generate. Consequently, the eventual realized values, if any, of acquired IPR&D projects may vary from their estimated fair values.
- Trade and other payables
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| $ | $ | |
| Trade payables | 601 | 1,007 |
| Accrued research and development expenses | 565 | 133 |
| Accrued liabilities and other payables | 103 | 43 |
| Employee salaries and benefits payable | 661 | 501 |
| Total trade and other payables | 1,930 | 1,684 |
- Stockholders' equity
Preferred Stock
The Company is authorized to issue up to 10,000,000 shares of preferred stock, par value $0.0001 per share. No shares of the Company’s preferred stock are issued or outstanding.
Common Stock
In connection with the consummation of the Domestication, on October 7, 2024, the Company adopted a Certificate of Incorporation (as amended, the “Charter”) and Bylaws (as amended, the “Bylaws”). The rights of holders of the Company’s Common Stock are now governed by the Charter, the Bylaws, and the General Corporation Law of the State of Delaware. The Company is authorized to issue up to 100,000,000 shares of Common Stock, par value $0.0001 per share.
2025 Private Placement
In February 2025, the Company agreed to offer and sell in a private placement (the “2025 Private Placement”) an aggregate of 3,252,132 shares of the Company Common Stock at a purchase price of $3.395 per share of Common Stock (the “Shares”) and pre-funded warrants (the “2025 Pre-Funded Warrants”) to purchase up to 1,166,160 shares of Common Stock at a purchase price equal to the purchase price per Share less $0.0001 (the “2025 Pre-Funded Warrant Shares”). Each 2025 Pre-Funded Warrant is exercisable forone share of Common Stock at an exercise price of $0.0001 per share, exercisable immediately and will expire once exercised in full.
Pursuant to the 2025 Purchase Agreement, for each Share and each 2025 Pre-Funded Warrant issued, the Company agreed to issue to each purchaser an accompanying common warrant (the “2025 Common Warrants” and, together with the 2025 Pre-Funded Warrants, the “2025 Warrants”) to purchase shares of Common Stock (or 2025 Pre-Funded Warrants in lieu thereof), exercisable for an aggregate of 4,418,292 shares of Common Stock (or 2025 Pre-Funded Warrants in lieu thereof). Each 2025 Common Warrant is exercisable forone share of Common Stock at an exercise price of $3.395 per share (or one 2025 Pre-Funded Warrant at an exercise price of $3.3949 per share in lieu thereof), will be immediately exercisable and will expire on the earlier of (i) the 60th day after the date the FDA approves the new drug application (“NDA”) for GTx-104 and (ii) September 25, 2028. The 2025 Common Warrants were offered and sold at a purchase price of $0.125 per 2025 Common Warrant, which purchase price is included in the offering price per Share and 2025 Pre-Funded Warrant issued in the 2025 Private Placement.
The 2025 Private Placement included the issuance of Common Stock, 2025 Pre-Funded Warrants, and 2025 Common Warrants to related parties namely (i) Shore Pharma LLC, an entity held in a trust for the benefit of immediate family members of Vimal Kavuru, the Chair of the Company’s Board of Directors and (ii) ADAR1 Partners, LP, AIGH Investment Partners, LP, and SS Pharma LLC, each a beneficial owner of more than 5% of the Common Stock prior to the 2025 Private Placement, resulting in proceeds of $5,694 in 2025.
The Company has paid TD Securities (USA) LLC, the placement agent, customary placement fees in its capacity as placement agent for the sale of the Company’s securities to certain of the investors in the 2025 Private Placement.
The 2025 Private Placement closed on February 11, 2025 (the “Closing Date”). The net proceeds to the Company were $13,705, after deducting fees and expenses.
Both 2025 Pre-funded Warrants and 2025 Common Warrants are presented under additional paid-in capital in the equity section of the consolidated balance sheet as of March 31, 2025.
During the twelve months period March 31, 2025,24,742 of the 2025 Pre-Funded Warrants were exercised into 24,742 shares of Common Stock.
