Grace Therapeutics, lnc.(GRCE) - 2025 Q3 - Quarterly Results

Q3 FY2025 Highlights and Business Update Grace Therapeutics reported positive Phase 3 GTx-104 trial results, plans a 2025 NDA, and secured $30M financing Key Highlights 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][3][4] - 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][4] - 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][3][4] - Received FDA guidance on the design of a single pivotal efficacy and safety trial for GTx-102, which could support a future NDA[4][12] Financial Results Grace Therapeutics reported a $4.2M net loss in Q3 FY2025, driven by increased R&D and derivative liability changes Financial Summary 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 Details aSAH and the company's clinical-stage asset portfolio: GTx-104, GTx-102, and deprioritized GTx-101 About aneurysmal Subarachnoid Hemorrhage (aSAH) 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] - This condition accounts for about 5% of all strokes and impacts an estimated 42,500 U.S. hospital-treated patients[9] Asset Portfolio Overview Clinical portfolio targets unmet medical needs, led by GTx-104 for aSAH, GTx-102 for A-T, and deprioritized GTx-101 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] - It offers potential benefits over oral administration, including avoiding nasogastric tubes, lowering food effects and drug interactions, and eliminating potential dosing errors[11] - GTx-104 has shown significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine[11] 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] - The FDA has provided guidance on the design of a single pivotal trial that could support an NDA submission[12][4] 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] - 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] Corporate Information Overview of Grace Therapeutics as a biopharmaceutical company and the nature of forward-looking statements About Grace Therapeutics 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] - Lead clinical assets, including GTx-104, have been granted FDA Orphan Drug Designation, providing seven years of U.S. marketing exclusivity after launch[14] Forward-Looking Statements 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] - Actual results may differ due to risks such as regulatory requirements, changes to clinical trial designs, and legislative or economic developments[15] Financial Statements Presents the company's condensed consolidated balance sheets and statements of loss and comprehensive loss Condensed Consolidated Balance Sheets 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 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) |