Accessibility StatementSkip Navigation The shares of common stock described above were offered pursuant to a registration statement on Form S-3 (File No. 333-289979), which was filed with the U.S. Securities and Exchange Commission ("SEC") on September 2, 2025, and was declared effective by the SEC on September 4, 2025. The offering of shares of common stock was made only by means of a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement relating to the shar ...

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Accessibility StatementSkip Navigation CRANFORD, N.J., Sept. 9, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" ...

Core Insights - Citius Oncology has launched an innovative AI platform to enhance its commercial strategies and support the upcoming launch of LYMPHIR™, a novel therapy for cutaneous T-cell lymphoma (CTCL) [1][2][5] - The AI platform utilizes machine learning to identify treatment patterns and target prescribers effectively, thereby improving patient care and clinical decision-making [2][4][5] - LYMPHIR is a targeted immune therapy approved by the FDA in August 2024 for relapsed or refractory CTCL, with a market potential exceeding $400 million [6][7][32] Group 1: AI Platform and Commercial Strategy - The proprietary AI platform is designed to refine targeting and enhance the efficiency of the salesforce by providing data-informed engagement with healthcare providers [1][3] - It continuously learns from real-world data and marketing performance analytics, delivering predictive insights for tailored customer journeys [4] - The platform aims to optimize the commercial infrastructure and accelerate healthcare provider education [5] Group 2: Product Overview and Market Potential - LYMPHIR is indicated for adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy [10] - The therapy is a recombinant fusion protein that targets IL-2 receptors on tumor cells, leading to cell death and enhanced antitumor activity [6] - Citius Oncology estimates the initial market for LYMPHIR to exceed $400 million, indicating significant growth potential in an underserved market [32]

[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) Citius Pharmaceuticals reported improved Q3 2025 financials, is preparing for LYMPHIR™ launch, and secured significant capital [Fiscal Third Quarter 2025 Financial Highlights](index=1&type=section&id=FISCAL%20THIRD%20QUARTER%202025%20FINANCIAL%20RESULTS) 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](index=4&type=chunk) - Citius Oncology completed a public offering on July 17, 2025, generating approximately **$7.4 million** in net proceeds[4](index=4&type=chunk) [Strategic Priorities and LYMPHIR Launch](index=1&type=section&id=Strategic%20Priorities%20and%20LYMPHIR%20Launch) 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](index=2&type=chunk) - Final preparations are underway for the planned U.S. launch of LYMPHIR™ in the **fourth quarter of 2025**[2](index=2&type=chunk) - Major launch-enabling activities for LYMPHIR, including commercial-scale manufacturing, labeling, packaging, and distribution services agreements, have been completed[3](index=3&type=chunk) - 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](index=3&type=chunk) [Financing Activities](index=1&type=section&id=Financing%20Activities) 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](index=1&type=chunk) - 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](index=3&type=chunk) - In July 2025, Citius Oncology strengthened its capital position with **$9 million** in gross proceeds from a public offering[3](index=3&type=chunk) [Company Overview](index=2&type=section&id=About%20Citius%20Pharmaceuticals%2C%20Inc.) 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](index=2&type=section&id=About%20Citius%20Pharmaceuticals) 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](index=6&type=chunk) - LYMPHIR™ was approved by the FDA in **August 2024** for an initial indication in the treatment of cutaneous T-cell lymphoma[6](index=6&type=chunk) - Citius Pharma owns **84%** of Citius Oncology[6](index=6&type=chunk) [Product Pipeline](index=2&type=section&id=Product%20Pipeline) 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](index=6&type=chunk) - CITI-002 (Halo-Lido) is a topical formulation for the relief of hemorrhoids, for which a Phase 2b trial was completed in **2023**[6](index=6&type=chunk) - Citius Pharma is actively engaged with the FDA to outline next steps for both the Mino-Lok and Halo-Lido programs[6](index=6&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) 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](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) 