2023 Private Placement
In September 2023, the Company entered into the Purchase Agreement with certain institutional and accredited investors in connection with the 2023 Private Placement. Pursuant to the Purchase Agreement, the Company offered and sold 1,951,371 Common Shares, at a purchase price of $1.848 per Common Share and 2023 Pre-Funded Warrants to purchase up to 2,106,853 Common Shares at a purchase price equal to the purchase price per Common Share less $0.0001. Each 2023 Pre-Funded Warrant is exercisable forone Common Share at an exercise price of $0.0001 per Common Share, is immediately exercisable, and will expire once exercised in full. Pursuant to the Purchase Agreement, the Company also issued, to such institutional and accredited investors, 2023 Common Warrants to purchase Common Shares exercisable for an aggregate of 2,536,391 Common Shares. Under the terms of the Purchase Agreement, for each Common Share and each 2023 Pre-funded Warrant issued in the 2023 Private Placement, an accompanying five-eighths (0.625) of a 2023 Common Warrant was issued to the purchaser thereof. Each whole 2023 Common Warrant is exercisable forone Common Share at an exercise price of $3.003 per Common Share, is immediately exercisable, and will expire on the earlier of (i) the 60 th day after the date of the acceptance by the FDA of an NDA for the Company’s product candidate GTx-104 and (ii)five years from the date of issuance. The 2023 Private Placement closed on September 25, 2023. The net proceeds to the Company from the 2023 Private Placement were $7,338, after deducting fees and expenses.
The 2023 Private Placement included the issuance of Common Shares, 2023 Pre-Funded Warrants, and 2023 Common Warrants to related parties namely (i) Shore Pharma LLC, an entity that was controlled by Vimal Kavuru, the Chair of the Company’s Board of Directors, at the time of the 2023 Private Placement and (ii) SS Pharma LLC, the beneficial owner of 5.5% of Common Shares outstanding prior to the 2023 Private Placement, resulting in proceeds of $2,500 in 2023. As of March 31, 2025 and 2024, the balance of derivative warrant liabilities from related parties was $952 and $1,453, respectively.
During the twelve months period March 31, 2025,1,041,851 of the 2023 Pre-Funded Warrants were exercised into 1,041,828 Common Shares or Common Stock, as applicable. There wereno 2023 Common Warrants exercised during the twelve months ended March 31, 2024.
Warrants
As further discussed above, on September 25, 2023, the Company issued the 2023 Pre-Funded Warrants and the 2023 Common Warrants exercisable for 4,643,244 Common Shares in the 2023 Private Placement pursuant to the terms of the Purchase Agreement entered into with certain institutional and accredited investors.
The 2023 Common Warrants issued as a part of the 2023 Private Placement are derivative warrant liabilities given the 2023 Common Warrants did not meet the fixed-to-fixed criteria and that the 2023 Common Warrants are not indexed to the Company’s own stock. Proceeds were allocated amongst Common Shares, 2023 Pre-Funded Warrants, and 2023 Common Warrants by applying the residual method, with fair value of the 2023 Common Warrants determined using the Black-Scholes model, resulting in initial derivative warrant liabilities of $1,631 and issuance costs of $45 allocated to 2023 Common Warrants. Accordingly, $2,822 and $3,047 of the gross proceeds were allocated to the Common Shares and the 2023 Pre-Funded Warrants, respectively, and $78 and $84 of issuance costs were allocated to the Common Shares and the 2023 Pre-Funded Warrants, respectively.
The derivative warrant liabilities are measured at fair value at each reporting period and the reconciliation of changes in fair value is presented in the following table:
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| $ | $ | |
| Beginning balance | 4,359 | — |
| Issued during the year | — | 1,631 |
| Change in fair value | 3,218 | 2,728 |
| Ending balance | 1,141 | 4,359 |
The warrant liability was determined based on the fair value of warrants at the issue date and the reporting dates using the Black-Scholes model with the following weighted-average assumptions will expire on the earlier of (i) the 60th day after the date of the acceptance by the FDA of a NDA for the Company's product candidate GTx-104 and (ii)five years from the date on issuance.
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| Risk-free interest rate | 4.18% | 4.69% |
| Share price | $2.28 | $3.43 |
| Expected warrant life | 1.14 | 2.03 |
| Dividend yield | 0% | 0% |
| Expected volatility | 74.26% | 85.94% |
The weighted-average fair values of the 2023 Common Warrants were determined to be $0.45 and $1.72 per 2023 Common Warrant as of March 31, 2025 and 2024, respectively. The risk-free interest rate at the issue date and on the reporting date of March 31, 2025 was based on the interest rate corresponding to the U.S. Treasury rate issue with a remaining term equal to the expected term of the 2023 Common Warrants. The expected volatility was based on the historical volatility for the Company.
