Core Insights - Grace Therapeutics is advancing GTx-104, a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) with a New Drug Application (NDA) submission planned for the first half of 2025 [1][2][3] - The company secured $15 million in upfront financing, with the potential for an additional $15 million through warrant exercises, totaling up to approximately $30 million to support pre-commercial planning and product launch [1][2][3] - The Phase 3 STRIVE-ON safety trial met its primary endpoint, showing a 19% reduction in clinically significant hypotension incidents compared to oral nimodipine, indicating potential clinical benefits for GTx-104 [2][11] Corporate Highlights - The company held a Type C meeting with the FDA to discuss the STRIVE-ON trial results and NDA submission requirements, believing the current data will suffice for the NDA [3] - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with additional measures favoring GTx-104 [11] - The NDA submission for GTx-104 is on track for completion by the end of June 2025 [2][3] Financial Results - For the fiscal year ended March 31, 2025, the company reported a net loss of $9.6 million, a decrease from a net loss of $12.9 million in the previous fiscal year [4] - Research and development expenses increased to $9.5 million from $4.7 million, primarily due to the pivotal Phase 3 safety trial for GTx-104 [5] - General and administrative expenses rose to $7.2 million, reflecting increased professional fees and salaries [6] Cash Position - As of March 31, 2025, the company had cash and cash equivalents of $22.1 million, a slight decrease from $23.0 million a year earlier [7] - The private placement completed in February 2025 included common warrants with an exercise price of $3.395 per share, potentially generating $15 million upon exercise [8] - The company believes its current cash runway extends into the third quarter of 2026, potentially extending to the second quarter of 2027 if all common warrants are exercised [10] Product Overview - GTx-104 is designed to provide IV delivery of nimodipine, potentially improving management of hypotension in aSAH patients and eliminating the need for nasogastric tube administration [14][15] - The product has been administered to over 200 patients and healthy volunteers, demonstrating good tolerance and lower pharmacokinetic variability compared to oral nimodipine [15]

PART I [Business](index=7&type=section&id=Item%201.%20Business) Grace Therapeutics develops rare disease treatments using novel drug delivery, prioritizing GTx-104 for aSAH with an NDA planned for H1 2025 - The company focuses on applying new proprietary formulations to approved compounds to enhance efficacy and compliance, primarily targeting rare and orphan diseases[20](index=20&type=chunk) - The development strategy utilizes the Section 505(b)(2) regulatory pathway, potentially shortening approval timelines by referencing existing FDA data[22](index=22&type=chunk) - All three clinical-stage drug candidates have received Orphan Drug Designation (ODD), potentially providing **7 years of market exclusivity** upon approval[23](index=23&type=chunk) - The company completed domestication from Canada to Delaware in October 2024, changing its name from Acasti Pharma Inc. to Grace Therapeutics, Inc[156](index=156&type=chunk)[412](index=412&type=chunk) [Our Pipeline](index=7&type=section&id=Our%20Pipeline) The company's pipeline includes three clinical-stage candidates, prioritizing GTx-104 while de-prioritizing GTx-102 and GTx-101 Clinical Pipeline Overview | Drug Candidate | Indication | Development Stage & Key Feature | | :--- | :--- | :--- | | **GTx-104** | Aneurysmal Subarachnoid Hemorrhage (aSAH) | Lead candidate; novel injectable nimodipine. Phase 3 completed, NDA submission planned for H1 2025 | | **GTx-102** | Ataxia-Telangiectasia (A-T) | Oral-mucosal betamethasone spray. Phase 1 PK study completed. Development de-prioritized | | **GTx-101** | Postherpetic Neuralgia (PHN) | Topical bio-adhesive bupivacaine spray. Phase 1 studies completed. Development de-prioritized | [Commercialization Strategy](index=18&type=section&id=Commercialization%20Strategy) Grace Therapeutics plans U.S. commercialization of GTx-104 with a targeted sales force, considering partnerships for other assets - Plan to commercialize GTx-104 in the U.S. with a highly experienced and targeted hospital-based sales force if approved[83](index=83&type=chunk) - May seek commercial partnerships for GTx-104 in territories outside the U.S[83](index=83&type=chunk) - Considering out-licensing or selling GTx-102 and/or GTx-101 for U.S. and/or global markets[83](index=83&type=chunk) [Manufacturing and Supply](index=19&type=section&id=Manufacturing%20and%20Supply) The company relies entirely on third-party Contract Manufacturing Organizations (CMOs) for all drug manufacturing under cGMP - The company does not own any manufacturing facilities and utilizes a network of third-party CMOs for manufacturing its drug candidates[84](index=84&type=chunk) - All lots of drug substance and drug product for clinical supply are manufactured under cGMP, and the company plans to continue relying on CMOs for commercial quantities if a product is approved[85](index=85&type=chunk) [Intellectual Property Portfolio](index=19&type=section&id=Intellectual%20Property%20Portfolio) The company's IP strategy combines orphan drug exclusivity and over 40 patents globally to protect its drug candidates - The IP strategy includes orphan drug designation, which could result in **7 years of U.S. marketing exclusivity**, and a patent estate of over **40 granted