Citius Oncology, Inc.(CTOR) - 2025 Q2 - Quarterly Results

Fiscal Third Quarter 2025 Report Overview This section provides an overview of Citius Oncology's fiscal Q3 2025 performance, focusing on LYMPHIR's commercial launch preparations and financial results Introduction and Business Context Citius Oncology, Inc. reported its business and financial results for the fiscal third quarter ended June 30, 2025, as it prepares for the commercial launch of its primary asset, LYMPHIR - Citius Oncology, Inc. is a specialty biopharmaceutical company developing and commercializing novel targeted oncology therapies[1] - This report covers the fiscal third quarter ended June 30, 2025[1] Key Business Developments Citius Oncology is in the final stages of preparing for the U.S. commercial launch of LYMPHIR, planned for the fourth quarter of 2025, supported by recent financings and established distribution agreements - LYMPHIR commercial availability is planned for the fourth quarter of 2025[1][2] - Citius Pharmaceuticals raised $12.5 million in gross financings, with Citius Oncology securing an additional $9 million in July 2025 for LYMPHIR pre-launch initiatives[1] - The launch strategy includes cutting-edge technology, targeted marketing, ready supplies, distribution agreements, and strong key opinion leader engagement[2] Fiscal Third Quarter 2025 Financial Highlights The company completed a public offering generating $7.4 million in net proceeds. R&D expenses decreased year-over-year, while G&A expenses, stock-based compensation, and net loss increased. Cash and cash equivalents remained minimal at $112 - On July 17, 2025, Citius Oncology completed a public offering, generating net proceeds of approximately $7.4 million[3] Fiscal Third Quarter Financial Performance | Financial Metric (Q3) | June 30, 2025 ($) | June 30, 2024 ($) | Change (YoY) ($) | Percentage Change (YoY) (%) | | :-------------------- | :---------------- | :---------------- | :--------------- | :-------------------------- | | R&D expenses | 938,000 | 1,100,000 | (162,000) | -14.73 | | G&A expenses | 1,900,000 | 1,500,000 | 400,000 | 26.67 | | Stock-based comp. | 2,100,000 | 2,000,000 | 100,000 | 5.00 | | Net loss | (5,400,000) | (4,800,000) | (600,000) | 12.50 | | Net loss per share | (0.08) | (0.07) | (0.01) | 14.29 | - As of June 30, 2025, the Company held $112 in cash and cash equivalents with 71,552,402 common shares outstanding[3] - Citius Pharma, the parent company, received net proceeds of approximately $10.5 million from equity offerings during the three months ended June 30, 2025[3] Company Information This section provides an overview of Citius Oncology's business, its key product LYMPHIR, and a disclaimer regarding forward-looking statements About Citius Oncology, Inc. Citius Oncology is a biopharmaceutical company specializing in targeted oncology therapies, with its key asset LYMPHIR approved by the FDA for relapsed or refractory CTCL. The company estimates a significant and underserved market for LYMPHIR, supported by robust intellectual property - Citius Oncology is a specialty biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies[5] - LYMPHIR, the primary asset, received FDA approval in August 2024 for adults with relapsed or refractory Cutaneous T-cell Lymphoma (CTCL) after at least one prior systemic therapy[5] - Management estimates the initial market for LYMPHIR exceeds $400 million, is growing, and remains underserved by current therapies[5] - The company's competitive position is bolstered by robust intellectual property, including orphan drug designation, complex technology, trade secrets, and pending patents for immuno-oncology combination therapy[5] Forward-Looking Statements This section provides a standard disclaimer regarding forward-looking statements, highlighting that future performance is subject to various risks and uncertainties, including funding needs, commercialization challenges, regulatory compliance, and intellectual property matters - The press release contains forward-looking statements based on expectations and beliefs about future events, identifiable by specific keywords[6] - Key risks include the need for substantial additional funds beyond September 2025, LYMPHIR commercialization challenges, maintaining agreements, market acceptance, Nasdaq compliance, supplier dependence, and intellectual property matters[6] - Readers are cautioned against undue reliance on these statements, and the company disclaims any obligation to update or revise them, except as legally required[6] Financial Statements This section presents the condensed consolidated