At March 31, 2025, the Company had outstanding 2023 Common Warrants to purchase 2,536,391 shares of Common Stock, with an exercise price of $3.003, all of which were classified as derivative warrant liabilities. At March 31, 2025, the Company had outstanding 2023 Pre-funded Warrants to purchase 1,065,002 shares of Common Stock, with an exercise price of $0.0001, all of which were classified within stockholders’ equity.
At March 31, 2025, the Company had outstanding 2025 Common Warrants to purchase 4,418,292 shares of Common Stock, with an exercise price of $3.395, all of which were classified within stockholders’ equity. At March 31, 2025, the Company had outstanding 2025 Pre-funded Warrants to purchase 1,141,418 shares of Common Stock, with an exercise price of $0.0001, all of which were classified within stockholders’ equity.
In connection with the Continuance and the Domestication, the Company continues its obligations under the Purchase Agreement and the 2023 Warrants. At effectiveness of the Continuance, each outstanding 2023 Warrant exercisable for Common Shares remained exercisable for an equivalent number of common shares of Acasti British Columbia for the equivalent exercise price per share without any action by the holder. At effectiveness of the Domestication, each outstanding warrant exercisable for common shares of Acasti British Columbia remained exercisable for an equivalent number of shares of Common Stock for the equivalent exercise price per share without any action by the holder.
** 9**. Stock-based compensation
2024 Equity Incentive Plan
At the Annual and Special Meeting of Shareholders on September 30, 2024, the Company’s shareholders approved the Grace Therapeutics, Inc. 2024 Equity Incentive Plan (the “2024 Plan”) which became effective on the date of the Domestication. The 2024 Plan replaced the Acasti Pharma Inc. Stock Option Plan and the Acasti Pharma Inc. Equity Incentive Plan (the “Prior Plans”). The 2024 Plan provides for the grant of awards of stock options, stock appreciation rights, restricted stock, restricted stock units, deferred stock units, unrestricted stock, dividend equivalent rights, performance-based awards and other equity-based awards to eligible persons as defined under the 2024 Plan. Any of these awards may, but need not, be made as performance incentives to reward the holders of such awards for the achievement of performance goals in accordance with the terms of the 2024 Plan. Stock options granted under the 2024 Plan may be non-qualified stock options or incentive stock options, as provided in the 2024 Plan.
In connection with the Continuance and the Domestication, the Company continues its obligations under the Prior Plans and all of the outstanding equity awards under the Prior Plans. Upon effectiveness of the Continuance, each outstanding option exercisable for and restricted share unit settleable into Common Shares remained exercisable for or able to be settled into, as applicable, an equivalent number of common shares of Acasti British Columbia for the equivalent exercise price per share (if applicable), without any action by the holder. Upon effectiveness of the Domestication, each outstanding option exercisable for and restricted share unit settleable into common shares of Acasti British Columbia remained exercisable for or able to be settled into, as applicable, an equivalent number of shares of Common Stock for the equivalent exercise price per share (if applicable), without any action by the holder.
Following the Effective Date of the 2024 Plan, no awards shall be made under the Prior Plans. However, Common Shares reserved under the Prior Plans to settle awards which were made under the Prior Plans may be issued and delivered following the Effective Date to settle such awards.
The 2024 Plan is administered by a committee designated from time to time, by resolution of the Company’s Board of Directors. The committee will also be responsible for determining, among others, the key terms of the awards including their grant dates, pricing, basis for fair value determination, vesting terms, restrictions, and terminations. The Board has designated its Compensation Committee to administer the 2024 Plan. The 2024 Plan authorizes a total of 1,350,000 shares of Common Stock available for issuance As of March 31, 2025, there were 1,335,000 shares available for issuance under the 2024 Plan.
The 2024 Plan will terminate automaticallyten years after the Effective Date and may be terminated on any earlier date as provided by the 2024 Plan.