and pending patents** globally[86](index=86&type=chunk) - The patent portfolio includes **8 U.S. issued patents** and **4 filed U.S. patent applications**, primarily focused on composition and method-of-use patents[86](index=86&type=chunk) [Government Regulation](index=20&type=section&id=Government%20Regulation) The company is subject to extensive FDA regulation, pursuing the 505(b)(2) pathway, and navigating healthcare and data privacy laws - The company is pursuing the Section 505(b)(2) regulatory approval pathway for its candidates, which allows reliance on existing data for an approved reference drug, potentially shortening the development timeline[100](index=100&type=chunk) - All three clinical-stage product candidates have received Orphan Drug Designation (ODD), which provides benefits like tax credits, user fee waivers, and **7 years of market exclusivity** upon approval[124](index=124&type=chunk)[125](index=125&type=chunk) - The company is subject to various healthcare laws, including the Affordable Care Act (ACA), the Inflation Reduction Act (IRA) which impacts drug pricing and reimbursement, and data privacy laws like HIPAA and GDPR[126](index=126&type=chunk)[130](index=130&type=chunk)[132](index=132&type=chunk) [Human Capital Resources](index=29&type=section&id=Human%20Capital%20Resources) As of March 31, 2025, Grace Therapeutics had six full-time employees, all located in the United States - As of March 31, 2025, the company had a total of **six full-time employees**, all located in the United States[153](index=153&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including GTx-104 dependence, funding needs, development uncertainties, market acceptance, and third-party reliance - **Business Risks:** The company is heavily dependent on the success of its lead drug candidate, GTx-104, and requires additional funding to maintain operations and advance its programs. It has no history of commercializing drugs[162](index=162&type=chunk)[164](index=164&type=chunk)[166](index=166&type=chunk) - **Development & Commercialization Risks:** The company relies on the 505(b)(2) regulatory pathway, which is not guaranteed. Clinical development is lengthy and expensive with uncertain outcomes. Market success depends on physician and payor acceptance, and the company faces significant competition[187](index=187&type=chunk)[191](index=191&type=chunk)[247](index=247&type=chunk) - **Third-Party Dependence Risks:** The company relies on third-party CROs to conduct clinical trials and CMOs for all manufacturing, making it vulnerable to their performance, quality, and regulatory compliance[270](index=270&type=chunk)[272](index=272&type=chunk) - **Tax Risks:** There is a significant risk that the company was classified as a Passive Foreign Investment Company (PFIC) for U.S. tax purposes prior to its domestication, which could have adverse tax consequences for U.S. shareholders. The ability to use Net Operating Loss (NOL) carryforwards is also uncertain[282](index=282&type=chunk)[286](index=286&type=chunk) [Unresolved Staff Comments](index=53&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that there are no unresolved staff comments - Not applicable[301](index=301&type=chunk) [Cybersecurity](index=53&type=section&id=Item%201C.%20Cybersecurity) The company maintains a cybersecurity program overseen by an external IT consultant and Audit Committee, reporting no material incidents - The company's cybersecurity program is managed by an external IT consultant and overseen by the Audit Committee of the Board[304](index=304&type=chunk)[305](index=305&type=chunk) - A Cybersecurity Incident Response Plan is in place to manage potential threats[303](index=303&type=chunk) - The company did not experience any material cybersecurity incidents or threats in the last reporting year[307](index=307&type=chunk) [Properties](index=54&type=section&id=Item%202.%20Properties) The company's principal executive office and operations are located in Princeton, New Jersey - The company's principal executive office is located in Princeton, New Jersey[308](index=308&type=chunk) [Legal Proceedings](index=54&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any legal proceedings that management believes are likely to have a material adverse effect on the business[309](index=309&type=chunk) [Mine Safety Disclosures](index=54&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[310](index=310&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=55&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Grace Therapeutics' common stock trades on Nasdaq under 'GRCE', with 32 holders of record; no cash dividends are anticipated - The company's common stock is traded on the Nasdaq Capital Market under the symbol "GRCE"[312](index=312&type=chunk) - As of June 18, 2025, there were **32 holders of record** of the common stock[312](index=312&type=chunk) - The company does not anticipate paying any cash dividends in the foreseeable future[313](index=313&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operation](index=56&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) For FY2025, the company reported a net loss of **$9.6 million**, influenced by R&D increases and a positive change in derivative warrant liabilities, holding **$22.1 million** cash [Results of Operations](index=57&type=section&id=Results%20of%20Operations) Net loss decreased to **$9.6 million** in FY2025 from **$12.9 million** in FY2024, primarily due to a positive change in derivative warrant liabilities and increased R&D expenses Comparison of Operations (in thousands) | | Year ended March 31, 2025 | Year ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | **Net loss** | **$ (9,568)** | **$ (12,853)** | **$ 3,285** | | Loss per share | $ (0.79) | $ (1.35) | $ 0.56 | | R&D expenses, net | $ 9,511 | $ 4,683 | $ (4,828) | | G&A expenses | $ 7,168 | $ 6,684 | $ (484) | | Restructuring costs | $ — | $ 1,485 | $ 1,485 | | Change in fair value of derivative warrant liabilities | $ 3,218 | $ (2,728) | $ 5,946 | - Research and development expenses increased by **$4.8 million**, primarily due to increased activities for the GTx-104 pivotal Phase 3 safety clinical trial[327](index=327&type=chunk) [Liquidity and Capital Resources](index=59&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, cash was **$22.1 million**; a **$13.7 million** private placement in February 2025 is expected to fund operations for at least 12 months Cash Position and Flows (in thousands) | | As of/Year Ended March 31, 2025 | As of/Year Ended March 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,133 | $23,005 | | Net cash used in operating activities | $(14,904) | $(12,333) | | Net cash provided by financing activities | $14,032 | $7,359 | - In February 2025, a private placement generated net proceeds of **$13.7 million**[339](index=339&type=chunk)[345](index=345&type=chunk) - The company believes its existing cash will be sufficient to sustain planned operations through at least 12 months from the financial statement issuance date[321](index=321&type=chunk)[339](index=339&type=chunk) [Critical Accounting Policies](index=61&type=section&id=Critical%20Accounting%20Policies) Key accounting policies involve significant judgment, including expensing R&D costs and annually testing intangible assets and goodwill for impairment - Research and development costs are expensed as incurred, with accruals based on estimates of work performed by contractors[355](index=355&type=chunk) - In-process research and development (IPR&D) and goodwill, valued at **$49.3 million** (**68% of total assets**), are tested for impairment annually. Impairment assessment involves highly subjective assumptions[357](index=357&type=chunk)[358](index=358&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=63&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, Grace Therapeutics is not required to provide this information - The company is not required to provide this information as it qualifies as a smaller reporting company[369](index=369&type=chunk) [Financial Statements and Supplementary Data](index=63&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for FY2025 and FY2024, including the auditor's report and notes [Report of Independent Registered Public Accounting Firm](index=71&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) KPMG LLP issued an unqualified opinion on the financial statements, identifying the company's going concern ability as a critical audit matter - The auditor, KPMG LLP, issued an unqualified opinion on the financial statements[397](index=397&type=chunk) - A critical audit matter was identified regarding the assessment of the company's ability to continue as a going concern, due to the subjective nature of forecasting future expenses and cash flows[401](index=401&type=chunk)[403](index=403&type=chunk) [Consolidated Financial Statements](index=72&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show total assets of **$72.0 million** and a net loss of **$9.6 million** for FY2025, with **$14.9 million** cash used in operations Key Financial Data (Year Ended March 31, 2025, in thousands) | Metric | FY 2025 | FY 2024 | | :--- | :--- | :--- | | **Balance Sheet:** | | | | Cash and cash equivalents | $22,133 | $23,005 | | Total Assets | $71,993 | $73,300 | | Total Liabilities | $5,383 | $11,557 | | Total Stockholders' Equity | $66,610 | $61,743 | | **Income Statement:** | | | | Net Loss | $(9,568) | $(12,853) | | Basic and Diluted Loss Per Share | $(0.79) | $(1.35) | | **Cash Flow:** | | | | Net cash used in operating activities | $(14,904) | $(12,333) | | Net cash provided by financing activities | $14,032 | $7,359 | [Notes to the Consolidated Financial Statements](index=76&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) The notes detail corporate changes, liquidity risks, accounting policies, intangible assets, and recent financing, including a **$13.7 million** private placement - **(Note 1)** The company completed its domestication from Canada to Delaware in October 2024. Management believes existing cash is sufficient for at least 12 months but will require additional capital beyond that[413](index=413&type=chunk)[419](index=419&type=chunk) - **(Note 6)** Intangible assets (IPR&D) and goodwill totaled **$49.3 million** as of March 31, 2025, with no impairment recognized during the year[462](index=462&type=chunk) - **(Note 8)** The company raised **$13.7 million** in net proceeds from a private placement in February 2025. As of March 31, 2025, derivative warrant liabilities were valued at **$1.1 million**, a significant decrease from **$4.4 million** the prior year[467](index=467&type=chunk)[481](index=481&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=64&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting principles or financial disclosure - None reported[371](index=371&type=chunk) [Controls and Procedures](index=64&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of March 31, 2025 - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[371](index=371&type=chunk) - Management concluded that as of March 31, 2025, the company's internal control over financial reporting was effective, based on the COSO framework[372](index=372&type=chunk) - The company is a non-accelerated filer and is not required to provide an auditor attestation on internal controls[374](index=374&type=chunk) [Other Information](index=64&type=section&id=Item%209B.