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](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) 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](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) 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](index=15&type=chunk) [Additional Information](index=2&type=section&id=Additional%20Information) This section provides important disclaimers regarding forward-looking statements and contact details for investor and media inquiries [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) 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](index=7&type=chunk) - 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](index=7&type=chunk) - Readers are cautioned not to place undue reliance on these forward-looking statements, as they do not constitute guarantees of future performance[7](index=7&type=chunk) [Investor and Media Contact](index=2&type=section&id=Investor%20Contact) 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](index=8&type=chunk) - Media Contact: Greg Salsburg, Greg@STiR-communications.com[8](index=8&type=chunk)

```markdown [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited condensed consolidated financial statements for Citius Pharmaceuticals, Inc., covering balance sheets, operations, equity, and cash flows [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $127.68 million, driven by cash and inventory, while liabilities rose, decreasing equity Metric | Metric | June 30, 2025 | September 30, 2024 | | :-------------------------- | :-------------- | :----------------- | | Cash and cash equivalents | $6,089,126 | $3,251,880 | | Inventory | $17,208,967 | $8,268,766 | | Total Current Assets | $24,611,269 | $14,220,646 | | Total Assets | $127,676,859 | $116,651,751 | | Total Current Liabilities | $51,842,452 | $35,814,803 | | Total Liabilities | $60,115,929 | $42,549,921 | | Total Equity | $67,560,930 | $74,101,830 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) No revenues reported; operating losses decreased for three months but increased for nine months, with improved net loss per share Metric | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 9 Months Ended June 30, 2025 | 9 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenues | $0 | $0 | $0 | $0 | | Total Operating Expenses | $8,788,007 | $10,634,179 | $30,088,299 | $30,945,203 | | Operating Loss | $(8,788,007) | $(10,634,179) | $(30,088,299) | $(30,945,203) | | Net Loss | $(9,203,872) | $(10,573,336) | $(30,996,623) | $(28,348,675) | | Net Loss Per Share - Basic and Diluted | $(0.80) | $(1.57) | $(3.27) | $(4.37) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity decreased from $70.08 million to $65.06 million due to net losses, partially offset by stock offerings Metric | Metric | September 30, 2024 | June 30, 2025 | | :----------------------------------- | :----------------- | :-------------- | | Common Stock Shares Outstanding | 7,247,243 | 14,475,029 | | Additional Paid-In Capital | $271,440,421 | $295,888,916 | | Accumulated Deficit | $(201,370,218) | $(230,844,841) | | Total Citius Pharmaceuticals, Inc. Stockholders' Equity | $70,077,450 | $65,058,550 | [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased, while financing cash increased, resulting in a positive net change in cash Metric | Metric | 9 Months Ended June 30, 2025 | 9 Months Ended June 30, 2024 | | :----------------------------------- | :--------------------------- | :--------------------------- | | Net Cash Used In Operating Activities | $(14,671,948) | $(22,288,687) | | Net Cash Provided By Financing Activities | $17,509,194 | $13,718,951 | | Net Change in Cash and Cash Equivalents | $2,837,246 | $(8,569,736) | | Cash and Cash Equivalents - End of Period | $6,089,126 | $17,911,192 | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes cover business, accounting policies, going concern uncertainty, product license agreements, equity, and commitments - Citius Pharmaceuticals, Inc. is a late-stage biopharmaceutical company focused on oncology, anti-infectives, prescription products, and stem cell therapies, operating through its subsidiaries Leonard-Meron Biosciences, Inc., Citius Oncology, Inc., and NoveCite, Inc[28](index=28&type=chunk)[33](index=33&type=chunk) - The company faces substantial doubt about its ability to continue as a going concern beyond September 2025, due to negative cash flows from operations (**$14.67 million** for nine months ended June 30, 2025) and negative working capital of approximately **$27.2 million**[39](index=39&type=chunk)[40](index=40&type=chunk) - Citius Oncology received FDA approval for LYMPHIR in August 2024, triggering milestone payments of **$27.5 million** to Dr. Reddy's (with **$22.5 million** remaining