The following table summarizes information about activities within the 2024 Plan and Prior Plans for the year ended March 31, 2025:
| Number of options | Weighted-average exercise price | Weighted-averageRemaining Contractual Term (years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| $ | ||||
| Outstanding, March 31, 2024 | 721,793 | 3.68 | 9.08 | 527 |
| Granted | 213,130 | 2.98 | ||
| Outstanding, March 31, 2025 | 934,923 | 3.52 | 8.26 | 24 |
| Exercisable, March 31, 2025 | 586,478 | 3.96 | 8.08 | 20 |
The weighted-average grant date fair value of awards for options granted during the year ended March 31, 2025 was $2.53. The fair value of options granted was estimated using the Black-Scholes option pricing model, resulting in the following weighted-average assumptions for the options granted:
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| Weighted-average | Weighted-average | |
| Exercise price | $2.98 | $2.50 |
| Share price | $2.98 | $2.50 |
| Dividend | — | — |
| Risk-free interest | 4.42% | 3.95% |
| Estimated life (years) | 5.81 | 5.62 |
| Expected volatility | 114.19% | 117.94% |
Compensation expense recognized under the 2024 Plan is summarized as follows:
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| $ | $ | |
| Research and development expenses | 216 | 198 |
| General and administrative expenses | 514 | 715 |
| 730 | 913 |
As of March 31, 2025, there was $302 of total unrecognized compensation cost, related to non-vested stock options, which is expected to be recognized over a remaining weighted-average vesting period of 1.27 years.
- Loss per share
The Company has generated a net loss for all periods presented. Therefore, diluted loss per share is the same as basic loss per share since the inclusion of potentially dilutive securities would have had an anti-dilutive effect. All currently outstanding options and warrants could potentially be dilutive in the future.
The Company excluded the following potential Common Stock, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to stockholders for the periods indicated because including them would have had an anti-dilutive effect:
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| Options outstanding | 934,923 | 721,793 |
| 2023 Common Warrants | 2,536,391 | 2,536,391 |
| 2025 Common Warrants | 4,418,292 | — |
Basic and diluted net loss per share is calculated based upon the weighted-average number of shares of Common Stock outstanding during the year. Common Stock underlying the 2025 Pre-Funded Warrants and 2023 Pre-Funded Warrants are included in the calculation of basic and diluted earnings per share.
- Income taxes
Income taxes are provided for the tax effects of transactions reported in the financial statements and consist of taxes currently due. Deferred taxes relate to differences between the basis of assets and liabilities for financial and income tax reporting which will be either taxable or deductible when the assets or liabilities are recovered or settled.
The provision for income taxes consisted of the following:
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| $ | $ | |
| Current Provision | ||
| Federal | — | 2 |
| State | 3 | — |
| Total Current Provision | 3 | 2 |
| Deferred Provision | ||
| Federal | (2,392) | (1,834) |
| State | (810) | — |
| Total Deferred Provision | (3,202) | (1,834) |
| Total Provision for Income Taxes | (3,199) | (1,832) |
For the years ended March 31, 2025 and 2024, the income/(loss) before income taxes was $ (12,767) and ($14,685), respectively. The Company had an effective tax rate of 25.06% and 12.47% for the years ended March 31, 2025 and 2024, respectively.
The reconciliation of the statutory federal income tax rate to the Company’s effective tax rate for the years ended March 31, 2025 and 2024 were as follows:
| For the year ended | ||||
|---|---|---|---|---|
| March 31, 2025 | March 31, 2025 | March 31, 2024 | March 31, 2024 | |
| $ · $ | ||||
| U.S. statutory rate | (2,681) | 21.00% | (3,084) | 21.00% |
| State taxes, net of federal | (770) | 6.03% | (341) | 2.32% |
| Difference in foreign tax rates | (105) | 0.82% | (543) | 3.69% |
| Return to provision | (1) | 0.00% | — | 0.00% |
| Change in valuation allowance | 2,347 | (18.39)% | 1,635 | (11.13)% |
| Change in tax rates | — | 0.00% | (486) | 3.31% |
| Non-deductible stock-based compensation | — | 0.00% | 242 | (1.65)% |
| Non-deductible transaction costs | — | 0.00% | 723 | (4.92)% |
| Tax credits | (1,583) | 12.40% | — | 0.00% |
| Change in fair value of warrant liabilities | (876) | 6.86% | — | 0.00% |
| Other permanent differences | 468 | (3.67)% | 23 | (0.16)% |
| Total tax (benefit) expense | (3,199) | 25.06% | (1,832) | 12.47% |
The rate reconciliation was previously presented using the Canadian statutory tax rate. However, following the Company's redomiciliation from Canada to the U.S. during the year, the reconciliation now reflects the U.S. statutory tax rate. For consistency and comparison, the rate reconciliation for the year ended March 31, 2024, has been recalculated based on the U.S. statutory tax rate.
