PART I. FINANCIAL INFORMATION Financial Statements 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 million3435 - Management believes existing cash, supplemented by these proceeds, is sufficient to fund operations for at least 12 months from the financial statement issuance date3435 Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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) pathway8990 - 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 met92 - In May 2023, the company prioritized the development of its lead candidate, GTx-104, to advance it towards commercialization96 - Further development of GTx-102 and GTx-101 is contingent on securing additional funding or strategic partnerships96 Recent Developments 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 proceeds9899 - The Phase 3 STRIVE-ON trial for GTx-104 met its primary endpoint, showing clinical benefit compared to oral nimodipine100 - An NDA submission to the FDA is planned for the first half of calendar year 2025100 - 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'102104 GTx-104 Overview (for aSAH) 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 form109112 - The total addressable market for aSAH is estimated at approximately $300 million in the U.S., affecting about 42,500 patients annually117115 - 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 - Favorable outcomes were also seen in dose intensity and patient quality of life128 Results of Operations 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 trial175 - 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 salaries181 - 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 price183 Liquidity and Capital Resources 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, 2024190 - In February 2025, a private placement was completed, providing net proceeds of approximately $13.8 million19184 - 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 trial193 - The company has commitments of $230,000 to CMOs and $1.5 million to CROs for the next twelve months as of December 31, 2024199 Quantitative and Qualitative Disclosures About Market Risk 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 Item208 Controls and Procedures 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 effective209 - No material changes were made to the company's internal controls over financial reporting during the quarter ended December 31, 2024210 PART II. OTHER INFORMATION Legal Proceedings 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 business212 Risk Factors 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 Report214 Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - None215 Other Information 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 arrangement218
Grace Therapeutics, lnc.(GRCE) - 2025 Q3 - Quarterly Report