due as of June 30, 2025) and **$5.9 million** to Eisai. Payment schedules have been amended for these obligations[55](index=55&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) - A 1-for-25 reverse stock split was effective November 25, 2024, to regain Nasdaq compliance. The authorized common stock was increased from 16,000,000 to 250,000,000 shares on June 9, 2025[68](index=68&type=chunk)[69](index=69&type=chunk) Common Stock Offerings (Net Proceeds) | Offering Date | Net Proceeds | | :------------ | :----------- | | November 15, 2024 | $2,574,051 | | January 7, 2025 | $2,657,167 | | April 1, 2025 | $1,743,757 | | June 11, 2025 | $5,430,836 | | ATM Offering (Q1 2025) | $808,640 | | ATM Offering (Q2 2025) | $3,294,446 | - Total minimum purchase commitments under commercial manufacturing and supply agreements for LYMPHIR amount to approximately **$18.3 million** for drug substance (through 2026) and **$4.5 million** for finished drug products (through 2026)[107](index=107&type=chunk)[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, product development, and results, highlighting LYMPHIR commercialization and financing needs - Citius Pharmaceuticals is transitioning from a development-stage enterprise to a commercial organization, with preparations for the U.S. launch of FDA-approved LYMPHIR for CTCL nearing completion, anticipated in Q4 2025. Distribution agreements with Cardinal Health and Cencora have been executed[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) [Historical Background](index=27&type=section&id=Historical%20Background) Citius Pharmaceuticals, a biopharmaceutical company, focuses on product development and capital raising with no revenues to date - The company's in-process R&D assets include **$19.4 million** for Mino-Lok (amortized over 8 years post-revenue) and **$73.4 million** for LYMPHIR (amortized over 12 years post-revenue in 2025)[117](index=117&type=chunk) [Reverse Stock Split](index=27&type=section&id=Reverse%20Stock%20Split) A 1-for-25 reverse stock split was executed on November 25, 2024, to meet Nasdaq listing requirements - A 1-for-25 reverse stock split was effective November 25, 2024, to regain compliance with Nasdaq's minimum bid price requirement[119](index=119&type=chunk) [Patent and Technology License Agreements](index=28&type=section&id=Patent%20and%20Technology%20License%20Agreements) Details licensing agreements for key product candidates Mino-Lok, NoveCite, and LYMPHIR, outlining milestone payments, royalties, and obligations - Mino-Lok: Exclusive worldwide license with NAT, requiring annual maintenance fees (**$90,000**), low double-digit royalties on net sales (10-15%), and up to **$1.1 million** in regulatory/sales milestones[120](index=120&type=chunk) - NoveCite: Exclusive worldwide license with Eterna for stem cell therapy, requiring up to **$51 million** in regulatory/development milestones and mid-teens royalties on net sales[123](index=123&type=chunk) - LYMPHIR: Exclusive license (via Citius Oncology) from Dr. Reddy's and Eisai. Requires up to **$40 million** in CTCL development milestones, **$70 million** for additional indications, **$300 million** for commercial sales milestones, and low double-digit tiered royalties (10-15%)[126](index=126&type=chunk) - Following FDA approval of LYMPHIR, a **$27.5 million** milestone payment to Dr. Reddy's (with **$22.5 million** outstanding as of June 30, 2025) and a **$5.9 million** milestone payment to Eisai were triggered. Payment schedules have been agreed upon for these obligations[128](index=128&type=chunk)[129](index=129&type=chunk)[130](index=130&type=chunk) [RESULTS OF OPERATIONS](index=31&type=section&id=RESULTS%20OF%20OPERATIONS) No revenues reported; operating expenses decreased for three months but increased for nine months due to LYMPHIR R&D and G&A [Three months ended June 30, 2025 compared with the three months ended June 30, 2024](index=31&type=section&id=Three%20months%20ended%20June%2030%2C%202025%20compared%20with%20the%20three%20months%20ended%20June%2030%2C%202024) Net loss decreased by $1.37 million, driven by lower R&D and G&A expenses, partially offset by interest changes Metric | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change ($) | Change (%) | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $1,621,325 | $2,763,865 | $(1,142,540) | -41.3% | | General and administrative | $4,447,008 | $4,808,551 | $(361,543) | -7.5% | | Stock-based compensation expense | $2,719,674 | $3,061,763 | $(342,089) | -11.2% | | Total Operating Expenses | $8,788,007 | $10,634,179 | $(1,846,172) | -17.4% | | Interest income | $20,637 | $204,843 | $(184,206) | -89.9% | | Interest expense | $(172,262) | $0 | $(172,262) | N/A | | Net