The table below presents the effects of temporary differences that gave rise to significant portions of deferred tax assets and liabilities as of March 31, 2025 and 2024:
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| $ | $ | |
| Deferred income tax assets | ||
| Tax losses carried forward | 43,049 | 40,659 |
| Research and development expenses | 10,928 | 8,522 |
| Property, plant and equipment | — | 523 |
| Intangible assets | 206 | 328 |
| Financing expenses | — | 169 |
| Net federal investment tax credits | 2,882 | 2,882 |
| Other accruals and other | 131 | 56 |
| Orphan drug credit | 1,583 | — |
| Total deferred income tax assets | 58,779 | 53,139 |
| Valuation allowance | (49,530) | (47,284) |
| Total deferred income tax assets, net of valuation allowance | 9,249 | 5,855 |
| Deferred income tax liabilities | ||
| Intangible assets | (11,561) | (11,369) |
| Total deferred tax liabilities | (11,561) | (11,369) |
| Net deferred tax liabilities | (2,312) | (5,514) |
The Company has U.S. Federal and State net operating loss carryforwards (“NOLs”) of approximately $18,621 and $18,621 and Canadian Federal and Quebec NOLs of $143,346 and $141,851, respectively, as of March 31, 2025. The Company’s U.S. Federal NOLs, generated after December 31, 2017, are available for indefinite carryforward; however, their utilization is limited to 80% of taxable income. State NOLs are subject to a 20-year carryforward period, with expirations beginning in 2038. The Company also has orphan drug tax credit totaling $1,583, which may be carried forward for 20 years and are set to begin expiring in 2045. Canadian and Quebec NOLs are scheduled to begin expiring in 2028, while scientific research and experimental development expenditures investment tax credit totaling $3,922 are set to begin expiring in 2029. Additionally, the Company has research and development expenses of $25,708 in Canada and $27,887 in Quebec, both of which are available for indefinite carryforward.
The utilization of the Company’s NOLs and research tax credit carryovers could be subject to annual limitations under Section 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), and similar state tax provisions, due to ownership change limitations that may have occurred previously or that could occur in the future. These ownership changes limit the amount of NOLs and other deferred tax assets that can be utilized to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382 and 383 of the Code, results from transactions increasing ownership of certain stockholders or public groups in the stock of the corporation by more than 50 percent points over athree-year period. The Company has not completed an analysis of an ownership change under Section 382 of the Code. To the extent that a study is completed and an ownership change is deemed to occur, the Company’s NOLs and tax credits could be limited.
In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all the deferred income tax assets will not be realized. The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred income tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on consideration of these items, management has determined that enough uncertainty exists relative to the realization of the deferred income tax asset balances to warrant the application of a partial valuation allowance as of March 31, 2025 and March 31, 2024.
As a result of changes made by the Tax Cuts and Jobs Act of 2017, that became effective as of January 1, 2022, the Company is required to capitalize for tax purposes certain research and development expenses, and amortize domestic expenses over a 5-year period and foreign expenses over a 15-year period, resulting in a deferred tax asset for the capitalized amounts.
In accordance with ASC 740,Income Taxes, specifically related to uncertain tax positions, a company is required to use a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. The Company believes its income tax filing positions and deductions will be sustained upon examination, and accordingly, no reserves or related accruals for interest and penalties have been recorded as of March 31, 2025.
The Company is subject to taxation in the United States at both the federal level and within the state jurisdictions of New Jersey, Pennsylvania, and California. The Company is not currently under examination by any tax authority. The statute of limitations remains open for each tax year to the extent of the net operating losses generated in that year.
