Citius Oncology, Inc.(CTOR) - 2024 Q3 - Quarterly Results

Business Highlights and Developments Citius Oncology achieved FDA approval for LYMPHIR, completed a Nasdaq merger, and is preparing for its H1 2025 commercial launch - Completed a merger and began trading on the Nasdaq under the ticker CTOR on August 13, 2024, establishing Citius Oncology as a standalone public company[9] - Received U.S. Food and Drug Administration (FDA) approval for LYMPHIR™ for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL)[4] - Advanced preparations for the commercial launch of LYMPHIR, expected in H1 2025, including sales force recruitment, NCCN guideline inclusion, initial inventory manufacturing, and J-code application[4][9][22] - Supported two investigator-initiated trials to evaluate LYMPHIR as a combination therapy, with interim Phase I results showing a 27% objective response rate in gynecological neoplasms with pembrolizumab[9][5][10] Full Year 2024 Financial Results Citius Oncology reported a net loss of $21.1 million in FY2024, widening from $12.7 million due to higher operating expenses Fiscal Year 2024 vs 2023 Key Financials | Financial Metric | FY 2024 ($ millions) | FY 2023 ($ millions) | Change ($ millions) | | :--- | :--- | :--- | :--- | | R&D Expenses | $4.9 | $4.2 | +$0.7 | | G&A Expenses | $8.1 | $5.9 | +$2.2 | | Stock-based Compensation | $7.5 | $2.0 | +$5.5 | | Net Loss | $(21.1) | $(12.7) | +$(8.4) | | Net Loss Per Share | ($0.31) | ($0.19) | ($0.12) | Research and Development (R&D) Expenses R&D expenses increased to $4.9 million in FY2024, driven by development activities for LYMPHIR's BLA resubmission R&D Expense Trend | Period | R&D Expenses ($ millions) | | :--- | :--- | | FY 2024 | $4.9 | | FY 2023 | $4.2 | General and Administrative (G&A) Expenses G&A expenses rose to $8.1 million in FY2024, primarily due to pre-commercial and launch activities for LYMPHIR G&A Expense Trend | Period | G&A Expenses ($ millions) | | :--- | :--- | | FY 2024 | $8.1 | | FY 2023 | $5.9 | Stock-based Compensation Expense Stock-based compensation expense significantly increased to $7.5 million in FY2024 due to a full year of expense recognition Stock-based Compensation Expense Trend | Period | Stock-based Compensation ($ millions) | | :--- | :--- | | FY 2024 | $7.5 | | FY 2023 | $2.0 | Net Loss Net loss widened to $21.1 million, or ($0.31) per share, in FY2024, primarily due to higher operating expenses Net Loss and EPS Trend | Metric | FY 2024 ($ millions) | FY 2023 ($ millions) | | :--- | :--- | :--- | | Net Loss | $(21.1) | $(12.7) | | Net Loss Per Share | $(0.31) | $(0.19) | Financial Statements This section presents the consolidated balance sheets, statements of operations, and cash flows Consolidated Balance Sheets Total assets increased to $84.4 million in FY2024, driven by in-process R&D, and liabilities rose to $38.2 million Balance Sheet Highlights (as of Sept 30) | Account | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $112 | $0 | | Total Current Assets | $11.0 million | $7.7 million | | In-process R&D | $73.4 million | $40.0 million | | Total Assets | $84.4 million | $47.7 million | | Total Current Liabilities | $32.7 million | $21.0 million | | Total Liabilities | $38.2 million | $22.2 million | | Total Stockholders' Equity | $46.1 million | $25.5 million | Consolidated Statements of Operations The company reported no revenue in FY2024, with total operating expenses increasing to $20.6 million, resulting in a net loss of $21.1 million Statement of Operations (for the year ended Sept 30) | Line Item | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Total Operating Expenses | $20,572,747 | $12,121,241 | | Loss before Income Taxes | $(20,572,747) | $(12,121,241) | | Net Loss | $(21,148,747) | $(12,697,241) | | Net Loss Per Share | $(0.31) | $(0.19) | Consolidated Statements of Cash Flows In FY2024, Citius Oncology generated $126,353 from operations, used $5.0 million in investing, and ended with $112 cash Cash Flow Summary (for the year ended Sept 30, 2024) | Cash Flow Activity | Amount ($) | | :--- | :--- | | Net Cash Provided By Operating Activities | $126,353 | | Net Cash Used In Investing Activities | $(5,000,000) | | Net Cash Provided By Financing Activities | $4,873,759 | | Net Change in Cash | $112 | | Cash at End of Year | $112 | About Citius Oncology, Inc. Citius Oncology is a biopharmaceutical company focused on targeted oncology therapies, with LYMPHIR FDA-approved for CTCL - The company's primary asset, LYMPHIR, was approved by the FDA in August 2024 for the treatment of adults with relapsed or refractory CTCL[13] - Management estimates the initial, underserved market for LYMPHIR currently exceeds $400 million and is growing[13] Forward-Looking Statements This section outlines forward-looking statements, cautioning investors about risks such as capital raising, LYMPHIR commercialization, and supplier dependence - Identifies key risks such as the ability to raise capital to fund operations, ability to commercialize LYMPHIR, dependence on third-party suppliers, and uncertainties in clinical testing[29]