Loss | $(9,203,872) | $(10,573,336) | $1,369,464 | -12.9% | - Mino-Lok R&D costs decreased by **$982,327** due to Phase 3 trial completion. Halo-Lido R&D costs decreased by **$25,602** due to Phase 2 study completion. LYMPHIR R&D costs decreased by **$128,370** due to reduced product validation studies[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) [Nine months ended June 30, 2025 compared with the nine months ended June 30, 2024](index=32&type=section&id=Nine%20months%20ended%20June%2030%2C%202025%20compared%20with%20the%20nine%20months%20ended%20June%2030%2C%202024) Net loss increased by $2.65 million, primarily due to higher G&A and decreased other income, offset by lower R&D and stock compensation Metric | Metric | 9 Months Ended June 30, 2025 | 9 Months Ended June 30, 2024 | Change ($) | Change (%) | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $7,514,888 | $8,991,673 | $(1,476,785) | -16.4% | | General and administrative | $14,626,882 | $12,755,190 | $1,871,692 | 14.7% | | Stock-based compensation expense | $7,946,529 | $9,198,340 | $(1,251,811) | -13.6% | | Total Operating Expenses | $30,088,299 | $30,945,203 | $(856,904) | -2.8% | | Interest income | $56,658 | $640,686 | $(584,028) | -91.2% | | Gain on sale of NJ net operating losses | $0 | $2,387,842 | $(2,387,842) | -100% | | Interest expense | $(172,262) | $0 | $(172,262) | N/A | | Net Loss | $(30,996,623) | $(28,348,675) | $(2,647,948) | 9.3% | - Mino-Lok R&D costs decreased by **$3,044,652** due to Phase 3 trial completion. Halo-Lido R&D costs decreased by **$463,448** due to Phase 2 study completion. LYMPHIR R&D costs increased by **$2,007,269**, primarily due to the expense of a drug substance batch for pre-license inspection[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=35&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Significant operating losses and negative working capital raise going concern doubts; financing is crucial for operations and LYMPHIR commitments - Accumulated deficit of **$230,844,841** as of June 30, 2025, with net cash used in operations of **$14,671,948** for the nine months ended June 30, 2025[162](index=162&type=chunk) - Negative working capital of approximately **$27.2 million** at June 30, 2025. Cash and cash equivalents were **$6,089,126**[163](index=163&type=chunk) - Citius Oncology completed a public offering on July 17, 2025, raising approximately **$7.44 million** in net proceeds, which is expected to provide sufficient funds for Citius Pharma's operations through September 2025[165](index=165&type=chunk)[167](index=167&type=chunk) - Significant outstanding milestone payments for LYMPHIR include **$22.5 million** to Dr. Reddy's (as of June 30, 2025) and a structured payment plan to Eisai totaling over **$9 million** through December 2025[166](index=166&type=chunk)[172](index=172&type=chunk) - Commercial manufacturing commitments for LYMPHIR total approximately **$18.3 million** for drug substance and **$4.5 million** for finished drug products through 2026[172](index=172&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) No applicable quantitative and qualitative disclosures about market risk are reported for the company [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control - The CEO and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025[175](index=175&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[176](index=176&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) No legal proceedings were reported by the company - No legal proceedings were reported[179](index=179&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported since the last Annual Report on Form 10-K and Quarterly Report on Form 10-Q - No material changes to risk factors were reported since the last Annual Report on Form 10-K and Quarterly Report on Form 10-Q[180](index=180&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - No unregistered sales of equity securities or use of proceeds were reported[181](index=181&type=chunk) [Item 3. Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported - No defaults upon senior securities were reported[182](index=182&type=chunk) [Item 4. Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine Safety Disclosures are not applicable to the company - Mine Safety Disclosures are not applicable[183](index=183&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) No director or officer trading plan changes; Board approved a one-year extension for warrants, potentially generating $7.2 million - On August 7, 2025, the Board approved a one-year extension for Investor Warrants (156,863 shares at **$28.75/share**; 111,732 shares at **$19.25/share**) and Placement Agent Warrants (7,577 shares at **$39.8438/share**; 7,774 shares at **$27.9719/share**)[185](index=185&type=chunk) - If fully exercised, these extended warrants could generate approximately **$7.2 million** in cash proceeds for the company[185](index=185&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the Form 10-Q, including amendments, warrants, securities purchase agreements, and certifications ```