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the fourth fiscal quarter - No directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the fourth fiscal quarter[375](index=375&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=64&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - None[376](index=376&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=65&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[379](index=379&type=chunk) [Executive Compensation](index=65&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive and director compensation is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[380](index=380&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=65&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership and equity compensation plans is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[381](index=381&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=65&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding related party transactions and director independence is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[382](index=382&type=chunk) [Principal Accountant Fees and Services](index=65&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[383](index=383&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=66&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits filed with or incorporated by reference into the Form 10-K, including financial statements and corporate documents - This section contains the list of all exhibits filed with or incorporated by reference into the Form 10-K[386](index=386&type=chunk) [Form 10-K Summary](index=68&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary provided - None[391](index=391&type=chunk)

Company Overview - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing GTx-104, a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [1][7] - The company has received Orphan Drug Designation from the FDA for its lead clinical assets, providing seven years of marketing exclusivity post-launch in the U.S. and has over 40 granted and pending patents [7] Product Details - GTx-104 is designed to address significant unmet medical needs in aSAH patients, facilitating a convenient IV delivery method that may eliminate the need for nasogastric tube administration [5][6] - The product has been administered to over 150 healthy volunteers, showing good tolerance and significantly lower pharmacokinetic variability compared to oral nimodipine [6] Market Context - Aneurysmal subarachnoid hemorrhage accounts for approximately 5% of all strokes, with an estimated 42,500 patients treated in U.S. hospitals annually [4] - The BIO International Convention, where the CEO will participate, is the largest biotechnology event globally, attracting over 20,000 leaders from various sectors including biopharma and investment [2]

Core Insights - Grace Therapeutics, Inc. is advancing GTx-104, a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [1][6] - The company has received positive feedback from the FDA regarding the Phase 3 STRIVE-ON safety trial and plans to submit a New Drug Application (NDA) in Q2 2025 [2][3] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on addressing rare and orphan diseases with innovative drug delivery technologies [9] - The lead clinical asset, GTx-104, has received Orphan Drug Designation from the FDA, providing seven years of marketing exclusivity post-launch in the U.S. [9] Clinical Trial Insights - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, meeting its primary endpoint with a 19% reduction in clinically significant hypotension incidents [4] - GTx-104 demonstrated higher relative dose intensity (RDI) with 54% of patients achieving RDI of 95% or higher compared to 8% for oral nimodipine [4] - The trial also showed improved functional outcomes at 90 days, with 29% more patients on GTx-104 achieving favorable results [4] Product Details - GTx-104 utilizes unique nanoparticle technology for aqueous formulation, facilitating IV infusion and potentially eliminating the need for nasogastric tube administration [6][7] - The product aims to lower food effects, drug-to-drug interactions, and dosing errors while better managing hypotension in aSAH patients [8] Market Context - aSAH accounts for about 5% of all strokes, with an estimated 42,500 U.S. hospital-treated patients annually, indicating a significant unmet medical need [5]

Company Overview - Grace Therapeutics, Inc. (formerly Acasti Pharma Inc.) is a late-stage biopharma company focused on developing innovative drug delivery technologies for rare and orphan diseases [7] - The company's lead clinical asset, GTx-104, is an injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH) [5][7] Product Development - GTx-104 is designed for intravenous infusion to address significant unmet medical needs in aSAH patients, potentially improving treatment outcomes compared to oral formulations [5][6] - The unique nanoparticle technology of GTx-104 allows for a standard peripheral IV infusion, which may eliminate the need for nasogastric tube administration in unconscious or dysphagic patients [6] - GTx-104 has been administered to over 150 healthy volunteers and demonstrated good tolerance with lower pharmacokinetic variability compared to oral nimodipine [6] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) is a rare and life-threatening condition that accounts for approximately 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. [4] - The company hosted a virtual key opinion leader (KOL) event discussing the high unmet medical need and current treatment landscape for aSAH patients [2] Regulatory and Commercial Strategy - Grace Therapeutics has received Orphan Drug Designation from the FDA for its lead clinical assets, providing seven years of marketing exclusivity post-launch in the U.S. [7] - The company holds over 40 granted and pending patents, enhancing its intellectual property protection [7] Upcoming Events - The CEO of Grace Therapeutics, Prashant Kohli, will participate in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, to discuss the company's developments [1][2]