Government assistance
Government assistance is comprised of research and development investment tax credits receivable from the Quebec provincial government which relate to qualifiable research and development expenditures under the applicable tax laws. The amounts recorded as receivables are subject to a government tax audit and the final amounts received may differ from those recorded. For the years ended March 31, 2025 and 2024, the Company recorded ($0) and ($55), respectively, as a reduction of research and development expenses in the consolidated statements of operations and comprehensive loss.
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| $ | $ | |
| Investment tax credit | — | 356 |
- Segment Information
An operating segment is a component of an entity whose operating results are regularly reviewed by its chief operating decision maker (“CODM”) to make decisions about resources to be allocated to the segment and assess its performance. Factors used by the Company in determining the reportable segment include the nature of the Company's operating activities, the organizational and reporting structure and the type of information reviewed by the CODM to allocate resources and evaluate financial performance.
The Company hasone reportable operating segment: the development and commercialization of pharmaceutical applications of its patents and licensed rights. The Company’s CODM is its Chief Executive Officer. The accounting policies of the segment are those described in the summary of significant accounting policies within Note 2.
The CODM assesses the performance of the segment based on net loss, which is reported on the income statement as consolidated net loss. The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets.
The Company has not generated any revenue and expects to continue to incur significant expenses and operating losses as it advances product candidates through all stages of development, and ultimately, receive regulatory approval. Accordingly, the CODM utilizes the cash budget and forecasts in assessing the entity-wide operating results and performance, and in deciding how to allocate resources across the organization and its segment. Net loss is used to monitor budgets against actual results, which then is used in assessing the performance of the segment.
The table below summarizes the significant expenses, by category regularly review by the CODM, for the years ended March 31, 2025 and 2024:
| March 31, 2025 $ | March 31, 2024 $ | |
|---|---|---|
| Clinical development programs | (8,164) | (3,167) |
| Professional fees | (3,707) | (3,475) |
| Salaries and benefits | (2,840) | (2,028) |
| Stock-based compensation | (730) | (913) |
| Government grants & tax credits | — | (55) |
| Other general and administrative expenses (1) | (1,238) | (1,729) |
| Other segment income (expense) (2) | 3,184 | (2,708) |
| Interest income, net | 728 | 875 |
| Restructuring costs | — | (1,485) |
| Income tax benefit | 3,199 | 1,832 |
| Segment and consolidated net loss | (9,568) | (12,853) |
Other general and administrative expenses include depreciation and loss on disposal, travel, and other administrative costs.
Other segment income includes change in fair value of derivative warrant liabilities, and foreign exchange (loss)/gain.
- Commitments and contingencies
Research and development contracts and contract research organizations agreements
The Company utilizes contract manufacturing organizations (“CMOs”) for the development and production of clinical materials and contract research organizations (“CROs”) to perform services related to its clinical trials. Pursuant to the agreements with these CMOs and CROs, the Company has either the right to terminate the agreements without penalties or under certain penalty conditions. As of March 31, 2025, the Company has $300 of commitments to CMOs and $110 of commitments to CROs for the next twelve months.
Legal proceedings and disputes
In the ordinary course of business, the Company is at times subject to various legal proceedings and disputes. The Company assesses its liabilities and contingencies in connection with outstanding legal proceedings utilizing the latest information available. Where it is probable that the Company will incur a loss and the amount of the loss can be reasonably estimated, the Company records a liability in its consolidated financial statements. These legal contingencies may be adjusted to reflect any relevant developments on a quarterly basis. Where a loss is not probable or the amount of loss is not estimable, the Company does not accrue legal contingencies. While the outcome of legal proceedings is inherently uncertain, based on information currently available, management believes that it has established appropriate legal reserves. No reserves or liabilities have been accrued as at March 31, 2025.
- Restructuring Costs
On May 8, 2023, the Company communicated its decision to terminate a substantial amount of its workforce as part of a plan that intended to align the Company’s organizational and management cost structure to prioritize resources to GTx-104, thereby reducing losses to improve cash flow and extend available cash resources. During the twelve months ended March 31, 2024, the Company incurred $1,485 in costs primarily consisting of employee severance costs and legal fees. There wasno restructuring costs incurred during the year ended March 31, 2025.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.