Financial Overview - Citius Pharmaceuticals raised $12.5 million in gross financings during the fiscal third quarter ended June 30, 2025, with an additional $9 million raised in July 2025 for LYMPHIR pre-launch initiatives [1][3] - The company reported a net loss of $9.2 million, or $0.80 per share, for the quarter, an improvement from a net loss of $10.6 million, or $1.57 per share, in the same quarter of the previous year [7][13] Business Development - Citius is transitioning from a development-stage enterprise to a fully integrated commercial organization, with final preparations for the U.S. launch of LYMPHIR™ planned for the fourth quarter of 2025 [2][3] - The company has completed major launch-enabling activities, including commercial-scale manufacturing and distribution agreements, indicating readiness to deliver LYMPHIR to patients with cutaneous T-cell lymphoma [3][6] Financial Results - Research and development expenses for the quarter were $1.6 million, down from $2.8 million in the same quarter of 2024 [7][15] - General and administrative expenses were $4.4 million, compared to $4.8 million in the prior year [7][15] - Cash and cash equivalents at June 30, 2025, were $6.1 million, an increase from $3.3 million at the end of the previous fiscal year [7][9] Capital Structure - The company completed a $6 million registered direct offering in June 2025, with potential additional proceeds of $9.8 million upon full warrant exercise [3][6] - Citius Oncology, a subsidiary, raised $9 million in gross proceeds from a public offering in July 2025 [1][3] Product Pipeline - Citius Pharma's late-stage pipeline includes LYMPHIR™, Mino-Lok®, and CITI-002 (Halo-Lido), with ongoing engagement with the FDA for next steps on these programs [6][3]

Company Overview - Citius Oncology, Inc. is a platform focused on developing and commercializing novel targeted oncology therapies, with its primary asset, LYMPHIR, approved by the FDA for treating adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL) [5] - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [5] - Citius Pharmaceuticals, Inc. owns 92% of Citius Oncology and is dedicated to developing first-in-class critical care products [6] Recent Offering - Citius Oncology announced the closing of a public offering of 6,818,182 shares of common stock at a price of $1.32 per share, generating gross proceeds of approximately $9.0 million [1][2] - The offering included warrants to purchase shares at the same exercise price of $1.32, which are immediately exercisable and expire five years from issuance [1] Use of Proceeds - The net proceeds from the offering will primarily support the commercialization of LYMPHIR, including milestone and royalty payments under existing license agreements, as well as for working capital and general corporate purposes [2] Regulatory Information - The securities were offered under a registration statement filed with the U.S. Securities and Exchange Commission (SEC), which was declared effective on July 16, 2025 [3]

Core Viewpoint - Citius Oncology, Inc. has announced a public offering of 6,818,182 shares of common stock at a price of $1.32 per share, aiming to raise approximately $9.0 million in gross proceeds to support the commercialization of its product LYMPHIR and for general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes warrants to purchase shares at an exercise price of $1.32, which will be immediately exercisable and expire five years from issuance [1]. - Maxim Group LLC is acting as the sole placement agent for this offering [2]. - The offering is expected to close on or about July 17, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily support the commercialization of LYMPHIR, including milestone and royalty payments under existing license agreements, as well as working capital and general corporate purposes [2]. Group 3: Company Overview - Citius Oncology, Inc. focuses on developing and commercializing novel targeted oncology therapies, with its primary asset LYMPHIR approved by the FDA for treating adults with relapsed or refractory CTCL [5]. - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [5]. - Citius Pharmaceuticals, Inc. owns 92% of Citius Oncology and is dedicated to developing first-in-class critical care products, with a late-stage pipeline that includes Mino-Lok® and CITI-002 [6].