[Q3 FY2025 Highlights and Business Update](index=1&type=section&id=Grace%20Therapeutics%20Announces%20Third%20Fiscal%20Quarter%202025%20Financial%20Results%2C%20Provides%20Business%20Update) Grace Therapeutics reported positive Phase 3 GTx-104 trial results, plans a 2025 NDA, and secured $30M financing [Key Highlights](index=1&type=section&id=Highlights%20for%20Third%20Quarter%20Fiscal%20Quarter%202025%20and%20Recent%20Weeks) Positive Phase 3 GTx-104 trial results, secured financing, and received FDA guidance for GTx-102 - The Phase 3 STRIVE-ON safety trial for GTx-104 met its primary endpoint and demonstrated **clinical benefit** compared to oral nimodipine for aneurysmal subarachnoid hemorrhage (aSAH) patients[2](index=2&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) - The company plans to submit a New Drug Application (NDA) to the FDA for GTx-104 in the **first half of calendar year 2025**[2](index=2&type=chunk)[4](index=4&type=chunk) - Secured a private placement financing for up to **$30 million** in potential gross proceeds, with an initial **$15 million** upfront, yielding **$13.8 million** net proceeds[2](index=2&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) - Received FDA guidance on the design of a single pivotal efficacy and safety trial for GTx-102, which could support a future NDA[4](index=4&type=chunk)[12](index=12&type=chunk) [Financial Results](index=2&type=section&id=Third%20Fiscal%20Quarter%202025%20Financial%20Results) Grace Therapeutics reported a **$4.2M net loss** in Q3 FY2025, driven by increased R&D and derivative liability changes [Financial Summary](index=2&type=section&id=Financial%20Summary) Q3 FY2025 net loss increased to **$4.2M** due to higher R&D and derivative adjustments, with cash at **$11.1M** Q3 FY2025 vs. Q3 FY2024 Financial Performance | Metric | Q3 FY2025 (ended Dec 31, 2024) (in millions) | Q3 FY2024 (ended Dec 31, 2023) (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | **Net Loss** | $4.2 | $2.4 | +$1.8 | | **Loss per Share** | $0.36 | $0.21 | +$0.15 | | **R&D Expenses** | $2.2 | $1.4 | +$0.8 | | **G&A Expenses** | $1.5 | $1.6 | -$0.1 | Cash Position | Metric | Dec 31, 2024 (in millions) | Mar 31, 2024 (in millions) | | :--- | :--- | :--- | | **Cash and Cash Equivalents** | $11.1 | $23.0 | [Business and Asset Portfolio](index=2&type=section&id=Business%20and%20Asset%20Portfolio) Details aSAH and the company's clinical-stage asset portfolio: GTx-104, GTx-102, and deprioritized GTx-101 [About aneurysmal Subarachnoid Hemorrhage (aSAH)](index=2&type=section&id=About%20aneurysmal%20Subarachnoid%20Hemorrhage%20%28aSAH%29) aSAH is a rare, severe stroke from a ruptured brain aneurysm, affecting ~42,500 U.S. patients annually - aSAH is a type of stroke caused by bleeding in the subarachnoid space, often from a ruptured brain aneurysm[9](index=9&type=chunk) - This condition accounts for about **5% of all strokes** and impacts an estimated **42,500 U.S. hospital-treated patients**[9](index=9&type=chunk) [Asset Portfolio Overview](index=2&type=section&id=About%20the%20Grace%20Therapeutics%20Asset%20Portfolio) Clinical portfolio targets unmet medical needs, led by GTx-104 for aSAH, GTx-102 for A-T, and deprioritized GTx-101 [GTx-104](index=2&type=section&id=GTx-104) GTx-104 is a novel IV nimodipine formulation for aSAH, improving oral delivery via nanoparticle technology - GTx-104 is a novel, injectable formulation of nimodipine for IV infusion in aSAH patients, utilizing unique nanoparticle technology[10](index=10&type=chunk) - It offers potential benefits over oral administration, including avoiding nasogastric tubes, lowering food effects and drug interactions, and eliminating potential dosing errors[11](index=11&type=chunk) - GTx-104 has shown significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine[11](index=11&type=chunk) [GTx-102](index=2&type=section&id=GTx-102) GTx-102 is an oral betamethasone spray for A-T, with FDA guidance for a single pivotal trial supporting an NDA - GTx-102 is a concentrated oral spray of betamethasone for Ataxia-Telangiectasia (A-T), a condition with no FDA-approved therapies[12](index=12&type=chunk) - The FDA has provided guidance on the design of a single pivotal trial that could support an NDA submission[12](index=12&type=chunk)[4](index=4&type=chunk) [GTx-101](index=2&type=section&id=GTx-101) GTx-101 is a topical bupivacaine spray for PHN, deprioritized for GTx-104 focus, with potential licensing or sale - GTx-101 is a topical bupivacaine spray designed to treat postherpetic neuralgia (PHN) with a potential for rapid onset and up to **eight hours** of pain relief[13](index=13&type=chunk) - The development of GTx-101 has been deprioritized to focus resources on the lead asset, GTx-104. The company may license or sell GTx-101[13](index=13&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) Overview of Grace Therapeutics as a biopharmaceutical company and the