Citius Pharma(CTXR) - 2025 Q3 - Quarterly Results

Executive Summary & Business Update Citius Pharmaceuticals reported improved Q3 2025 financials, is preparing for LYMPHIR™ launch, and secured significant capital Fiscal Third Quarter 2025 Financial Highlights Citius Pharmaceuticals reported an improved net loss and EPS for Q3 2025 compared to Q3 2024, driven by reduced R&D, G&A, and stock-based compensation expenses. The company ended the quarter with $6.1 million in cash and cash equivalents, bolstered by recent equity and debt financings Fiscal Third Quarter 2025 Financial Performance (YoY) | Metric | Q3 2025 (Millions) | Q3 2024 (Millions) | Change (YoY) | | :-------------------------- | :----------------- | :----------------- | :----------- | | R&D expenses | $1.6 | $2.8 | ↓ $1.2 |\n| G&A expenses | $4.4 | $4.8 | ↓ $0.4 |\n| Stock-based compensation | $2.7 | $3.1 | ↓ $0.4 |\n| Net loss | $(9.2) | $(10.6) | ↑ $1.4 |\n| Net Loss Per Share (EPS) | $(0.80) | $(1.57) | ↑ $0.77 | - Cash and cash equivalents stood at $6.1 million as of June 30, 2025. The company received net proceeds of $16.5 million from equity issuance and $1 million from a note payable during the nine months ended June 30, 2025[4] - Citius Oncology completed a public offering on July 17, 2025, generating approximately $7.4 million in net proceeds[4] Strategic Priorities and LYMPHIR Launch Citius Pharmaceuticals is transitioning from a development-stage enterprise to a commercial organization, with final preparations underway for the planned U.S. launch of LYMPHIR™ in Q4 2025. The company has completed major launch-enabling activities and continues to advance its pipeline product, Mino-Lok - Citius is operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization[2] - Final preparations are underway for the planned U.S. launch of LYMPHIR™ in the fourth quarter of 2025[2] - Major launch-enabling activities for LYMPHIR, including commercial-scale manufacturing, labeling, packaging, and distribution services agreements, have been completed[3] - The company remains focused on advancing Mino-Lok and is engaging with the U.S. Food and Drug Administration (FDA) to determine the best path forward for this antibiotic lock solution[3] Financing Activities During the fiscal third quarter and shortly thereafter, Citius Pharmaceuticals and its subsidiary Citius Oncology raised significant capital to support commercialization activities and corporate operations, including pre-launch initiatives for LYMPHIR - Citius Pharmaceuticals raised $12.5 million in gross financings during the quarter[1] - In June 2025, the company completed a $6 million registered direct offering, with potential for an additional $9.8 million upon full warrant exercise[3] - In July 2025, Citius Oncology strengthened its capital position with $9 million in gross proceeds from a public offering[3] Company Overview Citius Pharmaceuticals is a late-stage biopharmaceutical company focused on critical care products, with FDA-approved LYMPHIR™ and an 84% stake in Citius Oncology About Citius Pharmaceuticals Citius Pharmaceuticals is a late-stage biopharmaceutical company focused on developing and commercializing first-in-class critical care products. Its lead product, LYMPHIR™, received FDA approval in August 2024, and the company holds an 84% ownership stake in its oncology subsidiary, Citius Oncology - Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products[6] - LYMPHIR™ was approved by the FDA in August 2024 for an initial indication in the treatment of cutaneous T-cell lymphoma[6] - Citius Pharma owns 84% of Citius Oncology[6] Product Pipeline Beyond LYMPHIR, Citius Pharma's late-stage pipeline includes Mino-Lok®, an antibiotic lock solution that successfully met its primary and secondary endpoints in a Phase 3 trial, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoids, which completed a Phase 2b trial. The company is actively engaging with the FDA for next steps on both programs - Mino-Lok® is an antibiotic lock solution designed to salvage catheters in patients with catheter-related bloodstream infections. Its Pivotal Phase 3 Trial was completed in 2023 and met primary and secondary endpoints[6] - CITI-002 (Halo-Lido) is a topical formulation for the relief of hemorrhoids, for which a Phase 2b trial was completed in 2023[6] - Citius Pharma is actively engaged with the FDA to outline next steps for both the Mino-Lok and Halo-Lido programs[6] Financial Results Citius Pharmaceuticals reported changes in its balance sheet, statements of operations, and cash flows, reflecting increased assets and liabilities, reduced net loss for Q3, and improved cash from financing activities Condensed Consolidated Balance Sheets As of June 30, 2025, Citius Pharmaceuticals reported an increase in total assets, primarily driven by higher cash and inventory. Total liabilities also increased significantly, mainly due to a rise in accounts payable and accrued expenses, while total equity saw a