Citius Oncology, Inc.(CTOR) - 2025 Q1 - Quarterly Results

Business Update Citius Oncology is transitioning from a development-stage to a commercial-stage company following the FDA approval of its primary asset, LYMPHIR, with immediate focus on disciplined capital deployment for a successful U.S. launch and seeking additional capital - Citius Oncology is advancing its transformation from a development-stage to a commercial-stage organization following the FDA approval of LYMPHIR[2] - The company is actively engaged in discussions with prospective commercial and strategic partners while also seeking to secure additional capital to ensure financial flexibility for the LYMPHIR launch[3] Fiscal Second Quarter 2025 Financial Results For the second fiscal quarter ended March 31, 2025, Citius Oncology reported a net loss of $7.7 million, driven by higher operating expenses, with critical liquidity of only $112 necessitating additional funding beyond May 2025 Liquidity and Capital Resources As of March 31, 2025, Citius Oncology's cash position was extremely low at $112, dependent on its parent, Citius Pharma, for continued funding and requiring additional capital to support operations beyond May 2025 Liquidity Status as of March 31, 2025 | Metric | Value | | :--- | :--- | | Cash and cash equivalents | $112 | | Common shares outstanding | 71,552,402 | - The company requires additional capital to fund operations beyond May 2025[5] - Citius Pharma, the parent company, intends to continue funding Citius Oncology until it can raise external capital or generate revenue, with Jefferies LLC retained to evaluate strategic alternatives[4] Operating Expenses Operating expenses increased significantly in Q2 2025 compared to the prior year, with R&D expenses more than doubling to $3.1 million and G&A expenses rising to $2.2 million due to pre-commercial and launch activities for LYMPHIR Operating Expenses Comparison (Three Months Ended March 31) | Expense Category | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Research and Development (R&D) | $3.1 million | $1.3 million | | General and Administrative (G&A) | $2.2 million | $1.4 million | | Stock-based Compensation | $2.1 million | $2.0 million | - The increase in R&D expenses is mainly related to the cost of a drug substance batch required for a pre-license inspection of the manufacturer[6] - The rise in G&A expenses was primarily due to pre-commercial and commercial launch activities for LYMPHIR, including market research, marketing, and distribution planning[7] Net Loss The company's net loss for Q2 2025 was $7.7 million, or ($0.11) per share, compared to a net loss of $4.8 million, or ($0.07) per share, for Q2 2024, attributed to higher operating expenses Net Loss and EPS Comparison | Period | Net Loss 2025 | EPS 2025 | Net Loss 2024 | EPS 2024 | | :--- | :--- | :--- | :--- | :--- | | Three Months Ended Mar 31 | $7.7 million | ($0.11) | $4.8 million | ($0.07) | | Six Months Ended Mar 31 | $14.4 million | ($0.20) | $9.6 million | ($0.14) | Financial Statements The unaudited condensed consolidated financial statements reflect the company's financial position as of March 31, 2025, and its results of operations and cash flows, showing increased inventory and liabilities, no revenue, and a growing net loss sustained by non-cash financing Condensed Consolidated Balance Sheets As of March 31, 2025, total assets increased to $91.4 million, driven by a rise in inventory to $15.3 million, while total liabilities grew substantially to $55.8 million, primarily due to increases in accounts payable and accrued expenses, leading to a decline in total stockholders' equity Key Balance Sheet Items (As of March 31, 2025 vs. Sept 30, 2024) | Account | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $112 | $112 | | Inventory | $15,339,253 | $8,268,766 | | Total Assets | $91,439,365 | $84,368,878 | | Total Current Liabilities | $49,740,142 | $32,700,428 | | Total Liabilities | $55,796,733 | $38,228,539 | | Total Stockholders' Equity | $35,642,632 | $46,140,339 | Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, Citius Oncology generated no revenue and reported total operating expenses of $7.5 million, leading to a net loss of $7.7 million, an increase from the prior year due to higher R&D and G&A spending Statement of Operations Summary (Three Months Ended March 31) | Line Item | 2025 | 2024 | | :--- | :--- | :--- | | Revenues | $0 | $0 | | Total Operating Expenses | $7,471,312 | $4,691,546 | | Net Loss | $(7,735,552) | $(4,835,546) | | Net Loss Per Share | $(0.11) | $(0.07) | Condensed Consolidated Statements of Cash Flows For the six months ended March 31, 2025, the company's cash flow statement shows a net loss of $14.4 million with no net change in cash, as operations were sustained by non-cash financing, including increases in inventory, accrued expenses, and amounts due to a related party - Net cash provided by operating activities was zero for the six months ended March 31, 2025, with the cash balance remaining unchanged at $112[18] Key Changes in Operating Assets & Liabilities (Six Months Ended March 31, 2025) | Account | Change (Use)/Source of Cash | | :--- | :--- | | Inventory | $(7,070,487) | | Accrued expenses | $8,722,168 | | Due to related party | $4,352,858 | About Citius Oncology, Inc. Citius Oncology is a specialty biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies, with its lead product LYMPHIR approved by the FDA for CTCL, targeting an initial market exceeding $400 million - The company's primary asset, LYMPHIR, was approved by the FDA in August 2024 for the treatment of relapsed or refractory CTCL[10] - Management estimates the initial, underserved market for LYMPHIR is greater than $400 million[10] Forward-Looking Statements This section serves as a legal disclaimer, cautioning that future-oriented statements are subject to significant risks and uncertainties, primarily the company's need for substantial additional funds to operate beyond May 2025, along with operational risks related to commercialization and supply chain - The company highlights a critical risk: its need for substantial additional funds to continue operations beyond May 2025 and to remain a going concern[11] - Major operational risks include the ability to commercialize LYMPHIR, dependence on third-party suppliers, and securing cGMP commercial-scale supply[11]