nature of forward-looking statements [About Grace Therapeutics](index=3&type=section&id=About%20Grace%20Therapeutics) Grace Therapeutics is a late-stage biopharma company focused on rare and orphan diseases, using novel drug delivery - The company is a late-stage biopharma firm focused on drug candidates for rare and orphan diseases[14](index=14&type=chunk) - Lead clinical assets, including GTx-104, have been granted FDA Orphan Drug Designation, providing **seven years** of U.S. marketing exclusivity after launch[14](index=14&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) Cautions that forward-looking statements are subject to inherent risks and uncertainties, and actual results may differ - The press release contains forward-looking statements regarding the future prospects of GTx-104 and GTx-102, including NDA submission timing and commercial potential[15](index=15&type=chunk) - Actual results may differ due to risks such as regulatory requirements, changes to clinical trial designs, and legislative or economic developments[15](index=15&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) Presents the company's condensed consolidated balance sheets and statements of loss and comprehensive loss [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of December 31, 2024, total assets decreased to **$61.2M**, driven by reduced cash, with liabilities and equity also declining Balance Sheet Summary | Account | December 31, 2024 (in thousands) | March 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $11,055 | $23,005 | | **Total Assets** | $61,224 | $73,300 | | **Total Liabilities** | $9,085 | $11,557 | | **Total Stockholders' Equity** | $52,139 | $61,743 | [Condensed Consolidated Statements of Loss and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) Net loss of **$4.2M** for Q3 FY2025 and **$10.2M** for nine months, primarily due to increased R&D expenses Statement of Loss - Three Months Ended | Metric | December 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | Research and development expenses | $(2,194) | $(1,443) | | General and administrative expenses | $(1,510) | $(1,600) | | **Net Loss** | **$(4,155)** | **$(2,391)** | | **Basic and diluted loss per share** | **$(0.36)** | **$(0.21)** | Statement of Loss - Nine Months Ended | Metric | December 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | Research and development expenses | $(7,877) | $(2,998) | | General and administrative expenses | $(5,619) | $(5,106) | | **Net Loss** | **$(10,204)** | **$(9,687)** | | **Basic and diluted loss per share** | **$(0.89)** | **$(1.09)** |

Core Insights - Grace Therapeutics announced that its Phase 3 STRIVE-ON safety trial for GTx-104 met its primary endpoint, showing improved clinical outcomes compared to orally administered nimodipine [1][15] - The company secured a private placement financing of up to $30 million, which will support pre-commercial planning and the potential launch of GTx-104 if approved [2][5] - The New Drug Application (NDA) submission for GTx-104 is anticipated in the first half of 2025, marking a significant step towards addressing unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients [1][2] Financial Highlights - For the quarter ended December 31, 2024, the company reported a net loss of $4.2 million, or $0.36 per share, an increase from a net loss of $2.4 million, or $0.21 per share, for the same period in 2023 [4][19] - Research and development expenses increased to $2.2 million for the quarter, up from $1.4 million in the prior year, primarily due to activities related to the GTx-104 pivotal Phase 3 trial [6][19] - As of December 31, 2024, cash and cash equivalents were $11.1 million, a decrease from $23.0 million at the end of March 2024 [8][19] Product Development - GTx-104 is a novel injectable formulation of nimodipine being developed for IV infusion in aSAH patients, addressing significant unmet medical needs [10][15] - The drug's unique nanoparticle technology allows for a standard peripheral IV infusion, potentially improving delivery and reducing complications associated with oral administration [11][15] - The company is also developing GTx-102, a novel oral-mucosal spray of betamethasone for Ataxia-Telangiectasia, with an NDA submission path outlined by the FDA [12][15] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) accounts for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually, indicating a significant market opportunity for GTx-104 [9][15] - The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, positioning GTx-104 as a potential breakthrough treatment if approved by the FDA [2][5]

PART I. FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Grace Therapeutics reported an increased net loss of $10.2 million for the nine months ended December 31, 2024, with cash decreasing to $11.1 million, supplemented by a $13.8 million private placement Condensed Consolidated Balance Sheet Highlights (in thousands) | | Dec 31, 2024 | Mar 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,055 | $23,005 | | Total current assets | $11,939 | $24,010 | | Intangible assets & Goodwill | $49,266 | $49,266 | | **Total assets** | **$61,224** | **$73,300** | | **Liabilities & Equity** | | | | Total current liabilities | $1,971 | $1,684 | | Derivative warrant liabilities | $3,781 | $4,359 | | **Total liabilities** | **$9,085** | **$11,557** | | **Total stockholders' equity** | **$52,139** | **$61,743** | Condensed Consolidated Statements of Loss (in thousands, except per share data) | | Three Months Ended Dec 31 | Nine Months Ended Dec 31 | | :--- | :--- | :--- | | | **2024** | **2023** | **2024** | **2023** | | Research