Core Insights - Citius Oncology has executed a distribution services agreement with Cencora to enhance its commercial infrastructure for the FDA-approved immunotherapy LYMPHIR [1][2][3] - The agreement aims to expand Citius Oncology's distribution network, ensuring product availability upon launch and supporting long-term scalability [2][3] - LYMPHIR is indicated for relapsed or refractory cutaneous T-cell lymphoma (CTCL) and is a targeted immune therapy that has shown antitumor activity [4][5] Company Overview - Citius Oncology is a majority-owned subsidiary of Citius Pharmaceuticals, focusing on developing and commercializing novel targeted oncology therapies [29][30] - The FDA approved LYMPHIR in August 2024, with an estimated initial market exceeding $400 million, indicating significant growth potential in an underserved market [29][30] - Citius Pharmaceuticals also has a late-stage pipeline that includes other critical care products, demonstrating a diverse portfolio [30] Product Details - LYMPHIR (denileukin diftitox-cxdl) is a recombinant fusion protein that targets IL-2 receptors, leading to cell death in tumors expressing these receptors [4][5] - The product is indicated for adult patients with r/r Stage I-III CTCL after at least one prior systemic therapy [8][29] - The drug has received regulatory approval in Japan for CTCL and peripheral T-cell lymphoma (PTCL) prior to its FDA approval [5]

Core Insights - Citius Oncology is preparing for the commercial launch of LYMPHIR™, an FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), expected in the second half of 2025 [1][2][36] Manufacturing and Supply Chain Readiness - The company has completed commercial-scale manufacturing of LYMPHIR, with sufficient inventory to meet projected demand for 12 to 18 months post-launch [3] - Citius Oncology has secured distribution agreements with top-tier global pharmaceutical logistics partners to ensure broad access and timely delivery across the U.S. [4] KOL Engagement - Engagement with U.S. Key Opinion Leaders (KOLs) and participation in medical congresses have informed the launch strategy and target patient profiles [5][6] - Early interest from the clinical community is evident, with 70 institutional oncology centers signed up via the LYMPHIR website [6] Commercial & Marketing Activities - A targeted launch strategy utilizing a proprietary generative AI model has been developed to enhance interactions with healthcare providers [7] - A comprehensive suite of marketing and educational materials has been created to support the introduction of LYMPHIR [8] Market Access Update - LYMPHIR's inclusion in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and the assignment of a permanent J-code under HCPCS positions the product for efficient reimbursement and coverage at launch [9] Financing and Strategic Partnerships - A recent capital raise by Citius Pharma supports the final preparations for LYMPHIR's commercialization and the planned launch [11] - The company is engaged in strategic partnership discussions to expand LYMPHIR's market reach [11] Product Information - LYMPHIR is a targeted immune therapy indicated for adults with relapsed or refractory CTCL after at least one prior systemic therapy [12][15] - The product was approved by the FDA in August 2024 and is expected to address a market currently exceeding $400 million [36]