balance sheets, statements of operations, and cash flows, detailing the company's financial position and performance Condensed Consolidated Balance Sheets As of June 30, 2025, total assets increased primarily due to a significant rise in inventory, while total liabilities also grew substantially, mainly driven by increases in accounts payable and accrued expenses. This led to a decrease in total stockholders' equity Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 ($) | September 30, 2024 ($) | Change ($) | Percentage Change (%) | | :------------------------ | :---------------- | :--------------------- | :------------ | :-------------------- | | Cash and cash equivalents | 112 | 112 | 0 | 0.00 | | Inventory | 17,208,967 | 8,268,766 | 8,940,201 | 108.14 | | Total Current Assets | 18,309,079 | 10,968,878 | 7,340,201 | 66.92 | | Total Assets | 91,709,079 | 84,368,878 | 7,340,201 | 8.70 | | Accounts payable | 8,667,419 | 3,711,622 | 4,955,797 | 133.52 | | Accrued expenses | 8,458,554 | — | 8,458,554 | N/A | | Total Current Liabilities | 52,990,335 | 32,700,428 | 20,289,907 | 62.05 | | Total Liabilities | 59,311,166 | 38,228,539 | 21,082,627 | 55.15 | | Total Stockholders' Equity| 32,397,913 | 46,140,339 | (13,742,426) | -29.78 | Condensed Consolidated Statements of Operations For the three and nine months ended June 30, 2025, Citius Oncology reported no revenues. Operating expenses, operating loss, and net loss all increased significantly year-over-year for both periods, primarily driven by higher general and administrative expenses and, for the nine-month period, increased R&D Condensed Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | Percentage Change (%) | | :-------------------------- | :------------ | :------------ | :------------ | :-------------------- | | Revenues | 0 | 0 | 0 | 0.00 | | Research and development | 938,277 | 1,131,439 | (193,162) | -17.07 | | General and administrative | 1,881,447 | 1,540,411 | 341,036 | 22.14 | | Total Operating Expenses | 4,944,961 | 4,628,850 | 316,111 | 6.83 | | Operating Loss | (4,944,961) | (4,628,850) | (316,111) | 6.83 | | Net Loss | (5,369,956) | (4,772,850) | (597,106) | 12.51 | | Net Loss Per Share | (0.08) | (0.07) | (0.01) | 14.29 | Condensed Consolidated Statements of Operations Highlights (Nine Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | Percentage Change (%) | | :-------------------------- | :------------ | :------------ | :------------ | :-------------------- | | Revenues | 0 | 0 | 0 | 0.00 | | Research and development | 5,342,198 | 3,628,900 | 1,713,298 | 47.21 | | General and administrative | 7,446,753 | 4,443,899 | 3,002,854 | 67.57 | | Total Operating Expenses | 18,811,238 | 13,903,799 | 4,907,439 | 35.30 | | Operating Loss | (18,811,238) | (13,903,799) | (4,907,439) | 35.30 | | Net Loss | (19,764,713) | (14,335,799) | (5,428,914) | 37.87 | | Net Loss Per Share | (0.28) | (0.21) | (0.07) | 33.33 | Condensed Consolidated Statements of Cash Flows For the nine months ended June 30, 2025, the company's net loss significantly increased. Adjustments to reconcile net loss to net cash provided by operating activities included substantial increases in inventory, accounts payable, accrued expenses, and amounts due to related parties, resulting in no net cash provided by operating activities for both periods Condensed Consolidated Statements of Cash Flows Highlights (Nine Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | Percentage Change (%) | | :---------------------------------------- | :------------ | :------------ | :------------ | :-------------------- | | Net loss | (19,764,713) | (14,335,799) | (5,428,914) | 37.87 | | Stock-based compensation expense | 6,022,287 | 5,831,000 | 191,287 | 3.28 | | Deferred income tax expense | 792,720 | 432,000 | 360,720 | 83.50 | | Inventory | (8,940,201) | 0 | (8,940,201) | N/A | | Prepaid expenses | 1,600,000 | (2,271,920) | 3,871,920 | -170.43 | | Accounts payable | 4,955,797 | (1,289,045) | 6,244,842 | -484.46 | | Accrued expenses | 8,458,554 | 185,930 | 8,272,624 | 4449.27 | | Due to related party | 6,875,556 | 11,447,834 | (4,572,278) | -39.94 | | Net Cash Provided By Operating Activities | 0 | 0 | 0 | 0.00 | | Cash and Cash Equivalents – End of Period | 112 | 0 | 112 | N/A | Additional Information This section provides contact details for investor relations and media inquiries Investor and Media Contacts Contact information is provided for investor relations and media inquiries - Investor Contact: Ilanit Allen at ir@citiuspharma.com or 908-967-6677 x113[7] - Media Contact: Greg Salsburg at Greg@STiR-communications.com[7]