and development expenses, net | ($2,194) | ($1,443) | ($7,877) | ($2,998) | | General and administrative expenses | ($1,510) | ($1,600) | ($5,619) | ($5,106) | | Loss from operating activities | ($3,704) | ($3,043) | ($13,496) | ($9,589) | | **Net loss** | **($4,155)** | **($2,391)** | **($10,204)** | **($9,687)** | | Basic and diluted loss per share | ($0.36) | ($0.21) | ($0.89) | ($1.09) | Condensed Consolidated Statements of Cash Flows Highlights (Nine months ended Dec 31, in thousands) | | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($11,950) | ($10,245) | | Net cash used in investing activities | $0 | ($6,444) | | Net cash provided by financing activities | $0 | $7,359 | | **Net decrease in cash and cash equivalents** | **($11,950)** | **($9,330)** | | Cash and cash equivalents, end of period | $11,055 | $18,545 | - In February 2025, the company completed a private placement raising net proceeds of approximately **$13.8 million**[34](index=34&type=chunk)[35](index=35&type=chunk) - Management believes existing cash, supplemented by these proceeds, is sufficient to fund operations for at least 12 months from the financial statement issuance date[34](index=34&type=chunk)[35](index=35&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company focuses on developing and commercializing products for rare and orphan diseases, prioritizing its lead candidate GTx-104, with recent financial results reflecting increased R&D expenses and a new private placement [Business Overview and Pipeline](index=19&type=section&id=Business%20Overview%20and%20Pipeline) Grace Therapeutics is a clinical-stage pharmaceutical company focused on rare and orphan diseases, strategically prioritizing its lead candidate GTx-104 for commercialization - The company's strategy is to apply new proprietary formulations to approved pharmaceutical compounds to enhance efficacy, reduce side effects, and improve delivery, potentially enabling a shorter path to regulatory approval via the Section 505(b)(2) pathway[89](index=89&type=chunk)[90](index=90&type=chunk) - All three drug candidates have received Orphan Drug Designation (ODD) from the FDA, which provides for seven years of marketing exclusivity in the U.S. post-launch if certain conditions are met[92](index=92&type=chunk) - In May 2023, the company prioritized the development of its lead candidate, GTx-104, to advance it towards commercialization[96](index=96&type=chunk) - Further development of GTx-102 and GTx-101 is contingent on securing additional funding or strategic partnerships[96](index=96&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) Recent developments include a successful $13.8 million private placement, positive Phase 3 GTx-104 trial results leading to planned NDA submission, and a corporate domestication to Delaware - Completed a private placement in February 2025, raising approximately **$13.8 million** in net proceeds[98](index=98&type=chunk)[99](index=99&type=chunk) - The Phase 3 STRIVE-ON trial for GTx-104 met its primary endpoint, showing clinical benefit compared to oral nimodipine[100](index=100&type=chunk) - An NDA submission to the FDA is planned for the first half of calendar year 2025[100](index=100&type=chunk) - In October 2024, the company changed its jurisdiction to Delaware, changed its name to Grace Therapeutics, Inc., and began trading on Nasdaq under the symbol 'GRCE'[102](index=102&type=chunk)[104](index=104&type=chunk) [GTx-104 Overview (for aSAH)](index=22&type=section&id=GTx-104%20Overview) GTx-104 is an IV nimodipine formulation for aSAH, targeting a $300 million U.S. market, with its Phase 3 trial successfully meeting endpoints and an NDA submission planned for early 2025 - GTx-104 is an injectable nimodipine formulation for aSAH patients, designed to provide **100% bioavailability**, better blood pressure control, and lower variability compared to the oral form[109](index=109&type=chunk)[112](index=112&type=chunk) - The total addressable market for aSAH is estimated at approximately **$300 million** in the U.S., affecting about **42,500 patients annually**[117](index=117&type=chunk)[115](index=115&type=chunk) - The Phase 3 STRIVE-ON trial met its primary endpoint, with GTx-104 showing a **19% reduction** in drug-related hypotension episodes (**28% vs 35%** for oral nimodipine)[128](index=128&type=chunk) - Favorable outcomes were also seen in dose intensity and patient quality of life[128](index=128&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) The company's net loss increased to $4.2 million for Q3 2024 and $10.2 million for the nine-month period, primarily driven by higher R&D expenses for the GTx-104 trial and increased G&A costs Comparison of Operating Results (in thousands) | | Three Months Ended Dec 31 | Nine Months Ended Dec 31 | | :--- | :--- | :--- | | | **2024** | **2023** | **2024** | **2023** | | R&D Expenses | $2,194 | $1,443 | $7,877 | $2,998 | | G&A Expenses | $1,510 | $1,600 | $5,619 | $5,106 | | Restructuring Costs | $0 | $0 | $0 | $1,485 | | **Net Loss** | **($4,155)** | **($2,391)** | **($10,204)** | **($9,687)** | - Research and development expenses increased by **$4.9 million** for the nine months ended Dec 31, 2024, primarily due to increased research activities for the GTx-104 pivotal Phase 3 safety clinical trial[175](index=175&type=chunk) - General and administrative expenses increased by **$513,000** for the nine months ended Dec 31, 2024, mainly due to higher legal, tax, and accounting fees related to the Continuance and Domestication, as well as increased salaries[181](index=181&type=chunk) - The