decrease Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 | Sept 30, 2024 | Change (Absolute) | | :-------------------------- | :------------ | :------------ | :---------------- | | Cash and cash equivalents | $6,089,126 | $3,251,880 | ↑ $2,837,246 |\n| Inventory | $17,208,967 | $8,268,766 | ↑ $8,940,201 |\n| Total Current Assets | $24,611,269 | $14,220,646 | ↑ $10,390,623 |\n| Total Assets | $127,676,859 | $116,651,751 | ↑ $11,025,108 |\n| Accounts payable | $10,094,042 | $4,927,211 | ↑ $5,166,831 |\n| Accrued expenses | $8,523,675 | $17,027 | ↑ $8,506,648 |\n| Total Current Liabilities | $51,842,452 | $35,814,803 | ↑ $16,027,649 |\n| Total Liabilities | $60,115,929 | $42,549,921 | ↑ $17,566,008 |\n| Total Equity | $67,560,930 | $74,101,830 | ↓ $6,540,900 | Condensed Consolidated Statements of Operations For the three months ended June 30, 2025, Citius Pharma reported a reduced net loss and improved EPS compared to the prior year, primarily due to lower operating expenses. However, for the nine-month period, while operating expenses slightly decreased, the net loss increased, and EPS improved due to a higher weighted average common shares outstanding Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric | 2025 | 2024 | Change (Absolute) | | :---------------------------------------- | :------------ | :------------ | :---------------- | | Research and development | $1,621,325 | $2,763,865 | ↓ $1,142,540 |\n| General and administrative | $4,447,008 | $4,808,551 | ↓ $361,543 |\n| Stock-based compensation – G&A | $2,719,674 | $3,061,763 | ↓ $342,089 |\n| Total Operating Expenses | $8,788,007 | $10,634,179 | ↓ $1,846,172 |\n| Operating Loss | $(8,788,007) | $(10,634,179) | ↑ $1,846,172 |\n| Net Loss | $(9,203,872) | $(10,573,336) | ↑ $1,369,464 |\n| Net Loss Per Share - Basic and Diluted | $(0.80) | $(1.57) | ↑ $0.77 | Condensed Consolidated Statements of Operations (Nine Months Ended June 30) | Metric | 2025 | 2024 | Change (Absolute) | | :---------------------------------------- | :------------ | :------------ | :---------------- | | Research and development | $7,514,888 | $8,991,673 | ↓ $1,476,785 |\n| General and administrative | $14,626,882 | $12,755,190 | ↑ $1,871,692 |\n| Stock-based compensation – G&A | $7,946,529 | $9,198,340 | ↓ $1,251,811 |\n| Total Operating Expenses | $30,088,299 | $30,945,203 | ↓ $856,904 |\n| Operating Loss | $(30,088,299) | $(30,945,203) | ↑ $856,904 |\n| Net Loss | $(30,996,623) | $(28,348,675) | ↓ $2,647,948 |\n| Net Loss Per Share - Basic and Diluted | $(3.27) | $(4.37) | ↑ $1.10 | Condensed Consolidated Statements of Cash Flows For the nine months ended June 30, 2025, Citius Pharmaceuticals significantly reduced cash used in operating activities and increased cash provided by financing activities, resulting in a positive net change in cash and cash equivalents, a notable improvement from the prior year's negative change Condensed Consolidated Statements of Cash Flows (Nine Months Ended June 30) | Metric | 2025 | 2024 | Change (Absolute) | | :-------------------------------------- | :------------- | :------------- | :---------------- | | Net Cash Used In Operating Activities | $(14,671,948) | $(22,288,687) | ↑ $7,616,739 |\n| Net Cash Provided By Financing Activities | $17,509,194 | $13,718,951 | ↑ $3,790,243 |\n| Net Change in Cash and Cash Equivalents | $2,837,246 | $(8,569,736) | ↑ $11,406,982 |\n| Cash and Cash Equivalents - End of Period | $6,089,126 | $17,911,192 | ↓ $11,822,066 | - Net proceeds from common stock offerings increased to $16.5 million in 2025 from $13.7 million in 2024[15] Additional Information This section provides important disclaimers regarding forward-looking statements and contact details for investor and media inquiries Forward-Looking Statements This section contains standard forward-looking statements that are subject to various risks and uncertainties, which could negatively impact the company's business, operating results, financial condition, and stock price. Investors are cautioned not to place undue reliance on these statements - The press release contains forward-looking statements based on expectations and beliefs concerning future events, identifiable by words such as 'will,' 'anticipate,' 'estimate,' 'expect,' 'plan,' 'should,' and 'may'[7] - These statements are subject to risks and uncertainties, including the need for substantial additional funds, ability to commercialize LYMPHIR, compliance with Nasdaq standards, financing agreements, market acceptance, R&D risks, dependence on third-party suppliers, government regulation, and competition[7] - Readers are cautioned not to place undue reliance on these forward-looking statements, as they do not constitute guarantees of future performance[7] Investor and Media Contact Contact information for investor and media inquiries is provided for direct communication with company representatives - Investor Contact: Ilanit Allen, ir@citiuspharma.com, 908-967-6677 x113[8] - Media Contact: Greg Salsburg, Greg@STiR-communications.com[8]