change in fair value of derivative warrant liabilities resulted in a **$1.2 million expense** for the three months ended Dec 31, 2024, compared to a **$125,000 gain** in the prior-year period, primarily due to changes in the company's stock price[183](index=183&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2024, cash and cash equivalents were $11.1 million, with a $13.8 million private placement in February 2025 expected to fund operations for at least 12 months - Cash and cash equivalents were **$11.1 million** as of December 31, 2024[190](index=190&type=chunk) - In February 2025, a private placement was completed, providing net proceeds of approximately **$13.8 million**[191](index=191&type=chunk)[84](index=84&type=chunk) - Net cash used in operating activities for the nine months ended December 31, 2024, was **$12.0 million**, an increase from **$10.2 million** in the prior-year period, driven by increased R&D for the GTx-104 trial[193](index=193&type=chunk) - The company has commitments of **$230,000** to CMOs and **$1.5 million** to CROs for the next twelve months as of December 31, 2024[199](index=199&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Grace Therapeutics is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide the information required by this Item[208](index=208&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024, with no material changes to internal controls over financial reporting during the quarter - Based on an evaluation as of December 31, 2024, management concluded that the company's disclosure controls and procedures were effective[209](index=209&type=chunk) - No material changes were made to the company's internal controls over financial reporting during the quarter ended December 31, 2024[210](index=210&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business[212](index=212&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K - There have been no material changes from the risk factors disclosed in the company's Annual Report[214](index=214&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[215](index=215&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information) During the third quarter of 2024, no director or officer of the company adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - During the three months ended December 31, 2024, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement[218](index=218&type=chunk)

Core Insights - Grace Therapeutics, Inc. announced positive topline data from its Phase 3 STRIVE-ON safety trial of GTx-104, demonstrating clinical benefits compared to oral nimodipine in patients with aneurysmal Subarachnoid Hemorrhage (aSAH) [1][2] Trial Results - The trial met its primary endpoint, showing a 19% reduction in clinically significant hypotension incidents for patients receiving GTx-104 (28% vs. 35% for nimodipine) [2] - Adverse events were comparable between GTx-104 and nimodipine, with no new safety issues identified [2] - All deaths in the trial were attributed to the severity of the underlying disease, not the treatment [2] Future Plans - A new drug application submission to the US is anticipated in the first half of 2025 [3] - Grace Therapeutics announced a private placement of approximately $30 million, with $15 million upfront and an additional $15 million possible through investor warrants [3][4] Financial Details - The company will issue 4.42 million common shares and warrants at a combined purchase price of $3.395 [4] - The net proceeds from this placement will be used to fund the development of GTx-104 [4] Market Reaction - Following the announcement, GRCE stock increased by 4.32%, reaching $3.38 [4] - A significant 54% of patients receiving GTx-104 achieved a relative dose intensity of 95% or higher, compared to only 8% for nimodipine [4] - There was a 29% relative increase in favorable outcomes at 90 days follow-up on the modified Rankin scale for patients receiving GTx-104 [4] - Patients on GTx-104 experienced fewer ICU readmissions, ICU days, and ventilator days compared to those on nimodipine [4]

Core Viewpoint - Grace Therapeutics, Inc. has announced a financing round to raise up to approximately $30 million, aimed at advancing its clinical-stage drug GTx-104 for treating aneurysmal Subarachnoid Hemorrhage (aSAH) patients [1][5][12] Financing Details - The financing is led by Nantahala Capital and ADAR1 Partners, LP, with participation from both new and existing healthcare-focused institutional investors, including Stonepine Capital Management [2] - The financing consists of $15 million in upfront gross proceeds, with the potential for an additional $15 million from warrant exercises, totaling up to approximately $30 million [1][3] - Grace Therapeutics will issue 4,418,292 shares of common stock and accompanying common warrants at a combined purchase price of $3.395 per share [3][4] Use of Proceeds - The upfront net proceeds from the private placement will be utilized for general corporate purposes and to fund the pre-commercial development of GTx-104 [5] Product Overview - GTx-104 is a novel injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients [10][12] - The drug aims to provide a convenient IV delivery method, potentially eliminating the need for nasogastric tube administration and reducing dosing errors [11] Clinical Background - aSAH is a type of stroke that accounts for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. [9] - Grace Therapeutics' lead clinical asset, GTx-104, has met its primary endpoint in the Phase 3 STRIVE-ON safety trial, showing clinical benefits over orally administered nimodipine [12]